TrichotillomaniaNCT07224126
Technology Assisted Treatment of Trichotillomania: Open Trial
A study testing Keen2 Predictive Awareness Bracelet in people with Trichotillomania, run by HabitAware Inc. at 1 site in United States.
Trial summary
This open-label feasibility trial evaluates the use of the Keen2 awareness bracelet for adults with trichotillomania (hair-pulling disorder). Participants will use the bracelet for eight weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trichotillomania
- What is being tested?
- Keen2 Predictive Awareness Bracelet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2025to 9 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 (criterion 1a) with a diagnosis of TTM (criterion 1b)
- Must reportEnglish as their primary language (criterion 2)
- Report no current pharmacological or psychosocial intervention targeting TTM symptoms OR a6-week course of either intervention modality without change in frequency,intensity, or dosage (criterion 3)
- Reliable and consistent access to the internet and/or mobile device permitting the participant to meet withsomeone virtually for 90 min.
- Must report owning/access to a mobilephone running on Apple's operating system (iOS)
- Identifies a support person that is able to be contacted is an emergency arises.
- Agrees to allow the Kent State research team to share home address, mobile number, andalternate number/email with HabitAware, Inc., for purposes of mailing Keen2device and setting up Keen2 system.
Who cannot join
- Current suicidal/homicidal ideation, intent, or plan
- a diagnosis of another psychiatric condition that may impeded a participant's ability to fully utilize the app (e.g., psychotic disorder, major depressive disorder)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Department of Psychological Sciences
Kent, Ohio, 44242
Christopher Flessner, PhD, (330) 672-2200, anxiety@kent.edu
About this study
Official title: Technology Assisted Treatment for Trichotillomania: Open Trial
This open-label feasibility trial evaluates the use of the Keen2 awareness bracelet for adults with trichotillomania (hair-pulling disorder). Participants will use the bracelet for eight weeks. During the first four weeks, they will wear the device and log contextual information (such as emotions, location, and activity) after each detected hair-pulling episode. Based on these data, participants will then receive tailored predictive alerts designed to support use of stimulus control, competing responses, and coping strategies. The study will assess usability, adherence, and changes in self-reported hair-pulling severity and awareness.
Read the detailed description
This single-arm study is designed to test the feasibility and preliminary behavioral impact of a digital awareness intervention for trichotillomania. Participants aged 18 and older who report recurrent hair-pulling will receive a Keen2 bracelet and companion mobile app for an eight-week period.
Phase 1 (Weeks 1-4): Participants will use the device to detect pulling episodes and will record contextual information (such as time of day, emotional state, and environmental triggers) in the app following each detection.
Phase 2 (Weeks 5-8): Using data from the first phase, the system will deliver individualized predictive vibration alerts when behavioral patterns suggest increased risk of pulling. Alerts correspond to three intervention domains: (1) Stimulus control (reducing environmental cues), (2) Competing response training (engaging hands in alternative actions), and (3) Coping strategies (implementing relaxation or cognitive techniques).
Primary outcomes include usability, adherence, and changes in hair-pulling severity measured by the Massachusetts General Hospital Hairpulling Scale (MGH-HPS) from baseline to week 8, with a follow up at week 12. Secondary outcomes include knowledge of interventional domains as well as qualitative feedback on device helpfulness.
- Conditions
- Trichotillomania
- Being tested
- Keen2 Predictive Awareness Bracelet
- Keywords
- hair pulling disorder, BFRB, Body-Focused Repetitive Behavior, trichotillomania, trich
- 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.
Keen2 Predictive Awareness BraceletBehavioural
The Keen2 is a wrist-worn awareness bracelet paired with a mobile app that helps individuals with trichotillomania recognize and reduce hair-pulling behavior. The bracelet uses motion sensors to detect hand movements consistent with pulling and delivers gentle vibration alerts to increase awareness. During the first four weeks, participants log contextual information about each detected episode, including emotional state, location, and activity. Based on these data, the system delivers predictive vibration alerts during weeks five through eight to prompt behavior change strategies across three domains: (1) stimulus control, (2) competing response training, and (3) coping strategies.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm Intervention: Keen2 Predictive Awareness Bracelet | Experimental | Participants in this single-arm study will receive a Keen2 awareness bracelet and companion mobile app for an 8-week period. During the first 4 weeks, participants will use the device to detect hair-pulling episodes and record contextual details (such as time, emotional state, activity, and location) after each detection. In the second 4 weeks, participants will receive predictive vibration alerts generated from their prior behavioral patterns. These alerts are designed to prompt preventive actions across three domains: (1) stimulus control (reducing environmental triggers), (2) competing response training (engaging hands in alternative behaviors), and (3) coping strategies (using relaxation or cognitive techniques). Receives: Behavioral: Keen2 Predictive Awareness Bracelet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Trichotillomania Symptom Severity (NIMH-TSS)
The primary outcome is the change in total score on the NIMH Trichotillomania Symptom Severity Scale (NIMH-TSS) from baseline to week 8. The NIMH-TSS is a clinician-rated scale assessing the frequency, intensity, and distress associated with hair-pulling behavior. Higher scores indicate greater symptom severity. A reduction in score reflects improvement.
