An interventional study of Mindfulness-based exercise in Stress Disorders, Post-Traumatic, sponsored by University of New Mexico. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-06.
Sponsored by University of New Mexico · Not applicable, Interventional, and Treatment
This study will explore the relationship between changes in plasma cortisol and symptom reduction resulting from individuals with posttraumatic stress disorder (PTSD) participating in an 8-week program of mindfulness-based stretching and breathing exercise. The investigators hypothesize that at the completion of participation in the 8-week program, exercise-induced symptom reduction will be associated with changes in cortisol levels.
This study will employ an intent-to-treat design to evaluate the relationship between exercise-induced posttraumatic stress disorder (PTSD) symptom reduction and exercise-induced changes in cortisol level. The participants consist of nurses and the intervention will be conducted at the Clinical and Translational Science Center of the University of New Mexico. The study was approved by the Human Research Protections Office of the university. Nurses who are screened positively for PTSD will be randomly assigned to either control or exercise group. At baseline and in weeks 4, 8, 12 and 16, immediately after the phlebotomy for serum cortisol, the investigators will ask the participants to rate the severity of their PTSD symptoms using the PTSD Checklist (PCL).
1,148 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's enrollment of 29 is below the median of 60 across 909 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →University of New Mexico is the lead sponsor of 306 studies on the registry; 28 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.
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Exclusion Criteria:
Participants who are screened positive for PTSD and participate in the series of 16 standardized, semiweekly 60-minute mindfulness-based exercise sessions. The intervention consists of stretching and balancing movements combined with breathing and a focus on mindfulness.Over the course of 8 weeks, the intensity of the exercise increases, but the sequence of the movements is the same.
Behavioral: Mindfulness-based exercise
Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
8-week program of mindfulness-based stretching and breathing exercises
Also known as: Mindfulness stretching and breathing exercises
Change From Baseline in PTSD Checklist - Civilian Version (PCL-C) Score
The PCL-C is a 17-item self-report instrument that measures the symptoms of PTSD. A total score, ranging from 17 to 85, is found by summing the scores of the 17 items. Higher values are considered to be a worse outcome. The inclusion criteria in the PTSD symptomatic group is a PCL-C total score of at least 28 with a score of 3 or higher on 1 or more items.To detect a reduction in PTSD symptom severity with a 2-sided 5% significance level and a power of 80%, the mean difference of PCL-C scores of 5.16 or greater requires a sample size of 20 participants for Exercise and Control groups, given an anticipated dropout rate of 10%. Data analyses are conducted using an a priori intention-to-treat approach. The analysis for the between-group differences of the intervention is conducted using t-tests comparing Exercise and Control groups at post-intervention. The analysis for the within-group difference is conducted using repeated measures ANOVA for both groups at baseline and week 8.
Time frame: Baseline and 8 weeks
Cortisol
Change from baseline in serum cortisol levels at 8 weeks. Serum cortisol samples were collected at 8:00 Ante Meridian (AM). The changes are calculated from two time points as the values at 8 weeks minus the values at baseline.
Time frame: baseline and 8 weeks
Nurse volunteers were recruited from the University of New Mexico Hospital through advertisement,between September 1, 2011 and March 31, 2012.
| Milestone | Exercise Group | Control Group | Base Group |
|---|---|---|---|
| Started | 11 | 11 | 7 |
| Completed | 11 | 10 | 7 |
| Not completed | 0 | 1 | 0 |
| Withdrew: Family matter | 0 | 1 | 0 |
The PCL-C is a 17-item self-report instrument that measures the symptoms of PTSD. A total score, ranging from 17 to 85, is found by summing the scores of the 17 items. Higher values are considered to be a worse outcome. The inclusion criteria in the PTSD symptomatic group is a PCL-C total score of at least 28 with a score of 3 or higher on 1 or more items.To detect a reduction in PTSD symptom severity with a 2-sided 5% significance level and a power of 80%, the mean difference of PCL-C scores of 5.16 or greater requires a sample size of 20 participants for Exercise and Control groups, given an anticipated dropout rate of 10%. Data analyses are conducted using an a priori intention-to-treat approach. The analysis for the between-group differences of the intervention is conducted using t-tests comparing Exercise and Control groups at post-intervention. The analysis for the within-group difference is conducted using repeated measures ANOVA for both groups at baseline and week 8.
| scores on a scale | Exercise Group | Control Group | Base Group |
|---|---|---|---|
| Change From Baseline in PTSD Checklist - Civilian Version (PCL-C) Score | -18.8 ± 10.6 | -5.2 ± 15.8 | 21.8 ± 3.4 |
Change from baseline in serum cortisol levels at 8 weeks. Serum cortisol samples were collected at 8:00 Ante Meridian (AM). The changes are calculated from two time points as the values at 8 weeks minus the values at baseline.
| μg/dl | Exercise Group | Control Group | Base Group |
|---|---|---|---|
| Cortisol | 5.1 ± 4.5 | -0.7 ± 6.5 | -0.04 ± 9.4 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exercise Group | — | 0/11 (0%) | 0/11 (0%) |
| Control Group | — | 0/11 (0%) | 0/11 (0%) |
| Base Group | — | 0/7 (0%) | 0/7 (0%) |
| Age, Categorical(Participants) | Exercise Group | Control Group | Base Group | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 11 | 6 | 28 |
| >=65 years | 0 | 0 | 1 | 1 |
| Age, Continuous(years) | Exercise Group | Control Group | Base Group | Total |
|---|---|---|---|---|
| Mean | 49 ± 6.4 | 45 ± 9.9 | 44 ± 15.1 | 46 ± 10.1 |
| Sex: Female, Male(Participants) | Exercise Group | Control Group | Base Group | Total |
|---|---|---|---|---|
| Female | 10 | 11 | 7 | 28 |
| Male | 1 | 0 | 0 | 1 |
| Region of Enrollment(participants) | Exercise Group | Control Group | Base Group | Total |
|---|---|---|---|---|
| United States | 11 | 11 | 7 | 29 |
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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University of New Mexico