Technology Assisted Treatment for Trichotillomania

ConditionTrichotillomania

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorHabitAware Inc.

About this trial

The investigators are testing two digital health interventions for trichotillomania (TTM), via a randomized trial design.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older (criterion 1a) with a diagnosis of TTM focused on primary hair pulling location(s) above the neck (e.g., scalp, eyebrows, eye lashes, beard) (criterion 1b).

English language fluency (criterion 2).

Report no current pharmacological intervention targeting TTM symptoms OR a 6-week course of the intervention without change in dosage and intent for that dosage to remain stable for the 12 weeks of this trial (criterion 3a).

Report no current psychosocial intervention targeting TTM (criterion 3b)

Disqualifiers

Current suicidal/homicidal ideation, intent, or plan (criterion 1a) or a diagnosis of another psychiatric condition that may impede a participant's ability to fully utilize the app (e.g., psychotic disorder, eating disorder, moderate to severe major depressive disorder [defined by meeting diagnostic criteria on the MINI and a score >13 on DASS-21]) (criterion 1b)

Has not used HabitAware's Keen or Keen2 bracelet in the past 24 months.

Residing outside the United States

Trial design

Design model

Parallel

Treatments tested in this trial

Keen2 bracelet
Device
Participants will receive an awareness bracelet (Keen2) which vibrates upon detection of hair pulling motion, supporting behavior therapy for hair pulling delivered by the Keen2 app.
Reminder bracelet
Device
Participants will receive a non-vibrating bracelet to wear as a visual reminder not to pull.
Keen2 app
Behavioral
Participants will be given access to a smartphone app. The bracelet and app work together to implement key features of habit reversal training for TTM, including psychoeducation, awareness training, competing response training, and personalized just-in-time stimulus control and other behavioral strategy reminders.
Health Reminders App
Behavioral
Participants will be given access to a smartphone app that will prompt them to log their context (e.g., location and activity) throughout the day and provide general health tips.

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: Keen2 bracelet and appExperimental treatment 2 interventions

Group B: Reminder bracelet and health tips appPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

Clinician-rated trichotillomania (TTM) symptom severity at endpoint (week 8)

Scores on the NIMH Trichotilomania Severity Scale (NIMH-TSS), a clinician-administered assessment of TTM symptom severity, will be compared across conditions at endpoint (week 8), controlling for baseline severity. The NIMH-TSS is a 5-item clinician rated measure of TTM severity ranging from 0-25, with higher scores indicating more severe symptoms.

Time frame

Eight weeks

Secondary outcomes

Self-reported trichotillomania (TTM) severity at endpoint (week 8)

Scores on the Massachusetts General Hospital Hair Pulling Scale (MGH-HS), a validated and widely used 7-item Likert self-report measure of TTM symptom severity, will be compared across conditions at endpoint (week 8), controlling for baseline severity. MGH-HS scores range from 0 to 28, with higher scores corresponding with more severe TTM symptoms.

Time frame

8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HabitAware Inc.

Lead sponsor

Kent State University

Collaborator

Source ClinicalTrials.gov

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