Testing a New Therapy for Trichotillomania
Primary Purpose
Trichotillomania
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acceptance enhanced behavior therapy (AEBT)
Psychoeducation and supportive therapy (PST)
Sponsored by
About this trial
This is an interventional treatment trial for Trichotillomania focused on measuring Impulse Control Disorders, Behavior Therapy, Acceptance, Habit Reversal
Eligibility Criteria
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
Sites / Locations
- Marquette University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Participants will receive acceptance enhanced behavior therapy (AEBT) for trichotillomania (TTM).
Participants will receive psychoeducation and supportive therapy (PST) for TTM.
Outcomes
Primary Outcome Measures
Clinical Global Impressions-Improvement Scale
Secondary Outcome Measures
Massachusetts General Hospital Hairpulling Scale
National Institute of Mental Health (NIMH) Trichotillomania Severity and Impairment Scales
Clinical Global Impressions-Severity Scale
Full Information
NCT ID
NCT00872742
First Posted
March 30, 2009
Last Updated
September 27, 2021
Sponsor
University of Wisconsin, Milwaukee
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00872742
Brief Title
Testing a New Therapy for Trichotillomania
Official Title
Acceptance Enhanced Behavior Therapy for Trichotillomania
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Wisconsin, Milwaukee
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will test the effectiveness of a new behavioral therapy for adults with trichotillomania (compulsive hair pulling).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania
Keywords
Impulse Control Disorders, Behavior Therapy, Acceptance, Habit Reversal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive acceptance enhanced behavior therapy (AEBT) for trichotillomania (TTM).
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive psychoeducation and supportive therapy (PST) for TTM.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance enhanced behavior therapy (AEBT)
Other Intervention Name(s)
Acceptance and Commitment Therapy, ACT, Habit Reversal, Behavior Therapy
Intervention Description
Ten 1-hour sessions over 12 weeks, enhancing awareness of hair-pulling behavior and teaching strategies to deal with hair pulling
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation and supportive therapy (PST)
Other Intervention Name(s)
Supportive Therapy, Psychoeducation
Intervention Description
Ten 1-hour sessions over 12 weeks, teaching the participant about hair pulling and discussing how hair pulling affects those who do it
Primary Outcome Measure Information:
Title
Clinical Global Impressions-Improvement Scale
Time Frame
Measured after 6 weeks, 12 weeks, and 6 months
Secondary Outcome Measure Information:
Title
Massachusetts General Hospital Hairpulling Scale
Time Frame
Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months
Title
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
Title
Clinical Global Impressions-Severity Scale
Time Frame
Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas W. Woods, PhD
Organizational Affiliation
Marquette University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marquette University
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27724833
Citation
Houghton DC, McFarland CS, Franklin ME, Twohig MP, Compton SN, Neal-Barnett AM, Saunders SM, Woods DW. DSM-5 Trichotillomania: Perception of Adults With Trichotillomania After Psychosocial Treatment. Psychiatry. 2016 Summer;79(2):164-169. doi: 10.1080/00332747.2016.1144438.
Results Reference
derived
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Testing a New Therapy for Trichotillomania
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