Trial Outcomes & Findings for Feasibility Study for Treating Trichotillomania With Wearable Device and App System (NCT NCT04241120)
NCT ID: NCT04241120
Last Updated: 2023-03-27
Results Overview
Measured via post-treatment surveys.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Four weeks
Results posted on
2023-03-27
Participant Flow
Participant milestones
| Measure |
Experimental Group - HabitAware Condition
This group will receive the device which alerts the participant when performing hair pulling behavior and the app which provides psychoeducation and components of Habit Reversal Training.
Device and app system designed for participant to self-administer Habit Reversal Training: Participants will receive an awareness bracelet and an app that work together to implement key features of Habit Reversal Training. The participant will take part in psychoeducation, awareness training, and competing response training related to trichotillomania.
|
Control Group - Reminder Bracelet Condition
This group will receive only a device that vibrates randomly several times per hour as a reminder not to pull.
Reminder bracelet control condition: Participants will receive a bracelet programmed to vibrate randomly several times per hour during waking hours. They will be instructed this is a reminder not to pull.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
|
Overall Study
COMPLETED
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility Study for Treating Trichotillomania With Wearable Device and App System
Baseline characteristics by cohort
| Measure |
Experimental Group - HabitAware Condition
n=10 Participants
This group will receive the device which alerts the participant when performing hair pulling behavior and the app which provides psychoeducation and components of Habit Reversal Training.
Device and app system designed for participant to self-administer Habit Reversal Training: Participants will receive an awareness bracelet and an app that work together to implement key features of Habit Reversal Training. The participant will take part in psychoeducation, awareness training, and competing response training related to trichotillomania.
|
Control Group - Reminder Bracelet Condition
n=5 Participants
This group will receive only a device that vibrates randomly several times per hour as a reminder not to pull.
Reminder bracelet control condition: Participants will receive a bracelet programmed to vibrate randomly several times per hour during waking hours. They will be instructed this is a reminder not to pull.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
31.2 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
36.7 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Four weeksPopulation: This outcome measure was only for the experimental group.
Measured via post-treatment surveys.
Outcome measures
| Measure |
Experimental Group - HabitAware Condition
n=10 Participants
This group will receive the device which alerts the participant when performing hair pulling behavior and the app which provides psychoeducation and components of Habit Reversal Training.
Device and app system designed for participant to self-administer Habit Reversal Training: Participants will receive an awareness bracelet and an app that work together to implement key features of Habit Reversal Training. The participant will take part in psychoeducation, awareness training, and competing response training related to trichotillomania.
|
Control Group - Reminder Bracelet Condition
This group will receive only a device that vibrates randomly several times per hour as a reminder not to pull.
Reminder bracelet control condition: Participants will receive a bracelet programmed to vibrate randomly several times per hour during waking hours. They will be instructed this is a reminder not to pull.
|
|---|---|---|
|
Percentage of Participants in the HabitAware Condition That Wore the Device for 6 Hours Per Day and More Than 4 Days Per Week.
|
9 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Four weeksPopulation: This outcome measure was only for the experimental group.
Measured by post treatment survey results
Outcome measures
| Measure |
Experimental Group - HabitAware Condition
n=10 Participants
This group will receive the device which alerts the participant when performing hair pulling behavior and the app which provides psychoeducation and components of Habit Reversal Training.
Device and app system designed for participant to self-administer Habit Reversal Training: Participants will receive an awareness bracelet and an app that work together to implement key features of Habit Reversal Training. The participant will take part in psychoeducation, awareness training, and competing response training related to trichotillomania.
|
Control Group - Reminder Bracelet Condition
This group will receive only a device that vibrates randomly several times per hour as a reminder not to pull.
Reminder bracelet control condition: Participants will receive a bracelet programmed to vibrate randomly several times per hour during waking hours. They will be instructed this is a reminder not to pull.
|
|---|---|---|
|
Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy.
|
10 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Four weeksPopulation: This outcome measure was only for the experimental group.
Measured by trained clinician observing the participant perform the procedures
Outcome measures
| Measure |
Experimental Group - HabitAware Condition
n=5 Participants
This group will receive the device which alerts the participant when performing hair pulling behavior and the app which provides psychoeducation and components of Habit Reversal Training.
Device and app system designed for participant to self-administer Habit Reversal Training: Participants will receive an awareness bracelet and an app that work together to implement key features of Habit Reversal Training. The participant will take part in psychoeducation, awareness training, and competing response training related to trichotillomania.
|
Control Group - Reminder Bracelet Condition
This group will receive only a device that vibrates randomly several times per hour as a reminder not to pull.
Reminder bracelet control condition: Participants will receive a bracelet programmed to vibrate randomly several times per hour during waking hours. They will be instructed this is a reminder not to pull.
|
|---|---|---|
|
Number of Participants That Can Implement HRT Procedures With 80% Accuracy
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Four weeksMeasured via pre- and post-treatment MGH-HPS (Massachusetts General Hospital Hair Pulling Scale) and/or NIMH-TSS (National Institute of Mental Health - Trichotillomania Symptom Severity) scores for those in the HabitAware conditions.
Outcome measures
| Measure |
Experimental Group - HabitAware Condition
n=10 Participants
This group will receive the device which alerts the participant when performing hair pulling behavior and the app which provides psychoeducation and components of Habit Reversal Training.
Device and app system designed for participant to self-administer Habit Reversal Training: Participants will receive an awareness bracelet and an app that work together to implement key features of Habit Reversal Training. The participant will take part in psychoeducation, awareness training, and competing response training related to trichotillomania.
|
Control Group - Reminder Bracelet Condition
n=5 Participants
This group will receive only a device that vibrates randomly several times per hour as a reminder not to pull.
Reminder bracelet control condition: Participants will receive a bracelet programmed to vibrate randomly several times per hour during waking hours. They will be instructed this is a reminder not to pull.
|
|---|---|---|
|
Number of Participants With 30% Improvement in Clinical Symptoms
|
6 Participants
|
3 Participants
|
Adverse Events
Experimental Group - HabitAware Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group - Reminder Bracelet Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place