TrichotillomaniaPhase 2NCT00872742
Testing a New Therapy for Trichotillomania
A Phase 2 study testing Acceptance enhanced behavior therapy (AEBT) and Psychoeducation and supportive therapy (PST) in people with Trichotillomania, run by University of Wisconsin, Milwaukee at 1 site in United States.
Trial summary
This study will test the effectiveness of a new behavioral therapy for adults with trichotillomania (compulsive hair pulling). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trichotillomania
- What is being tested?
- Acceptance enhanced behavior therapy (AEBT) and Psychoeducation and supportive therapy (PST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to 30 Nov 2015
- Phase
- Phase 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current DSM-IV diagnosis of trichotillomania
- Massachusetts General Hospital Hair Scale score greater than 12
- Wechsler Test of Adult Reading score greater than 85
- Fluent in English
- Outpatient status
- Agreement to not alter the dosage of any psychotropic medication throughout the course of the study, or, if such a dosage change is required, understanding that the participant will continue to receive treatment, and data will continue to be collected on him or her
- Individuals who eat their hair after pulling will be eligible for participation only after they have received a physical exam from their primary care physician to determine whether there is any gastrointestinal blockage due to hair pulling, which would require more immediate clinical care.
Who cannot join
- Diagnosis of bipolar disorder, psychotic disorder, mental retardation, pervasive developmental disorder, or current substance dependence (with the exception of nicotine dependence)
- Current mood or anxiety disorder with an active suicide risk
- Currently receiving psychotherapy for trichotillomania or another psychiatric condition
- Initiation or change in the dosage of any psychotropic medication for up to 8 weeks preceding participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptance Enhanced Behavior Therapy for Trichotillomania
This study will test the effectiveness of a new behavioral therapy for adults with trichotillomania (compulsive hair pulling).
Read the detailed description
Trichotillomania (TTM) is a disorder in which people compulsively pull out their own hair. Treatments for TTM sometimes do not have long-term effectiveness. Acceptance and commitment therapy (ACT) is a therapeutic approach thought to have longer lasting effects than standard cognitive behavioral therapy (CBT) approaches, because ACT focuses on accepting thoughts and behaviors as opposed to changing them. Previous research indicates that a combination of ACT and habit reversal behavioral therapy is more effective than no treatment. This study will test whether a combination of ACT and behavioral therapy, called acceptance enhanced behavioral therapy (AEBT), is more effective than the current standard treatment for TTM.
Participation in this study will last 12 weeks, and follow-up assessments will last for 6 months. At study entry, participants will complete a brief intelligence test and an in-person interview about their medical history, psychiatric history, and hair pulling. At their second visit, participants will have digital pictures taken of their hair-pulling sites and complete two computer tasks measuring their response inhibition and cognitive flexibility. After the second visit, participants will be randomly assigned to receive either AEBT or psychoeducation and supportive therapy (PST)-a standard treatment for TTM. Both treatments will involve ten 1-hour sessions completed over 12 weeks. Assessments of participants will occur after 6 weeks of treatment, at treatment completion, and after 6 months. These assessments will measure treatment effectiveness, based on several clinical scales and measures of TTM symptoms. Participants who receive PST during this study will be offered AEBT afterward.
