HabitAware Keen2 for Trichotillomania

JM
Overseen ByJoseph McGuire, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the HabitAware Keen2 wrist device can assist individuals with trichotillomania, a condition characterized by a strong urge to pull out hair. The Keen2 device alerts users when they begin pulling their hair, aiming to increase awareness and reduce automatic pulling behaviors. The study aims to determine if this increased awareness can also decrease overall hair-pulling severity and improve related mental health symptoms. Individuals diagnosed with trichotillomania who experience automatic hair-pulling behaviors may be suitable for this trial. Participants must wear the device for four weeks and attend three study visits. As an unphased trial, this study offers a unique opportunity to contribute to understanding and potentially improving management strategies for trichotillomania.

Will I have to stop taking my current medications?

You can continue taking your current psychiatric medications if you have been on a stable dose for at least 8 weeks before joining the trial.

What prior data suggests that the HabitAware Keen2 device is safe for use in trichotillomania?

Research has shown that the HabitAware Keen2 wrist device may assist people with trichotillomania, a condition where individuals pull out their hair. The device alerts users when they start pulling their hair, increasing their awareness of the habit.

Studies have found that similar devices can reduce the severity of hair-pulling behaviors. The HabitAware Keen2 is non-invasive, meaning it doesn't enter the body or use medication, which generally enhances its safety.

No serious safety issues have been reported with its use. The device includes safety features, such as controlled charging to prevent overheating, indicating that users generally tolerate the Keen2 well.12345

Why are researchers excited about this trial?

Unlike traditional treatments for trichotillomania that often involve therapy or medication, the HabitAware Keen2 offers a unique approach by using a wearable device. This wristband is designed to alert users when they start pulling their hair, helping them become more aware of the behavior in real time. Researchers are excited about this device because it empowers individuals with immediate feedback and promotes self-regulation, potentially offering a non-invasive and medication-free option for managing the condition.

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

Research has shown that the HabitAware Keen2 device may assist people with trichotillomania, a condition characterized by the urge to pull out hair. In this trial, participants will use the Keen2 bracelet, which can reduce hair-pulling by increasing user awareness. A small trial demonstrated that participants significantly reduced hair-pulling behaviors while using the device. The Keen2 bracelet alerts wearers when they start pulling their hair, enhancing their awareness of these actions. This increased awareness is crucial in reducing automatic pulling and improving the overall condition.46789

Who Is on the Research Team?

JM

Joseph McGuire, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Trichotillomania (TTM), who can wear the Keen2 device for four weeks and attend three study visits. Participants should have a stable dose of psychiatric medication, if any, speak English, and score high enough on specific tests measuring TTM severity.

Inclusion Criteria

meet diagnostic criteria for TTM using the TDI-R
be English speaking.
have an "automatic" pulling score ≥ 15 on the MIST;
See 4 more

Exclusion Criteria

an inability to complete rating scales,
I cannot attend the study visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Keen 2 device to increase awareness of hair pulling behaviors

1 week
1 visit (in-person)

Follow-up

Participants are monitored for changes in hair pulling severity and related psychiatric symptoms

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • HabitAware Keen2
Trial Overview The trial is testing the Keen2 device's effectiveness in increasing awareness of hair-pulling behaviors in people with TTM. It aims to see if this leads to a reduction in automatic pulling behavior and improves related psychiatric symptoms.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: HabitAware Keen 2Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Citations

Pilot trial of a technology assisted treatment ...The current pilot trial suggests that the HabitAware® wrist-worn device and accompanying app system has the potential to be an effective tool ...
Pilot Trial Shows Significant Hair Pulling Reduction With ...The results of the pilot trial were promising and demonstrated that HabitAware's Keen bracelet is a feasible and effective tool for reducing BFRBs.
Study Details | NCT05003401 | Leveraging Technological ...This project will examine the effect using the Keen 2 on hair pulling styles (automatic and focused), the severity of hair pulling behaviors, and related ...
HabitAware Keen2 for Trichotillomania · Info for ParticipantsHabitAware Keen2. Trial Overview The trial is testing the Keen2 device's effectiveness in increasing awareness of hair-pulling behaviors in people with TTM.
HabitAware Initiates Research to Further Develop Keen ...“Keen has great potential to improve trichotillomania outcomes and we are looking forward to collaborating to determine the effectiveness of Keen as a treatment ...
HabitAware: A Smart Bracelet for Trichotillomania TreatmentBreak the Trance and Retrain Your Brain with HabitAware. Take control of hair pulling (trichotillomania) skin picking (dermatillomania) and nail biting ...
How Keen2 Works: Keen2 Bracelet Reviews and Guide*Keen2 is recommended for hair pulling and skin picking behaviors on the face, scalp, shoulders, and nail biting. For finger picking or gestures below the ...
From Sketching to Shipping: Keen's StoryWhat started as a fun side project for a husband and wife trying to solve her specific hair pulling (trichotillomania) problem is now a 4-founder company poised ...
Product ManualFor safety reasons, Keen2 has built in electronics to limit how fast it can be charged. Once the battery is fully charged, our electronics turn ...
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