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start15 Sep 2025
- Primary completion9 Jan 2026 (estimated)
- Study completion9 Jan 2026 (estimated)
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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HabitAware Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), Kent State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224126
- Sponsor's protocol ID
- 1943
- Other IDs
- R44MH114773
- Status last verified
- Nov 2025
- First submitted
- 31 Oct 2025
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Assisted Treatment for Trichotillomania: Open Trial
- ClinicalTrials.gov ID
- NCT07224126
- Acronym / sponsor ID
- 1943
- Conditions
- Trichotillomania
- Keywords
- hair pulling disorder, BFRB, Body-Focused Repetitive Behavior, trichotillomania, trich
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- HabitAware Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), Kent State University
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 9 Jan 2026 (estimated)
- Study completion
- 9 Jan 2026 (estimated)
- First posted
- 4 Nov 2025 (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.
This open-label feasibility trial evaluates the use of the Keen2 awareness bracelet for adults with trichotillomania (hair-pulling disorder). Participants will use the bracelet for eight weeks. During the first four weeks, they will wear the device and log contextual information (such as emotions, location, and activity) after each detected hair-pulling episode. Based on these data, participants will then receive tailored predictive alerts designed to support use of stimulus control, competing responses, and coping strategies. The study will assess usability, adherence, and changes in self-reported hair-pulling severity and awareness.
Detailed description
This single-arm study is designed to test the feasibility and preliminary behavioral impact of a digital awareness intervention for trichotillomania. Participants aged 18 and older who report recurrent hair-pulling will receive a Keen2 bracelet and companion mobile app for an eight-week period.
Phase 1 (Weeks 1-4): Participants will use the device to detect pulling episodes and will record contextual information (such as time of day, emotional state, and environmental triggers) in the app following each detection.
Phase 2 (Weeks 5-8): Using data from the first phase, the system will deliver individualized predictive vibration alerts when behavioral patterns suggest increased risk of pulling. Alerts correspond to three intervention domains: (1) Stimulus control (reducing environmental cues), (2) Competing response training (engaging hands in alternative actions), and (3) Coping strategies (implementing relaxation or cognitive techniques).
Primary outcomes include usability, adherence, and changes in hair-pulling severity measured by the Massachusetts General Hospital Hairpulling Scale (MGH-HPS) from baseline to week 8, with a follow up at week 12. Secondary outcomes include knowledge of interventional domains as well as qualitative feedback on device helpfulness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm Intervention: Keen2 Predictive Awareness Bracelet | Experimental | Behavioral: Keen2 Predictive Awareness BraceletParticipants in this single-arm study will receive a Keen2 awareness bracelet and companion mobile app for an 8-week period. During the first 4 weeks, participants will use the device to detect hair-pulling episodes and record contextual details (such as time, emotional state, activity, and location) after each detection. In the second 4 weeks, participants will receive predictive vibration alerts generated from their prior behavioral patterns. These alerts are designed to prompt preventive actions across three domains: (1) stimulus control (reducing environmental triggers), (2) competing response training (engaging hands in alternative behaviors), and (3) coping strategies (using relaxation or cognitive techniques). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age (criterion 1a) with a diagnosis of TTM (criterion 1b)
- Must reportEnglish as their primary language (criterion 2)
- Report no current pharmacological or psychosocial intervention targeting TTM symptoms OR a6-week course of either intervention modality without change in frequency,intensity, or dosage (criterion 3)
- Reliable and consistent access to the internet and/or mobile device permitting the participant to meet withsomeone virtually for 90 min.
- Must report owning/access to a mobilephone running on Apple's operating system (iOS)
Key exclusion criteria (2 listed)
- Current suicidal/homicidal ideation, intent, or plan
- a diagnosis of another psychiatric condition that may impeded a participant's ability to fully utilize the app (e.g., psychotic disorder, major depressive disorder)
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 |
|---|---|---|
| Keen2 Predictive Awareness BraceletThe Keen2 is a wrist-worn awareness bracelet paired with a mobile app that helps individuals with trichotillomania recognize and reduce hair-pulling behavior. The bracelet uses motion sensors to detect hand movements consistent with pulling and delivers gentle vibration alerts to increase awareness. During the first four weeks, participants log contextual information about each detected episode, including emotional state, location, and activity. Based on these data, the system delivers predictive vibration alerts during weeks five through eight to prompt behavior change strategies across three domains: (1) stimulus control, (2) competing response training, and (3) coping strategies. | Behavioural | Single-Arm Intervention: Keen2 Predictive Awareness Bracelet |
Primary outcome
Change in Trichotillomania Symptom Severity (NIMH-TSS)
Time frame: Baseline, Week 4, and Week 8
The primary outcome is the change in total score on the NIMH Trichotillomania Symptom Severity Scale (NIMH-TSS) from baseline to week 8. The NIMH-TSS is a clinician-rated scale assessing the frequency, intensity, and distress associated with hair-pulling behavior. Higher scores indicate greater symptom severity. A reduction in score reflects improvement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Link to KSU page describing the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keen2 Predictive Awareness Bracelet 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 7 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 10 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Flessner, PhD ((330) 672-2200, anxiety@kent.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Trichotillomania Symptom Severity (NIMH-TSS) (time frame: Baseline, Week 4, and Week 8). 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 10 Nov 2025.