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Leveraging Technological Advancements to Improve the Treatment of Trichotillomania

Leveraging Technological Advancements to Improve the Treatment of Trichotillomania

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05003401
Enrollment
25
Registered
2021-08-12
Start date
2021-11-17
Completion date
2024-07-16
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hair Pulling, Trichotillomania, Trichotillomania (Hair-Pulling Disorder)

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.

Interventions

DEVICEHabitAware Keen2

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.

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version1 weekThe 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

MeasureTime frameDescription
Massachusetts General Hospital Hair Pulling Scale1 weekThe 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026