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Tracking Information | |
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First Received Date † | August 9, 2002 |
Last Updated Date | November 17, 2005 |
Start Date † | January 2001 |
Current Primary Outcome Measures † | |
Original Primary Outcome Measures † | |
Change History | Complete list of historical versions of study NCT00043563 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † | |
Original Secondary Outcome Measures † | |
Descriptive Information | |
Brief Title † | Cognitive Behavioral Treatment of Pediatric Trichotillomania |
Official Title † | Cognitive Behavioral Treatment of Pediatric Trichotillomania |
Brief Summary | This study will compare the effectiveness of cognitive-behavior therapy (CBT) to a minimal attention control (AC) condition for treatment of pediatric trichotillomania (TTM). |
Detailed Description | TTM is a persistent impulse control disorder in which the individual acts on urges to pull out his or her own hair. Onset typically occurs by adolescence, and TTM is often associated with significant functional impairment and distress. CBT is a type of psychotherapy designed to change problematic behaviors and thinking. It includes self-monitoring of hair-pulling urges and homework assignments to practice the use of cognitive and behavioral strategies. Participants are assigned randomly to receive either CBT or AC for 8 weeks. Participants assigned to CBT receive weekly 1-hour sessions of CBT for 8 weeks; participants assigned to AC receive 6 telephone contacts and 2 in-person sessions for 8 weeks. After 8 weeks, CBT participants who respond to treatment enter Phase II, which lasts an additional 8 weeks and includes 4 in-person maintenance sessions. AC participants who are still symptomatic after 8 weeks are offered CBT. |
Study Phase | Phase I |
Study Type † | Interventional |
Study Design † | Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study |
Condition † | Trichotillomania |
Intervention † | Behavioral: Cognitive-Behavior Therapy |
Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Completed |
Enrollment † | 24 |
Completion Date | December 2003 |
Primary Completion Date | |
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 8 Years to 17 Years |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00043563 |
Responsible Party | |
Secondary IDs †† | DSIR CT-S |
Study Sponsor † | National Institute of Mental Health (NIMH) |
Collaborators †† | |
Investigators † | |
Information Provided By | National Institute of Mental Health (NIMH) |
Verification Date | November 2005 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |