Testing a New Therapy for Trichotillomania

Trichotillomania Clinical Trial

Official title:

Acceptance Enhanced Behavior Therapy for Trichotillomania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872742
• Other study ID #: R01MH080966
• Secondary ID: R01MH080966DATR
• Status: Completed
• Phase: Phase 2
• Start date: March 2009
• Est. completion date: November 30, 2015

Study information

• Verified date: September 2021
• Source: University of Wisconsin, Milwaukee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: November 30, 2015
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Trichotillomania

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Marquette University	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Milwaukee	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impressions-Improvement Scale		Measured after 6 weeks, 12 weeks, and 6 months
Secondary	Massachusetts General Hospital Hairpulling Scale		Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months
Secondary	National Institute of Mental Health (NIMH) Trichotillomania Severity and Impairment Scales		Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months
Secondary	Clinical Global Impressions-Severity Scale		Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months