Trichotillomania
Conditions
Keywords
Hair Pulling Disorder, Body-Focused Repetitive Behaviors, Trichotillomania
Brief summary
Trichotillomania is characterized by recurrent hair pulling resulting in hair loss causing significant distress and impairment which persists despite repeated attempts to stop. Behavioral based therapies focused on increasing awareness of hair pulling followed by the use of an incompatible behavior have proven effective. In an effort to enhance awareness, a wrist worn motion detection device was created. In this study, we will test the feasibility of the HabitAware device and accompanying app as a system for delivering self-administered habit reversal training (HRT).
Interventions
BEHAVIORALDevice 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.
BEHAVIORALReminder 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.
Sponsors
Marquette University
National Institute of Mental Health (NIMH)
HabitAware Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
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 2. Speak fluent English 3. Current diagnosis of TTM 4. Score above the normative mean on the automatic pulling subscale of the MIST-A 5. Not on psychotropic medication or on a stable dose (i.e., same dose for past 6 weeks)
Exclusion criteria
1. Currently receiving psychotherapy 2. Other psychiatric condition requiring more immediate care 3. Have previously used any behavior awareness devices (e.g. Keen)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in the HabitAware Condition That Wore the Device for 6 Hours Per Day and More Than 4 Days Per Week. | Four weeks | Measured via post-treatment surveys. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy. | Four weeks | Measured by post treatment survey results |
| Number of Participants That Can Implement HRT Procedures With 80% Accuracy | Four weeks | Measured by trained clinician observing the participant perform the procedures |
| Number of Participants With 30% Improvement in Clinical Symptoms | Four weeks | Measured 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 5 |
| Total | 15 |
Baseline characteristics
| Characteristic | Control Group - Reminder Bracelet Condition | Total | Experimental Group - HabitAware Condition |
|---|---|---|---|
| Age, Continuous | 31.2 years STANDARD_DEVIATION 7.6 | 36.7 years STANDARD_DEVIATION 13.7 | 39.5 years STANDARD_DEVIATION 15.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 13 Participants | 8 Participants |
| Sex: Female, Male Female | 5 Participants | 15 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 5 |
| other Total, other adverse events | 0 / 10 | 0 / 5 |
| serious Total, serious adverse events | 0 / 10 | 0 / 5 |
Outcome results
Primary
Percentage of Participants in the HabitAware Condition That Wore the Device for 6 Hours Per Day and More Than 4 Days Per Week.
Measured via post-treatment surveys.
Time frame: Four weeks
Population: This outcome measure was only for the experimental group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Group - HabitAware Condition | 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 |
| Control Group - Reminder Bracelet Condition | Percentage of Participants in the HabitAware Condition That Wore the Device for 6 Hours Per Day and More Than 4 Days Per Week. | 0 Participants |
Secondary
Number of Participants That Can Implement HRT Procedures With 80% Accuracy
Measured by trained clinician observing the participant perform the procedures
Time frame: Four weeks
Population: This outcome measure was only for the experimental group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Group - HabitAware Condition | Number of Participants That Can Implement HRT Procedures With 80% Accuracy | 4 Participants |
| Control Group - Reminder Bracelet Condition | Number of Participants That Can Implement HRT Procedures With 80% Accuracy | 0 Participants |
Secondary
Number of Participants With 30% Improvement in Clinical Symptoms
Measured 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.
Time frame: Four weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Group - HabitAware Condition | Number of Participants With 30% Improvement in Clinical Symptoms | 6 Participants |
| Control Group - Reminder Bracelet Condition | Number of Participants With 30% Improvement in Clinical Symptoms | 3 Participants |
Secondary
Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy.
Measured by post treatment survey results
Time frame: Four weeks
Population: This outcome measure was only for the experimental group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Group - HabitAware Condition | Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy. | 10 Participants |
| Control Group - Reminder Bracelet Condition | Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy. | 0 Participants |