NCT03486041

Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: American University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trichotillomania

Interventions

Type	Name	Description
BEHAVIORAL	Comprehensive Behavior Modification	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.
BEHAVIORAL	Attention	Weekly brief calls from therapist to check on safety and clinical status. No focus on TTM.

Timeline

• Start date: 2018-05-10
• Primary completion: 2020-04-30
• Completion: 2020-04-30
• First posted: 2018-04-03
• Last updated: 2021-01-13

Locations

1 site across 1 country: United States