Clinical trial NCT05003401: Leveraging Technological Advancements to Improve the Treatment of Trichotillomania
Official title: Leveraging Technological Advancements to Improve the Treatment of Trichotillomania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trichotillomania (Hair-Pulling Disorder)
Trichotillomania
Hair Pulling
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version
timeFrame: 1 week
Secondary outcomes:
measure: Massachusetts General Hospital Hair Pulling Scale
timeFrame: 1 week
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Joseph McGuire, PhD
role: PRINCIPAL_INVESTIGATOR
References: