90 Participants NeededMy employer runs this trial

Digital Health Interventions for Trichotillomania

SK
Overseen BySameer Kumar, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: HabitAware Inc.

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two digital tools to assist individuals with trichotillomania, a condition characterized by the urge to pull out hair. One group will use a specialized bracelet and app system for self-administering Habit Reversal Training and Stimulus Control. The other group will use a simple reminder bracelet and a journaling app with health tips. The study seeks participants who have experienced hair-pulling from areas like the scalp or eyebrows and are not currently on specific medications or treatments for it. Participants should also have an Apple smartphone and internet access. The goal is to evaluate how effectively these digital methods support symptom management. As an unphased trial, this study provides a unique opportunity to explore innovative digital tools that could enhance quality of life.

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

You don't have to stop your current medications if they are not targeting trichotillomania symptoms. If you are on medication for trichotillomania, you must have been on a stable dose for at least 6 weeks and plan to keep it stable during the 12-week trial.

What prior data suggests that these digital health interventions are safe for trichotillomania?

Studies have shown that users generally find the Keen2 bracelet and app easy to handle and accept. In earlier research, participants found the device helpful in increasing awareness of their hair-pulling habits. These studies reported no major negative effects, suggesting the treatment is safe for users.

This digital health tool aids individuals with trichotillomania by employing Habit Reversal Training. The device vibrates to alert users when they begin pulling their hair, encouraging them to stop. Overall, evidence indicates that the Keen2 bracelet and app system is safe for those seeking to manage their trichotillomania.12345

Why are researchers excited about this trial?

Researchers are excited about the digital health interventions for trichotillomania because they offer a novel approach by using technology to deliver behavior therapy. Unlike traditional treatments, which often rely on in-person therapy sessions, this intervention uses a Keen2 bracelet and a smartphone app to enable self-administered Habit Reversal Training and Stimulus Control. This system allows for real-time tracking and personalized feedback, making it more accessible and convenient for users. Additionally, the inclusion of a placebo comparator with a reminder bracelet and health tips app helps to evaluate the effectiveness of this new method. These digital tools could revolutionize how trichotillomania is managed, offering a more engaging and user-friendly alternative to existing therapies.

What evidence suggests that these digital health interventions could be effective for trichotillomania?

Research has shown that the Keen2 bracelet and app, available to participants in this trial, can increase awareness of hair-pulling habits in individuals with trichotillomania. In one study, users rated its effectiveness at an average of 4.40 out of 5. Another study found that 90% of users improved their hair-pulling behavior. The system employs Habit Reversal Training, which teaches new responses to the urge to pull hair. Overall, early findings suggest the Keen2 device and app can effectively manage trichotillomania.12367

Are You a Good Fit for This Trial?

This trial is for adults (18+) diagnosed with trichotillomania who mainly pull hair from above the neck. Participants must speak English, have stable or no current treatment for TTM, own an iPhone, have reliable internet access, and be able to identify a support person.

Inclusion Criteria

I have reliable internet or a mobile device for 90-minute virtual meetings.
I am fluent in English.
I am not taking medication for TTM, or my dose has been stable for at least 6 weeks.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week digital health intervention for trichotillomania, involving either a behavior therapy app with a motion detection device or a general wellness app with a reminder bracelet.

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Device and app system designed for participant to self-administer Habit Reversal Training and Stimulus Control
  • Reminder bracelet and journaling app control condition

Trial Overview

The study compares two digital tools—a Keen2 bracelet paired with its app versus a health reminders app plus a basic reminder bracelet—to see which helps more in managing trichotillomania symptoms. Participants are randomly assigned to one of these groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Keen2 bracelet and appExperimental Treatment2 Interventions
Group II: Reminder bracelet and health tips appPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

HabitAware Inc.

Lead Sponsor

Trials
3
Recruited
120+

Kent State University

Collaborator

Trials
46
Recruited
6,900+

Citations

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 ...

Pilot trial of a technology assisted treatment for trichotillomania

Participants in the device and app condition reported high usability, acceptability, and perceived efficacy of the system. The device and HRT ...

Keen2 Bracelet for Trichotillomania

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 ...

HabitAware: A Smart Bracelet for Trichotillomania Treatment

We've lived the pain of hair pulling, skin picking and nail biting - and found freedom in the power of Keen Awareness. You can too! 90% show improvement with ...

Lake Clinical Trials

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

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 ...

Keen2: Track Trichotillomania - App Store - Apple

Keen2 by HabitAware provides two ways for YOU to take control of hair pulling (trichotillomania), skin picking (dermatillomania), and nail biting.