Clinical trial NCT02747771: Cognitive Behavioral Group Therapy for Trichotillomania (Hair Pulling Disorder)
Official title: The Norwegian Trichotillomania Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trichotillomania
Keywords: effectiveness
trichotillomania
hair pulling
habit reversal training
acceptance and commitment therapy
cognitive behavioral therapy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Sorlandet Hospital HF
name: St. Olavs Hospital
name: Texas A&M University
name: University of Michigan
First posted: 2016-04-22
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Maximum age (years): 67
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for treatment of trichotillomania (TTM)

Brief summary: 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.

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.

Primary outcomes:
measure: Change in National Institute of Mental Health Trichotillomania Severity Scale (NIMH-TSS)
timeFrame: baseline, 12 weeks, 12 months
measure: Change in Massachusetts General Hospital - Hairpulling Scale (MGH-HS)
timeFrame: baseline, 12 weeks, 12 months
Secondary outcomes:
measure: Change Patient Health Questionnaire-9 (PHQ-9)
timeFrame: baseline, 12 weeks, 12 months
measure: Change General Anxiety Disorder Scale (GAD-7)
timeFrame: baseline, 12 weeks, 12 months
measure: Change Metacognition Questionnaire (MCQ-30)
timeFrame: baseline, 12 weeks, 12 months
measure: Change in Acceptance and Action Questionnaire for Trichotillomania
timeFrame: baseline, 12 weeks, 12 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital, Oslo, Norway
name: Benjamin Hummelen, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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.