Cognitive Behavioral Therapy for Trichotillomania - Full Text View

Sponsors and Collaborators:	Massachusetts General Hospital Emory University
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00740909

Purpose

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 and 3-month follow-up will be better for the CBT vs. MAC condition including higher responder rates and greater reduction in hair pulling severity.

Condition	Intervention	Phase
Trichotillomania	Behavioral: Cognitive Behavioral Therapy	Phase I Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment
Official Title:	Cognitive Behavioral Therapy for Trichotillomania

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Massachusetts General Hospital Hair Pulling Scale (MGHHPS) [ Time Frame: Baseline, weekly visits, follow-up ] [ Designated as safety issue: No ]
Psychiatric Institute Trichotillomania Scale (PITS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
NIMH Trichotillomania Severity Scale (NIMH-TSS) [ Time Frame: Baseline, weekly visits, follow-up ] [ Designated as safety issue: No ]
NIMH Trichotillomania Impairment Scale (NIMH-TIS) [ Time Frame: Baseline, weekly visits, follow-up ] [ Designated as safety issue: No ]
Clinical Global Improvement Scale (CGI) [ Time Frame: baseline, weekly visits, follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	5
Study Start Date:	November 2008
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
MAC: No Intervention Minimal Attention Control
CBT: Experimental Cognitive Behavioral Therapy	Behavioral: Cognitive Behavioral Therapy A therapy designed to help patients with response prevention skills.

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 Barratt Impulsivity Scale (BIS-11), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Clinical Global Impressions Scale (CGI), Hair Pulling Scale (HPS), Trichotillomania (TTM) Impact Scale, Psychiatric Institute Trichotillomania Scale (PITS), National Institute of Mental Health Trichotillomania Severity Scale(NIMH-TSS), The Milwaukee Inventory for Subtypes of Trichotillomania- Adult Version (MIST-A), the Quality of Life Inventory (QOLI), the Self-Esteem Scale (SES), 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
involvement in other psychiatric treatment
psychotropic medications within 2 months of baseline assessment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740909

Contacts

Contact: Caitlin Taylor, B.A.

617-643-6204

ctaylor15@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Emory University

Investigators

Principal Investigator:

Nancy Keuthen, PhD

Massachusetts General Hospital

More Information

Responsible Party:	Massachusetts General Hospital and Harvard Medical School ( Nancy Keuthen, PhD )
Study ID Numbers:	2008P000565
Study First Received:	August 21, 2008
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00740909
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Trich
Hair Pulling
Cognitive Behavioral Therapy
Behavioral Therapy

Study placed in the following topic categories:

Impulse Control Disorders
Mental Disorders
Trichotillomania

ClinicalTrials.gov processed this record on January 16, 2009