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Yoga and Physical Activity for Veterans

Mechanisms of Change in Yoga and Physical Activity for Veterans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03509909
Enrollment
117
Registered
2018-04-26
Start date
2019-05-16
Completion date
2023-12-31
Last updated
2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD

Keywords

yoga, exercise, randomized controlled trial

Brief summary

Posttraumatic stress disorder (PTSD) is a major health problem for the nation's Veterans, leading to significant physical and mental health morbidity and mortality. Current empirically-supported interventions ameliorate symptoms but generally do not restore full functioning, so the development of alternative or complementary approaches is a critical need. Large numbers of Veterans are seeking out yoga as a part of their recovery plans, but there is not enough evidence to recommend yoga for treatment of PTSD. Likely reflecting this heterogeneity, evidence of yoga's efficacy is highly variable. This project aims to address this problem by comparing the effect of yoga to a matched exercise control condition. The study will also explore the mechanisms by which yoga impacts PTSD. Ultimately, the goal of this research would be to contribute to integrative care planning, whereby multiple approaches can be applied in a synergistic manner to restore wellness for Veterans affected by PTSD.

Detailed description

Posttraumatic stress disorder (PTSD) is a chronic, debilitating condition with a broad negative impact on physical and mental health functioning. Excellent, empirically-supported interventions for PTSD are readily available to Veterans, but the majority of patients who receive the best available treatments continue to have a diagnosable disorder after treatment. This suggests that complementary interventions may be useful to fully restore functioning. In addition, many patients seek alternatives to psychotherapy or pharmacotherapy. This is evident in the increasing numbers of individuals with PTSD are turning to alternative approaches. At present, however, the investigators lack a good evidence base from which to make recommendations about the use of complementary and alternative approaches. Yoga is very popular practice, touted to enhance physical, mental and spiritual well-being. Many Veterans with PTSD have turned to yoga as a part of their recovery plan, often seeking care outside the specialty mental health system. Initial evidence suggests that the practice leads to clinically significant change in symptoms, but results are yet inconclusive, particularly in Veterans. Thus, this project will provide additional data as to efficacy of yoga for Veterans PTSD. The study is a randomized controlled trial involving approximately 100 Veterans with PTSD from the San Diego area. These Veterans will be randomized to receive a manualized hatha yoga intervention or a supportive exercise control condition. Both interventions will be delivered by trained instructors via livestreaming or recorded classes over a 12-week period. Assessment of clinical outcomes and methodological variables will take place before, during, immediately after, and 3-months after the intervention. Analyses will focus on change in the intervention groups over time and the degree to which change is associated with the candidate mechanisms. Results of this study have the potential to inform the way in which yoga is delivered to Veterans as well as to increase knowledge about the underlying processes by which PTSD can be ameliorated. Given the high demand for yoga demand by individuals with PTSD and the degree to which the practice is already being provided in many clinical settings, findings from this study will be immediately relevant. Findings may also guide future research in complementary and alternative approaches by demonstrating the principle of targeting different processes of change to create an integrative care plan.

Interventions

BEHAVIORALHatha yoga

Manualized hatha yoga

BEHAVIORALSupportive physical activity

Manualized stretching and strengthening

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcome evaluator is blind to experimental condition

Intervention model description

Experimental condition: Manualized hatha yoga, a 12-session group-based yoga class led by a trained teacher Control condition: Manualized supportive physical activity, a 12-session group-based stretching and strengthening class led by a trained instructor

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Veterans who have clinically meaningful PTSD symptoms

Exclusion criteria

* serious suicidality or homicidality that has required urgent or emergent evaluation or treatment within the past three months * a known, untreated substance abuse or dependence problem * inclusion is possible if there is evidence that the individual has been afforded and is complying with treatment for the substance problem * serious mental disorders, such as psychotic disorders or bipolar type I, or serious dissociative symptoms * cognitive impairment that would interfere with treatment * circumstances that lead to recurrent traumatization * e.g., engaged in a violent relationship * any medical condition for which exercise is contraindicated, including pregnancy * concurrent enrollment in any other treatment specifically targeting PTSD symptoms or in any meditative or mind-body intervention * including yoga practice \>1 class/month in the preceding 6 months

Design outcomes

Primary

MeasureTime frameDescription
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual Version 5 (CAPS-5)Baseline to post-treatment (approx 12 weeks)Semi-structured clinical interview assessing severity of PTSD symptoms administered by a trained, blinded assessor. The range of scores is 0-80. Mpre-Mpost is presented, so positive numbers indicate a reduction in PTSD symptom severity from before to after the intervention.

