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This study is a randomized clinical trial measuring outcomes up to 6-months post-intervention. The objective of this study is to evaluate outcomes of two different group interventions for Veterans with Chronic Multisymptom Illness (CMI). The interventions to be compared are Mindfulness-Based Stress Reduction and an adapted version of the Chronic Disease Self-Management Program (aCDSMP) for Veterans experiencing symptoms of Chronic Multi-Symptom Illness (CMI) - musculoskeletal pain, fatigue, and cognitive failures - especially those who were deployed to Gulf War I. Hypothesis One (re: Outcomes): Participants randomized to the adapted Chronic Disease Self-Management Program (aCDSMP) will derive benefit for the primary outcomes, but with smaller effects than the participants randomized to Mindfulness-Based Stress Reduction (MBSR). The investigators hypothesize that Veterans randomized to MBSR will report greater reductions in each of the three primary outcome measures (pain, fatigue, and cognitive failures) at 6-month follow-up as compared to aCDSMP. Hypothesis Two (re: Acceptability): MBSR will be an acceptable and satisfactory program for Veterans with CMI, as measured by attendance rates, a self-report measure of satisfaction, and qualitative interviews. The investigators hypothesize that Veterans with CMI randomized to MBSR will report greater satisfaction with care than their peers randomized to aCDSMP.
The investigators will enroll 308 participants. Half of these will be Gulf War Veterans who meet criteria for CMI, and the other half will be Veterans from other periods of service who also meet criteria for CMI. Each participant will be randomized to either participate in MBSR or aCDSMP (stratified by Gulf War deployment status so there are ~7-8 Gulf War Veterans in each group for every cohort). Measures to collect primary outcome data (pain, fatigue, cognitive failures, patient satisfaction), secondary outcomes, and potential mediators will be administered at four assessments: (1) Baseline; (2) Post-Intervention; (3) at 3-months after the group ended; and (4) at 6-months after the group ended. Sample demographic data (age, gender, race, income, education, etc.) will be collected at baseline only. All study procedures will take place at VA Puget Sound Health Care System in Seattle, WA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | An 8-week standardized group program to teach mindfulness skills. In MBSR, participants meet for 2.5 hours per week for 8 weeks in a group format. Participants receive instruction in mindfulness meditation according to a standardized curriculum and have the opportunity to ask questions. |
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| Chronic Disease Self-Management Program | Active Comparator | The CDSMP is a structured program to teach self-management skills based on self-efficacy theory. CDSMP teaches self-management strategies and attempts to modify illness beliefs, enhance self-management capabilities and reinforce successful management strategies. CDSMP is based on self-efficacy theory, which posits that key determinants of behavior are: 1). self-efficacy (confidence in the ability to carry out an action) and 2). outcome expectancy (expectation that a particular goal will be achieved). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Stress Reduction | Behavioral | An 8-week standardized group program to teach mindfulness skills. In MBSR, participants meet for 2.5 hours per week for 8 weeks in a group format. Participants receive instruction in mindfulness meditation according to a standardized curriculum and have the opportunity to ask questions. |
| Measure | Description | Time Frame |
|---|---|---|
| Short Form McGill Pain Questionnaire (SF-MPQ-2) Total Score | A validated measure of pain, minimum value: 0, maximum value: 222, higher scores indicate worse outcomes. | Change from baseline to 6 months after completing the intervention |
| General Fatigue Subscale of the Multidimensional Fatigue Inventory (MFI) | A measure of general fatigue symptoms. Minimum value: 0, maximum value: 80, higher scores indicate worse outcomes. | Change from baseline to 6 months after completing the intervention |
| Cognitive Failures Questionnaire (CFQ) | A measure of concentration and memory disturbances. Minimum value: 0, maximum value: 100, higher scores indicate worse outcomes. | Change from baseline to 6 months after completing the intervention |
| Client Satisfaction Questionnaire (CSQ-8) | A measure of satisfaction with the interventions. Minimum value: 8, maximum value: 32, higher scores indicate higher satisfaction. | report at post-intervention assessment, 3-4 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) | A measure of depression. Minimum value: 0, maximum value: 27, higher scores indicate worse outcomes. | Change from baseline to 6 months after completing the intervention |
| PTSD Checklist - Civilian Version (PCL-C) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tracy L Simpson, PhD | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108 | United States |
A de-identified, anonymized dataset will be created and shared. Only de-identified data, with no individually identifiable patient information, will be shared.
