Abstract
This study aimed to concretize and pilot test comprehensive behavioral (ComB) treatment of trichotillomania (TTM), to facilitate rigorous testing of its efficacy. ComB provides a conceptualization to develop individualized treatment and choose interventions for managing distinct factors that maintain the individual’s hair pulling. It has been used by clinicians for almost three decades, yet was not previously manualized or studied empirically. A manual was drafted and revised based on patient (N = 16) and therapist feedback, an intervention choice study demonstrated therapists reliably selected model-consistent interventions, and a therapist adherence measure was developed and tested. Uncontrolled preliminary data showed ComB to be highly acceptable, and it led to reduced TTM symptom severity and impairment, with large effects. Quality of life and disability also improved, with effects maintained at follow-up. This study resulted in the development of a manual and measures to be used in a randomized controlled trial (RCT) of ComB for TTM.
Introduction
Trichotillomania (TTM), also called hair-pulling disorder, is an obsessive-compulsive related disorder (OCD) associated with significant distress and impairment that is estimated to affect 1% to 2% of adolescents and young adults (Diagnostic and Statistical Manual of Mental Disorders–5th ed. [DSM-5]; American Psychiatric Association, 2013). McGuire and colleagues (2014) conducted a meta-analysis of randomized controlled trials (RCTs) for TTM, which showed that behavior therapy had a large effect on TTM severity (pooled standardized mean difference = 1.41), whereas SSRIs had smaller effects (pooled effect size [ES] = 0.41). Habit reversal training (HRT) is the intervention for TTM that has the most empirical support (Bloch et al., 2007), although it has not been deemed an empirically supported treatment (EST; APA Presidential Task Force on Evidence-Based Practice, 2006). It is a type of behavioral therapy that has four key elements: (a) self-monitoring, in which the client logs instances of their hair pulling; (b) awareness training, enabling the client to become more aware of their triggers for pulling; (c) stimulus control, which involves making pulling more difficult by limiting opportunities to pull; and (d) competing response training, implementing techniques that make pulling physically impossible. Studies of individual HRT and group HRT along with some cognitive behavior therapy techniques (i.e., relaxation training and cognitive restructuring) have yielded post-treatment response rates of 64% to 100%, although it is important to keep in mind that these studies have inconsistent methods for measuring “post-treatment response” (Lerner, Franklin, Meadows, Hembree, & Foa, 1998; Ninan, Rothbaum, Marsteller, Knight, & Eccard, 2000; van Minnen, Hoogduin, Keijsers, Hellenbrand, & Hendriks, 2003).
In the last decade, TTM researchers have begun to include emotion regulation skills in conjunction with traditional HRT in their treatment studies, in hopes of improving treatment outcome for individuals with TTM with affective regulation difficulties (e.g., Begotka, Woods, & Wetterneck, 2004; Chamberlain et al., 2008; Shusterman, Feld, Baer, & Keuthen, 2009). It is commonly believed that there are two styles of hair pulling, “focused” and “automatic.” Christenson and Mackenzie (1994), Christenson, Mackenzie, and Mitchell (1991), and Christenson, Ristvedt, and Mackenzie (1993) referred to “focused pulling” as when a puller is focused on the actual pulling itself, which was found to be associated with being cued by negative affect, and pulling that is more habit-like and outside of conscious awareness was later named “automatic pulling.” Thus, researchers adding emotion regulation skills in their treatment protocols have hoped to help pullers during “focused” pulling episodes. Woods, Wetterneck, and Flessner (2006) conducted a study of acceptance and commitment therapy (ACT)-enhanced HRT in which 66% of participants were considered treatment responders. Keuthen and colleagues have conducted a pilot trial and RCT of dialectical behavior therapy (DBT)-enhanced HRT, in which 80% of participants were treatment responders at post-treatment in the pilot trial, and 61% were responders in the RCT (Keuthen et al., 2012; Keuthen et al., 2010).
Although treatment response rates have generally been considered satisfactory, failure to maintain gains from HRT is common in TTM treatment studies, with 50% to 67% of treatment responders showing relapse during follow-up assessments (e.g., Lerner et al., 1998; Mouton & Stanley, 1996). Based on these data, it appears that the treatments that have previously been tested for TTM could use improvement. It is possible that the treatments in these previous studies were not individualized enough for clients and that a treatment with more flexibility regarding patients’ individual needs could make treatments for TTM more universally successful.
