Testing a New Therapy for Trichotillomania

Sponsor
University of Wisconsin, Milwaukee (Other)
Overall Status
Completed
CT.gov ID
NCT00872742
Collaborator
National Institute of Mental Health (NIMH) (NIH)
85
1
2
81
1

Study Details

Study Description

Brief Summary

This study will test the effectiveness of a new behavioral therapy for adults with trichotillomania (compulsive hair pulling).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Acceptance enhanced behavior therapy (AEBT)
  • Behavioral: Psychoeducation and supportive therapy (PST)
Phase 2

Detailed Description

Trichotillomania (TTM) is a disorder in which people compulsively pull out their own hair. Treatments for TTM sometimes do not have long-term effectiveness. Acceptance and commitment therapy (ACT) is a therapeutic approach thought to have longer lasting effects than standard cognitive behavioral therapy (CBT) approaches, because ACT focuses on accepting thoughts and behaviors as opposed to changing them. Previous research indicates that a combination of ACT and habit reversal behavioral therapy is more effective than no treatment. This study will test whether a combination of ACT and behavioral therapy, called acceptance enhanced behavioral therapy (AEBT), is more effective than the current standard treatment for TTM.

Participation in this study will last 12 weeks, and follow-up assessments will last for 6 months. At study entry, participants will complete a brief intelligence test and an in-person interview about their medical history, psychiatric history, and hair pulling. At their second visit, participants will have digital pictures taken of their hair-pulling sites and complete two computer tasks measuring their response inhibition and cognitive flexibility. After the second visit, participants will be randomly assigned to receive either AEBT or psychoeducation and supportive therapy (PST)-a standard treatment for TTM. Both treatments will involve ten 1-hour sessions completed over 12 weeks. Assessments of participants will occur after 6 weeks of treatment, at treatment completion, and after 6 months. These assessments will measure treatment effectiveness, based on several clinical scales and measures of TTM symptoms. Participants who receive PST during this study will be offered AEBT afterward.

Study Design

Study Type:
Interventional
Actual Enrollment :
85 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Acceptance Enhanced Behavior Therapy for Trichotillomania
Study Start Date :
Mar 1, 2009
Actual Primary Completion Date :
Oct 1, 2013
Actual Study Completion Date :
Nov 30, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Participants will receive acceptance enhanced behavior therapy (AEBT) for trichotillomania (TTM).

Behavioral: Acceptance enhanced behavior therapy (AEBT)
Ten 1-hour sessions over 12 weeks, enhancing awareness of hair-pulling behavior and teaching strategies to deal with hair pulling
Other Names:
  • Acceptance and Commitment Therapy
  • ACT
  • Habit Reversal
  • Behavior Therapy
  • Active Comparator: 2

    Participants will receive psychoeducation and supportive therapy (PST) for TTM.

    Behavioral: Psychoeducation and supportive therapy (PST)
    Ten 1-hour sessions over 12 weeks, teaching the participant about hair pulling and discussing how hair pulling affects those who do it
    Other Names:
  • Supportive Therapy
  • Psychoeducation
  • Outcome Measures

    Primary Outcome Measures

    1. Clinical Global Impressions-Improvement Scale [Measured after 6 weeks, 12 weeks, and 6 months]

    Secondary Outcome Measures

    1. Massachusetts General Hospital Hairpulling Scale [Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months]

    2. National Institute of Mental Health (NIMH) Trichotillomania Severity and Impairment Scales [Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months]

    3. Clinical Global Impressions-Severity Scale [Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Current DSM-IV diagnosis of trichotillomania

    • Massachusetts General Hospital Hair Scale score greater than 12

    • Wechsler Test of Adult Reading score greater than 85

    • Fluent in English

    • Outpatient status

    • Agreement to not alter the dosage of any psychotropic medication throughout the course of the study, or, if such a dosage change is required, understanding that the participant will continue to receive treatment, and data will continue to be collected on him or her

    • Individuals who eat their hair after pulling will be eligible for participation only after they have received a physical exam from their primary care physician to determine whether there is any gastrointestinal blockage due to hair pulling, which would require more immediate clinical care.

    Exclusion Criteria:
    • Diagnosis of bipolar disorder, psychotic disorder, mental retardation, pervasive developmental disorder, or current substance dependence (with the exception of nicotine dependence)

    • Current mood or anxiety disorder with an active suicide risk

    • Currently receiving psychotherapy for trichotillomania or another psychiatric condition

    • Initiation or change in the dosage of any psychotropic medication for up to 8 weeks preceding participation in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Marquette University Milwaukee Wisconsin United States 53211

    Sponsors and Collaborators

    • University of Wisconsin, Milwaukee
    • National Institute of Mental Health (NIMH)

    Investigators

    • Principal Investigator: Douglas W. Woods, PhD, Marquette University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Douglas Woods, Professor of Psychology, Marquette University
    ClinicalTrials.gov Identifier:
    NCT00872742
    Other Study ID Numbers:
    • R01MH080966
    • R01MH080966
    • DATR A2-AIR
    • 1R01MH080966
    • NIMH-3065236
    First Posted:
    Mar 31, 2009
    Last Update Posted:
    Oct 5, 2021
    Last Verified:
    Sep 1, 2021
    Keywords provided by Douglas Woods, Professor of Psychology, Marquette University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 5, 2021