NCT02747771

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jan 2013Dec 2026

Study Start

First participant enrolled

January 1, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

11.3 years

First QC Date

April 14, 2016

Last Update Submit

March 1, 2024

Conditions

Trichotillomania

Keywords

effectivenesstrichotillomaniahair pullinghabit reversal trainingacceptance and commitment therapycognitive behavioral therapy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Change Patient Health Questionnaire-9 (PHQ-9)

    baseline, 12 weeks, 12 months

  • Change General Anxiety Disorder Scale (GAD-7)

    baseline, 12 weeks, 12 months

  • Change Metacognition Questionnaire (MCQ-30)

    baseline, 12 weeks, 12 months

  • Change in Acceptance and Action Questionnaire for Trichotillomania

    baseline, 12 weeks, 12 months

Interventions

Cognitive behavioral therapyBEHAVIORAL

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.

Also known as: Acceptance and commitment therapy (ACT), Habit reversal training (HRT)

Eligibility Criteria

Age16 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred for treatment of trichotillomania (TTM)

You may qualify if:

  • Clinical diagnosis of Trichotillomania
  • Age between 16 and 67

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0607, Norway

RECRUITING

Related Publications (5)

  • 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: 20533371BACKGROUND

  • 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: 17880861BACKGROUND

  • 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: 16039603BACKGROUND

  • 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: 26165460BACKGROUND

  • 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: 26422605RESULT

MeSH Terms

Conditions

Trichotillomania

Interventions

Cognitive Behavioral TherapyAcceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Obsessive-Compulsive DisorderAnxiety DisordersMental DisordersDisruptive, Impulse Control, and Conduct Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Benjamin Hummelen, Ph.D., M.D.

    Oslo University Hospital, Oslo, Norway

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Hummelen, Ph.D., M.D.

CONTACT

+4795741039uxbeum@ous-hf.no

Erna M Moen, Master

CONTACT

+4722118080ernmoe@ous-hf.no

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 14, 2016

First Posted

April 22, 2016

Study Start

January 1, 2013

Primary Completion

April 1, 2024

Study Completion (Estimated)

December 31, 2026

Last Updated

March 5, 2024

Record last verified: 2024-03

Locations

NO(1)