The Comprehensive Behavioral Model (ComB; Mansueto, Stemberger, Thomas, & Golomb, 1997) is a conceptual model that was developed to address the distinct factors that maintain individual patients’ hair pulling. The ComB treatment model (Mansueto, Golomb, Thomas, & Stemberger, 1999) was designed to provide therapeutic strategies for these distinct factors by categorizing assessment information and interventions according to “modality,” as in Multimodal Therapy by Arnold Lazarus (1976). ComB consists of five modalities that help identify and organize antecedents and consequences of pulling that can become targets for interventions during treatment: (a) Sensory (tactile, visual triggers, oral, olfactory, or auditory), (b) Cognitive (thoughts that provoke, facilitate or maintain hair pulling), (c) Affective (feeling states such as boredom, stress, or anxiety), (d) Motor (facilitative postural cues and unconscious motor habits), and (e) Place (external or environmental cues). These modalities are more specialized than pulling subtype (focused vs. automatic) and thus potentially more useful for individualization across people and also across episodes for these people. This type of specificity can be useful for people who do both focused and automatic pulling, or who pull as a function of sensory, cognitive, affective, motoric, and place cues (the mnemonic SCAMP aids in the recall of these modalities). The treatment consists of four overall phases: (a) Assessment and Functional Analysis, in which the antecedents, behaviors, and consequences that maintain pulling are identified; (b) Identification and Targeting of modalities, in this phase the modalities in which the antecedents, behaviors, and consequences function are identified; (c) Identification and Implementation of Relevant Interventions in which interventions that target the factors within the modalities are identified and applied; (d) Evaluation, Modification, and Relapse Prevention in which the effectiveness of the interventions are evaluated and modified as needed, and effective intervention use is reviewed and future needs are anticipated. (Mansueto et al., 1999). Although many clinicians have used ComB since the 1990s, and it was described in Cognitive and Behavioral Practice in 1999, the treatment is yet to be tested in a clinical trial. However, before large-scale RCTs can be implemented, further treatment development work is needed to determine whether different clinicians are reliably administering ComB in a similar fashion, as it is a flexible, modular treatment.
The aim of this study was to standardize and pilot test the ComB treatment model, with the ultimate goal of enabling more rigorous testing of the efficacy of treatment based on the model. The National Institutes of Health (NIH) has developed a framework, the NIH stage model, in which an intervention is developed until it is optimally efficacious and implementable with reliable adherence by clinicians. The objective of the stage model is to understand which interventions and strategies for implementation are most effective, whom they work the best for, and why the interventions work. Intervention development under this model is not considered finished until the intervention is believed to be operating at its optimal level with the maximum amount of people in its targeted population. This study represents the first of these stages, Stage I: Intervention Generation/Refinement. This consists of research aimed at developing and modifying as needed: clinician training, supervision, fidelity-enhancing interventions, and interventions that help ensure that adherence to the interventions is preserved. Specifically, Stage IA consists of a treatment being created, modified, adapted, refined, and then in Stage IB, the treatment is examined for feasibility and is pilot tested. The overarching goal of Stage I is typically to develop the materials needed to conduct a Stage II or Stage III project (Onken, Carroll, Shoham, Cuthbert, & Riddle, 2013).
To meet the goals of Stage 1, the current study had several objectives. First, we drafted a manual to provide session-by-session guidelines for ComB therapists and to revise the manual in accordance with feedback from patients and from therapists who have attempted to put the manual into practice. Second, we assessed the acceptability of the ComB treatment to patients, which was done by measuring session attendance and patients’ treatment satisfaction ratings. Third, we tested whether therapists could reliably select ComB interventions by conducting an intervention choice study in which agreement among therapists in correctly choosing decisions consistent with the ComB manual was measured. The goal of standardizing the interventions chosen in response to particular clinical presentations is important for preparing to study ComB because, in a RCT, it enables the measurement of the quality of the therapy and the determination of when therapists are ready to begin seeing participants. Fourth, we developed a measure of therapist adherence for ComB and tested its interrater reliability. Fifth, we conducted a preliminary examination of the efficacy of the ComB treatment and whether patients maintained their gains, primarily by measuring TTM symptom severity, related impairment, and quality of life at post-treatment and a 3-month follow-up. Finally, we explored individual differences in response to ComB. Sample size in this treatment development study was inadequate to support powerful inferential tests of prediction, moderation, or mediation of response, but to help inform future research we studied several issues in this vein: (a) Would TTM symptom improvement during ComB treatment predict improvement in emotion regulation as it did in the ACT-enhanced and DBT-enhanced HRT studies (Keuthen et al., 2012; Woods et al., 2006); (b) Would participants high in either “focused” or “automatic” pulling derive equal benefit from the treatment, as ComB is designed to help with both styles of pulling; and (c) Would TTM symptom improvement during ComB treatment predict improvements in psychosocial impairment?
Method
Participants
Study patients
The American University Institutional Review Board approved all study procedures. A total of 18 participants were assessed for eligibility for the treatment development study of the ComB model, with 16 participants meeting eligibility criteria. Two participants were excluded (n = 1, comorbid substance abuse; n = 1, did not meet TTM diagnosis). The trial consisted of two phases of pilot testing the manual, with seven participants in the first cohort, and nine in the second cohort. The sample ranged in age from 17 to 59, with a mean age of 31 (12.81). The sample was primarily non-Hispanic White (81%, n = 1 White Hispanic, n = 1 Asian, n = 1 biracial) and female (88%). The participants had a mean length of time from initial TTM onset of 16.31 years (11.61), with 81% of the sample having previously been in therapy for TTM, 69% of whom reported the therapy involved cognitive or behavioral techniques, and 31% of whom described it as supportive psychotherapy. The most common pulling sites were scalp (88% of sample), eyebrows (56%), eyelashes (44%), and legs (25%). The mean Readiness score for our sample was 9.98 (SD = 1.24; see Table 1), which is comparable with scores found in OCD treatment studies (e.g., Simpson et al., 2010) and according to DiClemente, Schlundt, and Gemmell (2004) suggests that on average the patients were Contemplators. The Contemplation stage is when a person has become aware of a desire to change their behavior and they are weighting the pros and cons of changing this behavior.
