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Completed

NCT Number: NCT00740909

Cognitive Behavioral Therapy for Trichotillomania

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cognitive behavioral therapy

Behavioral

A therapy designed to help patients with response prevention skills.

Primary outcomes

  1. Massachusetts General Hospital Hair Pulling Scale (MGHHPS)

    Time frame: Baseline, weekly visits, follow-up

  2. NIMH Trichotillomania Severity Scale (NIMH-TSS)

    Time frame: Baseline, weekly visits, follow-up

  3. NIMH Trichotillomania Impairment Scale (NIMH-TIS)

    Time frame: Baseline, weekly visits, follow-up

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Emory University

Registry information

Acronym: CBT for TTM

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Aug 25, 2008
Registry last updated
Jun 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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