Cognitive Behavioral Therapy for Trichotillomania (CBT for TTM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00740909
Recruitment Status : Completed
First Posted : August 25, 2008
Last Update Posted : June 20, 2012
Emory University
Information provided by (Responsible Party):
Nancy J. Keuthen, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Trichotillomania Behavioral: Cognitive Behavioral Therapy Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy for Trichotillomania
Study Start Date : November 2008
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Arm Intervention/treatment
No Intervention: MAC
Minimal Attention Control
Experimental: CBT
Cognitive Behavioral Therapy
Behavioral: Cognitive Behavioral Therapy
A therapy designed to help patients with response prevention skills.

Primary Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00740909

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Emory University
Principal Investigator: Nancy Keuthen, PhD Massachusetts General Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nancy J. Keuthen, Nancy J. Keuthen, Ph.D, Massachusetts General Hospital Identifier: NCT00740909     History of Changes
Other Study ID Numbers: 2008P000565
First Posted: August 25, 2008    Key Record Dates
Last Update Posted: June 20, 2012
Last Verified: June 2012

Keywords provided by Nancy J. Keuthen, Massachusetts General Hospital:
Hair Pulling
Cognitive Behavioral Therapy
Behavioral Therapy

Additional relevant MeSH terms:
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders