TrichotillomaniaPhase 1/2CBT for TTMNCT00740909
Cognitive Behavioral Therapy for Trichotillomania
A Phase 1/2 study testing Cognitive Behavioral Therapy in people with Trichotillomania, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study aims to develop a comprehensive Cognitive Behavioral Therapy protocol for adult patients with Trichotillomania that emphasizes relapse prevention and that addresses comorbid affective symptoms, as well. The study will compare the efficacy of CBT with a minimal attention control (MAC)condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trichotillomania
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jan 2012
- Phase
- Phase 1/2
- 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
- primary DSM-IV diagnosis of TTM
- outpatients who are 18 or older
- a minimum MGHHPS total scale score of 10
- a minimum TTM symptom duration of 1 year with no significant remissions (as defined by complete abstinence of hair extraction for a 2-week period during the prior 6 months)
Who cannot join
- presence of a serious psychiatric condition including mental retardation, psychosis, pervasive developmental disorder, organic mental disorders, manic episode, ADHD, suicidality, lifetime alcohol or substance dependence, or alcohol or substance abuse within the past 3 months
- presence of a serious medical condition that would limit ability to routinely attend sessions and complete homework assignments
- individual or group psychotherapy (not addressing TTM) that has not been ongoing for the past 3 months and/or without intent to continue same treatment during study tenure)
- previous CBT for TTM
- involvement in other treatment for TTM
- psychotropic medication that has not been stable for 3 months prior to study enrollment and/or without intent to continue same medication regimen during study tenure)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This study aims to develop a comprehensive Cognitive Behavioral Therapy protocol for adult patients with Trichotillomania that emphasizes relapse prevention and that addresses comorbid affective symptoms, as well. The study will compare the efficacy of CBT with a minimal attention control (MAC)condition. We hypothesize that outcome at post-treatment, 3-month, and 6-month follow-up will be better for the CBT vs. MAC condition including higher responder rates and greater reduction in hair pulling severity.
Read the detailed description
The purpose of this study is to assess the efficacy of cognitive behavioral therapy for patients with trichotillomania.
Following entry into the study, subjects will be randomized into a cognitive behavioral therapy (CBT) or a minimized attention control (MAC) condition. Subjects will be assessed with the Acceptance and Action Questionnaire (AAQ), the Affective Regulation Rating (ARR), the Barratt Impulsivity Scale (BIS-11), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Clinical Global Impressions Scale (CGI), the Difficulties in Emotion Regulation Scale (DERS), Hair Pulling Scale (HPS), Trichotillomania (TTM) Impact Scale, Psychiatric Institute Trichotillomania Scale (PITS), National Institute of Mental Health Trichotillomania Severity Scale(NIMH-TSS), the Generalized Expectancy for Negative Mood Regulation Scale (NMR), The Milwaukee Inventory for Subtypes of Trichotillomania- Adult Version (MIST-A), the Positive and Negative Affect Scale (PANAS), the Quality of Life Inventory (QOLI), the Readiness to Change Hairpulling Behavior (RCHPB), the Self-Esteem Scale (SES), the Skin Picking Scale (SPS) and the Scales of Psychological Well-Being (SPWB). Subject randomization to a treatment arm will be determined by a random number generator.
Subject change scores will be assessed for the above scales.
- Conditions
- Trichotillomania
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Trich, Hair Pulling, Cognitive Behavioral Therapy, Behavioral Therapy
- Medical subject headings
- Trichotillomania, Trichomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
A therapy designed to help patients with response prevention skills.
| Study group | Role | What they receive |
|---|---|---|
| MAC | No intervention | Minimal Attention Control |
| CBT | Experimental | Cognitive Behavioral Therapy Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Massachusetts General Hospital Hair Pulling Scale (MGHHPS)
Measured: Baseline, weekly visits, follow-up
NIMH Trichotillomania Severity Scale (NIMH-TSS)
Measured: Baseline, weekly visits, follow-up
NIMH Trichotillomania Impairment Scale (NIMH-TIS)
Measured: Baseline, weekly visits, follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2012
- Study completionJan 2012
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 Massachusetts General 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Principal investigator, Nancy J. Keuthen, Massachusetts General Hospital
- Investigators
- Nancy Keuthen, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740909
- Sponsor's protocol ID
- 2008P000565
- Acronym
- CBT for TTM
- Status last verified
- Jun 2012
- First submitted
- 21 Aug 2008
- Last updated
- 20 Jun 2012
- Results posted
- No
Publications
Keuthen NJ, Rothbaum BO, Falkenstein MJ, Meunier S, Timpano KR, Jenike MA, Welch SS. DBT-enhanced habit reversal treatment for trichotillomania: 3-and 6-month follow-up results. Depress Anxiety. 2011 Apr;28(4):310-3. doi: 10.1002/da.20778. Epub 2010 Dec 15.
