TrichotillomaniaNCT02044237
Online Treatment of Trichotillomania
A study testing Decoupling and Progressive relaxation in people with Trichotillomania and Alexithymia, run by University of Zurich at 1 site in Switzerland.
Trial summary
Online study for patients with trichotillomania. 4 main hypothesis. 1. Alexithymia and Trichotillomania correlated and regression analyses find association between them 2. we will be able to find patient who have never been treated before. Those will suffer to the same amount as previously treated patients 3. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trichotillomania, Alexithymia, Quality of Life
- What is being tested?
- Decoupling and Progressive relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suffering from trichotillomania 18 to 65 years old
Who cannot join
- current drug or alcohol addiction current psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decoupling as Internet Based Intervention: an Randomized Controlled Study to Treat Trichotillomania
Online study for patients with trichotillomania. 4 main hypothesis.
- Alexithymia and Trichotillomania correlated and regression analyses find association between them
- we will be able to find patient who have never been treated before. Those will suffer to the same amount as previously treated patients
- Decoupling will be more helpful than progressive muscle relaxation
- different constructs of emotion regulation will show different trait and state characteristics in patients with trichotillomania
Read the detailed description
Randomized controlled trial with about 100 participants.
- Conditions
- Trichotillomania, Alexithymia, Quality of Life
- Being tested
- Decoupling, Progressive relaxation
- Keywords
- trichotillomania, online therapy
- Medical subject headings
- Trichotillomania, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecouplingBehavioural
Progressive relaxationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Decoupling | Experimental | specific technic to reduce hair pulling Receives: Behavioral: Decoupling |
| progressive muscle relaxation | Active comparator | Progressive relaxation relaxation technic Receives: Behavioral: Progressive relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of trichotillomania
Measured: 7 months
Secondary outcomes (1)
alexithymia
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startAug 2011
- Primary completionJul 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TrichotillomaniaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, Julia Bangerter-Rhyner Foundation Bale switzerland
- Responsible party
- Sponsor
- Investigators
- Michael Rufer, MD, Prof, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044237
- Sponsor's protocol ID
- TTM
- Status last verified
- May 2016
- First submitted
- 21 Jan 2014
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Moritz S, Treszl A, Rufer M. A randomized controlled trial of a novel self-help technique for impulse control disorders: a study on nail-biting. Behav Modif. 2011 Sep;35(5):468-85. doi: 10.1177/0145445511409395. Epub 2011 Jun 8.
PubMed 21659318
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decoupling as Internet Based Intervention: an Randomized Controlled Study to Treat Trichotillomania
- ClinicalTrials.gov ID
- NCT02044237
- Acronym / sponsor ID
- TTM
- Conditions
- Trichotillomania, Alexithymia, Quality of Life
- Keywords
- trichotillomania, online therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Novartis, Julia Bangerter-Rhyner Foundation Bale switzerland
- Study start
- Aug 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Jan 2014 (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.
Online study for patients with trichotillomania. 4 main hypothesis.
- Alexithymia and Trichotillomania correlated and regression analyses find association between them
- we will be able to find patient who have never been treated before. Those will suffer to the same amount as previously treated patients
- Decoupling will be more helpful than progressive muscle relaxation
- different constructs of emotion regulation will show different trait and state characteristics in patients with trichotillomania
Detailed description
Randomized controlled trial with about 100 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decoupling | Experimental | Behavioral: Decouplingspecific technic to reduce hair pulling |
| progressive muscle relaxation | Active comparator | Behavioral: Progressive relaxationProgressive relaxation relaxation technic |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- suffering from trichotillomania 18 to 65 years old
Key exclusion criteria (1 listed)
- current drug or alcohol addiction current psychosis
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 |
|---|---|---|
| Decoupling | Behavioural | Decoupling |
| Progressive relaxation | Behavioural | progressive muscle relaxation |
Primary outcome
Severity of trichotillomania
Time frame: 7 months
1 secondary outcome
alexithymia
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
- Background: PubMed 21659318Moritz S, Treszl A, Rufer M. A randomized controlled trial of a novel self-help technique for impulse control disorders: a study on nail-biting. Behav Modif. 2011 Sep;35(5):468-85. doi: 10.1177/0145445511409395. Epub 2011 Jun 8.
- affective regualation in trichotillomania - publicationLink provided by the sponsor.
- randomized therapy study for trichotillomania- publicationLink provided by the sponsor.
- alexithymia in trichotillomania - publicationLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Michael Rufer, MD, Prof principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decoupling and Progressive relaxation in people with Trichotillomania and Alexithymia, run by University of Zurich at 1 site in Switzerland.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 May 2016. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of trichotillomania (time frame: 7 months). 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 NCT02044237, which also lists 1 linked publication.
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 10 May 2016.