TrichotillomaniaNorTriPNCT02747771
Cognitive Behavioral Group Therapy for Trichotillomania (Hair Pulling Disorder)
An observational study of Trichotillomania, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This study aims at evaluating the effectiveness of group-based cognitive behavioral therapy for trichotillomania at three clinical sites in Norway. Read more about this study
- Who is it for?
- Ages 16 to 67 years
- Conditions the study is for
- Trichotillomania
- What is being tested?
- Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2013to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 67 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients referred for treatment of trichotillomania (TTM)
Who may be able to join
- Clinical diagnosis of Trichotillomania
- Age between 16 and 67
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0607
Benjamin Hummelen, PhD, +4795741039, uxbeum@ous-hf.no
About this study
Official title: 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.
Read the 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.
- Conditions
- Trichotillomania
- Being tested
- Cognitive behavioral therapy
- Keywords
- effectiveness, trichotillomania, hair pulling, habit reversal training, acceptance and commitment therapy, cognitive behavioral therapy
- Medical subject headings
- Trichotillomania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
Also called Acceptance and commitment therapy (ACT), Habit reversal training (HRT)
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in National Institute of Mental Health Trichotillomania Severity Scale (NIMH-TSS)
clinical interview
Measured: baseline, 12 weeks, 12 months
Change in Massachusetts General Hospital - Hairpulling Scale (MGH-HS)
self-report
Measured: baseline, 12 weeks, 12 months
Secondary outcomes (4)
Change Patient Health Questionnaire-9 (PHQ-9)
self-report depressive symptoms
Measured: baseline, 12 weeks, 12 months
Change General Anxiety Disorder Scale (GAD-7)
self-report anxiety symptoms
Measured: baseline, 12 weeks, 12 months
Change Metacognition Questionnaire (MCQ-30)
self-reported metacognitions
Measured: baseline, 12 weeks, 12 months
Change in Acceptance and Action Questionnaire for Trichotillomania
self-report
Measured: baseline, 12 weeks, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study start1 Jan 2013
- Primary completion1 Apr 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for TrichotillomaniaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sorlandet Hospital HF, St. Olavs Hospital, Texas A&M University, University of Michigan
- Responsible party
- Principal investigator, Benjamin Hummelen, Oslo University Hospital
- Investigators
- Benjamin Hummelen, Ph.D., M.D., Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747771
- Sponsor's protocol ID
- 2013/632
- Acronym
- NorTriP
- Status last verified
- Mar 2024
- First submitted
- 14 Apr 2016
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 20533371Stein 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.
PubMed 17880861Woods 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.
PubMed 16039603Keuthen 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.
PubMed 26165460Houghton 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.
PubMed 26422605
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Norwegian Trichotillomania Project
- ClinicalTrials.gov ID
- NCT02747771
- Acronym / sponsor ID
- NorTriP / 2013/632
- Conditions
- Trichotillomania
- Keywords
- effectiveness, trichotillomania, hair pulling, habit reversal training, acceptance and commitment therapy, cognitive behavioral therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Sorlandet Hospital HF, St. Olavs Hospital, Texas A&M University, University of Michigan
- Study start
- 1 Jan 2013
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients referred for treatment of trichotillomania (TTM)
Key inclusion criteria (2 listed)
Key exclusion criteria (7 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapyAlso: Acceptance and commitment therapy (ACT), Habit reversal training (HRT)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. | Behavioural | – |
Primary outcome
Change in National Institute of Mental Health Trichotillomania Severity Scale (NIMH-TSS)
Time frame: baseline, 12 weeks, 12 months
clinical interview
Change in Massachusetts General Hospital - Hairpulling Scale (MGH-HS)
Time frame: baseline, 12 weeks, 12 months
self-report
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 20533371Stein 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.
- Background: PubMed 17880861Stein 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.
- Background: PubMed 16039603Woods 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.
- Background: PubMed 26165460Keuthen 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.
- Results publication: PubMed 26422605Houghton 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Hummelen, Ph.D., M.D. principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trichotillomania, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Hummelen, Ph.D., M.D. (+4795741039, uxbeum@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in National Institute of Mental Health Trichotillomania Severity Scale (NIMH-TSS) (time frame: baseline, 12 weeks, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02747771, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.