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| Name | Class |
|---|---|
| University of Chicago | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immediate ComB | Experimental | 12 weekly sessions of ComB treatment in individual therapy, following a detailed manual. |
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| 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]. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version [Revised by Keuthen et al.] |
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Inclusion Criteria:
18 years of age or older
Exclusion Criteria:
active suicidality
--probable bipolar disorder
probable psychosis
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American University | Washington D.C. | District of Columbia | 20016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34656205 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 15, 2022 | |
| Reset | Apr 14, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 15, 2022 | Apr 14, 2022 |
| ID | Term |
|---|---|
| D014256 | Trichotillomania |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
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| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| ID | Term |
|---|---|
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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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).
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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.
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| Attention | Behavioral | Weekly brief calls from therapist to check on safety and clinical status. No focus on TTM. |
|
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)](streamdown:incomplete-link) |
| baseline (week 0), week 6, week 12, week 25, week 38 |
| 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 |
| 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 |