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NCT Number: NCT03486041

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American University

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

ATTENTION

Behavioral

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

Primary outcomes

  1. Change in Massachusetts General Hospital Hairpulling Scale

    Time frame: 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.

  2. Change in National Institute of Mental Health (NIMH) Trichotillomania Severity and Impairment Scales

    Time frame: 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

  3. Change in Trichotillomania Diagnostic Interview (modified for DSM-5)

    Time frame: baseline (week 0), week 6, week 12, week 25, week 38

    structured diagnostic interview to determine presence/absence of TTM

Secondary outcomes

  1. Alopecia rating

    Time frame: 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)

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

    Time frame: 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)

  3. Client Satisfaction Questionnaire

    Time frame: 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.

  4. Stop Signal task

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

American University

Other

Collaborators

  • University of Chicago

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 3, 2018
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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