Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania

NCT03486041 | Completed

• 1 other identifier: ComB controlled trial
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Trichotillomania

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Alopecia rating

  baseline (week 0), week 6, week 12, week 25, week 38

• Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version [Revised by Keuthen et al.]

  baseline (week 0), week 6, week 12, week 25, week 38

• Client Satisfaction Questionnaire

  week 6, week 12, week 25, week 38

• Stop Signal task

  baseline (week 0), week 6, week 12

Study Arms (2)

immediate ComB

EXPERIMENTAL

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

Behavioral: Comprehensive Behavior Modification

Minimal Attention Control

PLACEBO COMPARATOR

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

Interventions

Comprehensive Behavior Modification 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.

immediate ComB

Attention BEHAVIORAL

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

Minimal Attention Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• diagnosed with Trichotillomania
• medication type and dosage \[if any\] stable for at least 3 months

You may not qualify if:

• active suicidality
• probable bipolar disorder
• probable psychosis
• other pressing clinical problem requiring immediate treatment
• current psychotherapy and unable/unwilling to discontinue

Sponsors & Collaborators

• American University: lead
• University of Chicago: collaborator

Study Sites (1)

American University

Washington D.C., District of Columbia, 20016, United States

Location

Related Publications (1)

• 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.

  PMID: 34656205 DERIVED

MeSH Terms

Conditions

Trichotillomania

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: 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).

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: April 3, 2018
• Study Start: May 10, 2018
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Locations

US (1)