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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00043563
Other study ID # R21MH061457
Secondary ID R21MH061457DSIR
Status Completed
Phase N/A
First received August 9, 2002
Last updated December 15, 2015
Start date January 2001
Est. completion date October 2004

Study information

Verified date December 2015
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date October 2004
Est. primary completion date October 2004
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 17 Years
Eligibility Inclusion Criteria:

- Primary diagnosis of Trichotillomania

- Minimum symptom duration of 6 months

- Presence of a stable parent or guardian

Exclusion Criteria:

- Other primary psychiatric diagnosis

- Bipolar illness, pervasive developmental disorder, thought disorder, current major depression, ADD/ADHD

- Concurrent psychotherapy

- Currently receiving psychotropic medications

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive-Behavior Therapy


Locations

Country Name City State
United States Center for the Treatment and Study of Anxiety 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 National Institute of Mental Health (NIMH) Trichotillomania Severity Scale Semi-structured interview about hair-pulling and related symptoms 1 week No
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