University of Rhode Island Change Assessment (URICA) Subscales.
Participants were recruited from newspaper advertisements, routine referrals at the Behavior Therapy Center of Greater Washington, local support groups, and the website, electronic newsletters, and Facebook page of the Trichotillomania Learning Center, Inc. Prospective participants who responded to advertisements completed a telephone screening with a graduate student research assistant. Participants were compensated US$30 per study assessment and enrolled participants paid normal clinic fees for therapy sessions.
Inclusion criteria for this study were as follows: (a) ≥17 years old (participants less than 18 years old required parental permission), and (b) principal DSM-5 diagnosis of TTM. Psychotropic medication was allowable for any mental disorder, but the dosage should have been stable for at least 4 weeks prior to study enrollment. 1 Exclusion criteria were (a) concurrent psychotherapy focused on TTM, and (b) current suicidality, severe depression, psychosis, or substance abuse. Interested participants were pre-screened on the phone and invited to schedule an in-person assessment to further assess their eligibility. Ineligible participants were provided with referral information.
Intervention choice study participants
The study therapists (n = 7, four unlicensed trainees and three licensed psychologists; see “Procedure” subsection of “Method” section for further information) were themselves participants in the intervention choice study component of the project (see “Reliability of ComB Intervention Choices” subsections of “Measures” and “Procedure” subsections of “Method” section and “ComB Intervention Choice” subsection of “Results”) As described in the “Procedure” subsection, interpretation of the study therapists’ intervention choices required us to assemble a comparison group with exposure to clinical work but not to ComB in particular. This second group, referred to as “ComB-naïve” or “lay” graduate students, consisted of seven clinical psychology doctoral students who did not treat patients in this study and who possessed no prior knowledge of the ComB treatment approach.
Measures
Treatment development
Therapist adherence
Falkenstein and Haaga developed a measure of adherence for ComB therapists, with consultation from the ComB manual authors. The adherence measure is 102 items, and designed to be used for an entire course of treatment. The adherence score is the proportion of applicable items rated present. Some items may be scored as present regardless of when they occur, whereas others must occur in a designated session to count. This is because with the flexibility of the manual, therapists must perform specific tasks throughout the course of treatment yet not necessarily at specific sessions. For example, therapists may deem some patients ready to begin implementing interventions at Session 4, and others at Session 5, which affects the content discussed in each session and the homework forms that are administered. However, other tasks are not dependent on patient presentation such as providing psychoeducation in Session 1 or administering symptom measures at specific time points.
Reliability of ComB intervention choices
Using materials from the first cohort of participants, a 20-item intervention choice measure was developed which included session video clips, previously completed homework assignments, and written case vignettes in which a client presents with information about their symptoms during the time period when interventions are given. There were four possible answers per item. The ComB manual authors reviewed these materials and selected choices they deemed most appropriate in response to the prompts in these materials. Participants received one point for each item on which they chose the same intervention as did the manual authors. Total scores could thus range from 0 to 20, with higher scores indicating greater agreement with the expert consensus of what should be done in ComB.
Clinical assessments
Exclusionary diagnoses
Structured Clinical Interview for DSM-IV-TR (text rev.; APA, 2000) Axis I Disorders, Research Version, Patient Edition with Psychotic Screen (SCID-I/P with Psychotic Screen; First, Spitzer, Gibbon, & Williams, 2002). The SCID-I/P is a semi-structured interview that was used to establish whether prospective participants met exclusion criteria. A random sample (20%) of interviews was rated by a second assessor, masked to the time point of assessment (overall agreement on diagnoses made with SCID = 100%, κ = 1.0).
Study measures
For eligible participants, all measures were administered by trained doctoral-level graduate students at baseline, post-treatment, and for Cohort 2 only, 3-month follow-up. All assessments were recorded, and a random sample of the interviews (20%) were evaluated by a second rater, masked to the time point of the assessment. Self-report measures were completed in an online survey supported by surveymonkey.com.
TTM symptom history, severity, and impairment
Massachusetts General Hospital Hairpulling Scale (MGH-HPS)
The MGH-HPS (Keuthen et al., 1995) is a well-validated seven-item self-report measure of hair pulling symptom severity during the preceding week (overall score range = 0-28).
Trichotillomania Diagnostic Interview–Revised for DSM-5 (TDI-DSM-5)
The TDI-DSM-5 is a clinician-based, semi-structured interview modeled after the SCID for DSM-5 TTM criteria, using a 3-point rating system. It was developed for this study and is a revision of the original TDI, which was based on DSM-IV criteria (Rothbaum & Ninan, 1994). Participants needed to meet the DSM-5 criteria for TTM as assessed in this measure in this study at baseline. Interrater reliability was fair across the random sample of interviews rated from all time points (overall agreement = 63%, κ = .25).
NIMH Trichotillomania Severity Scale (NIMH-TSS)
The NIMH-TSS (Swedo et al., 1989) is a clinician-rated interview assessing pulling frequency (both on the previous day and during the past week), urge intensity, urge resistance, subjective distress, and interference with daily activities. The total score can range from 0 to 24, and the measure has shown acceptable convergent validity with self-reported TTM severity (e.g., Diefenbach, Tolin, Crocetto, Maltby, & Hannan, 2005). In rating the total score of a random sample of the interviews (20%), single rater reliability was high between the initial interviewer and a second rater masked to the time point of assessment (r = .98).
