About this trial
This open-label feasibility trial evaluates the use of the Keen2 awareness bracelet for adults with trichotillomania (hair-pulling disorder). Participants will use the bracelet for eight weeks. During the first four weeks, they will wear the device and log contextual information (such as emotions, location, and activity) after each detected hair-pulling episode. Based on these data, participants will then receive tailored predictive alerts designed to support use of stimulus control, competing responses, and coping strategies. The study will assess usability, adherence, and changes in self-reported hair-pulling severity and awareness.
Eligibility criteria
Qualifiers
18 years of age (criterion 1a) with a diagnosis of TTM (criterion 1b)
Must reportEnglish as their primary language (criterion 2)
Report no current pharmacological or psychosocial intervention targeting TTM symptoms OR a6-week course of either intervention modality without change in frequency,intensity, or dosage (criterion 3)
Reliable and consistent access to the internet and/or mobile device permitting the participant to meet withsomeone virtually for 90 min.
Disqualifiers
Current suicidal/homicidal ideation, intent, or plan
a diagnosis of another psychiatric condition that may impeded a participant's ability to fully utilize the app (e.g., psychotic disorder, major depressive disorder)
Trial design
Treatments tested in this trial
- Keen2 Predictive Awareness Bracelet
Treatment groups
Sponsors and collaborators
HabitAware Inc.
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Kent State University
Collaborator