Cognitive Behavioral Group Therapy for Trichotillomania (Hair Pulling Disorder) (NorTriP)

The Norwegian Trichotillomania Project

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

Study Overview

• Status: Recruiting
• Conditions: Trichotillomania
• Intervention / Treatment: Behavioral: Cognitive behavioral therapy

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Benjamin Hummelen, Ph.D., M.D.; Phone Number: +4795741039; Email: uxbeum@ous-hf.no
• Study Contact Backup: Name: Erna M Moen, Master; Phone Number: +4722118080; Email: ernmoe@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway, 0607
    • Recruiting
    • Oslo University Hospital
    • Contact: Benjamin Hummelen, PhD; Phone Number: +4795741039; Email: uxbeum@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 67 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients referred for treatment of trichotillomania (TTM)

Description

• 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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in National Institute of Mental Health Trichotillomania Severity Scale (NIMH-TSS)	clinical interview	baseline, 12 weeks, 12 months
Change in Massachusetts General Hospital - Hairpulling Scale (MGH-HS)	self-report	baseline, 12 weeks, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Patient Health Questionnaire-9 (PHQ-9)	self-report depressive symptoms	baseline, 12 weeks, 12 months
Change General Anxiety Disorder Scale (GAD-7)	self-report anxiety symptoms	baseline, 12 weeks, 12 months
Change Metacognition Questionnaire (MCQ-30)	self-reported metacognitions	baseline, 12 weeks, 12 months
Change in Acceptance and Action Questionnaire for Trichotillomania	self-report	baseline, 12 weeks, 12 months

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Michigan; Sorlandet Hospital HF; St. Olavs Hospital; Texas A&M University
• Investigators: Principal Investigator: Benjamin Hummelen, Ph.D., M.D., Oslo University Hospital, Oslo, Norway

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 14, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimated): April 22, 2016

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: effectiveness; trichotillomania; hair pulling; habit reversal training; acceptance and commitment therapy; cognitive behavioral therapy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Disruptive, Impulse Control, and Conduct Disorders; Obsessive-Compulsive Disorder; Trichotillomania
• Other Study ID Numbers: 2013/632

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No