Trichotillomania: Group Cognitive-Behavioral Therapy

Trichotillomania Clinical Trial

Official title:

Group Treatment for Trichotillomania: Cognitive-Behavioral Therapy Versus Supportive Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968343
• Other study ID #: CaPPesq 0013/08
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2013
• Last updated: August 18, 2015
• Start date: January 2008

Study information

• Verified date: October 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Information System on Research Ethics Involving Human Beings (SISNEP - http://portal2.saude.gov.br/sisnep/)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Trichotillomania

Intervention

Behavioral:
• Cognitive-behavioral therapy.
Subjects receive 22 sessions of cognitive-behavioral therapy.

Other:
• Supportive therapy.
Subjects receive 22 sessions of supportive therapy.

Locations

Country	Name	City	State
Brazil	Instituto de Psiquiatria da Universidade de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Social Adjustment Scale (SAS) Self-Report (SR)	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.	22 weeks	No
Primary	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	No
Secondary	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.	22 weeks	No