NIMH Trichotillomania Impairment Scale (NIMH-TIS)
The NIMH-TIS (Swedo et al., 1989) is a clinician-rated assessment of severity of impairment, scores ranging from 0 to 10. Psychometric data are limited, though interrater reliability scores have been acceptable, and scores are sensitive to changes in symptom severity with treatment (Swedo et al., 1989).
The Psychiatric Institute Trichotillomania Scale (PITS)
The PITS (Winchel et al., 1992) is a six-item semi-structured interview rating of TTM symptom severity and impairment (total score range = 0-42). One of the six items used to calculate the total score involves observing the hair loss, which was not possible for the second rater; thus interrater reliability calculations were based on a total of the first five items of the measure for a random sample of 20% of PITS interviews. Single rater reliability was strong between the initial interviewer and a second rater masked to the time point of the assessment (r = .96).
The Milwaukee Inventory for Subtypes of Trichotillomania–Adult Version (MIST-A)
The MIST-A (Flessner, Woods, Franklin, Cashin, & Keuthen, 2008) is a 15-item self-report measure with items rated on a 0- to 9-point scale indicating the extent to which the respondent endorses an automatic and/or focused pulling style. The focused and automatic pulling subscales are weakly interrelated, and each is internally consistent (Flessner et al., 2008).
Trichotillomania Course and Treatment Interview
This structured interview (Haaga et al., unpublished measure) concerns the course of TTM symptoms and treatment history.
Sample characterization
Demographics Survey
This self-report measure collected demographic information including age, gender, race, ethnicity, highest level of education, and employment status.
Treatment-relevant measures
Treatment Utilization Interview
This clinician-administered interview (Haaga et al., unpublished measure) asks participants about their actual and planned use of psychosocial and psychiatric treatments outside of the study.
Client Satisfaction Questionnaire (CSQ-8)
The CSQ-8 (Attkinson & Zwick, 1982) is an eight-item self-report questionnaire, total scores ranging from 8 to 32, which elicits the client’s perception about the mental health services they have received. The CSQ has demonstrated good internal consistency and construct validity (e.g., Larsen, Attkisson, Hargreaves, & Nguyen, 1979).
Psychosocial impairment
Sheehan Disability Scale (SDS)
The SDS (Sheehan, 1983) is a 3-item self-report measure of impairment in work/school, social life, and family life, with each item scored from 0 to 10. The SDS has been shown to have high internal consistency and re-test reliability, and acceptable concurrent validity (Arbuckle et al., 2009; Leon, Olfson, Portera, Farber, & Sheehan, 1997).
Quality of Life Enjoyment and Satisfaction Questionnaire–Short Form (Q-LES-Q-SF)
This is a 16-item self-report measure of quality of life (Endicott, Nee, Harrison, & Blumenthal, 1993) over the past week in leisure, household, work, emotional well-being, physical, and school domains. A raw total score is obtained from summing the first 14 items, with possible total scores ranging from 14 to 70. Higher scores reflect higher quality of life.
Emotion regulation and functioning
Acceptance and Action Questionnaire II (AAQ-II)
This is a 7-item self-report measure of general psychological acceptance, with higher scores indicating more experiential avoidance. The AAQ-II (Bond et al., 2011) has been found to have high internal consistency, construct validity, and convergent and divergent validity (Bond et al., 2011).
Beck Depression Inventory II (BDI-II)
The BDI-II (Beck, Steer, & Brown, 1996) is a reliable and well-validated 21-item self-report measure of the severity of depressive symptoms over the course of the preceding 2 weeks.
Readiness to change
The University of Rhode Island Change Assessment Scale (URICA)
The URICA (McConnaughy, Prochaska, & Velicer, 1983) assesses willingness to change as conceptualized in the Transtheoretical Model of Behavior Change (Prochaska & DiClemente, 1986). A Readiness to Change score was calculated by summing the scores for the Contemplation, Action, and Maintenance subscales, and then subtracting from that sum the Precontemplation score (DiClemente et al., 2004). This index has shown acceptable reliability and validity, for instance, in predicting premature termination from therapy (Brogan, Prochaska, & Prochaska, 1999).
Criteria for treatment response
The MGH-HPS is the primary outcome measure in this study because of its common usage and validation (e.g., Diefenbach, Tolin, Hannan, Maltby, & Crocetto, 2006; Nelson et al., 2014).
Treatment response was operationalized as clinically significant improvement in self-reported symptoms. In particular, clinical significance criteria from Nelson et al. (2014) were implemented, which are post-treatment MGH-HPS of 9 or below and reduction of at least 6 points from baseline. This is based on calculations put forth by Jacobson and Truax (1991), which stipulates that participants meet both (a) recovery of normal-range functioning, and (b) reliable change (RC).
Criteria for maintenance of response
Participants who continued to meet clinical significance criteria at a 3-month follow-up were considered as having maintained response, yet if they ceased meeting this criterion, they were considered as having experienced relapse.
