AEBT Website With Check-insNCT05610839
A RCT of a Fully-automated Self-help AEBT Website
A study testing Acceptance-Enhanced Behavior Therapy in people with AEBT Website With Check-ins and AEBT Website Without Check-ins, run by Utah State University at 1 site in United States.
Trial summary
Trichotillomania (TTM) is characterized by hair pulling that is repetitive in nature leading to notable hair loss, causing clinically significant distress and resulting in impairments across social and functional domains (APA, 2013). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AEBT Website With Check-ins, AEBT Website Without Check-ins
- What is being tested?
- Acceptance-Enhanced Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2022to 29 Sep 2023
- 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
- Currently meet DSM-5 criteria for trichotillomania
- searching for trichotillomania-based treatment
- are atleast 18 years old
- fluent English speakers
- living in the U.S.
Who cannot join
- currently receiving alternative therapy
- currently modifying or starting psychotropic medication
- previously met DSM-5 criteria for trichotillomania but are not, at the time of intake session, engaging in hair pulling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of a Fully-automated Self-help AEBT Website for Adults With Trichotillomania
Trichotillomania (TTM) is characterized by hair pulling that is repetitive in nature leading to notable hair loss, causing clinically significant distress and resulting in impairments across social and functional domains (APA, 2013). Trichotillomania causes significant social impairment including affecting close relationships, pursuing occupational changes or advancement, or interfering with schooling (Grant et al., 2017; Woods, Flessner, Franklin, Wetterneck, et al., 2006). The core of the treatment of trichotillomania has traditionally been Habit Reversal Training (HRT) (Twohig, Bluett, et al., 2014). Another form of treatment that is gaining empirical support is Acceptance and Commitment Therapy (ACT) which has been studied in four randomized controlled trials, one studying ACT as a standalone treatment (Lee, Homan, et al., 2018), and three examining ACT combined with HRT (Twohig et al., 2021; Lee, Haeger, et al., 2018; Woods, Wetterneck, et al., 2006) which demonstrated efficacy of the combined treatment in decreasing pulling symptom severity.
The prevalence of trichotillomania in the US is 1-2% of the population and yet treatment access is limited by many issues including processionals' lack of knowledge of the disorder and low treatment accessibility (Walther et al., 2010). ACT- enhanced behavior therapy has been implemented using telehealth to reach a larger population (42.2% decrease pre-to-post treatment), but telehealth still requires therapist time and incurs notable costs (Lee, Haeger, et al., 2018). The present study aims to address the gap in trichotillomania treatment accessibility by examining the role of check-ins on adherence and efficacy on afully automated, web-based ACT-enhanced HRT treatment for adults with trichotillomania across the United States. We predict that the condition with check-ins will increase adherence and efficacy of the treatment significantly more than the condition without check-ins. Additionally, we predict that hair pulling severity and psychological flexibility will be significantly improved by the condition with check-ins compared to the condition without check-ins.
- Being tested
- Acceptance-Enhanced Behavior Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance-Enhanced Behavior TherapyBehavioural
8-module intervention delivering acceptance-enhanced behavior therapy through a fully automated website. This intervention was adapted from the Acceptance-enhanced behavior therapy workbook (Woods \& Twohig, 2008).
| Study group | Role | What they receive |
|---|---|---|
| AEBT website with check-ins | Experimental | Participants will complete the 8-module intervention of Acceptance-enhanced behavior therapy (AEBT) and will receive weekly check-ins. Acceptance-enhanced behavior therapy is a manualized treatment approach created by Woods and Twohig 2008 that provides both Acceptance and Commitment Therapy and Habit Reversal Therapy. Receives: Behavioral: Acceptance-Enhanced Behavior Therapy |
| AEBT website without check-ins | Active comparator | Participants will complete the 8-module intervention of Acceptance-enhanced behavior therapy (AEBT) but will not receive weekly check-ins. Acceptance-enhanced behavior therapy is a manualized treatment approach created by Woods and Twohig 2008 that provides both Acceptance and Commitment Therapy and Habit Reversal Therapy. Receives: Behavioral: Acceptance-Enhanced Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Massachusetts General Hospital- Hair Pulling Scale (MGH-HPS)
The MGH-HPS assesses urges to pull, pulling behavior, and the distress caused by pulling through a seven-item self-report measure. Items are rated individually on a scale from 0-4 and then the total scale is summed from 0-28-point total score. Higher scores indicate greater hair pulling severity. Treatment response is indicated by a seven-point reduction in score (Houghton et al., 2015). The MGH-HPS demonstrates good internal consistency (Keuthen et al., 1995), test-retest reliability and convergent and divergent validity (O'Sullivan et al., 1995).
