Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania

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

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.

Study Overview

• Status: Completed
• Conditions: Trichotillomania
• Intervention / Treatment: Behavioral: Comprehensive Behavior Modification; Behavioral: Attention

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • American University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: immediate ComB; 12 weekly sessions of ComB treatment in individual therapy, following a detailed manual.	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.
Placebo Comparator: 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].	Behavioral: Attention; Weekly brief calls from therapist to check on safety and clinical status. No focus on TTM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Massachusetts General Hospital Hairpulling Scale	7-item self-report measure of TTM symptom severity. Score range = 0 to 28. Higher scores = more severe hairpulling symptoms in past week.	baseline (week 0), week 6, week 12, week 25, week 38
Change in National Institute of Mental Health (NIMH) Trichotillomania Severity and Impairment Scales	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	baseline (week 0), week 6, week 12, week 25, week 38
Change in Trichotillomania Diagnostic Interview (modified for DSM-5)	structured diagnostic interview to determine presence/absence of TTM	baseline (week 0), week 6, week 12, week 25, week 38

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alopecia rating	Masked rater evaluation of hair loss evident in photo taken of most affected pulling site (1 to 7, higher scores reflecting greater hair loss)	baseline (week 0), week 6, week 12, week 25, week 38
Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version [Revised by Keuthen et al.]	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)	baseline (week 0), week 6, week 12, week 25, week 38
Client Satisfaction Questionnaire	self-report measure of treatment satisfaction. Scores range 0 to 32, higher scores reflecting greater satisfaction with services received.	week 6, week 12, week 25, week 38
Stop Signal task	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.	baseline (week 0), week 6, week 12

Collaborators and Investigators

• Sponsor: American University
• Collaborators: University of Chicago

Publications and helpful links

General Publications

• Carlson EJ, Malloy EJ, Brauer L, Golomb RG, Grant JE, Mansueto CS, Haaga DAF. Comprehensive Behavioral (ComB) Treatment of Trichotillomania: A Randomized Clinical Trial. Behav Ther. 2021 Nov;52(6):1543-1557. doi: 10.1016/j.beth.2021.05.007. Epub 2021 Jun 3.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2018
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Trichotillomania
• Other Study ID Numbers: ComB controlled trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No