Procedure
Development and implementation of the treatment manual
Members of the Scientific Advisory Board of the Trichotillomania Learning Center, Inc. (second, third, and fourth authors) wrote the treatment manual. The third author is the original author of the ComB treatment protocol. These authors have more than two decades of experience in training other clinicians on ComB treatment at national conferences, workshops, and 3-day professional training institutes. The second author also developed a web-based treatment program based on the ComB treatment model for TTM.
Two cohorts of participants were treated, and all sessions were videotaped for use in adherence ratings. Following the initial baseline assessment, participants deemed eligible were scheduled for 12 consecutive weeks of treatment sessions, which followed the protocol outlined in the ComB manual. The first cohort was treated using an initial draft of the ComB manual. After these seven patients were treated, therapists and patients were solicited for their feedback about the manual. Patients also completed a treatment satisfaction measure. Session attendance and treatment satisfaction were measured. The manual was revised according to feedback from both the therapists and patients. Nine new patients were subsequently recruited and then treated with the revised version of the manual.
Study therapists
Clinicians ranging in experience from doctoral-level graduate students to licensed professionals conducted therapy sessions at both the Behavior Therapy Center and American University (unlicensed clinicians received supervision). All study therapists had attended a ComB-specific training workshop. The manual authors at the Behavior Therapy Center, who are licensed clinicians, supervised the unlicensed therapists.
Therapist adherence
Two trained clinical psychology doctoral students rated a random sample of two full therapy cases for adherence.
Reliability of ComB intervention choices
A study of the interrater reliability of ComB therapist intervention choices at key decision points was conducted. The objective was to examine whether the study therapists would reliably make similar choices, according to the guidelines in the manual, in response to particular clinical presentations. ComB study therapists were instructed to select one intervention out of four multiple-choice options, in response to the clinical presentation. This portion of the project was conducted while treatment with the last few cases of Cohort 2 was still ongoing. As such, all study therapists participating in the intervention choice study had already completed at least one full case, but in some instances were still working with another client. No one rated materials selected from a case in which she or he was the study therapist.
Because this 20-item measure of ComB intervention choices is novel, with no prior data on item difficulty, interpretation of the results would be tenuous if we administered it only to the study therapists. To take an extreme example, suppose that an excerpt from a self-monitoring log shows one client to experience urges to pull when looking at herself in the mirror, and the following interventions were offered as response options: (a) suggest putting on bandaids when using sink in the bathroom, (b) bounce a basketball on your office floor and ignore the patient, (c) invite the patient to join you at a Nationals game this weekend, and (d) say nothing and stick your head out the window to get a sense of how warm it is. It seems probable that most therapists would choose (a) in agreement with the experts, but this would not be convincing evidence of a reliable sense of what to do in ComB in particular; it is just what makes the most sense, relative to the other options, as being helpful and potentially therapeutic. We did not set out to write such “easy” items for the measure, but only by administering it to ComB-naïve participants with some training in psychotherapy in general could we be sure that agreement with ComB experts on what to do means something more than general therapy savvy. Accordingly, we recruited a sample of seven lay (ComB-naïve) clinical psychology graduate students to complete the intervention choice measure as well.
Data Analysis
The Statistical Package for the Social Sciences (SPSS, Version 19) was used for all statistical analyses. Acceptability of ComB treatment to patients was measured by examining the mean treatment satisfaction ratings on the Client Satisfaction Questionnaire and the mean number of sessions attended. The intervention choice study was analyzed by examining the mean percentage of instances in which therapists correctly chose the decisions that were deemed appropriate by the ComB manual authors. A preliminary examination of the efficacy of the ComB treatment was done through dependent t tests comparing pre–post mean scores on measures of TTM severity, impairment, quality of life, and associated characteristics such as emotion regulation. For Cohort 2 only, maintenance was also examined by comparing post-treatment and 3-month follow-up scores on these measures. Within-group effect sizes (d’s) were used to characterize the magnitude of effects.
Results
ComB Manual Draft
The ComB manual authors drafted a 110-page manual (plus appendices), which laid out ComB treatment as 12 sessions, composed of four sections. After Cohort 1 was treated, the manual was revised based on feedback on the manual from both therapists and Cohort 1 participants. Some revisions were minor matters of clarification and user-friendliness (e.g., putting all the handouts in the back). The most substantial change was the timing for administering interventions. In Version 1, the first four sessions were entirely assessment and functional analysis to lay the groundwork for choice of interventions used to reduce hair pulling. Although there was a statement to readers that if the client was ready, therapists could give interventions during this time, the therapists gave feedback that the manual was not sufficiently explicit about this option to give interventions at this point in treatment. All the therapists and many of the patients gave feedback that interventions should start earlier, with no one suggesting interventions should start later. Thus, in the second version of the manual, there is the option to teach intervention tactics as early as Session 3 if the therapist believes the functional analysis is sufficiently clear at that point.
