Leveraging Technological Advancements to Improve the Treatment of Trichotillomania
Primary Purpose
Trichotillomania (Hair-Pulling Disorder), Trichotillomania, Hair Pulling
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HabitAware Keen2
Sponsored by
About this trial
This is an interventional treatment trial for Trichotillomania (Hair-Pulling Disorder)
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older;
- meet diagnostic criteria for TTM using the TDI-R
- have a MGH-HPS total score ≥ 12 at baseline;
(3) have an "automatic" pulling score ≥ 15 on the MIST; (4) able to wear the Keen2 device for four weeks; (5) able to attend three study visits; (6) unmedicated or a stable dose of psychiatric medication for 8 weeks prior to enrollment; (7) be English speaking.
Exclusion Criteria:
- an inability to complete rating scales, and
- an inability to attend study visits
Sites / Locations
- Johns Hopkins University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HabitAware Keen 2
Arm Description
Participants will receive the wrist device device that alerts the participant when the participant is engaging in hair pulling behavior.
Outcomes
Primary Outcome Measures
Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version
The Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version (MIST-A) is a 15-item self-report measure that assesses automatic (5-items) and focused (10-items) hair-pulling styles. Items are rated on a 10-point Likert scale from 0=not true of any of my hair pulling to 9= true for all of my hair pulling. Items are summed to produce an automatic hair pulling (range: 0 - 45) and focused hair pulling score (range: 0 - 90). Higher scores suggest greater presence of this hair pulling behavior. The MIST-A has demonstrated good reliability and validity.
Secondary Outcome Measures
Massachusetts General Hospital Hair Pulling Scale
The Massachusetts General Hospital Hair Pulling Scale (MGH-HPS) is a 7-item self-report measure assessing urges to pull, actual pulling, perceived control, and associated distress. The items are rated on a 5-point Likert scale ranging from 0 to 4, with a total score derived from the summation of all 7-items (range: 0 to 28). Higher total scores are indicative of greater hair pulling severity. The MGH-HPS exhibited good internal consistency with strong test-retest reliability between 2 and 4 weeks. Convergent validity for the MGH-HPS received support from significant correlations within measurement type. Discriminant validity was demonstrated by non-significant correlations with ratings of depression. The MGH-HPS has been used as a treatment outcome measure and appears to be sensitive to behavioral and pharmacological treatments in a sample that included both youth and adults (McGuire et al., 2012).
Full Information
NCT ID
NCT05003401
First Posted
August 6, 2021
Last Updated
September 27, 2023
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT05003401
Brief Title
Leveraging Technological Advancements to Improve the Treatment of Trichotillomania
Official Title
Leveraging Technological Advancements to Improve the Treatment of Trichotillomania
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project will examine the effect using the Keen 2 on hair pulling styles (automatic and focused), the severity of hair pulling behaviors, and related psychiatric symptoms. Given that the Keen2 is anticipated to increase awareness of pulling behavior (but not necessarily change pulling behavior), the investigators hypothesize that the Keen 2 will increase awareness of pulling behaviors and reduce automatic pulling behavior. The investigators will explore reductions in overall hair pulling severity and related psychiatric symptoms.
Detailed Description
Novel technologies present one solution to help identify and reduce automatic pulling behaviors associated with trichotillomania (TTM). The Keen 2 is one such novel technology, which is a bracelet which gives the user alerts in the form of a vibration when the user is engaging in hair pulling behavior. Thus, using the Keen 2 could positively increase the awareness of automatic pulling behaviors, which is largely unaffected by existing evidence-based treatments like HRT. This information would be advantageous for the scientific community to determine the possible benefit of this approach to help individuals with TTM.
This project will examine the effect using the Keen 2 on hair pulling styles (automatic and focused), the severity of hair pulling behaviors, and related psychiatric symptoms. Given that the Keen2 is anticipated to increase awareness of pulling behavior (but not necessarily change pulling behavior), the investigators hypothesize that the Keen 2 will increase awareness of pulling behaviors and reduce automatic pulling behavior. The investigators will explore reductions in overall hair pulling severity and related psychiatric symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania (Hair-Pulling Disorder), Trichotillomania, Hair Pulling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will be provided with the Keen2 wrist-worn device to determine whether this device increases awareness of automatic hair pulling behaviors over a period of 4 weeks.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HabitAware Keen 2
Arm Type
Experimental
Arm Description
Participants will receive the wrist device device that alerts the participant when the participant is engaging in hair pulling behavior.
Intervention Type
Device
Intervention Name(s)
HabitAware Keen2
Intervention Description
Participants will receive an awareness bracelet to be worn on the dominant wrist over a period of 4 weeks. The bracelet device will vibrate when the participant is engaging in hair pulling behaviors. As hair pulling behaviors may occur outside of awareness (i.e., automatic pulling behaviors), this vibration and detection is anticipated to increase the participants awareness of hair pulling behaviors.
Primary Outcome Measure Information:
Title
Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version
Description
The Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version (MIST-A) is a 15-item self-report measure that assesses automatic (5-items) and focused (10-items) hair-pulling styles. Items are rated on a 10-point Likert scale from 0=not true of any of my hair pulling to 9= true for all of my hair pulling. Items are summed to produce an automatic hair pulling (range: 0 - 45) and focused hair pulling score (range: 0 - 90). Higher scores suggest greater presence of this hair pulling behavior. The MIST-A has demonstrated good reliability and validity.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Massachusetts General Hospital Hair Pulling Scale
Description
The Massachusetts General Hospital Hair Pulling Scale (MGH-HPS) is a 7-item self-report measure assessing urges to pull, actual pulling, perceived control, and associated distress. The items are rated on a 5-point Likert scale ranging from 0 to 4, with a total score derived from the summation of all 7-items (range: 0 to 28). Higher total scores are indicative of greater hair pulling severity. The MGH-HPS exhibited good internal consistency with strong test-retest reliability between 2 and 4 weeks. Convergent validity for the MGH-HPS received support from significant correlations within measurement type. Discriminant validity was demonstrated by non-significant correlations with ratings of depression. The MGH-HPS has been used as a treatment outcome measure and appears to be sensitive to behavioral and pharmacological treatments in a sample that included both youth and adults (McGuire et al., 2012).
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older;
meet diagnostic criteria for TTM using the TDI-R
have a MGH-HPS total score ≥ 12 at baseline;
(3) have an "automatic" pulling score ≥ 15 on the MIST; (4) able to wear the Keen2 device for four weeks; (5) able to attend three study visits; (6) unmedicated or a stable dose of psychiatric medication for 8 weeks prior to enrollment; (7) be English speaking.
Exclusion Criteria:
an inability to complete rating scales, and
an inability to attend study visits
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph McGuire, PhD
Phone
443-327-9864
Email
coach@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph McGuire, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nordia Simmonds
Phone
443-327-9864
Email
coach@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Joseph McGuire, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Leveraging Technological Advancements to Improve the Treatment of Trichotillomania
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