TrichotillomaniaNCT01878110
Efficacy of COMB (Comprehensive Behavioral) Model of Treatment of Trichotillomania
A study testing COMB in people with Trichotillomania and Hair-Pulling Disorder, run by American University at 1 site in United States.
Trial summary
This pilot study is being conducted in order to help make the case for later, more systematic research on the effectiveness of the Comprehensive Behavioral (COMB) model of treating trichotillomania (compulsive hair pulling). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trichotillomania, Hair-Pulling Disorder
- What is being tested?
- COMB
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Primary Diagnostic and Statistical Manual, Fifth Edition (DSM-5) diagnosis of Trichotillomania (TTM)
Who cannot join
- Current suicidality or severe depression
- Current psychosis
- Current alcohol or substance abuse
- Concurrent psychotherapy for TTM
- Psychotropic meds (for any disorder) that have not been stable for >4 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
American University
Washington D.C., District of Columbia
About this study
Official title: Treatment Development Study of the COMB Model of Trichotillomania
This pilot study is being conducted in order to help make the case for later, more systematic research on the effectiveness of the Comprehensive Behavioral (COMB) model of treating trichotillomania (compulsive hair pulling). The goals are to standardize COMB treatment techniques in the form of a clear written manual for therapists; determine whether therapists can use these guidelines in a consistent manner in making treatment decisions; develop and test the reliability of measures of how well therapists are conducting the treatment; and collect preliminary data on the acceptability of the treatment to patients.
- Conditions
- Trichotillomania, Hair-Pulling Disorder
- Being tested
- COMB
- Keywords
- Trichotillomania, Hair pulling, Behavior therapy
- Medical subject headings
- Trichotillomania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMBBehavioural
| Study group | Role | What they receive |
|---|---|---|
| COMB | Experimental | Not described Receives: Behavioral: COMB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Massachusetts General Hospital Hairpulling Scale (MGH-HS)
Improvement in hair pulling symptoms
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrichotillomaniaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University
- Sponsor type
- University, hospital or other
- Collaborators
- Trichotillomania Learning Center
- Responsible party
- Principal investigator, David A. F. Haaga, American University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878110
- Sponsor's protocol ID
- TLC COMB Pilot Study
- Other IDs
- TLC
- Status last verified
- Apr 2015
- First submitted
- 10 Jun 2013
- Last updated
- 15 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Development Study of the COMB Model of Trichotillomania
- ClinicalTrials.gov ID
- NCT01878110
- Acronym / sponsor ID
- TLC COMB Pilot Study
- Conditions
- Trichotillomania, Hair-Pulling Disorder
- Keywords
- Trichotillomania, Hair pulling, Behavior therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- American UniversityUniversity, hospital or other
- Collaborators
- Trichotillomania Learning Center
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (actual)
- First posted
- 14 Jun 2013 (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 pilot study is being conducted in order to help make the case for later, more systematic research on the effectiveness of the Comprehensive Behavioral (COMB) model of treating trichotillomania (compulsive hair pulling). The goals are to standardize COMB treatment techniques in the form of a clear written manual for therapists; determine whether therapists can use these guidelines in a consistent manner in making treatment decisions; develop and test the reliability of measures of how well therapists are conducting the treatment; and collect preliminary data on the acceptability of the treatment to patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COMB | Experimental | Behavioral: COMB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Primary Diagnostic and Statistical Manual, Fifth Edition (DSM-5) diagnosis of Trichotillomania (TTM)
Key exclusion criteria (5 listed)
- Current suicidality or severe depression
- Current psychosis
- Current alcohol or substance abuse
- Concurrent psychotherapy for TTM
- Psychotropic meds (for any disorder) that have not been stable for >4 weeks
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 |
|---|---|---|
| COMB | Behavioural | COMB |
Primary outcome
Massachusetts General Hospital Hairpulling Scale (MGH-HS)
Time frame: 12 weeks
Improvement in hair pulling symptoms
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 15 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COMB in people with Trichotillomania and Hair-Pulling Disorder, run by American University at 1 site in United States.
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 5 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 15 Apr 2015. 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 United States. 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?
Massachusetts General Hospital Hairpulling Scale (MGH-HS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2015.