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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02747771
Other study ID # 2013/632
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2013
Est. completion date December 31, 2026

Study information

Verified date March 2024
Source Oslo University Hospital
Contact Benjamin Hummelen, Ph.D., M.D.
Phone +4795741039
Email uxbeum@ous-hf.no
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 31, 2026
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years to 67 Years
Eligibility - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive behavioral therapy
10 sessions Group therapy during 10-12 weeks. The first three sessions focus on habit reversal training, the fourth to sixth session on acceptance and commitment therapy and the last four sessions aims at integrating the two approaches.

Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (5)

Lead Sponsor Collaborator
Oslo University Hospital Sorlandet Hospital HF, St. Olavs Hospital, Texas A&M University, University of Michigan

Country where clinical trial is conducted

Norway, 

References & Publications (5)

Houghton DC, Capriotti MR, De Nadai AS, Compton SN, Twohig MP, Neal-Barnett AM, Saunders SM, Franklin ME, Woods DW. Defining treatment response in trichotillomania: a signal detection analysis. J Anxiety Disord. 2015 Dec;36:44-51. doi: 10.1016/j.janxdis.2 — View Citation

Keuthen NJ, Rothbaum BO, Fama J, Altenburger E, Falkenstein MJ, Sprich SE, Kearns M, Meunier S, Jenike MA, Welch SS. DBT-enhanced cognitive-behavioral treatment for trichotillomania: A randomized controlled trial. J Behav Addict. 2012 Sep;1(3):106-14. doi: 10.1556/JBA.1.2012.003. — View Citation

Stein DJ, Garner JP, Keuthen NJ, Franklin ME, Walkup JT, Woods DW. Trichotillomania, stereotypic movement disorder, and related disorders. Curr Psychiatry Rep. 2007 Aug;9(4):301-2. doi: 10.1007/s11920-007-0036-4. — View Citation

Stein DJ, Grant JE, Franklin ME, Keuthen N, Lochner C, Singer HS, Woods DW. Trichotillomania (hair pulling disorder), skin picking disorder, and stereotypic movement disorder: toward DSM-V. Depress Anxiety. 2010 Jun;27(6):611-26. doi: 10.1002/da.20700. — View Citation

Woods DW, Wetterneck CT, Flessner CA. A controlled evaluation of acceptance and commitment therapy plus habit reversal for trichotillomania. Behav Res Ther. 2006 May;44(5):639-56. doi: 10.1016/j.brat.2005.05.006. Epub 2005 Jul 22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in National Institute of Mental Health Trichotillomania Severity Scale (NIMH-TSS) clinical interview baseline, 12 weeks, 12 months
Primary Change in Massachusetts General Hospital - Hairpulling Scale (MGH-HS) self-report baseline, 12 weeks, 12 months
Secondary Change Patient Health Questionnaire-9 (PHQ-9) self-report depressive symptoms baseline, 12 weeks, 12 months
Secondary Change General Anxiety Disorder Scale (GAD-7) self-report anxiety symptoms baseline, 12 weeks, 12 months
Secondary Change Metacognition Questionnaire (MCQ-30) self-reported metacognitions baseline, 12 weeks, 12 months
Secondary Change in Acceptance and Action Questionnaire for Trichotillomania self-report baseline, 12 weeks, 12 months
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