- Conditions
- Trichotillomania
- Being tested
- Acceptance enhanced behavior therapy (AEBT), Psychoeducation and supportive therapy (PST)
- Keywords
- Impulse Control Disorders, Behavior Therapy, Acceptance, Habit Reversal
- Medical subject headings
- Trichotillomania, Disruptive, Impulse Control, and Conduct Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance enhanced behavior therapy (AEBT)Behavioural
Also called Acceptance and Commitment Therapy, ACT, Habit Reversal, Behavior Therapy
Ten 1-hour sessions over 12 weeks, enhancing awareness of hair-pulling behavior and teaching strategies to deal with hair pulling
Psychoeducation and supportive therapy (PST)Behavioural
Also called Supportive Therapy, Psychoeducation
Ten 1-hour sessions over 12 weeks, teaching the participant about hair pulling and discussing how hair pulling affects those who do it
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive acceptance enhanced behavior therapy (AEBT) for trichotillomania (TTM). Receives: Behavioral: Acceptance enhanced behavior therapy (AEBT) |
| 2 | Active comparator | Participants will receive psychoeducation and supportive therapy (PST) for TTM. Receives: Behavioral: Psychoeducation and supportive therapy (PST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impressions-Improvement Scale
Measured: Measured after 6 weeks, 12 weeks, and 6 months
Secondary outcomes (3)
Massachusetts General Hospital Hairpulling Scale
Measured: Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months
National Institute of Mental Health (NIMH) Trichotillomania Severity and Impairment Scales
Measured: Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months
Clinical Global Impressions-Severity Scale
Measured: Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2013
- Study completion30 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Douglas Woods, Marquette University
- Investigators
- Douglas W. Woods, PhD, Principal investigator, Marquette University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872742
- Sponsor's protocol ID
- R01MH080966
- Other IDs
- R01MH080966, DATR A2-AIR, 1R01MH080966, NIMH-3065236
- Status last verified
- Sep 2021
- First submitted
- 30 Mar 2009
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Barber KE, Woods DW, Deckersbach T, Bauer CC, Compton SN, Twohig MP, Ricketts EJ, Robinson J, Saunders SM, Franklin ME. Neurocognitive functioning in adults with trichotillomania: Predictors of treatment response and symptom severity in a randomized control trial. Behav Res Ther. 2024 Aug;179:104556. doi: 10.1016/j.brat.2024.104556. Epub 2024 May 9.
PubMed 38761558Barber KE, Woods DW, Ely LJ, Saunders SM, Compton SN, Neal-Barnett A, Franklin ME, Capriotti MR, Conelea CA, Twohig MP. Long-term follow-up of acceptance-enhanced behavior therapy for trichotillomania. Psychiatry Res. 2024 Mar;333:115767. doi: 10.1016/j.psychres.2024.115767. Epub 2024 Jan 30.
PubMed 38330639Houghton DC, McFarland CS, Franklin ME, Twohig MP, Compton SN, Neal-Barnett AM, Saunders SM, Woods DW. DSM-5 Trichotillomania: Perception of Adults With Trichotillomania After Psychosocial Treatment. Psychiatry. 2016 Summer;79(2):164-169. doi: 10.1080/00332747.2016.1144438.
PubMed 27724833
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance Enhanced Behavior Therapy for Trichotillomania
- ClinicalTrials.gov ID
- NCT00872742
- Acronym / sponsor ID
- R01MH080966
- Conditions
- Trichotillomania
- Keywords
- Impulse Control Disorders, Behavior Therapy, Acceptance, Habit Reversal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- 30 Nov 2015 (actual)
- First posted
- 31 Mar 2009 (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 will test the effectiveness of a new behavioral therapy for adults with trichotillomania (compulsive hair pulling).
Detailed description
Trichotillomania (TTM) is a disorder in which people compulsively pull out their own hair. Treatments for TTM sometimes do not have long-term effectiveness. Acceptance and commitment therapy (ACT) is a therapeutic approach thought to have longer lasting effects than standard cognitive behavioral therapy (CBT) approaches, because ACT focuses on accepting thoughts and behaviors as opposed to changing them. Previous research indicates that a combination of ACT and habit reversal behavioral therapy is more effective than no treatment. This study will test whether a combination of ACT and behavioral therapy, called acceptance enhanced behavioral therapy (AEBT), is more effective than the current standard treatment for TTM.
