What is the mechanism of action of this treatment?

Common treatments for Trichotillomania include behavioral therapies such as Habit Reversal Training (HRT) and Cognitive Behavioral Therapy (CBT). These therapies work by increasing the patient's awareness of their hair-pulling behaviors and teaching them alternative coping strategies. The Keen 2 device, a behavioral awareness tool, functions similarly by alerting users to their pulling actions, thereby promoting mindfulness and self-regulation. Understanding these mechanisms is crucial for patients as it empowers them to recognize and modify their behaviors, leading to better management of their condition.

What side effects are associated with this type of intervention?

Common treatments for Trichotillomania, such as behavioral awareness devices like Keen 2, cognitive-behavioral therapy (CBT), and habit reversal training (HRT), generally have minimal physical side effects. However, they can sometimes lead to emotional discomfort as patients become more aware of and confront their hair-pulling behaviors. This increased awareness can initially cause anxiety or distress, but these feelings typically decrease as patients gain better control over their behaviors.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Trichotillomania. Treatments often involve behavioral therapy, such as Habit Reversal Training (HRT), which is similar in approach to the behavioral awareness device Keen 2 being studied. This device aims to increase awareness of hair-pulling behaviors, which is a key component of HRT. While medications like selective serotonin reuptake inhibitors (SSRIs) have been used off-label to manage symptoms, they are not specifically approved for Trichotillomania.

What other types of research exist?

Promising alternatives to the Keen 2 device for Trichotillomania treatment in 2024 include: 1) HabitAware's Keen 3, an updated version of the Keen 2 with enhanced features for behavior tracking and awareness. 2) Mobile apps with cognitive-behavioral therapy (CBT) modules specifically designed for Trichotillomania, such as 'TrichStop' or 'PullFree'. 3) Wearable devices integrated with biofeedback and mindfulness training, which help users recognize and manage hair-pulling urges. 4) Virtual reality (VR) therapy programs that simulate triggering environments and provide coping strategies in a controlled setting.

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Behavioural Intervention

HabitAware Keen2 for Trichotillomania

N/A

Waitlist Available

Led By Joseph McGuire, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

able to attend three study visits;

18 years of age or older;

Must not have

an inability to attend study visits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if the Keen 2 bracelet, which vibrates to alert users when they pull their hair, can help people with trichotillomania become more aware of and reduce their automatic hair-pulling behaviors.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the Keen2 is a non-invasive wearable device designed to increase self-awareness rather than deliver medication or therapy, it may not have typical side effects but could cause skin irritation or discomfort from wearing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can attend three study visits.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot attend the study visits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version

Secondary study objectives

Massachusetts General Hospital Hair Pulling Scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: HabitAware Keen 2Experimental Treatment1 Intervention

Participants will receive the wrist device device that alerts the participant when the participant is engaging in hair pulling behavior.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HabitAware Keen2

2021

N/A

~30

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Trichotillomania include behavioral therapies such as Habit Reversal Training (HRT) and Cognitive Behavioral Therapy (CBT). These therapies work by increasing the patient's awareness of their hair-pulling behaviors and teaching them alternative coping strategies. The Keen 2 device, a behavioral awareness tool, functions similarly by alerting users to their pulling actions, thereby promoting mindfulness and self-regulation. Understanding these mechanisms is crucial for patients as it empowers them to recognize and modify their behaviors, leading to better management of their condition.

Trichotillomania: current issues in conceptualization and treatment.