Overview

This trial is active, not recruiting.

Condition trichotillomania
Treatments acceptance enhanced behavior therapy (aebt), psychoeducation and supportive therapy (pst)
Phase phase 2
Sponsor University of Wisconsin, Milwaukee
Collaborator National Institute of Mental Health (NIMH)
Start date March 2009
End date October 2013
Trial size 84 participants
Trial identifier NCT00872742, 1R01MH080966, DATR A2-AIR, NIMH-3065236, R01 MH080966, R01MH080966

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants will receive acceptance enhanced behavior therapy (AEBT) for trichotillomania (TTM).
acceptance enhanced behavior therapy (aebt) Acceptance and Commitment Therapy
Ten 1-hour sessions over 12 weeks, enhancing awareness of hair-pulling behavior and teaching strategies to deal with hair pulling
(Active Comparator)
Participants will receive psychoeducation and supportive therapy (PST) for TTM.
psychoeducation and supportive therapy (pst) Supportive Therapy
Ten 1-hour sessions over 12 weeks, teaching the participant about hair pulling and discussing how hair pulling affects those who do it

Primary Outcomes

Measure
Clinical Global Impressions-Improvement Scale
time frame: Measured after 6 weeks, 12 weeks, and 6 months

Secondary Outcomes

Measure
Massachusetts General Hospital Hairpulling Scale
time frame: Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months
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
Clinical Global Impressions-Severity Scale
time frame: Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Acceptance Enhanced Behavior Therapy for Trichotillomania
Principal investigator Douglas W. Woods, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by University of Wisconsin, Milwaukee.