NCT05516108: ReMind

Remote Mindfulness Training Following Early Life Adversity

Completed Phase 1 Results posted Last updated 8 August 2025

What this trial tests

Phase 1 trial testing Mindfulness in Stress in 81 participants. Completed in 22 May 2024.

Timeline

1 September 2022

Primary endpoint
22 May 2024

22 May 2024

Quick facts

Lead sponsor	University of Pittsburgh
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	81
Start date	1 September 2022
Primary completion	22 May 2024
Estimated completion	22 May 2024
Sites	1 location across United States

Drugs / interventions tested

• Mindfulness
• Coping

Conditions studied

• Stress — all drugs for Stress →
• Mindfulness — all drugs for Mindfulness →
• Early Life Adversity — all drugs for Early Life Adversity →

Sponsor

University of Pittsburgh

Who can join

Adults 18 to 29, any sex, with Stress or Mindfulness. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility of Recruitment (Screened Eligible) Primary · assessed pre-enrollment

Recruitment benchmark: \>10% of people screened will be eligible

Group	Value	95% CI
Screening & Enrollment	81
Screening & Enrollment	56
Screening & Enrollment	112
Screening & Enrollment	642

Feasibility of Retention Primary · assessed across the entire 8-week study period

Retention benchmark: \>80% retention through intervention and \>75% retention through follow-up

Group	Value	95% CI
Mindfulness	37
Coping	34
Mindfulness	4
Coping	5
Mindfulness	1
Coping	0

Feasibility of Adherence: Intervention Lessons Primary · assessed across the entire 2-week intervention period

Numbers represent percentages of intervention lessons completed in mindfulness and coping groups \[calculated as (average number of lessons completed / 14 total lessons among all participants in each group) \* 100\]. The original adherence benchmark was an average completion of \>85% of intervention lessons; reported percentages that are greater than that benchmark represent feasibility of intervention adherence.

Group	Value	95% CI
Mindfulness	94.57
Coping	94.71

Feasibility of Safe Implementation: Incidence of Treatment-emergent Increases in Mental Health Symptoms Primary · assessed across the entire 8-week study period

Safety benchmark: \<10% of participants showing substantial (\>2SD) increases in anxiety, trauma, or depressive symptoms (using PROMIS Anxiety and Depression scales and Posttraumatic Stress Disorder Checklist-Civilian scale described in other outcomes below) combined to create treatment-emergent symptom rate

Group	Value	95% CI
Mindfulness	35
Coping	34
Mindfulness	3
Coping	0

Acceptability: Treatment Expectancies Primary · assessed in-person at post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks)

Acceptability of interventions, with benchmark of \>80% of participants giving positive ratings of treatment expectancies (\>3 on 6-item Credibility/Expectancy Questionnaire)

Post-intervention

Group	Value	95% CI
Mindfulness	95
Coping	91

One-month follow-up

Group	Value	95% CI
Mindfulness	92
Coping	88

Change in Daily Life Subjective Stress: State Perceived Stress Primary · change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)

State perceived stress assessed in daily life four times per day for one week at three time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Stress was assessed on a 1-7 Likert scale, with higher scores indicating higher perceived stress.

Pre-intervention

Group	Value	95% CI
Mindfulness	2.48	± .13
Coping	2.5	± .13

Post-intervention

Group	Value	95% CI
Mindfulness	2.56	± .13
Coping	2.37	± .13

One-month follow-up

Group	Value	95% CI
Mindfulness	2.46	± .13
Coping	2.32	± .13

Change in Daily Life Subjective Stress: Daily Perceived Stress Primary · change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)

Daily perceived stress assessed in daily life each evening for one week at three time points via end-of day diary, totaling up to 7 assessments at each time point. All 7 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Stress was assessed on a 1-7 Likert scale, with higher scores indicating higher perceived stress.

