Micropractices for Unhoused LGBTQ Youth

NCT07566273 | Not Yet Recruiting Early Phase 1

• 1 other identifier: IRB0150559
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

In the present study, the investigators will conduct a pilot randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of brief, co-designed mindfulness and identity-affirming micropractices for LGBTQ youth and young adults experiencing housing instability. Participants (n = 200, accounting for anticipated attrition) will be randomly assigned to one of two conditions: (1) a mindfulness and identity-based micropractice condition or (2) a structurally equivalent neutral control condition. The intervention content will be developed using a participatory co-design process with members of the target population and standardized prior to trial implementation. The mindfulness and identity condition integrates brief practices targeting present-moment awareness and identity affirmation, whereas the control condition accounts for time and attention without including these components. Assessments will be conducted at baseline, post-intervention, and three-month follow-up. Primary outcomes include feasibility and acceptability, assessed using standardized implementation outcome measures and indicators of intervention adherence. Secondary outcomes include changes in mental health symptoms, psychological and emotional well-being, and substance use. The investigators will evaluate whether the mindfulness and identity-based condition demonstrates greater improvements in outcomes compared to the control condition and will estimate effect sizes to inform the design of future fully powered trials. The intervention will be delivered via a mobile-accessible platform.

Conditions

Well-Being (Psychological Flourishing); Internalizing Mental Health Symptoms; Substance Abuse

Keywords

Micropractice; Unhoused; Well-Being; Substance Abuse; LGBTQ; Internalizing Mental Health Symptoms

Outcome Measures

Primary Outcomes (4)

• Acceptability (Acceptability of Intervention Measure [AIM])

  Assessed using four items measuring participant-reported implementation outcome items evaluating approval, liking, and overall acceptance of the assigned activity. Responses are given on a 5-point Likert scale. Higher scores indicate greater acceptability.

  Assessed at post-intervention (30 days) and 3-month follow-up.

• Appropriateness (Intervention Appropriateness Measure [IAM])

  Assessed using four items measuring participant-reported implementation outcome items evaluating whether the assigned activity seems relevant, fitting, and compatible with participants' lives. Responses are given on a 5-point Likert scale. Higher scores indicate greater appropriateness.

  Assessed at post-intervention (30 days) and 3-month follow-up.

• Feasibility (Feasibility of Intervention Measure [FIM])

  Assessed using four items measuring participant-reported implementation outcome items evaluating whether the assigned activity seems workable, possible, and easy to do in daily life. Responses are given on a 5-point Likert scale. Higher scores indicate greater feasibility.

  Assessed at post-intervention (30 days) and 3-month follow-up.

• Intervention adherence

  Assessed by self-reported completion of the assigned daily activity during the 30-day intervention period. Higher adherence indicates a better outcome.

  Assessed daily during the 30-day intervention period.

Secondary Outcomes (7)

• Purpose in Life (Life Engagement Test [LET])

  Change from baseline to post-intervention (30 days), and to 3-month follow-up.

• Depressive Symptoms (Center for Epidemiologic Studies Depression Scale [CES-D])

  Change from baseline to post-intervention (30 days), and to 3-month follow-up.

• Anxiety Symptoms (Generalized Anxiety Disorder-7 Scale [GAD-7])

  Change from baseline to post-intervention (30 days), and to 3-month follow-up.

• Psychological, emotional, and social well-being (Mental Health Continuum- Short Form [MHC-SF])

  Change from baseline to post-intervention (30 days), and to 3-month follow-up.

• Self-Esteem (Rosenberg Self-Esteem Scale [RSE])

  Change from baseline to post-intervention (30 days), and to 3-month follow-up.

Other Outcomes (2)

• Likelihood of recommending the assigned activity to a friend

  Assessed at post-intervention (30 days) and 3-month follow-up.

• Participant feedback on barriers and overall experience

  Assessed during the 30-day intervention period.

Study Arms (2)

Mindfulness and Identity Condition

EXPERIMENTAL

Participants will be assigned to complete a brief daily micropractice that integrates mindfulness (e.g., attention to breathing or present-moment awareness) with reflection on personally meaningful aspects of identity. The micropractice is delivered via a mobile-accessible platform over a 30-day period.

Behavioral: Mindfulness and Identity-Based Micropractice

Control Condition

ACTIVE COMPARATOR

Participants will be assigned to complete a brief daily activity matched in structure, duration, and delivery format, but without mindfulness or identity-based content. Activities focus on neutral reflections (e.g., daily routines or surroundings) and are delivered via a mobile-accessible platform over a 30-day period.

Behavioral: Control Condition Micropractice

Interventions

Mindfulness and Identity-Based Micropractice BEHAVIORAL

Participants will complete a brief daily micropractice (approximately 1-5 minutes per day) that integrates mindfulness (e.g., attention to breathing or present-moment awareness) with reflection on personally meaningful aspects of identity. The micropractice is co-designed with members of the target population, standardized prior to the trial, and delivered via a mobile-accessible platform.

Mindfulness and Identity Condition

Control Condition Micropractice BEHAVIORAL

Participants will complete a brief daily activity (approximately 1-5 minutes per day) matched in structure and delivery format to the intervention condition, but without mindfulness or identity-based content. Activities include neutral reflections (e.g., daily routines or surroundings) and are delivered via a mobile-accessible platform.

Control Condition

Eligibility Criteria

• Age: 16 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 16 to 26 years
• Self-identify as LGBTQ
• Currently or recently experiencing housing instability (within the past six months)
• Have access to a mobile device with internet capability to complete study activities

You may not qualify if:

• Unable to complete study procedures (e.g., lack of device access)

Sponsors & Collaborators

• Cornell University: lead
• Mind & Life Institute: collaborator

Study Sites (1)

Ali Forney Center

New York, New York, 10018, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 5, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)