Trichotillomania
Conditions
Keywords
Hair Pulling Disorder, Body-Focused Repetitive Behaviors, Trichotillomania, habit reversal training
Brief summary
The investigators are testing two digital health interventions for trichotillomania (TTM), via a randomized trial design.
Detailed description
Trichotillomania is characterized by recurrent hair pulling despite repeated attempts to stop, resulting in hair loss as well as significant distress and impairment. Behavior therapies focused on increasing awareness of hair pulling followed by the use of an incompatible behavior (i.e., competing response) and other behavioral strategies (e.g., stimulus control) are efficacious. In this randomized control trial, we are testing the preliminary efficacy of two digital health interventions for adults with TTM (N=90). Participants will be randomly assigned (50/50 chance) to receive 8 weeks of (a) a digital behavior therapy that includes a wrist worn motion detection device to enhance awareness and a companion mobile application that provides psychoeducation, awareness training (e.g., self-monitoring), and behavioral strategy suggestions or (b) a digital general wellness intervention that includes a reminder bracelet (i.e., a wrist-worn visual reminder not to pull) accompanied by a smartphone app that includes general context logging and delivery of general health tips.
Interventions
DEVICEKeen2 bracelet
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.
DEVICEReminder bracelet
Participants will receive a non-vibrating bracelet to wear as a visual reminder not to pull.
BEHAVIORALKeen2 app
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.
BEHAVIORALHealth Reminders App
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.
Sponsors
HabitAware Inc.
Kent State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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). 2. English language fluency (criterion 2). 3. 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). 4. Report no current psychosocial intervention targeting TTM (criterion 3b) 4\. Reliable and consistent access to the internet and/or mobile device permitting the participant to meet with someone virtually for 90 min. 5\. Owns a mobile phone running on Apple's operating system (iOS 6+) 6. Identifies a support person that is able to be contacted if an emergency arises.
Exclusion criteria
1. 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) 2. Has not used HabitAware's Keen or Keen2 bracelet in the past 24 months. 3. Residing outside the United States
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician-rated trichotillomania (TTM) symptom severity at endpoint (week 8) | Eight weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported trichotillomania (TTM) severity at endpoint (week 8) | 8 weeks | 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. |
Countries
United States
Contacts
CONTACTSameer Kumar, BS
Outcome results
None listed