Trial Outcomes & Findings for Feasibility and Acceptability of Stress Induction, Physiological Data Collection, and Mindfulness-Based Stress Reduction Among Combat Veterans With PTSD (NCT NCT05938816)
NCT ID: NCT05938816
Last Updated: 2024-11-05
Results Overview
Qualitative data generated via focus group interviews. Questions will include common barriers to completing the intervention and strategies utilized by participants to maximize adherence.
TERMINATED
NA
7 participants
2 weeks post conclusion of intervention
2024-11-05
Participant Flow
7 participants screened eligible and were consented. However no participants were assigned to arms, and no participants began study interventions or received treatment due to closure of study resulting from PI career change.
Participant milestones
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Mindfulness-Based Stress Reduction
Mindfulness-Based Stress Reduction (MBSR): MBSR consists of weekly two-hour sessions for eight weeks, and a 7.5 hour retreat between weeks 6 and 7. The MBSR intervention will be facilitated by an experienced and certified MBSR teacher. MBSR curriculum strongly encourages completion of home practice assignments (\~30 minutes daily) to help integration of concepts into daily life. Participants will receive audio CDs and a DVD to help guide home practice.
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Health and Wellness Education
Health and Wellness Education (HWE): HWE is a didactic-based group intervention designed as an active comparator for randomized-controlled trials of MBSR. HWE provides instruction to participants regarding improving their emotional and physical health. In contrast to MBSR, there are no attempts to train participants' breathing, movement, or meditation habits or practices. HWE is administered in 8 weekly 2.5-hour classes with home practice to be completed between sessions (matched to MBSR for amount and effort). HWE also features one extended 7.5-hour retreat, similar to MBSR.84 Dr. Autumn Gallegos (consultant) has conducted trials of MBSR among veterans with PTSD using a HWE control group, and will provide mentorship to the PI in administering the HWE intervention. Dr. Kaplan and a trained RA will facilitate HWE.
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Overall Study
STARTED
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Overall Study
COMPLETED
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Overall Study
NOT COMPLETED
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility and Acceptability of Stress Induction, Physiological Data Collection, and Mindfulness-Based Stress Reduction Among Combat Veterans With PTSD
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 2 weeks post conclusion of interventionPopulation: Data were not collected due to prematurely study closure due to PI change of career.
Qualitative data generated via focus group interviews. Questions will include common barriers to completing the intervention and strategies utilized by participants to maximize adherence.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 weeks post conclusion of intervention. Data were not collected due to prematurely study closure due to PI change of career.Qualitative data generated via focus group interviews. Questions will include ratings of the relevance of the content presented to participants' lives, as well as assessment of the method of presentation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre (week 0), mid (week 4), and post intervention (week 10). Data were not collected due to prematurely study closure due to PI change of career.Measured by self-report measure: Brief Resilience Scale (BRS). Scale ranges from 1-5 and higher scores indicate higher psychological resilience.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre (week 0), mid (week 4), and post intervention (week 10).Reactivity of physiological parameters (e.g., systolic and diastolic blood pressure) to a cognitive stress task.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre (week 0), mid (week 4), and post intervention (week 10).Measured by a self-report questionnaire: the PTSD Symptom Checklist (PCL). Scores range from 0-4 and higher scores indicate more severe PTSD symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre (week 0), mid (week 4), and post intervention (week 10).Measured by self-report measure: Connor-Davidson Resilience Scale (CD-RISC). Scores range from 0-4 and higher scores indicate higher psychological resilience.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre (week 0), mid (week 4), and post intervention (week 10).Measured a clinician-administered semi-structured interview: the Clinician-Administered PTSD Scale (CAPS-5). Symptoms are rated for severity (0-absent; 1-mild/subthreshold; 2-moderate/threshold; 3-severe/markedly elevated; 4-extreme/incapacitating) and the presence of distress (minimal; clearly present; pronounced; extreme). Symptom clusters are also rated for the likelihood that they are related to the index trauma (definite; probable; unlikely).
Outcome measures
Outcome data not reported
Adverse Events
Mindfulness-Based Stress Reduction
Health and Wellness Education
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place