Randomized Controlled Trial of the Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Trichotillomania
- Sponsor
- American University
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change in Trichotillomania Diagnostic Interview (modified for DSM-5)
- Status
- Completed
- Last Updated
- 5 years ago
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.
Investigators
David A. F. Haaga
Professor of Psychology
American University
Eligibility Criteria
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)