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Trichotillomania: Group Cognitive-Behavioral Therapy

Primary Purpose

Trichotillomania

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Cognitive-behavioral therapy.
Supportive therapy.
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trichotillomania

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Instituto de Psiquiatria da Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group cognitive-behavioral therapy

Group supportive therapy (control)

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Beck Depression Inventory (BDI)
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.

Full Information

First Posted
September 20, 2013
Last Updated
August 18, 2015
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01968343
Brief Title
Trichotillomania: Group Cognitive-Behavioral Therapy
Official Title
Group Treatment for Trichotillomania: Cognitive-Behavioral Therapy Versus Supportive Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group cognitive-behavioral therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Group supportive therapy (control)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy.
Intervention Description
Subjects receive 22 sessions of cognitive-behavioral therapy.
Intervention Type
Other
Intervention Name(s)
Supportive therapy.
Intervention Description
Subjects receive 22 sessions of supportive therapy.
Primary Outcome Measure Information:
Title
Massachusetts General Hospital (MGH) Hairpulling Scale (HPS)
Description
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
Time Frame
22 weeks
Secondary Outcome Measure Information:
Title
Beck Depression Inventory (BDI)
Description
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.
Time Frame
22 weeks
Other Pre-specified Outcome Measures:
Title
Social Adjustment Scale (SAS) Self-Report (SR)
Description
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.
Time Frame
22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Instituto de Psiquiatria da Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
05403-010
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
25271779
Citation
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.
Results Reference
derived

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Trichotillomania: Group Cognitive-Behavioral Therapy

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