Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania

Not Applicable

Completed

• Conditions: Trichotillomania
• Interventions: Behavioral: Comprehensive Behavior Modification; Behavioral: Attention

• Registration Number: NCT03486041
• Lead Sponsor: American University

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 Timeline

• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-30
• Study First Posted: 2018-04-03
• Study Start: 2018-05-10
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
immediate ComB	Comprehensive Behavior Modification	12 weekly sessions of ComB treatment in individual therapy, following a detailed manual.
Minimal Attention Control	Attention	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 \[as in the Experimental condition -- 12 weekly sessions of individual therapy for TTM based on ComB model\].

Primary Outcome Measures

Name	Time	Method
Change in Trichotillomania Diagnostic Interview (modified for DSM-5)	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	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	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 Outcome Measures

Name	Time	Method
Alopecia rating	baseline (week 0), week 6, week 12, week 25, week 38	Masked rater evaluation of hair loss evident in photo taken of most affected pulling site (1 to 7, higher scores reflecting greater hair loss)
Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version [Revised by Keuthen et al.]	baseline (week 0), week 6, week 12, week 25, week 38	self-report measure of pulling styles, scores ranging from 0 to 72 on Intention subscale and 0-45 on Emotion subscale \[higher scores = better fit for that pulling style)
Stop Signal task	baseline (week 0), week 6, week 12	computer-implemented neurocognitive test of impulsivity vs. ability to inhibit responses. Measured in milliseconds. One indicator is Stop Signal Reaction Time, higher scores reflecting poorer inhibitory control.
Client Satisfaction Questionnaire	week 6, week 12, week 25, week 38	self-report measure of treatment satisfaction. Scores range 0 to 32, higher scores reflecting greater satisfaction with services received.

Trial Locations

Locations (1)

American University; 🇺🇸 Washington, District of Columbia, United States