Pre-intervention

Group	Value	95% CI
Mindfulness	3.01	± .14
Coping	2.91	± .15

Post-intervention

Group	Value	95% CI
Mindfulness	3.19	± .15
Coping	2.69	± .15

One-month follow-up

Group	Value	95% CI
Mindfulness	2.90	± .15
Coping	2.63	± .15

Change in Daily Life Objective Stress: Stress Events in the Past 2.5 Hours Primary · change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)

Stress events assessed on a binary scale (yes/no) in daily life four times per day for one week at three time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in logistic MLM analyses. Outcomes are reported as mean percentage of surveys at each time point that stress events were endorsed, with higher percentages indicating more stress events.

Pre-intervention

Group	Value	95% CI
Mindfulness	22.71	± 2.26
Coping	18.5	± 2.09

Post-intervention

Group	Value	95% CI
Mindfulness	15.84	± 1.91
Coping	12.33	± 1.72

One-month follow-up

Group	Value	95% CI
Mindfulness	15.31	± 1.89
Coping	10.78	± 1.6

Change in Daily Life Objective Stress: Daily Stress Events Primary · change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)

Daily stress events assessed in daily life each evening for one week at three time points via end-of day diary, totaling up to 7 assessments at each time point. All 7 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in logistic MLM analyses. Outcomes are reported as mean percentage of days at each time point that stress events were endorsed, with higher percentages indicating more stress events.

Pre-intervention

Group	Value	95% CI
Mindfulness	65.93	± 4.01
Coping	51.52	± 4.46

Post-intervention

Group	Value	95% CI
Mindfulness	57.54	± 4.46
Coping	47.75	± 4.69

One-month follow-up

Group	Value	95% CI
Mindfulness	48.18	± 4.61
Coping	46.08	± 4.70

Change in Daily Life Physiological Stress Reactivity Primary · change in HR reactivity assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)

Heart Rate (HR) measured continuously in daily life, with HR averaged in 30-minute windows around daily life stress reported via EMA up to four times per day for one week at three time points, totaling up to 28 windows at each time point. All (up to) 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Higher scores indicate higher HR in beats per minute (relative to an individual's average daily HR) at high stress moments (relative to an in

Pre-intervention

Group	Value	95% CI
Mindfulness	5.82	± .67
Coping	4.77	± .68

Post-intervention

Group	Value	95% CI
Mindfulness	4.94	± .69
Coping	6.49	± .73

One-month follow-up

Group	Value	95% CI
Mindfulness	6.6	± .73
Coping	5.80	± .78

Change in Circulating Inflammatory Markers Primary · change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks)

Circulating IL-6 assessed via dried blood spot (DBS), reported as raw concentration in pg/mL assessed via ProteinSimple Simple Plex Human IL-6 (3rd gen) on Ella instrument

pre-intervention

Group	Value	95% CI
Mindfulness	.365	± .034
Coping	.266	± .035

post-intervention

Group	Value	95% CI
Mindfulness	.343	± .036
Coping	.267	± .038

one-month follow-up

Group	Value	95% CI
Mindfulness	.344	± .036
Coping	.279	± .037

Feasibility of Recruitment (Enrollment) Primary · assessed pre-enrollment

Recruitment benchmark: \>60% of those eligible will enroll

Group	Value	95% CI
Screening & Enrollment	81

Sponsor's own description

This study will test the feasibility of delivering smartphone-based mindfulness and coping interventions to a sample of emerging/young adults with a history of early life adversity (ELA). 80 participants with a history of ELA will be randomly assigned to complete a two-week mindfulness training intervention or matched coping control intervention, both involving 14 foundational audio-guided lessons and practice prompts randomly delivered 3x daily. At baseline, post-intervention, and one-month follow-up lab assessments, participants will complete questionnaires and provide blood samples for assessment of markers of inflammation. Data assessing subjective and physiological stress in daily life will be collected during the intervention and for one week before, immediately after, and one month after the intervention. Passive sensor data will be continuously collected from participants' smartphones and wearable devices to develop exploratory models that estimate and predict daily life stress. Data will be used to evaluate feasibility and acceptability of interventions and assessments in an ELA sample, test effects of mindfulness training on daily life stress and markers of inflammation in an ELA sample, and develop exploratory machine learning models of stress from passive sensor data.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.