NCT01968343

Brief Summary

Objective: Trichotillomania is a psychiatric condition characterized by chronic pulling and plucking of one's own hair. Cognitive behavioral therapy shows promise as a treatment. However, there have been no randomized, controlled studies of the efficacy of group cognitive-behavioral therapy. Methods: We evaluated 44 subjects, whom met the criteria for a diagnosis of trichotillomania. Subjects were randomized to receive 22 sessions of either group cognitive-behavioral therapy or group supportive therapy (control).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 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

January 1, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 24, 2013

Completed
Last Updated

August 19, 2015

Status Verified

October 1, 2013

Enrollment Period

2.9 years

First QC Date

September 20, 2013

Last Update Submit

August 18, 2015

Conditions

Trichotillomania

Outcome Measures

Primary Outcomes (1)

  • Massachusetts General Hospital (MGH) Hairpulling Scale (HPS)

    The MGH-HPS comprises seven self-report items that are scored on a Likert scale (0-4 points).22 Higher MGH-HPS scores correspond to greater severity of trichotillomania symptoms. Reference: Psychotherapy and Psychosomatic Journal 1995;64:141-5

    22 weeks

Secondary Outcomes (1)

  • Beck Depression Inventory (BDI)

    22 weeks

Other Outcomes (1)

  • Social Adjustment Scale (SAS) Self-Report (SR)

    22 weeks

Study Arms (2)

Group cognitive-behavioral therapy

EXPERIMENTAL

22 subjects, all of whom met the criteria for a diagnosis of trichotillomania established in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Subjects receive 22 sessions of group cognitive-behavioral therapy.

Behavioral: Cognitive-behavioral therapy.

Group supportive therapy (control)

ACTIVE COMPARATOR

22 subjects, all of whom met the criteria for a diagnosis of trichotillomania established in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Subjects receive 22 sessions of group supportive therapy (control).

Other: Supportive therapy.

Interventions

Cognitive-behavioral therapy.BEHAVIORAL

Subjects receive 22 sessions of cognitive-behavioral therapy.

Group cognitive-behavioral therapy
Supportive therapy.OTHER

Subjects receive 22 sessions of supportive therapy.

Group supportive therapy (control)

Eligibility Criteria

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

You may qualify if:

  • Patients having been diagnosed with trichotillomania according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria; being at least 18 years of age; and having had four or more years of schooling.

You may not qualify if:

  • Patients that having been diagnosed with trichotillomania according to DSM-IV criteria; having less of 18 years of age; and having less of four years of schooling.
  • Patients with a history of suicidal ideation,
  • Patients with any clinical pathology requiring emergency treatment at admission,
  • Patients with mental retardation or any other central nervous system disorder that severely impairs cognitive function,
  • those with a psychotic disorder,
  • those currently being treated with psychotropic drugs,
  • those with any DSM-IV axis II diagnosis,
  • those who scored ≤ 2 on the MGH-HPS in an initial screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Psiquiatria da Universidade de São Paulo

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (1)

  • Toledo EL, De Togni Muniz E, Brito AM, de Abreu CN, Tavares H. Group treatment for trichotillomania: cognitive-behavioral therapy versus supportive therapy. J Clin Psychiatry. 2015 Apr;76(4):447-55. doi: 10.4088/JCP.13m08964.

    PMID: 25271779DERIVED

MeSH Terms

Conditions

Trichotillomania

Interventions

Cognitive Behavioral TherapyPalliative Care

Condition Hierarchy (Ancestors)

Obsessive-Compulsive DisorderAnxiety DisordersMental DisordersDisruptive, Impulse Control, and Conduct Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 20, 2013

First Posted

October 24, 2013

Study Start

January 1, 2008

Primary Completion

December 1, 2010

Last Updated

August 19, 2015

Record last verified: 2013-10

Locations

BR(1)