Each section contained specific instructions with example therapist/client dialogues, homework assignments with corresponding forms, and therapist note templates. The four sections are as follows: Section (1) Assessment and Functional Analysis, to be implemented during Sessions 1 through 4. This part of treatment consists of orienting the client to treatment, providing psychoeducation about TTM, setting therapy goals and discussing motivation, conducting a functional analysis of their hair pulling, and beginning self-monitoring. Section (2) Identification and Targeting of Modalities, to be covered in Session 5, consists of introducing the client to the SCAMP (Sensory, Cognitive, Affective, Motoric, and Place) modalities and how their hair pulling fits into these modalities, and beginning to discuss interventions relevant to these modalities for the client’s particular pulling triggers and patterns. Some examples of interventions that fit into particular SCAMP modalities include using a scalp massager for the Sensory modality, cognitive restructuring for the Cognitive modality, deep breathing for the Affective modality, wearing bandages on fingertips in the Motoric modality, and covering mirrors in the Place modality. Section (3) Identification and Implementation of Specific Interventions, in Sessions 6 through 10, aims to develop and troubleshoot the utilization of specific interventions week by week for the client’s hair pulling, according to the SCAMP modalities. Section (4) Evaluation, Modification, and Relapse Prevention, in Sessions 11 and 12, is focused on emphasizing the maintenance of vigilance as therapy ends, distinguishing between lapses and relapses, and developing a plan for hair pulling during future stressful events.
Acceptability of ComB Treatment
The acceptability of ComB treatment to patients was measured through session attendance and patients’ treatment satisfaction ratings. Attendance was high, with a mean of 11.19 of 12 scheduled sessions attended; 81% of participants attended the 12 sessions. Two participants dropped out of the study before Session 12, one due to an unplanned geographical move and another due to conflicting work schedule. One participant received 13 sessions due to therapist error. For treatment satisfaction, the mean CSQ score among participants in Cohort 1 (n = 7) ranged from 20 through 32, with a mean of 25.71 (5.19) at post-treatment. For Cohort 2 participants (n = 9), CSQ scores ranged from 17 through 32, with a mean of 27.89 (5.42) at post-treatment and a range of 17 through 32 with a mean of 26.0 (4.50) at 3-month follow-up. For Item 7 of the CSQ, “In an overall, general sense, how satisfied are you with the service you received?” 56% endorsed “very satisfied,” 25% endorsed “mostly satisfied,” and 19% endorsed “indifferent or mildly dissatisfied.”
ComB Intervention Choice Study
The reliability of therapists’ selection of ComB interventions was measured by conducting an intervention choice study, in which agreement among therapists in correctly choosing decisions consistent with the ComB manual was measured. Seven ComB study therapists completed this measure and responded correctly on average 15.65 (SD = 1.17; median = 16, range = 14.44-17) times out of 20 (78% overall agreement with the ComB manual authors). The seven ComB-naïve (“lay”) clinical psychology graduate students responded correctly on average 13.43 (SD = 1.27; median = 13, range = 12-15) times out of 20 (66% overall agreement with the ComB manual authors). The ComB study therapists’ scores were significantly higher than those of the ComB-naïve clinical psychology graduate students (t = 3.40, p = .005).
Therapist Adherence
An interrater reliability study of the adherence measure was conducted between two trained, doctoral-level graduate students who rated videos of two randomly selected therapy cases from Cohort 2. The reliability results were acceptable; for the first therapy case, adherence was .70 and in the second case, adherence was .83 (overall agreement = 80%, κ = .55).
Preliminary Efficacy of ComB
For means and standard deviations for all variables presented, see Tables 2 and 3. Note that Cohorts 1 and 2 had comparable levels on these measures, for example, the baseline MGH-HPS score in Cohort 1 was 18.00 (SD = 4.04), and in Cohort 2, it was 17.78 (SD = 4.21). At post-treatment, Cohort 1 had an MGH-HPS mean score of 11.71 (SD = 4.07), and Cohort 2 had 10.89 (SD = 7.00). Analyses include baseline data for all 16 participants, post-treatment self-report data for all 16 participants (yet, interview and BDI-II data for only 15 participants), and follow-up data for all nine Cohort 2 participants, with the exception of follow-up BDI-II data for only seven participants. As the scores in Cohorts 1 and 2 did not differ markedly, the data are combined across cohorts for ease of presentation for all the remaining analyses with the exception of those involving maintenance data, as Cohort 1 did not have a follow-up assessment. 2
Clinical Measures at Pre-Treatment and Post-Treatment for Cohorts 1 and 2.
Note. Standard deviations appear in parentheses next to means. N = 16 for pre-treatment data and Ns range from 15 to 16 for post-treatment data. MGH-HPS = Massachusetts General Hospital Hairpulling Scale; NIMH-TSS = National Institute of Mental Health Trichotillomania Severity Scale; PITS = Psychiatric Institute Trichotillomania Scale; NIMH-TIS = National Institute of Mental Health Trichotillomania Impairment Scale; BDI-II = Beck Depression Inventory II; Q-LES-Q = Quality of Life Enjoyment and Satisfaction Questionnaire; SDS = Sheehan Disability Scale; AAQ-II = Acceptance and Action Questionnaire II.
Clinical Measures at Post-Treatment and Follow-Up for Cohort 2.
Note. Standard deviations appear in parentheses next to means. Ns range from 8 to 9 for post-treatment data. Ns range from 7 to 9 for follow-up data. MGH-HPS = Massachusetts General Hospital Hairpulling Scale; NIMH-TSS = National Institute of Mental Health Trichotillomania Severity Scale; PITS = Psychiatric Institute Trichotillomania Scale; NIMH-TIS = National Institute of Mental Health Trichotillomania Impairment Scale; BDI-II = Beck Depression Inventory II; Q-LES-Q = Quality of Life Enjoyment and Satisfaction Questionnaire; SDS = Sheehan Disability Scale; AAQ-II = Acceptance and Action Questionnaire II.
