Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03486041
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
University of Chicago
Information provided by (Responsible Party):
David A. F. Haaga, American University

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.

Condition or disease Intervention/treatment Phase
Trichotillomania Behavioral: Comprehensive Behavior Modification Behavioral: Attention Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
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.
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of the Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania
Actual Study Start Date : May 10, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: immediate ComB
12 weekly sessions of ComB treatment in individual therapy, following a detailed manual.
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.

Placebo Comparator: Minimal Attention Control
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
Weekly brief calls from therapist to check on safety and clinical status. No focus on TTM.




Primary Outcome Measures :
  1. Change in Massachusetts General Hospital Hairpulling Scale [ Time Frame: 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.

  2. Change in National Institute of Mental Health (NIMH) Trichotillomania Severity and Impairment Scales [ Time Frame: 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

  3. Change in Trichotillomania Diagnostic Interview (modified for DSM-5) [ Time Frame: baseline (week 0), week 6, week 12, week 25, week 38 ]
    structured diagnostic interview to determine presence/absence of TTM


Secondary Outcome Measures :
  1. Alopecia rating [ Time Frame: 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)

  2. Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version [Revised by Keuthen et al.] [ Time Frame: 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)

  3. Client Satisfaction Questionnaire [ Time Frame: 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.

  4. Stop Signal task [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486041


Contacts
Layout table for location contacts
Contact: David A.F. Haaga, Ph.D. 202-885-1718 dhaaga@american.edu
Contact: Emily Carlson, BA 202-885-1710 ec9671a@american.edu

Locations
Layout table for location information
United States, District of Columbia
American University Recruiting
Washington, District of Columbia, United States, 20016
Contact: David Haaga, PhD       dhaaga@american.edu   
Contact: Emily Carlson, BA       ec9671a@student.american.edu   
Sponsors and Collaborators
American University
University of Chicago

Layout table for additonal information
Responsible Party: David A. F. Haaga, Professor of Psychology, American University
ClinicalTrials.gov Identifier: NCT03486041     History of Changes
Other Study ID Numbers: ComB controlled trial
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Trichotillomania
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders