Testing a New Therapy for Trichotillomania
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Purpose
This study will test the effectiveness of a new behavioral therapy for adults with trichotillomania (compulsive hair pulling).
| Condition | Intervention | Phase |
|---|---|---|
|
Trichotillomania |
Behavioral: Acceptance enhanced behavior therapy (AEBT) Behavioral: Psychoeducation and supportive therapy (PST) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Acceptance Enhanced Behavior Therapy for Trichotillomania |
- Clinical Global Impressions-Improvement Scale [ Time Frame: Measured after 6 weeks, 12 weeks, and 6 months ] [ Designated as safety issue: No ]
- Massachusetts General Hospital Hairpulling Scale [ Time Frame: Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months ] [ Designated as safety issue: No ]
- National Institute of Mental Health (NIMH) Trichotillomania Severity and Impairment Scales [ Time Frame: Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months ] [ Designated as safety issue: No ]
- Clinical Global Impressions-Severity Scale [ Time Frame: Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 84 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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| Contact: Douglas W. Woods, PhD | 414-229-5335 | dwoods@uwm.edu |
| Contact: Michael R. Walther, BA | 414-229-2830 | mwalther@uwm.edu |
| United States, Wisconsin | |
| University of Wisconsin-Milwaukee | Recruiting |
| Milwaukee, Wisconsin, United States, 53201 | |
| Contact: Douglas W. Woods, PhD 414-229-5335 dwoods@uwm.edu | |
| Contact: Michael R. Walther, BA 414-229-6078 mwalther@uwm.edu | |
| Principal Investigator: Douglas W. Woods, PhD | |
| Principal Investigator: | Douglas W. Woods, PhD | University of Wisconsin, Milwaukee |
More Information
No publications provided
| Responsible Party: | Douglas W. Woods, PhD, University of Wisconsin-Milwaukee |
| ClinicalTrials.gov Identifier: | NCT00872742 History of Changes |
| Other Study ID Numbers: | R01 MH080966, DATR A2-AIR, 1R01MH080966, NIMH-3065236 |
| Study First Received: | March 30, 2009 |
| Last Updated: | April 3, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Impulse Control Disorders Behavior Therapy Acceptance Habit Reversal |
Additional relevant MeSH terms:
|
Trichotillomania Impulse Control Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013