PubMed 21456040
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Trichotillomania
- ClinicalTrials.gov ID
- NCT00740909
- Acronym / sponsor ID
- CBT for TTM / 2008P000565
- Conditions
- Trichotillomania
- Keywords
- Trich, Hair Pulling, Cognitive Behavioral Therapy, Behavioral Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- Nov 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 25 Aug 2008 (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 to develop a comprehensive Cognitive Behavioral Therapy protocol for adult patients with Trichotillomania that emphasizes relapse prevention and that addresses comorbid affective symptoms, as well. The study will compare the efficacy of CBT with a minimal attention control (MAC)condition. We hypothesize that outcome at post-treatment, 3-month, and 6-month follow-up will be better for the CBT vs. MAC condition including higher responder rates and greater reduction in hair pulling severity.
Detailed description
The purpose of this study is to assess the efficacy of cognitive behavioral therapy for patients with trichotillomania.
Following entry into the study, subjects will be randomized into a cognitive behavioral therapy (CBT) or a minimized attention control (MAC) condition. Subjects will be assessed with the Acceptance and Action Questionnaire (AAQ), the Affective Regulation Rating (ARR), the Barratt Impulsivity Scale (BIS-11), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Clinical Global Impressions Scale (CGI), the Difficulties in Emotion Regulation Scale (DERS), Hair Pulling Scale (HPS), Trichotillomania (TTM) Impact Scale, Psychiatric Institute Trichotillomania Scale (PITS), National Institute of Mental Health Trichotillomania Severity Scale(NIMH-TSS), the Generalized Expectancy for Negative Mood Regulation Scale (NMR), The Milwaukee Inventory for Subtypes of Trichotillomania- Adult Version (MIST-A), the Positive and Negative Affect Scale (PANAS), the Quality of Life Inventory (QOLI), the Readiness to Change Hairpulling Behavior (RCHPB), the Self-Esteem Scale (SES), the Skin Picking Scale (SPS) and the Scales of Psychological Well-Being (SPWB). Subject randomization to a treatment arm will be determined by a random number generator.
Subject change scores will be assessed for the above scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAC | No intervention | –Minimal Attention Control |
| CBT | Experimental | Behavioral: Cognitive Behavioral TherapyCognitive Behavioral Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- primary DSM-IV diagnosis of TTM
- outpatients who are 18 or older
- a minimum MGHHPS total scale score of 10
- a minimum TTM symptom duration of 1 year with no significant remissions (as defined by complete abstinence of hair extraction for a 2-week period during the prior 6 months)
Key exclusion criteria (6 listed)
- presence of a serious psychiatric condition including mental retardation, psychosis, pervasive developmental disorder, organic mental disorders, manic episode, ADHD, suicidality, lifetime alcohol or substance dependence, or alcohol or substance abuse within the past 3 months
- presence of a serious medical condition that would limit ability to routinely attend sessions and complete homework assignments
- individual or group psychotherapy (not addressing TTM) that has not been ongoing for the past 3 months and/or without intent to continue same treatment during study tenure)
- previous CBT for TTM
- involvement in other treatment for TTM
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 TherapyA therapy designed to help patients with response prevention skills. | Behavioural | CBT |
Primary outcome
Massachusetts General Hospital Hair Pulling Scale (MGHHPS)
Time frame: Baseline, weekly visits, follow-up
NIMH Trichotillomania Severity Scale (NIMH-TSS)
Time frame: Baseline, weekly visits, follow-up
NIMH Trichotillomania Impairment Scale (NIMH-TIS)
Time frame: Baseline, weekly visits, follow-up
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 20 Jun 2012.
- Derived from this study: PubMed 21456040Keuthen NJ, Rothbaum BO, Falkenstein MJ, Meunier S, Timpano KR, Jenike MA, Welch SS. DBT-enhanced habit reversal treatment for trichotillomania: 3-and 6-month follow-up results. Depress Anxiety. 2011 Apr;28(4):310-3. doi: 10.1002/da.20778. Epub 2010 Dec 15.
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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.
Nancy Keuthen, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cognitive Behavioral Therapy in people with Trichotillomania, run by Massachusetts General Hospital 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 4 inclusion and 6 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 20 Jun 2012. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hair Pulling Scale (MGHHPS) (time frame: Baseline, weekly visits, follow-up). The study lists 3 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 NCT00740909, 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 20 Jun 2012.