Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania

American University

Status: Completed

Conditions: Trichotillomania

Treatments: Behavioral: Comprehensive Behavior Modification; Behavioral: Attention

Study type: Interventional

Funder types: Other

Identifiers

NCT03486041

ComB controlled trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups, including a placebo group

immediate ComB

Experimental group

Description:

12 weekly sessions of ComB treatment in individual therapy, following a detailed manual.

Treatment:

Behavioral: Comprehensive Behavior Modification

Minimal Attention Control

Placebo Comparator group

Description:

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 \[as in the Experimental condition -- 12 weekly sessions of individual therapy for TTM based on ComB model\].

Treatment:

Behavioral: Attention