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Recruiting NCT02747771

Cognitive Behavioral Group Therapy for Trichotillomania (Hair Pulling Disorder)

— Observational Trichotillomania

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive behavioral therapy.
Who it may be relevant to
Registry conditions: Trichotillomania. Basic parameters: 16 years — 67 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Norwegian Trichotillomania Project

Overview

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

Detailed 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.

Interventions

  • 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.

Primary outcome measures

  • 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 outcome measures (4)
  • 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

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Norway · 1 center
  • Oslo University Hospital — Oslo

Publications

  • 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. PMID 20533371
  • 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. PMID 17880861
  • 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. PMID 16039603
  • 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. PMID 26165460
  • 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.2015.09.008. Epub 2015 Sep 24. PMID 26422605

Identifiers

NCT: NCT02747771 · 2013/632

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