Keen2 Bracelet for Trichotillomania

Overseen By Sameer A Kumar, BS, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HabitAware Inc.

Disqualifiers: Suicidal ideation, Psychotic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a special bracelet designed to help people with trichotillomania, a condition where individuals feel compelled to pull out their hair. The Keen2 Predictive Awareness Bracelet tracks hair-pulling episodes and, after collecting data for four weeks, sends alerts to help users manage their behavior. The study aims to assess the bracelet's ease of use and its effectiveness in reducing hair-pulling incidents. Ideal participants are adults who have struggled with hair-pulling but are not currently undergoing treatment for it. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new behavioral management tools.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you must not be undergoing any current treatment for trichotillomania or have been on a stable treatment for at least six weeks without changes.

What prior data suggests that the Keen2 awareness bracelet is safe for use in trichotillomania?

Research has shown that the Keen2 Predictive Awareness Bracelet is designed to assist individuals with trichotillomania, a condition characterized by hair-pulling. The bracelet vibrates to alert users when they might start pulling their hair, helping them stop before they begin.

Regarding safety, no evidence suggests harmful side effects from wearing the bracelet. Previous studies on similar devices found that users generally found the wearable technology easy to use and accept. Since this device remains external to the body, it is considered safe for most users.

While researchers continue to test the bracelet's effectiveness in reducing hair-pulling, the safety results so far are reassuring. Participants in the studies reported that the device was comfortable to wear and did not cause any serious problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Keen2 Predictive Awareness Bracelet is unique because it combines wearable technology with personalized behavioral insights to manage trichotillomania, a condition marked by compulsive hair-pulling. Unlike traditional treatments, which might include cognitive behavioral therapy or medication, this bracelet uses predictive vibration alerts based on the user's past behavior patterns. These alerts help individuals take preventive actions by reducing triggers, engaging in alternative hand activities, and employing coping strategies. Researchers are excited because this method offers a non-invasive, real-time intervention that empowers users to manage their condition autonomously.

What evidence suggests that the Keen2 bracelet is effective for trichotillomania?

Research has shown that the Keen2 awareness bracelet can assist people with trichotillomania, a condition characterized by hair-pulling. In a previous study, participants reported increased awareness of their hair-pulling, with an average effectiveness score of 4.40 out of 5. Other studies have found that the bracelet, along with its app, helps users recognize their hair-pulling habits more effectively. This heightened awareness can reduce the frequency and severity of hair-pulling by reminding users to take preventive actions. In this trial, participants will receive the Keen2 bracelet, which vibrates to prompt users to try different behaviors or coping strategies. Overall, this technology appears promising as a tool for managing trichotillomania. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with trichotillomania, a condition where someone can't resist the urge to pull out their hair. Participants should be willing to wear an awareness bracelet and log information about their hair-pulling episodes. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

Reliable and consistent access to the internet and/or mobile device permitting the participant to meet with someone virtually for 90 min

Must report owning/access to a mobile phone running on Apple's operating system (iOS)

Identifies a support person that is able to be contacted is an emergency arises

Exclusion Criteria

Current suicidal/homicidal ideation, intent, or plan

I do not have a psychiatric condition that would stop me from using an app effectively.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1

Participants use the Keen2 device to detect hair-pulling episodes and record contextual information

4 weeks

Weekly virtual check-ins

Phase 2

Participants receive individualized predictive alerts to support intervention strategies

4 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for changes in hair-pulling severity and device usability

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Keen2 Predictive Awareness Bracelet

Trial Overview The Keen2 Predictive Awareness Bracelet is being tested in this study. It's designed to help users become more aware of when they're likely to pull their hair by sending them alerts. The trial lasts eight weeks, with the first four weeks dedicated to logging data for tailoring these predictive alerts.

How Is the Trial Designed?

Group I: Single-Arm Intervention: Keen2 Predictive Awareness Bracelet Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

HabitAware Inc.

Lead Sponsor

Trials

3

Recruited

120+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Kent State University

Collaborator

Trials

46

Recruited

6,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07224126

Technology Assisted Treatment of Trichotillomania: Open ... This open-label feasibility trial evaluates the use of the Keen2 awareness bracelet for adults with trichotillomania (hair-pulling disorder). Participants will ...

2. habitaware.com habitaware.com/blogs/habitaware-blog/breakthrough-technology-shows-promise-in-treating-hair-pulling-habitawares-keen2-device-receives-phase-ii-nih-award?srsltid=AfmBOorL-sj59befroG_JhTBp8FvFr96tiXtKEy_pu3Gp6Wh87pngBMR

HabitAware's Keen2 Device Receives Phase II NIH Award The study involved 15 adults diagnosed with trichotillomania who interacted with the Keen2 device and app system for a duration of 4 weeks. The results ...

3. withpower.com withpower.com/trial/phase-trichotillomania-8-2025-8d198

Keen2 Bracelet for Trichotillomania This open-label feasibility trial evaluates the use of the Keen2 awareness bracelet for adults with trichotillomania (hair-pulling disorder).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10256116/

Pilot trial of a technology assisted treatment ... Perceived Efficacy. Participants felt the device and app system was effective at increasing their awareness of hair pulling (M = 4.40, SD ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05003401/leveraging-technological-advancements-to-improve-the-treatment-of-trichotillomania

Leveraging Technological Advancements to Improve the ... This project will examine the effect using the Keen 2 on hair pulling styles (automatic and focused), the severity of hair pulling behaviors ...

6. habitaware.com habitaware.com/?srsltid=AfmBOoo6bvK_rBw5nhnbE8Erjcw_CmkhFMefAdVkaBoo5S6NeSDb6xNy

HabitAware: A Smart Bracelet for Trichotillomania Treatment Take control of hair pulling (trichotillomania) skin picking (dermatillomania) and nail biting (onychophagia) with our evidence-based buzzing bracelet, helping ...

7. medicaldevicenavigator.com medicaldevicenavigator.com/new_trial_explores_smart_device_for_trichotillomania_treatment/

New Trial Explores Smart Device for Trichotillomania Treatment This open trial is actively recruiting to evaluate the effectiveness of the Keen2 Predictive Awareness Bracelet for individuals diagnosed with trichotillomania.