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Trichotillomania: Group Cognitive-Behavioral Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01968343
First Posted: October 24, 2013
Last Update Posted: August 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hermano Tavares, University of Sao Paulo
  Purpose
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).

Condition Intervention Phase
Trichotillomania Behavioral: Cognitive-behavioral therapy. Other: Supportive therapy. Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Group Treatment for Trichotillomania: Cognitive-Behavioral Therapy Versus Supportive Therapy

Further study details as provided by Hermano Tavares, University of Sao Paulo:

Primary Outcome Measures:
  • Massachusetts General Hospital (MGH) Hairpulling Scale (HPS) [ Time Frame: 22 weeks ]
    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


Secondary Outcome Measures:
  • Beck Depression Inventory (BDI) [ Time Frame: 22 weeks ]
    The BDI consists of 21 items, scored from 0 to 3, higher scores corresponding to greater severity of depression. It is a self-report measure of depression that is widely used in research and in clinical practice. Reference: Archives of General Psychiatry 1961;4:53-63.


Other Outcome Measures:
  • Social Adjustment Scale (SAS) Self-Report (SR) [ Time Frame: 22 weeks ]
    The SAS-SR is a self-report scale consisting of 54 questions addressing seven specific areas in relation to the last two weeks25: work; social life and leisure; family relationships; marital relationship; relationships with children; home life; and financial status, each corresponding to a partial score. Reference: Archives of General Psychiatry 1976;33:111-5.


Enrollment: 44
Study Start Date: January 2008
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group cognitive-behavioral therapy
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.
Subjects receive 22 sessions of cognitive-behavioral therapy.
Active Comparator: Group supportive therapy (control)
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.
Subjects receive 22 sessions of supportive therapy.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968343


Locations
Brazil
Instituto de Psiquiatria da Universidade de São Paulo
São Paulo, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hermano Tavares, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01968343     History of Changes
Other Study ID Numbers: CaPPesq 0013/08
First Submitted: September 20, 2013
First Posted: October 24, 2013
Last Update Posted: August 19, 2015
Last Verified: October 2013

Additional relevant MeSH terms:
Trichotillomania
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders