Trichotillomania (Hair-Pulling Disorder)NCT05003401
Leveraging Technological Advancements to Improve the Treatment of Trichotillomania
A study testing HabitAware Keen2 in people with Trichotillomania (Hair-Pulling Disorder) and Trichotillomania, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trichotillomania (Hair-Pulling Disorder), Trichotillomania, Hair Pulling
- What is being tested?
- HabitAware Keen2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2021to 16 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older;
- meet diagnostic criteria for TTM using the TDI-R
- have a MGH-HPS total score ≥ 12 at baseline;
- 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.
Who cannot join
- an inability to complete rating scales, and
- an inability to attend study visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
About this study
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.
Read the 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.
- Being tested
- HabitAware Keen2
- Medical subject headings
- Trichotillomania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HabitAware Keen2Device
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.
| Study group | Role | What they receive |
|---|---|---|
| HabitAware Keen 2 | Experimental | Participants will receive the wrist device device that alerts the participant when the participant is engaging in hair pulling behavior. Receives: Device: HabitAware Keen2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (1)
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).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start17 Nov 2021
- Primary completion16 Jul 2024
- Study completion16 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trichotillomania (Hair-Pulling Disorder)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph McGuire, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003401
- Sponsor's protocol ID
- IRB00279950
- Status last verified
- Sep 2024
- First submitted
- 6 Aug 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Technological Advancements to Improve the Treatment of Trichotillomania
- ClinicalTrials.gov ID
- NCT05003401
- Acronym / sponsor ID
- IRB00279950
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 16 Jul 2024 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| HabitAware Keen 2 | Experimental | Device: HabitAware Keen2Participants will receive the wrist device device that alerts the participant when the participant is engaging in hair pulling behavior. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older;
- meet diagnostic criteria for TTM using the TDI-R
- have a MGH-HPS total score ≥ 12 at baseline;
- 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.
Key exclusion criteria (2 listed)
- an inability to complete rating scales, and
- an inability to attend study visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HabitAware Keen2Participants 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. | Device | HabitAware Keen 2 |
Primary outcome
Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version
Time frame: 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.
1 secondary outcome
Massachusetts General Hospital Hair Pulling Scale
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Trichotillomania (Hair-Pulling Disorder)
Recruiting
Mindfulness Intervention for Psychological and Family Dynamics in Children With Body-Focused Repetitive Behaviors
Mindfulness Skills, Psychosocial Education
Recruiting
Neural Mechanisms of Response Inhibition Training for OCRD
Obsessive-Compulsive Disorder, Tricholemmoma
Active, not recruitingPhase 2/3
Behavioral Treatment and Memantine in Body Focused Repetitive Behaviors
Skin-Picking, Trichotillomania (Hair-Pulling Disorder)
Not yet recruitingPhase 2
Semaglutide (Wegovy) Treatment for Trichotillomania
Trichotillomania (Hair-Pulling Disorder), Trichotillomania
Recruiting
Technology Assisted Treatment for Trichotillomania
Trichotillomania
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph McGuire, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HabitAware Keen2 in people with Trichotillomania (Hair-Pulling Disorder) and Trichotillomania, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.