- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05516108
Remote Mindfulness Training Following Early Life Adversity (ReMind)
June 6, 2023 updated by: Emily Lindsay, University of Pittsburgh
Smartphone-based Mindfulness Training for Health Following Early Life Adversity
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Emily K Lindsay, PhD
- Phone Number: 724-361-3157
- Email: emily.lindsay@pitt.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- University of Pittsburgh
-
Contact:
- Emily K Lindsay, PhD
- Phone Number: 724-361-3157
- Email: emily.lindsay@pitt.edu
-
Principal Investigator:
- Emily K Lindsay, PhD
-
Sub-Investigator:
- Anna L Marsland, PhD
-
Sub-Investigator:
- Carissa A Low, PhD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 29 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Ages 18-29 years
- English speaking
- History of moderate-to-severe physical, emotional, or sexual abuse in childhood
- 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
- Substance use disorder
- 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
- Regular systematic mind-body practice (>2 times per week)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness
Mindfulness intervention involving 14 foundational audio-guided lessons plus daily brief practice prompts.
Lessons train meditation techniques for 3 mindfulness skills: concentration, sensory clarity, and equanimity.
Practice prompts delivered 3x daily build on the skills trained in each lesson.
|
The mindfulness intervention includes 14 daily 20-minute audio lessons plus brief daily practice prompts.
Lessons train specific meditation techniques through didactic explanation and guided practice.
Based on the Unified Mindfulness system, lessons train 3 mindfulness skills: concentration, sensory clarity, and equanimity.
Concentration, a state of stable attention on the intended target, enables participants to monitor present-moment physical and emotional body experiences.
Sensory clarity, the monitoring of momentary experiences, involves detecting subtle sensations and discriminating between different experiences.
Equanimity, an attitude of acceptance toward momentary experiences, is trained through 3 strategies: (a) body relaxation, (b) mental welcoming, and (c) a gentle tone of voice.
Practice prompts build on the skills trained in each lesson, encouraging participants to practice brief moments of mindful awareness, mindfulness while doing daily tasks, or formal meditation.
|
Active Comparator: Coping
Coping intervention involving 14 foundational audio-guided lessons plus daily brief practice prompts.
Lessons train techniques for 3 coping skills: reflection, reappraisal, and problem solving.
Practice prompts delivered 3x daily build on the skills trained in each lesson.
|
The coping intervention includes 14 daily 20-minute audio lessons plus brief daily practice prompts.
Lessons train specific coping techniques through didactic explanation and guided practice.
Lessons train coping skills (reflection, reappraisal, and problem solving) without encouraging focus on or acceptance of present experience (i.e., mindfulness skills).
Participants are instructed to: (1) reflect and let their minds drift, (2) reframe or reappraise past and anticipated events, and (3) analyze and solve personal problems.
Practice prompts build on the skills trained in each lesson, encouraging participants to take brief reflection breaks or to practice reappraisal or problem-solving skills.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of recruitment
Time Frame: assessed pre-enrollment
|
Recruitment benchmark: >10% of people screened will be eligible and >60% of those eligible will enroll
|
assessed pre-enrollment
|
Feasibility of retention
Time Frame: assessed across the entire 8-week study period
|
Retention benchmark: >80% retention through intervention and >75% retention through follow-up
|
assessed across the entire 8-week study period
|
Feasibility of adherence
Time Frame: assessed across the entire 8-week study period
|
Adherence benchmark: average completion of >85% of intervention lessons, >60% of practice prompts, >75% of ambulatory assessments, and mobile sensor data on >75% of days
|
assessed across the entire 8-week study period
|
Feasibility of safe implementation: Incidence of treatment-emergent increases in mental health symptoms
Time Frame: 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
|
assessed across the entire 8-week study period
|
Acceptability: Treatment Expectancies
Time Frame: assessed post-intervention (an average of 4 weeks) and one-month follow-up (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)
|
assessed post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Change in Daily Life Subjective Stress: State Perceived Stress
Time Frame: change in stress assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
State perceived stress assessed four times daily via Ecological Momentary Assessment (EMA)
|
change in stress assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Change in Daily Life Subjective Stress: Daily Perceived Stress
Time Frame: change in stress assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Daily perceived stress assessed daily via end-of day diary
|
change in stress assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Change in Daily Life Subjective Stress: Stress events in the past 2.5 hours
Time Frame: change in stress assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Stress events assessed four times daily via Ecological Momentary Assessment (EMA)
|
change in stress assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Change in Daily Life Subjective Stress: Daily stress events
Time Frame: change in stress assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Daily stress events assessed daily via end-of day diary
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change in stress assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Change in Daily Life Physiological Stress Reactivity
Time Frame: change in HR reactivity assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
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Heart Rate (HR) measured continuously and analyzed in response to daily life stress assessed via EMA
|
change in HR reactivity assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Change in Circulating Inflammatory Markers
Time Frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Circulating IL-6 assessed via dried blood spot (DBS)
|
change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Daily Life Positive Affect: State
Time Frame: change in affect assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
