TrichotillomaniaNCT04241120
Feasibility Study for Treating Trichotillomania With Wearable Device and App System
A study testing Device and app system designed for participant to self-administer Habit Reversal Training in people with Trichotillomania, run by HabitAware Inc. at 1 site in United States.
Trial summary
Trichotillomania is characterized by recurrent hair pulling resulting in hair loss causing significant distress and impairment which persists despite repeated attempts to stop. Behavioral based therapies focused on increasing awareness of hair pulling followed by the use of an incompatible behavior have proven… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trichotillomania
- What is being tested?
- Device and app system designed for participant to self-administer Habit Reversal Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2020to 4 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 of age or older
- Speak fluent English
- Current diagnosis of TTM
- Score above the normative mean on the automatic pulling subscale of the MIST-A
- Not on psychotropic medication or on a stable dose (i.e., same dose for past 6 weeks)
Who cannot join
- Currently receiving psychotherapy
- Other psychiatric condition requiring more immediate care
- Have previously used any behavior awareness devices (e.g. Keen)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study for Treating Trichotillomania With Wearable Device and App System Using Habit Reversal Training
Trichotillomania is characterized by recurrent hair pulling resulting in hair loss causing significant distress and impairment which persists despite repeated attempts to stop. Behavioral based therapies focused on increasing awareness of hair pulling followed by the use of an incompatible behavior have proven effective. In an effort to enhance awareness, a wrist worn motion detection device was created. In this study, we will test the feasibility of the HabitAware device and accompanying app as a system for delivering self-administered habit reversal training (HRT).
- Conditions
- Trichotillomania
- Being tested
- Device and app system designed for participant to self-administer Habit Reversal Training, Reminder bracelet control condition
- Keywords
- Hair Pulling Disorder, Body-Focused Repetitive Behaviors, Trichotillomania
- Medical subject headings
- Trichotillomania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device and app system designed for participant to self-administer Habit Reversal TrainingBehavioural
Participants will receive an awareness bracelet and an app that work together to implement key features of Habit Reversal Training. The participant will take part in psychoeducation, awareness training, and competing response training related to trichotillomania.
Reminder bracelet control conditionBehavioural
Participants will receive a bracelet programmed to vibrate randomly several times per hour during waking hours. They will be instructed this is a reminder not to pull.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group - HabitAware condition | Experimental | This group will receive the device which alerts the participant when performing hair pulling behavior and the app which provides psychoeducation and components of Habit Reversal Training. Receives: Behavioral: Device and app system designed for participant to self-administer Habit Reversal Training |
| Control group - reminder bracelet condition | Placebo comparator | This group will receive only a device that vibrates randomly several times per hour as a reminder not to pull. Receives: Behavioral: Reminder bracelet control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants in the HabitAware Condition That Wore the Device for 6 Hours Per Day and More Than 4 Days Per Week.
Measured via post-treatment surveys.
Measured: Four weeks
Secondary outcomes (3)
Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy.
Measured by post treatment survey results
Measured: Four weeks
Number of Participants That Can Implement HRT Procedures With 80% Accuracy
Measured by trained clinician observing the participant perform the procedures
Measured: Four weeks
Number of Participants With 30% Improvement in Clinical Symptoms
Measured via pre- and post-treatment MGH-HPS (Massachusetts General Hospital Hair Pulling Scale) and/or NIMH-TSS (National Institute of Mental Health - Trichotillomania Symptom Severity) scores for those in the HabitAware conditions.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start16 Jan 2020
- Primary completion4 Mar 2020
- Study completion4 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- HabitAware Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Marquette University, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241120
- Sponsor's protocol ID
- 31257150
- Other IDs
- R43MH114773
- Status last verified
- Feb 2023
- First submitted
- 21 Jan 2020
- Last updated
- 27 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for Treating Trichotillomania With Wearable Device and App System Using Habit Reversal Training
- ClinicalTrials.gov ID
- NCT04241120
- Acronym / sponsor ID
- 31257150
- Conditions
- Trichotillomania
- Keywords
- Hair Pulling Disorder, Body-Focused Repetitive Behaviors, Trichotillomania
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- HabitAware Inc.Industry (pharma, biotech, devices)
- Collaborators
- Marquette University, National Institute of Mental Health (NIMH)
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Posted 27 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Trichotillomania is characterized by recurrent hair pulling resulting in hair loss causing significant distress and impairment which persists despite repeated attempts to stop. Behavioral based therapies focused on increasing awareness of hair pulling followed by the use of an incompatible behavior have proven effective. In an effort to enhance awareness, a wrist worn motion detection device was created. In this study, we will test the feasibility of the HabitAware device and accompanying app as a system for delivering self-administered habit reversal training (HRT).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group - HabitAware condition | Experimental | Behavioral: Device and app system designed for participant to self-administer Habit Reversal TrainingThis group will receive the device which alerts the participant when performing hair pulling behavior and the app which provides psychoeducation and components of Habit Reversal Training. |
| Control group - reminder bracelet condition | Placebo comparator | Behavioral: Reminder bracelet control conditionThis group will receive only a device that vibrates randomly several times per hour as a reminder not to pull. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Speak fluent English
- Current diagnosis of TTM
- Score above the normative mean on the automatic pulling subscale of the MIST-A
- Not on psychotropic medication or on a stable dose (i.e., same dose for past 6 weeks)
Key exclusion criteria (3 listed)
- Currently receiving psychotherapy
- Other psychiatric condition requiring more immediate care
- Have previously used any behavior awareness devices (e.g. Keen)
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 |
|---|---|---|
| Device and app system designed for participant to self-administer Habit Reversal TrainingParticipants will receive an awareness bracelet and an app that work together to implement key features of Habit Reversal Training. The participant will take part in psychoeducation, awareness training, and competing response training related to trichotillomania. | Behavioural | Experimental group - HabitAware condition |
| Reminder bracelet control conditionParticipants will receive a bracelet programmed to vibrate randomly several times per hour during waking hours. They will be instructed this is a reminder not to pull. | Behavioural | Control group - reminder bracelet condition |
Primary outcome
Percentage of Participants in the HabitAware Condition That Wore the Device for 6 Hours Per Day and More Than 4 Days Per Week.
Time frame: Four weeks
Measured via post-treatment surveys.
3 secondary outcomes
Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy.
Time frame: Four weeks
Number of Participants That Can Implement HRT Procedures With 80% Accuracy
Time frame: Four weeks
Number of Participants With 30% Improvement in Clinical Symptoms
Time frame: Four weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Device and app system designed for participant to self-administer Habit Reversal Training in people with Trichotillomania, run by HabitAware Inc. 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 27 Mar 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 27 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants in the HabitAware Condition That Wore the Device for 6 Hours Per Day and More Than 4 Days Per Week. (time frame: Four 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 27 Mar 2023.