Trichotillomania
Conditions
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.
Interventions
BEHAVIORALComprehensive 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.
BEHAVIORALAttention
Weekly brief calls from therapist to check on safety and clinical status. No focus on TTM.
Sponsors
University of Chicago
American University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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.
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Massachusetts General Hospital Hairpulling Scale | 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. |
| Change in National Institute of Mental Health (NIMH) Trichotillomania Severity and Impairment Scales | 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 |
| Change in Trichotillomania Diagnostic Interview (modified for DSM-5) | baseline (week 0), week 6, week 12, week 25, week 38 | structured diagnostic interview to determine presence/absence of TTM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alopecia rating | 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) |
| Stop Signal task | 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. |
| Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version [Revised by Keuthen et al.] | 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) |
| Client Satisfaction Questionnaire | 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. |
Countries
United States
Outcome results
None listed