Leveraging Technological Advancements to Improve the Treatment of Trichotillomania

NCT05003401 | Completed

• 1 other identifier: IRB00279950
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Trichotillomania (Hair-Pulling Disorder); Trichotillomania; Hair Pulling

Outcome Measures

Primary Outcomes (1)

• 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.

  1 week

Secondary Outcomes (1)

• Massachusetts General Hospital Hair Pulling Scale

  1 week

Study Arms (1)

HabitAware Keen 2

EXPERIMENTAL

Participants will receive the wrist device device that alerts the participant when the participant is engaging in hair pulling behavior.

Device: HabitAware Keen2

Interventions

HabitAware Keen2 DEVICE

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.

HabitAware Keen 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• an inability to complete rating scales, and
• an inability to attend study visits

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Trichotillomania

Condition Hierarchy (Ancestors)

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders

Study Officials

• Joseph McGuire, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 12, 2021
• Study Start: November 17, 2021
• Primary Completion: July 16, 2024
• Study Completion: July 16, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)