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| ID | Type | Description | Link |
|---|---|---|---|
| R43MH114773 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Marquette University | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group - HabitAware condition | Experimental | 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. |
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| Control group - reminder bracelet condition | Placebo Comparator | This group will receive only a device that vibrates randomly several times per hour as a reminder not to pull. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device and app system designed for participant to self-administer Habit Reversal Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy. | Measured by post treatment survey results | Four weeks |
| Number of Participants That Can Implement HRT Procedures With 80% Accuracy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HabitAware, Inc. | Saint Louis Park | Minnesota | 55426 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This outcome measure was only for the experimental group. | Posted | Count of Participants | Participants | Four weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sameer Kumar | HabitAware | 2489904720 | sameer@habitaware.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2019 | Aug 2, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014256 | Trichotillomania |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
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| Reminder bracelet control condition | Behavioral | 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. |
|
Measured by trained clinician observing the participant perform the procedures
| Four weeks |
| 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. | Four weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | 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. |
|
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| Secondary | Percentage of Participants That Reported the Device >3 on a Scale of 1-5 for Accuracy. | Measured by post treatment survey results | This outcome measure was only for the experimental group. | Posted | Count of Participants | Participants | Four weeks |
|
|
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| Secondary | Number of Participants That Can Implement HRT Procedures With 80% Accuracy | Measured by trained clinician observing the participant perform the procedures | This outcome measure was only for the experimental group. | Posted | Count of Participants | Participants | Four weeks |
|
|
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| 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. | Posted | Count of Participants | Participants | Four weeks |
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|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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. | 0 | 5 | 0 | 5 | 0 | 5 |
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