Clinical trial NCT00872742: Testing a New Therapy for Trichotillomania
Official title: Acceptance Enhanced Behavior Therapy for Trichotillomania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Trichotillomania
Keywords: Impulse Control Disorders
Behavior Therapy
Acceptance
Habit Reversal
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-03-31
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical Global Impressions-Improvement Scale
timeFrame: Measured after 6 weeks, 12 weeks, and 6 months
Secondary outcomes:
measure: Massachusetts General Hospital Hairpulling Scale
timeFrame: Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months
measure: National Institute of Mental Health (NIMH) Trichotillomania Severity and Impairment Scales
timeFrame: Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months
measure: Clinical Global Impressions-Severity Scale
timeFrame: Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Marquette University
state: Wisconsin
Study officials:
affiliation: Marquette University
name: Douglas W. Woods, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.