Secondary

MeasureTime frameDescription
Patient Health Questionnaire Depression Items (PHQ-9)Baseline to post-treatment (approx 12 weeks)Self-report measure of depressive symptoms with a range of 0-27. Mpre-Mpost is presented, so positive numbers indicate a reduction in depression severity.
State-Trait Anxiety Inventory, State SubscaleBaseline to post-treatment (approx 12 weeks)Self-report measure of anxiety symptoms with state and trait subscales; state is reported. The subscale scores range from 20 to 80. Mpre-Mpost is presented, so positive numbers indicate a reduction in anxiety.
State-Trait Anger Expression Inventory - II (STAXI-II), State Anger SubscaleBaseline to post-treatment (approx 12 weeks)Self-report measure of anger with three major subscales (state anger, trait anger and anger control index), which are quantified as T-scores (i.e., 50 indicates the population mean with a standard deviation of 10), calculated from published adult norms tables. Change in T-scores, Tpre-Tpost, is presented, so positive numbers indicate a reduction in anger.
Insomnia Severity IndexBaseline to post-treatment (approx 12 weeks)Self-report measure of insomnia with a range of 0-28. Mpre-Mpost is presented, so positive numbers indicate a reduction in sleep disturbance.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4aBaseline to post-treatment (approx 12 weeks)Self-report measure of pain interference, reported as a T-score (i.e., 50 indicates the population mean with a standard deviation of 10) calculated from published adult norms table. Change in T-scores, Tpre-Tpost, is presented, so positive numbers indicate a reduction in pain interference.

Countries

United States

Participant flow

Participants by arm

ArmCount
Hatha Yoga
12- week group-based yoga class Hatha yoga: Manualized hatha yoga
67
Supportive Exercise
12-week group-based stretching and strengthening class Supportive physical activity: Manualized stretching and strengthening
50
Total117

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event20
Overall StudyLost to Follow-up34
Overall StudyWithdrawal by Subject169

Baseline characteristics

CharacteristicHatha YogaTotalSupportive Exercise
Age, Continuous45.9 years
STANDARD_DEVIATION 13.2
47 years
STANDARD_DEVIATION 13.1
48.4 years
STANDARD_DEVIATION 13
Education
College degree
12 Participants23 Participants11 Participants
Education
High school or GED
16 Participants26 Participants10 Participants
Education
Post-college
18 Participants30 Participants12 Participants
Education
Some college
21 Participants38 Participants17 Participants
Employment
Full time
28 Participants45 Participants17 Participants
Employment
Not in paid workforce
22 Participants40 Participants18 Participants
Employment
Part time
8 Participants13 Participants5 Participants
Employment
Unemployed
9 Participants19 Participants10 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
21 Participants30 Participants9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
44 Participants85 Participants41 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants2 Participants0 Participants
Martial status
Divorced, separated or widowed
16 Participants27 Participants11 Participants
Martial status
Married, common law or permanent partner
37 Participants68 Participants31 Participants
Martial status
Never married
14 Participants22 Participants8 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants5 Participants3 Participants
Race (NIH/OMB)
Asian
3 Participants5 Participants2 Participants
Race (NIH/OMB)
Black or African American
8 Participants23 Participants15 Participants
Race (NIH/OMB)
More than one race
12 Participants16 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants2 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants
Race (NIH/OMB)
White
39 Participants65 Participants26 Participants
Sex: Female, Male
Female
24 Participants41 Participants17 Participants
Sex: Female, Male
Male
43 Participants76 Participants33 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 670 / 50
other
Total, other adverse events
25 / 6729 / 50
serious
Total, serious adverse events
2 / 671 / 50

Outcome results

Primary

Clinician Administered PTSD Scale for Diagnostic and Statistical Manual Version 5 (CAPS-5)

Semi-structured clinical interview assessing severity of PTSD symptoms administered by a trained, blinded assessor. The range of scores is 0-80. Mpre-Mpost is presented, so positive numbers indicate a reduction in PTSD symptom severity from before to after the intervention.

