Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania
Primary Purpose
Trichotillomania
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Behavior Modification
Attention
Sponsored by
About this trial
This is an interventional treatment trial for Trichotillomania
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
Sites / Locations
- American University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
immediate ComB
Minimal Attention Control
Arm Description
12 weekly sessions of ComB treatment in individual therapy, following a detailed manual.
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].
Outcomes
Primary Outcome Measures
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.
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
Change in Trichotillomania Diagnostic Interview (modified for DSM-5)
structured diagnostic interview to determine presence/absence of TTM
Secondary Outcome Measures
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)
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)
Client Satisfaction Questionnaire
self-report measure of treatment satisfaction. Scores range 0 to 32, higher scores reflecting greater satisfaction with services received.
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.
Full Information
NCT ID
NCT03486041
First Posted
March 15, 2018
Last Updated
January 11, 2021
Sponsor
American University
Collaborators
University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT03486041
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 10, 2018 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University
Collaborators
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
immediate ComB
Arm Type
Experimental
Arm Description
12 weekly sessions of ComB treatment in individual therapy, following a detailed manual.
Arm Title
Minimal Attention Control
Arm Type
Placebo Comparator
Arm Description
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].
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive Behavior Modification
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attention
Intervention Description
Weekly brief calls from therapist to check on safety and clinical status. No focus on TTM.
Primary Outcome Measure Information:
Title
Change in Massachusetts General Hospital Hairpulling Scale
Description
7-item self-report measure of TTM symptom severity. Score range = 0 to 28. Higher scores = more severe hairpulling symptoms in past week.
Time Frame
baseline (week 0), week 6, week 12, week 25, week 38
Title
Change in National Institute of Mental Health (NIMH) Trichotillomania Severity and Impairment Scales
Description
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
Time Frame
baseline (week 0), week 6, week 12, week 25, week 38
Title
Change in Trichotillomania Diagnostic Interview (modified for DSM-5)
Description
structured diagnostic interview to determine presence/absence of TTM
Time Frame
baseline (week 0), week 6, week 12, week 25, week 38
Secondary Outcome Measure Information:
Title
Alopecia rating
Description
Masked rater evaluation of hair loss evident in photo taken of most affected pulling site (1 to 7, higher scores reflecting greater hair loss)
Time Frame
baseline (week 0), week 6, week 12, week 25, week 38
Title
Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version [Revised by Keuthen et al.]
Description
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)
Time Frame
baseline (week 0), week 6, week 12, week 25, week 38
Title
Client Satisfaction Questionnaire
Description
self-report measure of treatment satisfaction. Scores range 0 to 32, higher scores reflecting greater satisfaction with services received.
Time Frame
week 6, week 12, week 25, week 38
Title
Stop Signal task
Description
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.
Time Frame
baseline (week 0), week 6, week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
American University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34656205
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.
Results Reference
derived
Learn more about this trial
Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania
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