Testing a New Therapy for Trichotillomania

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Douglas W. Woods, Texas A&M University
ClinicalTrials.gov Identifier:
NCT00872742
First received: March 30, 2009
Last updated: April 8, 2014
Last verified: April 2014
  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

Further study details as provided by University of Wisconsin, Milwaukee:

Primary Outcome Measures:
  • Clinical Global Impressions-Improvement Scale [ Time Frame: Measured after 6 weeks, 12 weeks, and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: October 2014
Primary Completion Date: October 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:
  • Acceptance and Commitment Therapy
  • ACT
  • Habit Reversal
  • Behavior Therapy
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:
  • Supportive Therapy
  • Psychoeducation

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872742

Locations
United States, Texas
Texas A&M University
College Station, Texas, United States, 77845
Sponsors and Collaborators
University of Wisconsin, Milwaukee
Investigators
Principal Investigator: Douglas W. Woods, PhD Texas A&M University
  More Information

No publications provided

Responsible Party: Douglas W. Woods, Professor of Psychology, Texas A&M University
ClinicalTrials.gov Identifier: NCT00872742     History of Changes
Other Study ID Numbers: R01 MH080966, R01MH080966, DATR A2-AIR, 1R01MH080966, NIMH-3065236
Study First Received: March 30, 2009
Last Updated: April 8, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Wisconsin, Milwaukee:
Impulse Control Disorders
Behavior Therapy
Acceptance
Habit Reversal

Additional relevant MeSH terms:
Trichotillomania
Impulse Control Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014