Remote Mindfulness Training Following Early Life Adversity 2 (ReMind 2)

University of Pittsburgh

Status: Enrolling

Conditions: Early Life Adversity; Mindfulness; Stress

Treatments: Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Study type: Interventional

Funder types: Other

Identifiers

NCT07085052

STUDY25020112

Details and patient eligibility

About

This pilot study aims to evaluate the effects of a 10-week online Mindfulness-Based Stress Reduction (MBSR) intervention on stress and inflammatory outcomes in a sample of emerging adults with a history of early life adversity. 15 participants (ages 18-29) with a history of childhood trauma will receive online, group-based MBSR sessions over 10 weeks. At pre- and post-intervention, participants will complete laboratory assessments, including self-report questionnaires and blood sample collection to assess markers of inflammation. Data assessing subjective and physiological stress in daily life will be collected for one week at pre- and post-intervention. This preliminary data will be used to test effects of online MBSR on health-relevant outcomes among young adults with a history of childhood trauma.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 29 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ages 18-29 years
• English speaking
• History of adverse childhood experiences (specifically, moderate-to-severe physical, emotional, or sexual abuse in childhood: scoring >9, >12, or >7 on respective Childhood Trauma Questionnaire subscales)
• Data-enabled Android or iOS smartphone
• Able to meet study requirements

Exclusion criteria

• Self-reported diagnosis of chronic physical disease (e.g., cancer, HIV, heart disease, diabetes, bleeding disorder)
• Self-reported diagnosis of chronic mental disorder (e.g., schizophrenia, personality disorder, or psychotic illness), major neurological disorder, or suicidal thoughts or wishes at baseline
• Medication use that interferes with HPA-axis activity (e.g., corticosteroids), autonomic activity (e.g., antihypertensive medication), inflammatory activity (e.g., cholesterol medications), or blood clotting
• Current antibiotic, antiviral, or antimicrobial treatment
• Shift workers
• Pregnancy
• Substance use disorder
• Regular systematic mind-body practice (>2 times per week)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Mindfulness-Based Stress Reduction (MBSR)

Experimental group

Description:

MBSR is a standardized curriculum-based group program. In this study, MBSR will be adapted to include 10 (rather than the standard 8) weekly 2.5-hour group sessions delivered online, plus a day-long online retreat and 30-45 minutes of home practice assignments six days per week. MBSR includes guided mindfulness meditations intended to foster awareness of present-moment experiences and an open, accepting, and nonjudgmental perspective. Guidance and group discussions also encourage nonjudgmental awareness in everyday life, including when experiencing stress or other challenging emotions. Group discussions involve exploration of habitual reactions to stress and the cultivation of skills such as pausing before responding. Foundationally, the course centers on self-care and group support, including support for the challenge of integrating meditation practice into daily life. Home practice recordings will guide participants through body awareness, mindful movement, and seated meditation.

Treatment:

Behavioral: Mindfulness-Based Stress Reduction (MBSR)