Clinical trial NCT03486041: Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania
Official title: Randomized Controlled Trial of the Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trichotillomania
Lead sponsor: American University
Sponsor class: OTHER
Collaborators: name: University of Chicago
First posted: 2018-04-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Massachusetts General Hospital Hairpulling Scale
timeFrame: baseline (week 0), week 6, week 12, week 25, week 38
measure: Change in National Institute of Mental Health (NIMH) Trichotillomania Severity and Impairment Scales
timeFrame: baseline (week 0), week 6, week 12, week 25, week 38
measure: Change in Trichotillomania Diagnostic Interview (modified for DSM-5)
timeFrame: baseline (week 0), week 6, week 12, week 25, week 38
Secondary outcomes:
measure: Alopecia rating
timeFrame: baseline (week 0), week 6, week 12, week 25, week 38
measure: Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version [Revised by Keuthen et al.]
timeFrame: baseline (week 0), week 6, week 12, week 25, week 38
measure: Client Satisfaction Questionnaire
timeFrame: week 6, week 12, week 25, week 38
measure: Stop Signal task
timeFrame: baseline (week 0), week 6, week 12
Other outcomes:
Locations:
city: Washington
country: United States
facility: American University
state: District of Columbia
Study officials:
References:
citation: 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.