Symptom severity and impairment
Hair pulling severity and impairment improved across all measures, with large effects. At the post-treatment assessment, 38% of the participants met criteria for clinical significance (two were in first cohort, four in second; n = 16). At follow-up, one of the nine participants in Cohort 2 met clinical significance criteria. MGH-HPS scores significantly improved, t(15) = 3.57, p = .003, d = 1.66, from baseline to post-treatment and for Cohort 2, follow-up scores had a non-significant increase from post-treatment, t(8) = −1.27, p = .239, d = −.348. For interviewer-rated measures, NIMH-TSS scores also significantly improved, t(13) = 3.48, p = .004, d = 1.19, from baseline to post-treatment, and remained lower at follow-up. PITS scores also saw a significant improvement, t(14) = 4.04, p = .001, d = 1.30, from baseline to post-treatment, and remained lower at follow-up. NIMH-TIS scores also significantly improved, t(13) = 2.49, p = .027, d = 1.09, decreasing from baseline to post-treatment, and remained lower at follow-up.
Psychosocial functioning
Quality of life and disability also improved from baseline to post-treatment. Q-LES-Q scores were representative of those found in many OCD treatment studies (e.g., Simpson et al., 2010) and were found to significantly improve, with a large ES, t(15) = −2.82, p = .013, d = −.665, from baseline to post-treatment, with scores remaining at approximately the same level at follow-up. SDS scores did not significantly improve, though there was a large effect, t(15) = 2.03, p = .061, d = .643, from baseline to post-treatment, and remained lower at follow-up.
Emotion regulation and functioning
Experiential avoidance scores (AAQ) did not significantly improve, t(15) = .305 p = .764, d = .059, from baseline to post-treatment, and though non-significant, there was a small to medium effect, t(8) = 1.87, p = .098, d = .337, from post-treatment to follow-up. Depression (BDI) scores did not significantly improve, though there was a medium effect, t(14) = 1.91, p = .077, d = .508, from baseline to post-treatment, and increased slightly at the time of follow-up.
Individual differences and treatment response
For a preliminary examination of individual differences that relate to ComB treatment response, Table 4 displays comparisons of the means and standard deviations throughout the duration of the study between participants who met and who did not meet clinical significance at the post-treatment assessment. With regard to improvement in emotion regulation during treatment, participants who achieved clinical significance were approximately one standard deviation lower on the AAQ (experiential avoidance) at baseline than participants who did not achieve clinical significance, with AAQ levels remaining at the same level for both groups of participants post-treatment. Responders had a mean decrease on the BDI (depressive symptoms) of more than two standard deviations from baseline to post-treatment (nine at baseline, one at post-treatment), whereas non-responders’ BDI scores remained at the same level of eight. For the question as to whether participants high in either “focused” or “automatic” pulling would benefit equally from ComB, when examining group differences by responder status (Table 4), responders had slightly lower MIST-A “focused” and “automatic” pulling scores than non-responders at baseline. Psychosocial impairment, as measured by the Q-LES-Q (quality of life) and SDS (disability), was lower among responders than non-responders at baseline. Although both responders and non-responders had improved scores on average at post-treatment, these improvements on the Q-LES-Q and SDS were greater among the responders.
Clinical Measures by Responder Status.
Note. Standard deviations appear in parentheses next to means. MGH-HPS = Massachusetts General Hospital Hairpulling Scale; URICA = University of Rhode Island Change Assessment Scale- Readiness to Change; MIST-A = Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version Focused and Automatic subscales; BDI-II = Beck Depression Inventory II; Q-LES-Q = Quality of Life Enjoyment and Satisfaction Questionnaire; SDS = Sheehan Disability Scale; AAQ-II = Acceptance and Action Questionnaire II.
Discussion
All aims related to Stage I (Intervention Generation/Refinement) of the NIH stage model of treatment development were met in this study of ComB treatment. A treatment manual was drafted and revised based on patient and therapist feedback. Attendance and treatment satisfaction were both high, suggesting that ComB treatment was highly acceptable to patients. ComB study therapists were found to reliably select interventions from the manual more than did clinical psychology graduate students who had not been trained in the manual, which is important for ensuring consistency with the ComB model that can generalize across therapists. A measure of therapist adherence was developed and pilot tested in an interrater reliability study, which demonstrated good reliability.
Maintenance of response has been a problem in numerous TTM clinical trials (Falkenstein, Rogers, Malloy, & Haaga, 2014). We hypothesize that one way to improve maintenance is to include more flexibility in our treatments regarding individuals’ pulling modalities, which is the case in the ComB treatment. The ComB approach is important to investigate further because it allows clinicians to expand the scope of current cognitive-behavioral treatment for TTM by maximizing the amount of tailoring therapists can do for each hair puller’s unique presentation. Nevertheless, our preliminary study of ComB efficacy showed pre–post improvements in TTM symptom severity about the same as in comparable previous trials of behavior therapy for TTM, and some fading of these gains was again apparent at 3-month follow-up. For instance, an open trial of ACT in combination with habit reversal therapy reported pre–post means of 16.2 and 10.0 on the MGH-HPS (Crosby, Dehlin, Mitchell, & Twohig, 2012), whereas the comparable figures were 17.9 and 11.3 in the present study. Our findings were also comparable with the Grant, Odlaug, and Kim (2009) N-acetylcysteine (NAC) versus placebo study, which showed a reduction in the MGH-HPS from 17.6 at baseline to 10.4 at study endpoint.