State positive affect assessed four times daily via Ecological Momentary Assessment (EMA)
|
change in affect assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Change in Daily Life Positive Affect: Daily
Time Frame: change in affect assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Daily positive affect (composite of 9 positive affect items across 3 subscales: happiness (happy, pleased, and cheerful), calm (calm, at-ease, and relaxed), and vigor (lively, full-of-pep, and energetic)) assessed daily via end-of day diary
|
change in affect assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Change in Daily Life Negative Affect: State
Time Frame: change in affect assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
State negative affect assessed four times daily via Ecological Momentary Assessment (EMA)
|
change in affect assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Change in Daily Life Negative Affect: Daily
Time Frame: change in affect assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Daily negative affect (composite of 9 negative affect items across 3 subscales: anxiety (on edge, nervous, and tense), depression (sad, depressed, and unhappy), and hostility (hostile, resentful, and angry)) assessed daily via end-of day diary
|
change in affect assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Change in Daily Life Social Interactions: Interactions in the past 2.5 hours
Time Frame: change in interactions assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Social interactions assessed four times daily via Ecological Momentary Assessment (EMA)
|
change in interactions assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Change in Daily Life Social Interactions: Daily
Time Frame: change in interactions assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Social interactions assessed daily via end-of day diary
|
change in interactions assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Change in Daily Life Mindfulness: Awareness
Time Frame: change in mindfulness assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Mindful awareness assessed via end-of-day diary using 3-item scale ("Today, I paid attention to what I was doing in the present moment" / "Today, I noticed body sensations come and go" / "Today, I noticed pleasant and unpleasant thoughts and emotions")
|
change in mindfulness assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Change in Daily Life Mindfulness: Acceptance
Time Frame: change in mindfulness assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Mindful acceptance assessed via end-of-day diary using 2-item scale ("Today, I was able to step back and be aware of distressing thoughts, emotions, and sensations, without being taken over by them" / Today, I did not want to feel the way I was feeling")
|
change in mindfulness assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Passive sensor stress models
Time Frame: collected continuously for 8 weeks
|
Passive sensor data from smartphones (location, activity, screen status, battery, weather, time zone, communication) and wearable devices (heart rate, activity, sleep) combined to develop machine learning models predicting state stress
|
collected continuously for 8 weeks
|
Change in state stress following intervention practice
Time Frame: change from pre- to post-practice across two-week intervention period
|
State stress following intervention practice used to evaluate immediate benefit of practice delivered at high-stress moments
|
change from pre- to post-practice across two-week intervention period
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Daily stress following intervention practice
Time Frame: daily stress across two-week intervention period
|
End-of-day stress on days with intervention practice used to evaluate day-level benefit of practice delivered at high-stress moments
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daily stress across two-week intervention period
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Early Life Adversity: Childhood Trauma
Time Frame: pre-intervention
|
Assessed via the Childhood Trauma Questionnaire (a 28-item scale with 5 subscales - physical, sexual, and emotional abuse, and physical and emotional neglect - with higher scores indicating higher childhood trauma)
|
pre-intervention
|
Early Life Adversity: Emotional neglect
Time Frame: pre-intervention
|
Early Life Adversity assessed via the Childhood Experiences of Care and Abuse Inventory (16-item scale in reference to mother and father figures, focused on 8-item emotional neglect subscale, with higher scores indicating higher levels of emotional neglect)
|
pre-intervention
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Early Life Adversity: Childhood SES indexed by parental education
Time Frame: pre-intervention
|
Childhood SES assessed via parental figure educational attainment (ranging from less than high school education to doctoral degree)
|
pre-intervention
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Early Life Adversity: Childhood SES indexed government assistance
Time Frame: pre-intervention
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Childhood SES assessed via National Comorbidity Survey: Adolescents item assessing government food assistance
|
pre-intervention
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Early Life Adversity: Domestic Violence
Time Frame: pre-intervention
|
Early Life Adversity assessed via Adverse Childhood Experiences Survey (5-item domestic violence subscale, with higher scores indicating higher levels of domestic violence)
|
pre-intervention
|
Change in Circulating Inflammatory Biomarkers: CRP
Time Frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Circulating CRP assessed via dried blood spot (DBS) [additional funding needed to assess]
|
change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Change in Circulating Inflammatory Biomarkers: TNF
Time Frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Circulating TNF assessed via dried blood spot (DBS) [additional funding needed to assess]
|
change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Change in Circulating Inflammatory Biomarkers: IL-8
Time Frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Circulating IL-8 assessed via dried blood spot (DBS) [additional funding needed to assess]
|
change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Change in Circulating Inflammatory Biomarkers: IL-10
Time Frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Circulating IL-10 assessed via dried blood spot (DBS) [additional funding needed to assess]
|
