- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00872742
Testing a New Therapy for Trichotillomania
Acceptance Enhanced Behavior Therapy for Trichotillomania
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Wisconsin
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Milwaukee, Wisconsin, United States, 53211
- Marquette University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 1
Participants will receive acceptance enhanced behavior therapy (AEBT) for trichotillomania (TTM).
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Ten 1-hour sessions over 12 weeks, enhancing awareness of hair-pulling behavior and teaching strategies to deal with hair pulling
Other Names:
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ACTIVE_COMPARATOR: 2
Participants will receive psychoeducation and supportive therapy (PST) for TTM.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical Global Impressions-Improvement Scale
Time Frame: Measured after 6 weeks, 12 weeks, and 6 months
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Measured after 6 weeks, 12 weeks, and 6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Massachusetts General Hospital Hairpulling Scale
Time Frame: Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months
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Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months
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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
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Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months
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Clinical Global Impressions-Severity Scale
Time Frame: Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months
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Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Douglas W. Woods, PhD, Marquette University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH080966 (NIH)
- DATR A2-AIR
- 1R01MH080966 (NIH)
- NIMH-3065236
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trichotillomania
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Johns Hopkins UniversityRecruitingTrichotillomania | Trichotillomania (Hair-Pulling Disorder) | Hair PullingUnited States
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University of ChicagoNot yet recruitingTrichotillomania (Hair-Pulling Disorder) | DermatillomaniaUnited States
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University of ChicagoCompletedTrichotillomania (Hair-Pulling Disorder) | DermatillomaniaUnited States
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University of ChicagoRecruitingTrichotillomania (Hair-Pulling Disorder) | Skin-PickingUnited States
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American UniversityCompletedTrichotillomania (Hair-Pulling Disorder) | Skin-PickingUnited States
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Yale UniversityNeurocrine BiosciencesRecruitingTrichotillomania (Hair-Pulling Disorder)United States
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HabitAware Inc.National Institute of Mental Health (NIMH); Marquette UniversityCompletedTrichotillomaniaUnited States
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University of Wisconsin, MilwaukeeCompleted
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University of PennsylvaniaNational Institute of Mental Health (NIMH)CompletedTrichotillomaniaUnited States
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University of Sao PauloCompleted
Clinical Trials on Acceptance enhanced behavior therapy (AEBT)
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Utah State UniversityUnknownTrichotillomaniaUnited States
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Utah State UniversityActive, not recruitingExcoriation (Skin-Picking) DisorderUnited States
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Utah State UniversityCompletedAEBT Website With Check-ins | AEBT Website Without Check-insUnited States
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Brown UniversityNational Institute of Mental Health (NIMH)RecruitingHIV/AIDSUnited States
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Drexel UniversityCompletedObesity | Overweight | Weight LossUnited States
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Karolinska InstitutetRegion StockholmCompletedSchizophrenia Spectrum and Other Psychotic Disorders
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Drexel UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Yale...Active, not recruitingBinge-Eating Disorder | Weight Loss | Binge Eating | Eating DisorderUnited States
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Brown UniversityNational Institute of Mental Health (NIMH)Recruiting
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University of AarhusKarolinska University Hospital; Aarhus University Hospital; National Research...CompletedAcceptance and Commitment Group Therapy for Adolescents With a Range of Functional Somatic SyndromesSomatoform Disorders | Somatization DisorderDenmark
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Oslo University HospitalCompletedIntentional Self HarmNorway