Examining Behavior Therapy for Trichotillomania in Children and Adolescents

Trichotillomania Clinical Trial

Official title:

Behavior Therapy for Pediatric Trichotillomania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917098
• Other study ID #: R01MH077197
• Secondary ID: R01MH077197DSIR
• Status: Completed
• Phase: N/A
• First received: June 8, 2009
• Last updated: July 31, 2017
• Start date: October 2008
• Est. completion date: March 26, 2014

Study information

• Verified date: July 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate a treatment for trichotillomania, or compulsive hair pulling, in children and adolescents.

Description:

Trichotillomania (TTM) is a chronic impulse control disorder that causes people to pull out their own hair. TTM typically develops in late childhood or early adolescence. It has been suggested that, like with obsessive-compulsive disorder, early identification and treatment of TTM might prevent the disorder and other co-occurring disorders in adults. The researchers in this study have developed the first treatment for TTM to target children and adolescents. Preliminary trials of this treatment, called behavior therapy (BT), indicate efficacy. This study is a larger, more rigorous examination of whether BT can successfully treat children and adolescents with TTM.

Participation in this study will be divided into two phases, each lasting 8 weeks. Follow-up visits will occur 3 and 6 months after completing treatment. In Phase 1, participants will be randomly assigned to receive either BT or supportive counseling (SC) for their TTM. Both groups of participants will complete eight weekly study visits. Those receiving BT will be encouraged to identify situations in which hair pulling is likely to occur and use behavioral techniques to resist urges to pull their hair. BT will also involve self-monitoring and homework throughout the week. Those receiving SC will discuss ways to minimize interference of hair pulling with everyday life and receive education and emotional support from a study therapist—but will not be taught specific behavioral techniques. After 8 weeks, participants will be evaluated to determine whether treatment is helping them. If participants are receiving BT and showing reduction in symptoms, they will continue to Phase 2, which involves four maintenance sessions of BT over 8 weeks. If participants receiving BT are not responding to treatment, they will be given referrals to other services. Participants receiving SC will end their participation after 8 weeks, and those not responding to treatment will be offered BT.

Study assessments will be completed at baseline, after Phase 1, after Phase 2, and at 3- and 6-month follow-ups. These assessments will include a clinical interview, questionnaires about symptoms, and family assessment measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 26, 2014
• Est. primary completion date: March 26, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• Diagnosis or symptoms of trichotillomania

• Presence of stable parent or guardian

Exclusion Criteria:

• Presence of another primary or co-primary psychiatric disorder that requires initiation of different active current treatment

• Current use of psychotropic medication (participants may be able to stop taking medications to start with study)

Related Conditions & MeSH terms

• Trichotillomania

Intervention

Behavioral:
• Behavior Therapy
Eight weekly sessions during Phase 1 and four sessions every other week during Phase 2; participants will work on implementing habit reversal techniques with psychoeducation, cognitive restructuring, and relaxation, if necessary
• Supportive Counseling
Eight weekly sessions during Phase 1 of psychoeducation, support, and emotion management related to trichotillomania and other stressors

Locations

Country	Name	City	State
United States	Child and Adolescent OCD, Tic, Trichotillomania, and Anxiety Group (COTTAGe)	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression Scale (CGIS)		Measured at baseline; Weeks 4, 8, 12, and 16; and 3- and 6-month follow-ups

External Links

•   Click here for information about the University of Pennsylvania Child & Adolescent OCD, Tic, Trich, & Anxiety Group