Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania

Study Overview
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Brief Summary
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This study will be the first randomized controlled trial of Comprehensive Behavior Modification (ComB) as a treatment of trichotillomania (TTM). ComB treatment (12 weekly sessions, following a manual developed in an earlier treatment development project) will be compared to Minimal Attention Control among adults (N = 42) with TTM.

Detailed Description
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Treatment based on the ComB model has been influential in the field of body-focused repetitive behaviors (BFRB's), but there is limited empirical research on its efficacy. Our first project (Falkenstein et al., 2016) developed a 12-session manual for ComB and a method for evaluating therapist adherence to the model that can be used reliably and provided encouraging (uncontrolled) data on the effects of ComB through 3-month follow-up. The proposed project extends the earlier work in two main ways: (a) using random assignment to ComB vs. comparison condition to test whether ComB works better than the passage of time + demand characteristics of being in a TTM study alone; and (b) gathering initial evidence on how ComB works. Treatment will be conducted at two sites -- Washington, DC (American University and the Behavior Therapy Center of Greater Washington) and Chicago (University of Chicago). Participants in the Minimal Attention Control condition will receive ComB therapy after the post-treatment [week 12] assessment is conducted. Uncontrolled follow-up data will be collected through 3 (MAC condition) or 6 (immediate ComB condition) months after the end of ComB treatment.

Official Title
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Randomized Controlled Trial of the Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania

Conditions
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Trichotillomania

Intervention / Treatment
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* Behavioral: Comprehensive Behavior Modification
* Behavioral: Attention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older diagnosed with Trichotillomania medication type and dosage [if any] stable for at least 3 months Exclusion Criteria: active suicidality --probable bipolar disorder probable psychosis other pressing clinical problem requiring immediate treatment current psychotherapy and unable/unwilling to discontinue

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Immediate ComB and MAC participants will each be assessed at baseline (week 0). ComB will begin weekly therapy sessions, and MAC will receive weekly phone check-ins. All will be assessed at week 6 [mid-treatment] and week 12 [end of controlled phase]. After week 12, ComB enters maintenance and MAC participants start to receive delayed ComB. There is another assessment at week 25 (3-month followup for immediate ComB, post-ComB for MAC) and a final assessment at week 38 (6-month followup for immediate ComB, 3-month followup for MAC).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immediate ComB<br>12 weekly sessions of ComB treatment in individual therapy, following a detailed manual. | Behavioral: Comprehensive Behavior Modification<br>* Behavior therapy approach to BFRBs involving targeted intervention tactics chosen in accordance with the modality of functioning (ex: Sensory, Cognitive.....) seeming to cause the most frequent and problematic urges to engage in the BFRB. Therapist and client work together, using careful assessments including detailed self-monitoring, to determine what behavioral methods will suffice for lasting change.<br>|
| Placebo Comparator: Minimal Attention Control<br>Weekly brief phone call from therapist to check on participant safety, medication changes if any, and recent stressors. After week 12, participants in this arm received delayed ComB [as in the Experimental condition -- 12 weekly sessions of individual therapy for TTM based on ComB model]. | Behavioral: Attention<br>* Weekly brief calls from therapist to check on safety and clinical status. No focus on TTM.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Massachusetts General Hospital Hairpulling Scale | 7-item self-report measure of TTM symptom severity. Score range = 0 to 28. Higher scores = more severe hairpulling symptoms in past week. | baseline (week 0), week 6, week 12, week 25, week 38 | 
| Change in National Institute of Mental Health (NIMH) Trichotillomania Severity and Impairment Scales | interviewer ratings [to be completed by independent evaluator masked to experimental condition] of TTM symptoms and impairment. Scores on the TSS (symptom severity) range 0 to 25, higher scores reflecting more severe symptoms. Scores on the TIS (impairment) range 0 to 10, higher scores reflecting greater impairment associated with hairpulling | baseline (week 0), week 6, week 12, week 25, week 38 | 
| Change in Trichotillomania Diagnostic Interview (modified for DSM-5) | structured diagnostic interview to determine presence/absence of TTM | baseline (week 0), week 6, week 12, week 25, week 38 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alopecia rating | Masked rater evaluation of hair loss evident in photo taken of most affected pulling site (1 to 7, higher scores reflecting greater hair loss) | baseline (week 0), week 6, week 12, week 25, week 38 | 
| Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version [Revised by Keuthen et al.] | self-report measure of pulling styles, scores ranging from 0 to 72 on Intention subscale and 0-45 on Emotion subscale [higher scores = better fit for that pulling style) | baseline (week 0), week 6, week 12, week 25, week 38 | 
| Client Satisfaction Questionnaire | self-report measure of treatment satisfaction. Scores range 0 to 32, higher scores reflecting greater satisfaction with services received. | week 6, week 12, week 25, week 38 | 
| Stop Signal task | computer-implemented neurocognitive test of impulsivity vs. ability to inhibit responses. Measured in milliseconds. One indicator is Stop Signal Reaction Time, higher scores reflecting poorer inhibitory control. | baseline (week 0), week 6, week 12 |