change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Change in Global Psychosocial Stress: Anxiety
Time Frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Assessed via PROMIS Anxiety (a 4-item scale, with higher scores indicating higher anxiety)
|
change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Change in Global Psychosocial Stress: Depressive Symptoms
Time Frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Assessed via PROMIS Depression (a 4-item scale with higher scores indicating higher depressive symptoms)
|
change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Change in Global Psychosocial Stress: Social Isolation
Time Frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Assessed via PROMIS Social Isolation (a 14-item scale, with higher scores indicating higher social isolation)
|
change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
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Change in Global Psychosocial Stress: Perceived Stress
Time Frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Assessed via Perceived Stress Scale (a 10-item scale, with higher scores indicating higher perceived stress)
|
change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Change in Global Psychosocial Stress: Trauma Symptoms
Time Frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Assessed via Posttraumatic Stress Disorder Checklist-Civilian (a 17-item scale, with higher scores indicating higher levels of trauma)
|
change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Change in Global Psychosocial Stress: Depersonalization
Time Frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Assessed via Cambridge Depersonalization Scale (a 29-item scale assessing frequency and duration of depersonalization symptoms, with higher scores indicating greater depersonalization)
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change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Change in Sleep Quality
Time Frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Assessed via Pittsburgh Sleep Quality Index (6-item short form, with higher scores indicating worse sleep)
|
change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Change in Global Psychosocial Resilience: Life Satisfaction
Time Frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Assessed via PROMIS Life Satisfaction (a 5-item scale, with higher scores indicating higher life satisfaction)
|
change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
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Change in Global Psychosocial Resilience: Positive Affect
Time Frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Assessed via PROMIS Positive Affect (a 15-item scale, with higher scores indicating higher positive affect)
|
change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Change in Global Psychosocial Resilience: Self-Efficacy
Time Frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Assessed via PROMIS Self-efficacy (a 4-item scale, with higher scores indicating higher life self-efficacy)
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change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
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Change in Global Mindfulness
Time Frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Five Facet Mindfulness Questionnaire-Short Form (a 24-item scale with observing, describing, acting with awareness, nonreactivity, and nonjudgment subscales, with higher scores indicating higher mindfulness)
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change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
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Change in Global Experiential Avoidance
Time Frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
|
Acceptance and Action Questionnaire-II (a 7-item scale, with higher scores indicating higher experiential avoidance)
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change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
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Change in Global Distress Tolerance
Time Frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
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Distress Tolerance Scale (a 15-item scale, with higher scores indicating lower distress tolerance)
|
change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
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Change in Global Self-Compassion
Time Frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
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Self-Compassion Scale (a 25-item scale, with higher scores indicating higher self-compassion)
|
change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Emily K Lindsay, PhD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2022
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
August 18, 2022
First Submitted That Met QC Criteria
August 22, 2022
First Posted (Actual)
August 25, 2022
Study Record Updates
Last Update Posted (Actual)
June 8, 2023
Last Update Submitted That Met QC Criteria
June 6, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- STUDY21030189
- K01AT011232 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All data sharing will follow NIH and Pitt IRB guidelines.
To gain access to IPD that underlie results in a publication, anyone not part of the original research will submit a Data Analysis Request Form, which requires a description of hypotheses, specific data requested, and investigator information.
The investigator must complete the Pitt Certification Program in Research Practice Fundamentals or a comparable program.
Upon approval, a de-identified dataset and codebook will be provided.
Investigators outside Pitt must also complete a Data Use and Confidentiality Agreement.
This signed letter of agreement states that the investigator (1) will cite the original study dataset and funding source in all presentations and publications, and (2) will not share these data and study materials with others.
Participants will be made aware of the potential for sharing of de-identified data with outside investigators on informed consent documents.
IPD Sharing Time Frame
Upon request, data collected for this study will also be made available to other investigators following publication of primary findings.
IPD Sharing Access Criteria
Data Analysis Request Form; completion of the University of Pittsburgh Certification Program in Research Practice Fundamentals or a comparable training program at their own institution; Data Use and Confidentiality Agreement for investigators outside University of Pittsburgh
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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