Well-Being (Psychological Flourishing)Early Phase 1NCT07566273
Micropractices for Unhoused LGBTQ Youth
A Early Phase 1 study testing Mindfulness and Identity-Based Micropractice in people with Well-Being (Psychological Flourishing) and Internalizing Mental Health Symptoms, run by Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Well-Being (Psychological Flourishing), Internalizing Mental Health Symptoms, Substance Abuse
- What is being tested?
- Mindfulness and Identity-Based Micropractice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jan 2027
- Phase
- Early Phase 1
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 16 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Unable to complete study procedures (e.g., lack of device access)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Developing and Evaluating Collaboratively Designed Mindfulness and Identity-Affirming Practices 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.
Read the detailed description
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.
- Conditions
- Well-Being (Psychological Flourishing), Internalizing Mental Health Symptoms, Substance Abuse
- Being tested
- Mindfulness and Identity-Based Micropractice, Control Condition Micropractice
- Keywords
- Micropractice, Unhoused, Well-Being, Substance Abuse, LGBTQ, Internalizing Mental Health Symptoms
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness and Identity-Based MicropracticeBehavioural
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 MicropracticeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control Condition Micropractice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at post-intervention (30 days) and 1-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.
Measured: Assessed at post-intervention (30 days) and 1-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.
Measured: Assessed at post-intervention (30 days) and 1-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.
Measured: Assessed daily during the 30-day intervention period.
Secondary outcomes (8)
Purpose in Life (Life Engagement Test [LET])
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.
Measured: Change from baseline to post-intervention (30 days), and to 1-month follow-up.
Depressive Symptoms (Center for Epidemiologic Studies Depression Scale [CES-D])
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.
Measured: Change from baseline to post-intervention (30 days), and to 1-month follow-up.
Anxiety Symptoms (Generalized Anxiety Disorder-7 Scale [GAD-7])
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.
Measured: Change from baseline to post-intervention (30 days), and to 1-month follow-up.
Psychological, emotional, and social well-being (Mental Health Continuum- Short Form [MHC-SF])
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.
Measured: Change from baseline to post-intervention (30 days), and to 1-month follow-up.
Self-Esteem (Rosenberg Self-Esteem Scale [RSE])
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.
Measured: Change from baseline to post-intervention (30 days), and to 1-month follow-up.
Authenticity (Authenticity Scale)
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.
Measured: Change from baseline to post-intervention (30 days), and to 1-month follow-up.
Substance Use Risk (CRAFFT Screening Test)
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.
Measured: Change from baseline to post-intervention (30 days), and to 1-month follow-up.
Daily Mood (PANAS-C)
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.
Measured: Assessed daily across the 30-day intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-Being (Psychological Flourishing)Studies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Mind & Life Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566273
- Sponsor's protocol ID
- IRB0150559
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: As this study involves community-based work with a marginalized population, we want to ensure that researchers accurately represent the population in future research.