Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-10

Study Completion Date

2020-04-30

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.

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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.

Conditions

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Trichotillomania

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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immediate ComB

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

Group Type EXPERIMENTAL

Comprehensive Behavior Modification

Intervention Type BEHAVIORAL

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.

Minimal Attention Control

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

Group Type PLACEBO_COMPARATOR

Attention

Intervention Type BEHAVIORAL

Weekly brief calls from therapist to check on safety and clinical status. No focus on TTM.

Interventions

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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.

Intervention Type BEHAVIORAL

Attention

Weekly brief calls from therapist to check on safety and clinical status. No focus on TTM.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No