Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania

Trichotillomania Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03486041
• Other study ID #: ComB controlled trial
• Status: Completed
• Phase: N/A
• Start date: May 10, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: January 2021
• Source: American University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Trichotillomania

Intervention

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

Locations

Country	Name	City	State
United States	American University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
American University	University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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