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Cognitive Behavioral Therapy for Trichotillomania (CBT for TTM)

Primary Purpose

Trichotillomania

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trichotillomania focused on measuring Trich, Hair Pulling, Cognitive Behavioral Therapy, Behavioral Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

MAC

CBT

Arm Description

Minimal Attention Control

Cognitive Behavioral Therapy

Outcomes

Primary Outcome Measures

Massachusetts General Hospital Hair Pulling Scale (MGHHPS)
NIMH Trichotillomania Severity Scale (NIMH-TSS)
NIMH Trichotillomania Impairment Scale (NIMH-TIS)

Secondary Outcome Measures

Full Information

First Posted
August 21, 2008
Last Updated
June 19, 2012
Sponsor
Massachusetts General Hospital
Collaborators
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT00740909
Brief Title
Cognitive Behavioral Therapy for Trichotillomania
Acronym
CBT for TTM
Official Title
Cognitive Behavioral Therapy for Trichotillomania
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Emory University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania
Keywords
Trich, Hair Pulling, Cognitive Behavioral Therapy, Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MAC
Arm Type
No Intervention
Arm Description
Minimal Attention Control
Arm Title
CBT
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
A therapy designed to help patients with response prevention skills.
Primary Outcome Measure Information:
Title
Massachusetts General Hospital Hair Pulling Scale (MGHHPS)
Time Frame
Baseline, weekly visits, follow-up
Title
NIMH Trichotillomania Severity Scale (NIMH-TSS)
Time Frame
Baseline, weekly visits, follow-up
Title
NIMH Trichotillomania Impairment Scale (NIMH-TIS)
Time Frame
Baseline, weekly visits, follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Keuthen, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21456040
Citation
Keuthen NJ, Rothbaum BO, Falkenstein MJ, Meunier S, Timpano KR, Jenike MA, Welch SS. DBT-enhanced habit reversal treatment for trichotillomania: 3-and 6-month follow-up results. Depress Anxiety. 2011 Apr;28(4):310-3. doi: 10.1002/da.20778. Epub 2010 Dec 15.
Results Reference
derived

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Cognitive Behavioral Therapy for Trichotillomania

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