Leveraging Technological Advancements to Improve the Treatment of Trichotillomania

Not Applicable

Recruiting

• Conditions: Trichotillomania (Hair-Pulling Disorder); Trichotillomania; Hair Pulling
• Interventions: Device: HabitAware Keen2

• Registration Number: NCT05003401
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-12
• Study Start: 2021-11-17
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. 18 years of age or older;
2. meet diagnostic criteria for TTM using the TDI-R
3. 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.

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Exclusion Criteria

1. an inability to complete rating scales, and
2. an inability to attend study visits

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HabitAware Keen 2	HabitAware Keen2	Participants will receive the wrist device device that alerts the participant when the participant is engaging in hair pulling behavior.

Primary Outcome Measures

Name	Time	Method
Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version	1 week	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

Name	Time	Method
Massachusetts General Hospital Hair Pulling Scale	1 week	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).

Trial Locations

Locations (1)

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States