Participation in this study will last 12 weeks, and follow-up assessments will last for 6 months. At study entry, participants will complete a brief intelligence test and an in-person interview about their medical history, psychiatric history, and hair pulling. At their second visit, participants will have digital pictures taken of their hair-pulling sites and complete two computer tasks measuring their response inhibition and cognitive flexibility. After the second visit, participants will be randomly assigned to receive either AEBT or psychoeducation and supportive therapy (PST)-a standard treatment for TTM. Both treatments will involve ten 1-hour sessions completed over 12 weeks. Assessments of participants will occur after 6 weeks of treatment, at treatment completion, and after 6 months. These assessments will measure treatment effectiveness, based on several clinical scales and measures of TTM symptoms. Participants who receive PST during this study will be offered AEBT afterward.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Acceptance enhanced behavior therapy (AEBT)Participants will receive acceptance enhanced behavior therapy (AEBT) for trichotillomania (TTM). |
| 2 | Active comparator | Behavioral: Psychoeducation and supportive therapy (PST)Participants will receive psychoeducation and supportive therapy (PST) for TTM. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Current DSM-IV diagnosis of trichotillomania
- Massachusetts General Hospital Hair Scale score greater than 12
- Wechsler Test of Adult Reading score greater than 85
- Fluent in English
- Outpatient status
Key exclusion criteria (4 listed)
- Diagnosis of bipolar disorder, psychotic disorder, mental retardation, pervasive developmental disorder, or current substance dependence (with the exception of nicotine dependence)
- Current mood or anxiety disorder with an active suicide risk
- Currently receiving psychotherapy for trichotillomania or another psychiatric condition
- Initiation or change in the dosage of any psychotropic medication for up to 8 weeks preceding participation in the study
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 |
|---|---|---|
| Acceptance enhanced behavior therapy (AEBT)Also: Acceptance and Commitment Therapy, ACT, Habit Reversal, Behavior TherapyTen 1-hour sessions over 12 weeks, enhancing awareness of hair-pulling behavior and teaching strategies to deal with hair pulling | Behavioural | 1 |
| Psychoeducation and supportive therapy (PST)Also: Supportive Therapy, PsychoeducationTen 1-hour sessions over 12 weeks, teaching the participant about hair pulling and discussing how hair pulling affects those who do it | Behavioural | 2 |
Primary outcome
Clinical Global Impressions-Improvement Scale
Time frame: Measured after 6 weeks, 12 weeks, and 6 months
3 secondary outcomes
Massachusetts General Hospital Hairpulling Scale
Time frame: Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months
National Institute of Mental Health (NIMH) Trichotillomania Severity and Impairment Scales
Time frame: Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 months
Clinical Global Impressions-Severity Scale
Time frame: Measured at screening, baseline, and after 6 weeks, 12 weeks, and 6 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 5 Oct 2021.
- Derived from this study: PubMed 38761558Barber KE, Woods DW, Deckersbach T, Bauer CC, Compton SN, Twohig MP, Ricketts EJ, Robinson J, Saunders SM, Franklin ME. Neurocognitive functioning in adults with trichotillomania: Predictors of treatment response and symptom severity in a randomized control trial. Behav Res Ther. 2024 Aug;179:104556. doi: 10.1016/j.brat.2024.104556. Epub 2024 May 9.
- Derived from this study: PubMed 38330639Barber KE, Woods DW, Ely LJ, Saunders SM, Compton SN, Neal-Barnett A, Franklin ME, Capriotti MR, Conelea CA, Twohig MP. Long-term follow-up of acceptance-enhanced behavior therapy for trichotillomania. Psychiatry Res. 2024 Mar;333:115767. doi: 10.1016/j.psychres.2024.115767. Epub 2024 Jan 30.
- Derived from this study: PubMed 27724833Houghton DC, McFarland CS, Franklin ME, Twohig MP, Compton SN, Neal-Barnett AM, Saunders SM, Woods DW. DSM-5 Trichotillomania: Perception of Adults With Trichotillomania After Psychosocial Treatment. Psychiatry. 2016 Summer;79(2):164-169. doi: 10.1080/00332747.2016.1144438.
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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.
Douglas W. Woods, PhD principal investigator
Marquette University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acceptance enhanced behavior therapy (AEBT) and Psychoeducation and supportive therapy (PST) in people with Trichotillomania, run by University of Wisconsin, Milwaukee 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 7 inclusion and 4 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 5 Oct 2021. 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 phase mean?
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?
Clinical Global Impressions-Improvement Scale (time frame: Measured after 6 weeks, 12 weeks, and 6 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 NCT00872742, which also lists 3 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 Oct 2021.