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Trichotillomania: Group Cognitive-Behavioral Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hermano Tavares, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01968343
First received: September 20, 2013
Last updated: October 20, 2013
Last verified: October 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Group Treatment for Trichotillomania: Cognitive-Behavioral Therapy Versus Supportive Therapy

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Massachusetts General Hospital (MGH) Hairpulling Scale (HPS) [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hermano Tavares, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01968343     History of Changes
Other Study ID Numbers: CaPPesq 0013/08
Study First Received: September 20, 2013
Last Updated: October 20, 2013
Health Authority: Brazil: National Information System on Research Ethics Involving Human Beings (SISNEP - http://portal2.saude.gov.br/sisnep/)

Additional relevant MeSH terms:
Trichotillomania
Impulse Control Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 20, 2014