Time frame: Baseline to post-treatment (approx 12 weeks)

Population: Differs from the total population due to missing data. Includes individuals with both time points because of the nature of the change score.

ArmMeasureValue (MEAN)Dispersion
Hatha YogaClinician Administered PTSD Scale for Diagnostic and Statistical Manual Version 5 (CAPS-5)3.92 change in units on a scaleStandard Deviation 10.05
Supportive ExerciseClinician Administered PTSD Scale for Diagnostic and Statistical Manual Version 5 (CAPS-5)3.46 change in units on a scaleStandard Deviation 10.55
p-value: 0.74Mixed Models Analysis
Secondary

Insomnia Severity Index

Self-report measure of insomnia with a range of 0-28. Mpre-Mpost is presented, so positive numbers indicate a reduction in sleep disturbance.

Time frame: Baseline to post-treatment (approx 12 weeks)

Population: Differs from the total population due to missing data. Includes individuals with both time points because of the nature of the change score.

ArmMeasureValue (MEAN)Dispersion
Hatha YogaInsomnia Severity Index2.73 change in units on a scaleStandard Deviation 4.24
Supportive ExerciseInsomnia Severity Index1.64 change in units on a scaleStandard Deviation 4.94
Secondary

Patient Health Questionnaire Depression Items (PHQ-9)

Self-report measure of depressive symptoms with a range of 0-27. Mpre-Mpost is presented, so positive numbers indicate a reduction in depression severity.

Time frame: Baseline to post-treatment (approx 12 weeks)

Population: Differs from the total population due to missing data. Includes individuals with both time points because of the nature of the change score.

ArmMeasureValue (MEAN)Dispersion
Hatha YogaPatient Health Questionnaire Depression Items (PHQ-9)3.79 change in units on a scaleStandard Deviation 6.01
Supportive ExercisePatient Health Questionnaire Depression Items (PHQ-9)2.11 change in units on a scaleStandard Deviation 4.47
Secondary

Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a

Self-report measure of pain interference, reported as a T-score (i.e., 50 indicates the population mean with a standard deviation of 10) calculated from published adult norms table. Change in T-scores, Tpre-Tpost, is presented, so positive numbers indicate a reduction in pain interference.

Time frame: Baseline to post-treatment (approx 12 weeks)

Population: Differs from the total population due to missing data. Includes individuals with both time points because of the nature of the change score. Loss of data increased as scale is invalid if all items are not answered.

ArmMeasureValue (MEAN)Dispersion
Hatha YogaPatient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a0.8 change in T-scoreStandard Deviation 8.47
Supportive ExercisePatient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a0.92 change in T-scoreStandard Deviation 6.05
Secondary

State-Trait Anger Expression Inventory - II (STAXI-II), State Anger Subscale

Self-report measure of anger with three major subscales (state anger, trait anger and anger control index), which are quantified as T-scores (i.e., 50 indicates the population mean with a standard deviation of 10), calculated from published adult norms tables. Change in T-scores, Tpre-Tpost, is presented, so positive numbers indicate a reduction in anger.

Time frame: Baseline to post-treatment (approx 12 weeks)

Population: Differs from the total population due to missing data. Includes individuals with both time points because of the nature of the change score.

ArmMeasureValue (MEAN)Dispersion
Hatha YogaState-Trait Anger Expression Inventory - II (STAXI-II), State Anger Subscale1.02 change in T-scoreStandard Deviation 9.65
Supportive ExerciseState-Trait Anger Expression Inventory - II (STAXI-II), State Anger Subscale1.08 change in T-scoreStandard Deviation 6.94
Secondary

State-Trait Anxiety Inventory, State Subscale

Self-report measure of anxiety symptoms with state and trait subscales; state is reported. The subscale scores range from 20 to 80. Mpre-Mpost is presented, so positive numbers indicate a reduction in anxiety.

Time frame: Baseline to post-treatment (approx 12 weeks)

Population: Differs from the total population due to missing data. Includes individuals with both time points because of the nature of the change score.

ArmMeasureValue (MEAN)Dispersion
Hatha YogaState-Trait Anxiety Inventory, State Subscale0.23 change in units on a scaleStandard Deviation 5.61
Supportive ExerciseState-Trait Anxiety Inventory, State Subscale-0.53 change in units on a scaleStandard Deviation 6.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026