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start8 Nov 2022
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AEBT Website With Check-insStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utah State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Twohig, Ph.D., Utah State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610839
- Sponsor's protocol ID
- 13026
- Status last verified
- Dec 2023
- First submitted
- 2 Nov 2022
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Fully-automated Self-help AEBT Website for Adults With Trichotillomania
- ClinicalTrials.gov ID
- NCT05610839
- Acronym / sponsor ID
- 13026
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Utah State UniversityUniversity, hospital or other
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 9 Nov 2022 (actual)
- 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.
Trichotillomania (TTM) is characterized by hair pulling that is repetitive in nature leading to notable hair loss, causing clinically significant distress and resulting in impairments across social and functional domains (APA, 2013). Trichotillomania causes significant social impairment including affecting close relationships, pursuing occupational changes or advancement, or interfering with schooling (Grant et al., 2017; Woods, Flessner, Franklin, Wetterneck, et al., 2006). The core of the treatment of trichotillomania has traditionally been Habit Reversal Training (HRT) (Twohig, Bluett, et al., 2014). Another form of treatment that is gaining empirical support is Acceptance and Commitment Therapy (ACT) which has been studied in four randomized controlled trials, one studying ACT as a standalone treatment (Lee, Homan, et al., 2018), and three examining ACT combined with HRT (Twohig et al., 2021; Lee, Haeger, et al., 2018; Woods, Wetterneck, et al., 2006) which demonstrated efficacy of the combined treatment in decreasing pulling symptom severity.
The prevalence of trichotillomania in the US is 1-2% of the population and yet treatment access is limited by many issues including processionals' lack of knowledge of the disorder and low treatment accessibility (Walther et al., 2010). ACT- enhanced behavior therapy has been implemented using telehealth to reach a larger population (42.2% decrease pre-to-post treatment), but telehealth still requires therapist time and incurs notable costs (Lee, Haeger, et al., 2018). The present study aims to address the gap in trichotillomania treatment accessibility by examining the role of check-ins on adherence and efficacy on afully automated, web-based ACT-enhanced HRT treatment for adults with trichotillomania across the United States. We predict that the condition with check-ins will increase adherence and efficacy of the treatment significantly more than the condition without check-ins. Additionally, we predict that hair pulling severity and psychological flexibility will be significantly improved by the condition with check-ins compared to the condition without check-ins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AEBT website with check-ins | Experimental | Behavioral: Acceptance-Enhanced Behavior TherapyParticipants will complete the 8-module intervention of Acceptance-enhanced behavior therapy (AEBT) and will receive weekly check-ins. Acceptance-enhanced behavior therapy is a manualized treatment approach created by Woods and Twohig 2008 that provides both Acceptance and Commitment Therapy and Habit Reversal Therapy. |
| AEBT website without check-ins | Active comparator | Behavioral: Acceptance-Enhanced Behavior TherapyParticipants will complete the 8-module intervention of Acceptance-enhanced behavior therapy (AEBT) but will not receive weekly check-ins. Acceptance-enhanced behavior therapy is a manualized treatment approach created by Woods and Twohig 2008 that provides both Acceptance and Commitment Therapy and Habit Reversal Therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Currently meet DSM-5 criteria for trichotillomania
- searching for trichotillomania-based treatment
- are atleast 18 years old
- fluent English speakers
- living in the U.S.
Key exclusion criteria (3 listed)
- currently receiving alternative therapy
- currently modifying or starting psychotropic medication
- previously met DSM-5 criteria for trichotillomania but are not, at the time of intake session, engaging in hair pulling
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 Therapy8-module intervention delivering acceptance-enhanced behavior therapy through a fully automated website. This intervention was adapted from the Acceptance-enhanced behavior therapy workbook (Woods \& Twohig, 2008). | Behavioural | AEBT website with check-ins, AEBT website without check-ins |
Primary outcome
Massachusetts General Hospital- Hair Pulling Scale (MGH-HPS)
Time frame: 36 weeks
The MGH-HPS assesses urges to pull, pulling behavior, and the distress caused by pulling through a seven-item self-report measure. Items are rated individually on a scale from 0-4 and then the total scale is summed from 0-28-point total score. Higher scores indicate greater hair pulling severity. Treatment response is indicated by a seven-point reduction in score (Houghton et al., 2015). The MGH-HPS demonstrates good internal consistency (Keuthen et al., 1995), test-retest reliability and convergent and divergent validity (O'Sullivan et al., 1995).
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 14 Dec 2023.
- Individual participant dataSharing planned: Undecided
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 Acceptance-Enhanced Behavior Therapy in people with AEBT Website With Check-ins and AEBT Website Without Check-ins, run by Utah State 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 5 inclusion and 3 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 14 Dec 2023. 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- Hair Pulling Scale (MGH-HPS) (time frame: 36 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 14 Dec 2023.