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CompletedNCT00740909CBT for TTMUpdated Jun 20, 2012

Cognitive Behavioral Therapy for Trichotillomania

A Phase 1/2 interventional study of Cognitive Behavioral Therapy in Trichotillomania, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-20.

Sponsored by Massachusetts General Hospital · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Trichotillomania

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Keywords

  • Trich
  • Hair Pulling
  • Cognitive Behavioral Therapy
  • Behavioral Therapy
03

In context

Trichotillomania

44 studies on the registry are indexed under Trichotillomania; 7 are open to participants now.

This study's enrollment of 38 is close to the median of 38 across 42 interventional studies indexed under Trichotillomania.

Browse Trichotillomania studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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)
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
38 participants (actual)

Study arms

  • No intervention
    MAC

    Minimal Attention Control

  • Experimental
    CBT

    Cognitive Behavioral Therapy

    Behavioral: Cognitive Behavioral Therapy

Interventions

  • BehavioralCognitive Behavioral Therapy

    A therapy designed to help patients with response prevention skills.

06

What researchers measure

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

07

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

References and documents

Publications

  • 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. PubMed 21456040 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00740909
Lead sponsor
Massachusetts General Hospital
Collaborators
Emory University
Responsible party
Nancy J. Keuthen (Nancy J. Keuthen, Ph.D, Massachusetts General Hospital) — Principal investigator
First posted
Aug 25, 2008
Start date
Nov 2008
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Jun 20, 2012

Study contacts

Nancy Keuthen, PhD
principal investigator · Massachusetts General Hospital
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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