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NCT Number: NCT07566273

Micropractices for Unhoused LGBTQ Youth

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 one-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.

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Key information

Conditions

Well-Being (Psychological Flourishing) Chemically-Induced Disorders Internalizing Mental Health Symptoms Mental Disorders Substance Abuse Substance-Related Disorders

Age range

16 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ali Forney Center

New York, 10018, United States

About this study

Specific Aim 1: Evaluate the feasibility and acceptability of delivering co-designed mindfulness and identity-based micropractices to LGBTQ youth receiving shelter or services from an LGBTQ youth-serving organization over a 30-day period.

Hypothesis 1: Participants assigned to the mindfulness and identity-based micropractice condition will demonstrate higher overall adherence across the 30-day intervention period and report greater acceptability, appropriateness, and feasibility at post-intervention and one-month post-intervention follow-up than participants assigned to the active control condition.

Specific Aim 2: Determine whether the mindfulness and identity-based micropractice condition, relative to the active control condition, improves psychosocial functioning and daily affect.

Hypothesis 2: Participants assigned to the mindfulness and identity-based micropractice condition will show greater increases in purpose in life, psychological, emotional, and social well-being, self-esteem, and authentic living, and greater reductions in self-alienation, depressive symptoms, anxiety symptoms, and substance use risk from baseline to post-intervention and one-month post-intervention follow-up than participants assigned to the active control condition. Participants in the intervention condition are also expected to report more favorable outcomes than participants in the active control condition at both follow-up assessments.

Hypothesis 3: Participants assigned to the mindfulness and identity-based micropractice condition will report higher average daily positive affect and lower average daily negative affect across the 30-day intervention period than participants assigned to the active control condition.

Hypothesis 4: Participants assigned to the mindfulness and identity-based micropractice condition will show greater increases in daily positive affect and greater decreases in daily negative affect across the 30-day intervention period than participants assigned to the active control condition.

Specific Aim 3: Examine whether engagement with the assigned daily activity is associated with changes in psychosocial outcomes and whether these associations differ by intervention condition.

Hypothesis 5: Greater adherence to the assigned daily activity will be associated with greater improvements in well-being and greater reductions in psychological distress from baseline to post-intervention and one-month post-intervention follow-up, with stronger associations expected in the mindfulness and identity-based micropractice condition than in the active control condition.

Hypothesis 6: Associations between daily activity completion and affect will be stronger in the mindfulness and identity-based micropractice condition than in the active control condition. Daily activity completion will be more strongly associated with higher same-day positive affect and lower same-day negative affect in the intervention condition, and greater overall adherence across the 30-day intervention period will be more strongly associated with higher average positive affect and lower average negative affect.

Exploratory Aim: Characterize participants' experiences with the assigned daily activity, including perceived benefits, challenges, relevance, and barriers to engagement. Open-ended responses collected during the study will be examined qualitatively to identify recurring patterns in participants' experiences with the intervention and active control activities.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 16 to 26 years
  • Self-identify as LGBTQ
  • Currently or recently received services from an LGBTQ community organization (within the past six months)
  • Have access to a mobile device with internet capability to complete study activities

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Acceptability (Acceptability of Intervention Measure [AIM])

    Time frame: Assessed at post-intervention (30 days) and 1-month follow-up.

    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.

  2. Appropriateness (Intervention Appropriateness Measure [IAM])

    Time frame: Assessed at post-intervention (30 days) and 1-month follow-up.

    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.

  3. Feasibility (Feasibility of Intervention Measure [FIM])

    Time frame: Assessed at post-intervention (30 days) and 1-month follow-up.

    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.

  4. Intervention adherence

    Time frame: Assessed daily during the 30-day intervention period.

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

Secondary outcomes

  1. Purpose in Life (Life Engagement Test [LET])

    Time frame: Change from baseline to post-intervention (30 days), and to 1-month follow-up.

    Assessed using 6 items measuring the extent to which participants experience purpose, meaning, and value in their daily activities. Responses are given on a 5-point Likert scale. Higher scores indicate greater purpose.

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

    Time frame: Change from baseline to post-intervention (30 days), and to 1-month follow-up.

    Assessed using 10 items measuring depressive symptoms during the past week. Responses are given on a 4-point Likert scale. Higher scores indicate greater depressive symptoms. Lower scores indicate a better outcome.

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

    Time frame: Change from baseline to post-intervention (30 days), and to 1-month follow-up.

    Assessed using 7 items measuring anxiety symptoms over the last 2 weeks. Responses are given on a 4-point Likert scale. Higher scores indicate greater anxiety symptoms. Lower scores indicate a better outcome.

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

    Time frame: Change from baseline to post-intervention (30 days), and to 1-month follow-up.

    Assessed using 14 items measuring emotional, psychological, and social well-being during the past month. Responses are given on a 6-point Likert scale. Higher scores indicate greater well-being.

  5. Self-Esteem (Rosenberg Self-Esteem Scale [RSE])

    Time frame: Change from baseline to post-intervention (30 days), and to 1-month follow-up.

    Assessed using 10 items measuring global self-esteem over the past 30 days. Responses are given on a 5-point Likert scale. Higher scores indicate greater self-esteem.

  6. Authenticity (Authenticity Scale)

    Time frame: Change from baseline to post-intervention (30 days), and to 1-month follow-up.

    Includes two dimensions of the Authenticity Scale: Self-Alienation and Authentic Living. Self-Alienation is assessed using 4 items measuring participants' sense of being out of touch with the "real me". Higher scores indicate lower authenticity. Authentic Living is assessed using 4 items measuring participants' sense of being true to themselves, their beliefs, and values. Higher scores indicate greater authenticity. Responses are given on a 7-point Likert scale.

  7. Substance Use Risk (CRAFFT Screening Test)

    Time frame: Change from baseline to post-intervention (30 days), and to 1-month follow-up.

    Assessed using 11 items measuring likelihood of alcohol- and drug-related risk behaviors over the past 30 days. Responses are given on a 5-point Likert scale. Higher scores indicate greater substance use risk. Lower scores indicate a better outcome.

  8. Daily Mood (PANAS-C)

    Time frame: Assessed daily across the 30-day intervention period.

    Assessed using 10 items measuring positive and negative affect throughout the day. Responses are given on a 5-point Likert scale. Higher positive affect scores and lower negative affect scores indicate better outcomes.

Other outcomes

  1. Likelihood of recommending the assigned activity to a friend

    Time frame: Assessed at post-intervention (30 days) and 1-month follow-up.

    Assessed using a single item asking how likely participants are to recommend the assigned activity to a friend, rated from 0 to 10. Higher scores indicate greater willingness to recommend the activity.

  2. Participant feedback on barriers and overall experience

    Time frame: Assessed during the 30-day intervention period.

    Assessed using open-ended items asking participants about reasons for not completing daily activities, comments about the study, and perceived benefits or challenges related to participation. Responses will be analyzed qualitatively.

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Collaborators

  • Mind & Life Institute

Registry information

Official study title

Developing and Evaluating Collaboratively Designed Mindfulness and Identity-Affirming Practices for Unhoused LGBTQ Youth

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 5, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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