NCT00872742

Brief Summary

This study will test the effectiveness of a new behavioral therapy for adults with trichotillomania (compulsive hair pulling).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2015

Completed
Last Updated

October 5, 2021

Status Verified

September 1, 2021

Enrollment Period

4.6 years

First QC Date

March 30, 2009

Last Update Submit

September 27, 2021

Conditions

Keywords

Impulse Control DisordersBehavior TherapyAcceptanceHabit Reversal

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Impressions-Improvement Scale

    Measured after 6 weeks, 12 weeks, and 6 months

Secondary Outcomes (3)

  • Massachusetts General Hospital Hairpulling Scale

    Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months

  • National Institute of Mental Health (NIMH) Trichotillomania Severity and Impairment Scales

    Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months

  • Clinical Global Impressions-Severity Scale

    Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months

Study Arms (2)

1

EXPERIMENTAL

Participants will receive acceptance enhanced behavior therapy (AEBT) for trichotillomania (TTM).

Behavioral: Acceptance enhanced behavior therapy (AEBT)

2

ACTIVE COMPARATOR

Participants will receive psychoeducation and supportive therapy (PST) for TTM.

Behavioral: Psychoeducation and supportive therapy (PST)

Interventions

Ten 1-hour sessions over 12 weeks, enhancing awareness of hair-pulling behavior and teaching strategies to deal with hair pulling

Also known as: Acceptance and Commitment Therapy, ACT, Habit Reversal, Behavior Therapy
1

Ten 1-hour sessions over 12 weeks, teaching the participant about hair pulling and discussing how hair pulling affects those who do it

Also known as: Supportive Therapy, Psychoeducation
2

Eligibility Criteria

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

You may qualify if:

  • Current DSM-IV diagnosis of trichotillomania
  • Massachusetts General Hospital Hair Scale score greater than 12
  • Wechsler Test of Adult Reading score greater than 85
  • Fluent in English
  • Outpatient status
  • Agreement to not alter the dosage of any psychotropic medication throughout the course of the study, or, if such a dosage change is required, understanding that the participant will continue to receive treatment, and data will continue to be collected on him or her
  • Individuals who eat their hair after pulling will be eligible for participation only after they have received a physical exam from their primary care physician to determine whether there is any gastrointestinal blockage due to hair pulling, which would require more immediate clinical care.

You may not qualify if:

  • Diagnosis of bipolar disorder, psychotic disorder, mental retardation, pervasive developmental disorder, or current substance dependence (with the exception of nicotine dependence)
  • Current mood or anxiety disorder with an active suicide risk
  • Currently receiving psychotherapy for trichotillomania or another psychiatric condition
  • Initiation or change in the dosage of any psychotropic medication for up to 8 weeks preceding participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marquette University

Milwaukee, Wisconsin, 53211, United States

Location

Related Publications (2)

  • Barber KE, Woods DW, Deckersbach T, Bauer CC, Compton SN, Twohig MP, Ricketts EJ, Robinson J, Saunders SM, Franklin ME. Neurocognitive functioning in adults with trichotillomania: Predictors of treatment response and symptom severity in a randomized control trial. Behav Res Ther. 2024 Aug;179:104556. doi: 10.1016/j.brat.2024.104556. Epub 2024 May 9.

  • Houghton DC, McFarland CS, Franklin ME, Twohig MP, Compton SN, Neal-Barnett AM, Saunders SM, Woods DW. DSM-5 Trichotillomania: Perception of Adults With Trichotillomania After Psychosocial Treatment. Psychiatry. 2016 Summer;79(2):164-169. doi: 10.1080/00332747.2016.1144438.

MeSH Terms

Conditions

TrichotillomaniaDisruptive, Impulse Control, and Conduct Disorders

Interventions

Acceptance and Commitment TherapyBehavior TherapyPalliative Care

Condition Hierarchy (Ancestors)

Obsessive-Compulsive DisorderAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyPsychotherapyBehavioral Disciplines and ActivitiesPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Douglas W. Woods, PhD

    Marquette University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

March 30, 2009

First Posted

March 31, 2009

Study Start

March 1, 2009

Primary Completion

October 1, 2013

Study Completion

November 30, 2015

Last Updated

October 5, 2021

Record last verified: 2021-09

Locations