An interventional study of Comprehensive Behavior Modification and Attention in Trichotillomania, sponsored by American University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-13.
Sponsored by American University · Not applicable, Interventional, and Treatment
Among 39 studies in Trichotillomania with a site in United States — 5 open to participants now, 7 under way, 1 of them phase 3. Trichotillomania · United States.
Among the 39 studies in Trichotillomania with a site in United States, this one is the 22nd largest by enrollment of the 37 interventional ones that give a count, is one of 4 that started in 2018, is one of 18 with no phase, and was the 24th registered.
48 studies on the registry are indexed under Trichotillomania; 8 are open to participants now.
This study's enrollment of 36 is close to the median of 39 across 45 interventional studies indexed under Trichotillomania.
Browse Trichotillomania studies →5 of the 39 studies in Trichotillomania with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 6 Trichotillomania studies recruiting now, 2 (33%) set no upper age limit and 4 (67%) stop at 75 or younger; 2 take children under 18; 0 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →39 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 17 · Phase 3 2 · Phase 4 1
First in 1996; this study’s year is marked. 4 started in 2018.
Median enrollment 39 across the 37 interventional studies, 734 across the 2 observational. Of the 31 that completed or were terminated, 13 (42%) have results posted.
5 of 39 have an industry lead sponsor. The 10 most frequent:
American University is the lead sponsor of 20 studies on the registry; 4 are open to participants now.
American University has 4 studies filed under Trichotillomania — fewer than ten, so there is no comparison to draw.
4 of the studies in Trichotillomania with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05118633HabitAware Inc.Technology Assisted Treatment for Trichotillomania | 2026-12-31 |
| NCT01075672Massachusetts General HospitalOutcomes of Cognitive Behavioral Therapy (CBT) Interventions Provided by Unlicensed Professionals | 2027-01 |
| NCT05207085Yale UniversityEfficacy of Valbenazine for the Treatment of Trichotillomania in Adults | 2027-02-15 |
| NCT05377125University of Wisconsin, MilwaukeeNeural Mechanisms of Response Inhibition Training for OCRD | 2027-07-31 |
Among the 39 studies in Trichotillomania with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
18 years of age or older
Exclusion Criteria:
active suicidality
--probable bipolar disorder
probable psychosis
12 weekly sessions of ComB treatment in individual therapy, following a detailed manual.
Behavioral: Comprehensive Behavior Modification
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 \[as in the Experimental condition -- 12 weekly sessions of individual therapy for TTM based on ComB model\].
Behavioral: Attention
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.
Weekly brief calls from therapist to check on safety and clinical status. No focus on TTM.
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.
Time frame: 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
Time frame: 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
Time frame: baseline (week 0), week 6, week 12, week 25, week 38
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)
Time frame: baseline (week 0), week 6, week 12, week 25, week 38
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)
Time frame: 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.
Time frame: 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.
Time frame: baseline (week 0), week 6, week 12
Ran from May 2018 to primary completion in Apr 2020, 23 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
American University