Technology Assisted Treatment of Trichotillomania: Open Trial
ConditionTrichotillomania
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHabitAware Inc.
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Keen2 Predictive Awareness Bracelet
BehavioralThe Keen2 is a wrist-worn awareness bracelet paired with a mobile app that helps individuals with trichotillomania recognize and reduce hair-pulling behavior. The bracelet uses motion sensors to detect hand movements consistent with pulling and delivers gentle vibration alerts to increase awareness. During the first four weeks, participants log contextual information about each detected episode, including emotional state, location, and activity. Based on these data, the system delivers predictive vibration alerts during weeks five through eight to prompt behavior change strategies across three domains: (1) stimulus control, (2) competing response training, and (3) coping strategies.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Single-Arm Intervention: Keen2 Predictive Awareness BraceletExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Trichotillomania Symptom Severity (NIMH-TSS)
The primary outcome is the change in total score on the NIMH Trichotillomania Symptom Severity Scale (NIMH-TSS) from baseline to week 8. The NIMH-TSS is a clinician-rated scale assessing the frequency, intensity, and distress associated with hair-pulling behavior. Higher scores indicate greater symptom severity. A reduction in score reflects improvement.
Time frame
Baseline, Week 4, and Week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
HabitAware Inc.
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Kent State University
Collaborator
Source ClinicalTrials.gov