Overview

This trial is active, not recruiting.

Condition trichotillomania
Treatment cognitive behavioral therapy
Sponsor Oslo University Hospital
Collaborator Sorlandet Hospital HF
Start date January 2013
End date December 2016
Trial size 75 participants
Trial identifier NCT02747771, 2013/632

Summary

This study aims at evaluating the effectiveness of group-based cognitive behavioral therapy for trichotillomania at three clinical sites in Norway.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Change in National Institute of Mental Health Trichotillomania Severity Scale (NIMH-TSS)
time frame: baseline, 12 weeks, 12 months
Change in Massachusetts General Hospital - Hairpulling Scale (MGH-HS)
time frame: baseline, 12 weeks, 12 months

Secondary Outcomes

Measure
Change Patient Health Questionnaire-9 (PHQ-9)
time frame: baseline, 12 weeks, 12 months
Change General Anxiety Disorder Scale (GAD-7)
time frame: baseline, 12 weeks, 12 months
Change Metacognition Questionnaire (MCQ-30)
time frame: baseline, 12 weeks, 12 months
Change in Acceptance and Action Questionnaire for Trichotillomania
time frame: baseline, 12 weeks, 12 months

Eligibility Criteria

Male or female participants from 16 years up to 67 years old.

- Inclusion Criteria: - Clinical diagnosis of Trichotillomania - Age between 16 and 67 - Exclusion Criteria: - schizophrenia spectrum disorder - substance addiction - severe antisocial, schizotypal, or paranoid personality disorder - severe eating disorder, - ongoing suicidal ideation - pervasive developmental disorder - mental retardation and severe sequelae after brain injury.

Additional Information

Official title The Norwegian Trichotillomania Project
Principal investigator Benjamin Hummelen, Ph.D., M.D.
Description The Norwegian Trichotillomania Project is a multicenter study that aims at evaluating the effectiveness of behavioral group therapy for TTM, i.e., ACT (Acceptance and commitment therapy) enhanced habit reversal training (ACT-enhanced HRT). Participants are adults or adolescents (16 year or older) who fulfill criteria for TTM according to DSM-IV. Inclusion started in January 2013 and will be completed by Mai 2016. Treatment is delivered at three treatment sites in Norway; in Kristiansand, Oslo, and Trondheim. Treatment is manualized, following the manual of Twohig and Woods, and consists of ten group sessions of three hours delivered at consecutive weeks, and two or three booster sessions during the first year after treatment. Treatment outcome is evaluated by three outcome measures; the Massachusetts General Hospital - Hairpulling Scale (self-report); the National Institute of Mental Health Trichotillomania Severity Scale (clinical interview, conducted by independent evaluators); and the Clinical Global Impression Scale for TTM. Outcome is measured at three points in time; at baseline, at the end of treatment, and at one-year follow-up. Mixed models procedures in SPSS is used to analyze longitudinal data. The first paper will be written on patients admitted to treatment from January 2013 to September 2014, and includes 53 patients (49 women and four men). By January 2016, fifty-one patients (96%) had participated in the one-year follow-up evaluation.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Oslo University Hospital.