Bearing in mind that it is hazardous to estimate future ESs from small studies, if equivalency of results for ComB with existing TTM treatments proves a robust finding, ComB would still be a worthwhile addition to the treatment armamentarium in the sense that it would expand therapist and patient choice. Just as depressed patients can choose from among numerous well-supported psychosocial interventions, it would be useful for TTM patients to have multiple options as well. Still, it would be preferable to continue improving efficacy, and particularly maintenance of the effects of ComB treatment. We see at least three possible avenues for enhancing size and durability of ComB effects. First, the protocol could be made longer; number of contact hours was positively associated with ES of behavioral treatments in a meta-analysis of TTM trials (McGuire et al., 2014). Second, rather than a longer fixed schedule, the duration of treatment could itself be made another aspect of the flexibility of ComB treatment. In particular, patients could be treated until such time as they become abstinent from hair pulling, which appears to predict better maintenance of response to TTM treatment (Falkenstein et al., 2014), along with some small number of subsequent sessions focused on maintenance. In other words, length of treatment might be something like “3 sessions after complete abstinence is achieved” rather than “12 sessions” or “15 sessions” or any fixed length. A controlled trial of behavioral couples’ treatment showed that introducing such flexibility of treatment duration and structure improved maintenance of effects (Jacobson et al., 1989). Third, it could be that improved outcomes would result from identifying moderators of response that would enable rational allocation of patients to ComB versus alternative interventions. For instance, perhaps participants with low baseline experiential avoidance would fare better in ComB, whereas participants with high experiential avoidance would benefit more from ACT-enhanced behavior therapy. Prediction of response data in a one-condition study like this one do not provide a basis for prescription of optimal treatments (Haaga & Stiles, 2000), but if a comparative trial obtained an aptitude-treatment interaction, then overall outcomes would be enhanced by matching treatments with patient subgroups accordingly.
Our preliminary study also addressed side effects beyond TTM symptom severity and individual differences in response. Quality of life improved at post-treatment, and remained improved at follow-up. Depression and emotion regulation scores did not show significant improvements, but they did have small to medium effects. When examining differences between participants who met clinical significance criteria (“responders”) and those who did not (“non-responders”), the sample size was insufficient for powerful inferential testing; thus, descriptives were examined and presented in Table 4. Responders showed a more sizable increase in quality of life, and a greater decline in BDI scores, impairment, and both focused and automatic pulling from pre- to post-treatment than did non-responders. Responders also scored lower in experiential avoidance at baseline, yet did not differ from non-responders in the change of experiential avoidance throughout treatment. It is possible that change did occur in experiential avoidance for participants who met clinical significance, but that the measure did not capture this change. The measure of experiential avoidance in this study, AAQ-II, has been revised to be more specifically applicable to individuals with TTM since the development of the methods for this study. The AAQ-TTM (Houghton et al., 2014) has been found to have incremental validity over the AAQ-II.
There were several limitations in this study that could be addressed in a future RCT of ComB treatment model with a larger sample. The sample in this pilot study was small (N = 16), and this sample was even smaller for follow-up data (N = 9), which limited our statistical power for inferential testing and our ability to draw meaningful conclusions about maintenance. Second, therapist adherence, and the reliability with which it was measured, was only assessed for a random sample of two cases in the second cohort. Thus, we had no information on adherence for five of the seven study therapists. A more extensive study of the ComB adherence scale could shed light on the generalizability of our findings. Finally, this study lacked data about the competence of the therapists in administering the ComB treatment. In an RCT, it will be important to develop and implement a measure of competence in addition to the existing measure of adherence, to measure the quality of therapy and also to determine when therapists are ready to begin seeing study cases.
Conclusion
This study aimed to develop and pilot test ComB treatment of TTM with the ultimate goal of rigorous testing of the efficacy of this approach. It resulted in the development of a manual and measures to be used in a future RCT of the ComB treatment model for TTM. The development of a manual is valuable not only for guiding therapists who want to practice ComB but also because it is a practical necessity for conducting research that might count toward its being considered an EST, of which there is none for TTM. Besides the completed manual, the study resulted in information suggesting that ComB is acceptable to patients, therapists can reliably select ComB interventions consistent with the manual, therapist adherence to ComB can be measured reliably, and preliminary efficacy data are encouraging. Modifying existing TTM treatments to include a focus on individual modalities of pulling behavior may be a valuable future direction. The ComB treatment protocol appears promising and is worth further study in a RCT.
Footnotes
Acknowledgements
We are grateful to the Trichotillomania Learning Center, Inc. for funding this research. We thank staff members of the Behavior Therapy Center of Greater Washington and James J. Gray Psychotherapy Training Clinic at American University for their assistance with the manual, conducting the therapy and assessments, and coding of data.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The Trichotillomania Learning Center, Inc. provided the financial support for this study.