NCT00740909

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

June 20, 2012

Status Verified

June 1, 2012

Enrollment Period

3.2 years

First QC Date

August 21, 2008

Last Update Submit

June 19, 2012

Conditions

Trichotillomania

Keywords

TrichHair PullingCognitive Behavioral TherapyBehavioral Therapy

Outcome Measures

Primary Outcomes (3)

  • Massachusetts General Hospital Hair Pulling Scale (MGHHPS)

    Baseline, weekly visits, follow-up

  • NIMH Trichotillomania Severity Scale (NIMH-TSS)

    Baseline, weekly visits, follow-up

  • NIMH Trichotillomania Impairment Scale (NIMH-TIS)

    Baseline, weekly visits, follow-up

Study Arms (2)

MAC

NO INTERVENTION

Minimal Attention Control

CBT

EXPERIMENTAL

Cognitive Behavioral Therapy

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

A therapy designed to help patients with response prevention skills.

CBT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 21456040DERIVED

MeSH Terms

Conditions

TrichotillomaniaTrichomonas Infections

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Obsessive-Compulsive DisorderAnxiety DisordersMental DisordersDisruptive, Impulse Control, and Conduct DisordersProtozoan InfectionsParasitic DiseasesInfections

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Nancy Keuthen, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nancy J. Keuthen, Ph.D

Study Record Dates

First Submitted

August 21, 2008

First Posted

August 25, 2008

Study Start

November 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

June 20, 2012

Record last verified: 2012-06

Locations

US(1)