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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Group | Experimental | 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. |
|
| Control Group | No Intervention | Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise. | |
| Base Group | No Intervention | Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based exercise | Behavioral | 8-week program of mindfulness-based stretching and breathing exercises |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark R Burge, MD | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23720785 | Result | Kim SH, Schneider SM, Bevans M, Kravitz L, Mermier C, Qualls C, Burge MR. PTSD symptom reduction with mindfulness-based stretching and deep breathing exercise: randomized controlled clinical trial of efficacy. J Clin Endocrinol Metab. 2013 Jul;98(7):2984-92. doi: 10.1210/jc.2012-3742. Epub 2013 May 29. |
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Participants gave their informed written consent before participation. Inclusion criteria were age greater than 18 years and employment as a nurse at the University of New Mexico (UNM) Hospital. Exclusion criteria included an inability to participate in the exercise program, or current use of systemic glucocorticoid.
Nurse volunteers were recruited from the University of New Mexico Hospital through advertisement,between September 1, 2011 and March 31, 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise Group | Participants who are screened positive for PTSD and participate in the mindfulness-based exercise. |
| FG001 | Control Group | Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise. |
| FG002 | Base Group | Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise Group | Participants who are screened positive for PTSD and participate in the mindfulness-based exercise. |
| BG001 | Control Group | Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | For Base Group, the values entered represent the mean value of the baseline PCL-C scores. The mean difference score for the Base Group is not available because the Base Group was assessed only at baseline. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 8 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise Group | Participants who are screened positive for PTSD and participate in the mindfulness-based exercise. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sang Hwan Kim, PhD/Lead Investigator | University of New Mexico | 5057954545 | sanghk@gmail.com |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D009043 | Motor Activity |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
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| BG002 | Base Group | Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Exercise Group | Participants who are screened positive for PTSD and participate in the mindfulness-based exercise. |
| OG001 | Control Group | Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise. |
| OG002 | Base Group | Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise. |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | μg/dl | baseline and 8 weeks |
|
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Control Group | Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise. | 0 | 11 | 0 | 11 |
| EG002 | Base Group | Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise. | 0 | 7 | 0 | 7 |
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| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D026741 |
| Physical Therapy Modalities |