Cognitive Behavioral Therapy for Trichotillomania

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Brief Title

Cognitive Behavioral Therapy for Trichotillomania

Official Title

Cognitive Behavioral Therapy for Trichotillomania

Brief Summary

      This study aims to develop a comprehensive Cognitive Behavioral Therapy protocol for adult
      patients with Trichotillomania that emphasizes relapse prevention and that addresses comorbid
      affective symptoms, as well. The study will compare the efficacy of CBT with a minimal
      attention control (MAC)condition. We hypothesize that outcome at post-treatment, 3-month, and
      6-month follow-up will be better for the CBT vs. MAC condition including higher responder
      rates and greater reduction in hair pulling severity.
    

Detailed Description

      The purpose of this study is to assess the efficacy of cognitive behavioral therapy for
      patients with trichotillomania.

      Following entry into the study, subjects will be randomized into a cognitive behavioral
      therapy (CBT) or a minimized attention control (MAC) condition. Subjects will be assessed
      with the Acceptance and Action Questionnaire (AAQ), the Affective Regulation Rating (ARR),
      the Barratt Impulsivity Scale (BIS-11), Beck Depression Inventory (BDI), Beck Anxiety
      Inventory (BAI), Clinical Global Impressions Scale (CGI), the Difficulties in Emotion
      Regulation Scale (DERS), Hair Pulling Scale (HPS), Trichotillomania (TTM) Impact Scale,
      Psychiatric Institute Trichotillomania Scale (PITS), National Institute of Mental Health
      Trichotillomania Severity Scale(NIMH-TSS), the Generalized Expectancy for Negative Mood
      Regulation Scale (NMR), The Milwaukee Inventory for Subtypes of Trichotillomania- Adult
      Version (MIST-A), the Positive and Negative Affect Scale (PANAS), the Quality of Life
      Inventory (QOLI), the Readiness to Change Hairpulling Behavior (RCHPB), the Self-Esteem Scale
      (SES), the Skin Picking Scale (SPS) and the Scales of Psychological Well-Being (SPWB).
      Subject randomization to a treatment arm will be determined by a random number generator.

      Subject change scores will be assessed for the above scales.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Massachusetts General Hospital Hair Pulling Scale (MGHHPS)


Condition

Trichotillomania

Intervention

Cognitive Behavioral Therapy

Study Arms / Comparison Groups

 MAC
Description:  Minimal Attention Control

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

38

Start Date

November 2008

Completion Date

January 2012

Primary Completion Date

January 2012

Eligibility Criteria

        Inclusion Criteria:

          -  primary DSM-IV diagnosis of TTM

          -  outpatients who are 18 or older

          -  a minimum MGHHPS total scale score of 10

          -  a minimum TTM symptom duration of 1 year with no significant remissions (as defined by
             complete abstinence of hair extraction for a 2-week period during the prior 6 months)

        Exclusion Criteria:

          -  presence of a serious psychiatric condition including mental retardation, psychosis,
             pervasive developmental disorder, organic mental disorders, manic episode, ADHD,
             suicidality, lifetime alcohol or substance dependence, or alcohol or substance abuse
             within the past 3 months

          -  presence of a serious medical condition that would limit ability to routinely attend
             sessions and complete homework assignments

          -  individual or group psychotherapy (not addressing TTM) that has not been ongoing for
             the past 3 months and/or without intent to continue same treatment during study
             tenure)

          -  previous CBT for TTM

          -  involvement in other treatment for TTM

          -  psychotropic medication that has not been stable for 3 months prior to study
             enrollment and/or without intent to continue same medication regimen during study
             tenure)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Nancy Keuthen, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00740909

Organization ID

2008P000565


Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital

Collaborators

 Emory University

Study Sponsor

Nancy Keuthen, PhD, Principal Investigator, Massachusetts General Hospital


Verification Date

June 2012