Testing a New Therapy for Trichotillomania

NCT ID: NCT00872742

Last Updated: 2021-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2015-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Trichotillomania

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Participants will receive acceptance enhanced behavior therapy (AEBT) for trichotillomania (TTM).

Group Type EXPERIMENTAL

Acceptance enhanced behavior therapy (AEBT)

Intervention Type BEHAVIORAL

Ten 1-hour sessions over 12 weeks, enhancing awareness of hair-pulling behavior and teaching strategies to deal with hair pulling

2

Participants will receive psychoeducation and supportive therapy (PST) for TTM.

Group Type ACTIVE_COMPARATOR

Psychoeducation and supportive therapy (PST)

Intervention Type BEHAVIORAL

Ten 1-hour sessions over 12 weeks, teaching the participant about hair pulling and discussing how hair pulling affects those who do it

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Other Intervention Names

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Acceptance and Commitment Therapy ACT Habit Reversal Behavior Therapy Supportive Therapy Psychoeducation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Wisconsin, Milwaukee

OTHER

Sponsor Role lead

Responsible Party

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Douglas Woods

Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Douglas W. Woods, PhD

Role: PRINCIPAL_INVESTIGATOR

Marquette University

Locations

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Marquette University

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Barber KE, Woods DW, Deckersbach T, Bauer CC, Compton SN, Twohig MP, Ricketts EJ, Robinson J, Saunders SM, Franklin ME. Neurocognitive functioning in adults with trichotillomania: Predictors of treatment response and symptom severity in a randomized control trial. Behav Res Ther. 2024 Aug;179:104556. doi: 10.1016/j.brat.2024.104556. Epub 2024 May 9.

Reference Type DERIVED
PMID: 38761558 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27724833 (View on PubMed)

Other Identifiers

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R01MH080966

Identifier Type: NIH

Identifier Source: secondary_id

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DATR A2-AIR

Identifier Type: -

Identifier Source: secondary_id

1R01MH080966

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIMH-3065236

Identifier Type: -

Identifier Source: secondary_id

R01MH080966

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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