Cognitive Behavioral Treatment of Pediatric Trichotillomania
| Tracking Information | |
|---|---|
| First Received Date ICMJE | August 9, 2002 |
| Last Updated Date | November 17, 2005 |
| Start Date ICMJE | January 2001 |
| Primary Completion Date | Not Provided |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT00043563 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Cognitive Behavioral Treatment of Pediatric Trichotillomania |
| Official Title ICMJE | 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 Type ICMJE | Interventional |
| Study Phase | Phase 1 |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Condition ICMJE | Trichotillomania |
| Intervention ICMJE | Behavioral: Cognitive-Behavior Therapy |
| Study Arm (s) | Not Provided |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 24 |
| Completion Date | December 2003 |
| Primary Completion Date | Not Provided |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 8 Years to 17 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT00043563 |
| Other Study ID Numbers ICMJE | R21 MH61457, DSIR CT-S |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Not Provided |
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | National Institute of Mental Health (NIMH) |
| Verification Date | November 2005 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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