Randomized Controlled Trial of the Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Change in Trichotillomania Diagnostic Interview (modified for DSM-5)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The project coordinator at each site will conduct baseline assessments. All later assessments will be conducted by different research assistants, masked to experimental condition of the participant.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in Trichotillomania Diagnostic Interview (modified for DSM-5)
Time Frame: baseline (week 0), week 6, week 12, week 25, week 38
structured diagnostic interview to determine presence/absence of TTM
Change in National Institute of Mental Health (NIMH) Trichotillomania Severity and Impairment Scales
Time Frame: baseline (week 0), week 6, week 12, week 25, week 38
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
Change in Massachusetts General Hospital Hairpulling Scale
Time Frame: baseline (week 0), week 6, week 12, week 25, week 38
7-item self-report measure of TTM symptom severity. Score range = 0 to 28. Higher scores = more severe hairpulling symptoms in past week.
Secondary Outcomes
- Alopecia rating(baseline (week 0), week 6, week 12, week 25, week 38)
- Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version [Revised by Keuthen et al.](baseline (week 0), week 6, week 12, week 25, week 38)
- Stop Signal task(baseline (week 0), week 6, week 12)
- Client Satisfaction Questionnaire(week 6, week 12, week 25, week 38)
Investigators
David A. F. Haaga
Professor of Psychology
American University