Mindfulness Training for Early Life Adversity

(ReMind 2 Trial)

Overseen By Emily K Lindsay, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Corticosteroids, Antihypertensives, Cholesterol meds, others

Disqualifiers: Chronic disease, Mental disorder, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a 10-week online Mindfulness-Based Stress Reduction (MBSR) program can reduce stress and inflammation in young adults who have faced early life adversity, such as childhood trauma. Participants will join online group sessions to learn mindfulness techniques that promote awareness and stress coping. This study suits English-speaking individuals aged 18-29 who have experienced significant childhood trauma and can commit to the study's requirements. As an unphased trial, it offers participants the opportunity to contribute to valuable research that could enhance stress reduction strategies for others in similar situations.

Will I have to stop taking my current medications?

Yes, if you are taking medications that affect stress hormones, inflammation, or blood clotting, you may need to stop, as these medications are not allowed in the trial.

What prior data suggests that this Mindfulness-Based Stress Reduction (MBSR) intervention is safe?

Research has shown that Mindfulness-Based Stress Reduction (MBSR) is generally easy for people to handle. Studies have found that structured mindfulness programs can reduce stress and improve well-being, especially for those who have faced difficult experiences early in life. This suggests that individuals with challenging early life experiences might find mindfulness training helpful and safe.

MBSR includes activities like guided meditations, which help individuals focus on the present moment without judgment. Many participants report feeling less stressed and more relaxed afterward. There are no significant reports of harm or negative effects from these mindfulness practices.

In summary, MBSR is considered safe, and many people experience positive benefits from this type of training. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Mindfulness-Based Stress Reduction (MBSR) is unique because it offers a holistic approach that blends meditation with stress management, unlike traditional treatments for early life adversity, which may focus more on medication or talk therapy. MBSR is adapted here to include more sessions and a dedicated online retreat, making it more intensive and accessible for busy lifestyles. Researchers are excited because this method emphasizes self-care and practical skills for managing stress, potentially leading to more sustainable mental health improvements.

What evidence suggests that Mindfulness-Based Stress Reduction (MBSR) might be an effective treatment for stress and inflammation in young adults with a history of childhood trauma?

Research has shown that Mindfulness-Based Stress Reduction (MBSR), the treatment under study in this trial, can lower stress and trauma symptoms, particularly for individuals who faced early life challenges. Studies have found that quality mindfulness sessions reduce anxiety and boost mood in people with such backgrounds. One study discovered that MBSR changed how participants viewed stress and improved their mental health. Another study found that MBSR reduced symptoms like anxiety and depression, common in those with a history of childhood trauma. Overall, MBSR appears effective in helping people manage stress and enhance their emotional well-being. ^{1 2 3 6 7}

Who Is on the Research Team?

Emily K Lindsay, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-29 who have experienced childhood trauma. Participants will engage in a 10-week online Mindfulness-Based Stress Reduction program to help manage stress.

Inclusion Criteria

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

Exclusion Criteria

Shift workers

Pregnancy

Substance use disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive online, group-based Mindfulness-Based Stress Reduction (MBSR) sessions over 10 weeks

10 weeks

10 weekly online group sessions, plus a day-long online retreat

Follow-up

Participants are monitored for changes in stress and inflammatory markers post-intervention

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness-Based Stress Reduction (MBSR)

Trial Overview The study tests if an online Mindfulness-Based Stress Reduction (MBSR) course can reduce stress and inflammation in individuals with early life adversity. It involves group sessions, questionnaires, and blood tests before and after the program.

How Is the Trial Designed?

Group I: Mindfulness-Based Stress Reduction (MBSR) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5368427/

The Role of Mindfulness in Reducing the Adverse Effects of ... This research suggests that high-quality, structured mindfulness instruction may mitigate the negative effects of stress and trauma related to adverse ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0005789425000838

Remote mindfulness training for health following early life ... Outcomes included anxiety, depressive symptoms, trauma symptoms, depersonalization symptoms, social isolation, perceived stress, positive affect ...

3. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1347336/full

Exploring the sustained impact of the Mindfulness-Based ... Results: The findings revealed that the effectiveness of the MBSR program varied at different times and across different variables. Immediately ...

4. bmccomplementmedtherapies.biomedcentral.com bmccomplementmedtherapies.biomedcentral.com/articles/10.1186/s12906-021-03295-1

The effect of a mindfulness-based stress intervention on ... To provide preliminary data concerning the impact of MBSR-T on biological and clinical outcomes, we assessed changes from pre to post-treatment ...

5. link.springer.com link.springer.com/article/10.1007/s40653-022-00454-5

The Efficacy of Targeted Mindfulness-Based Interventions ... This systematic mixed studies review (SMRS) reports the effectiveness of MBIs for improving mental health and cognition among individuals with ACE histories.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8474678/

Mindfulness interventions for offsetting health risk following ... Mindfulness interventions (MBIs) train acceptance of present-moment experiences, potentially reducing stress and offsetting health risks from early life stress.

7. withpower.com withpower.com/trial/phase-mindfulness-6-2025-b6839

Mindfulness Training for Early Life Adversity (ReMind 2 Trial) This pilot study aims to evaluate the effects of a 10-week online Mindfulness-Based Stress Reduction (MBSR) intervention on stress and inflammatory outcomes ...