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Of 258 enrolled participants, 245 met inclusion criteria and were randomized to treatment.
Participants were recruited based off of direct mailings generated by a VINCI data pull and the Gulf War Registry, between July 2017 and December 2020. The first participant was enrolled on August 8, 2017, and the last participant was enrolled on December 30, 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness-Based Stress Reduction | An 8-week standardized group program to teach mindfulness skills. In MBSR, participants meet for 2.5 hours per week for 8 weeks in a group format. Participants receive instruction in mindfulness meditation according to a standardized curriculum and have the opportunity to ask questions. Mindfulness-Based Stress Reduction: An 8-week standardized group program to teach mindfulness skills. In MBSR, participants meet for 2.5 hours per week for 8 weeks in a group format. Participants receive instruction in mindfulness meditation according to a standardized curriculum and have the opportunity to ask questions. |
| FG001 | Chronic Disease Self-Management Program | The CDSMP is a structured program to teach self-management skills based on self-efficacy theory. CDSMP teaches self-management strategies and attempts to modify illness beliefs, enhance self-management capabilities and reinforce successful management strategies. CDSMP is based on self-efficacy theory, which posits that key determinants of behavior are: 1). self-efficacy (confidence in the ability to carry out an action) and 2). outcome expectancy (expectation that a particular goal will be achieved). Chronic Disease Self-Management Program: The CDSMP is a structured program to teach self-management skills based on self-efficacy theory. CDSMP teaches self-management strategies and attempts to modify illness beliefs, enhance self-management capabilities and reinforce successful management strategies. CDSMP is based on self-efficacy theory, which posits that key determinants of behavior are: 1). self-efficacy (confidence in the ability to carry out an action) and 2). outcome expectancy (expectation that a particular goal will be achieved). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Note: for the cohort that was receiving intervention that was interrupted by the COVID-19 shutdown in March 2020, 16 participants were removed from the analysis data set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness-Based Stress Reduction | An 8-week standardized group program to teach mindfulness skills. In MBSR, participants meet for 2.5 hours per week for 8 weeks in a group format. Participants receive instruction in mindfulness meditation according to a standardized curriculum and have the opportunity to ask questions. Mindfulness-Based Stress Reduction: An 8-week standardized group program to teach mindfulness skills. In MBSR, participants meet for 2.5 hours per week for 8 weeks in a group format. Participants receive instruction in mindfulness meditation according to a standardized curriculum and have the opportunity to ask questions. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Short Form McGill Pain Questionnaire (SF-MPQ-2) Total Score | A validated measure of pain, minimum value: 0, maximum value: 222, higher scores indicate worse outcomes. | Intent-to-treat population with complete data on the measure | Posted | Mean | Standard Deviation | score on scale | Change from baseline to 6 months after completing the intervention |
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AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8-9 months.
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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 | Mindfulness-Based Stress Reduction | An 8-week standardized group program to teach mindfulness skills. In MBSR, participants meet for 2.5 hours per week for 8 weeks in a group format. Participants receive instruction in mindfulness meditation according to a standardized curriculum and have the opportunity to ask questions. Mindfulness-Based Stress Reduction: An 8-week standardized group program to teach mindfulness skills. In MBSR, participants meet for 2.5 hours per week for 8 weeks in a group format. Participants receive instruction in mindfulness meditation according to a standardized curriculum and have the opportunity to ask questions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization not due to intervention | Surgical and medical procedures | Non-systematic Assessment | Veteran was inpatient after multi-symptom organ failure. On ventilator, with palliative care planned. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tracy Simpson | VA Puget Sound | (206) 277-3337 | Tracy.Simpson@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2021 | Mar 31, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 7, 2021 | Mar 31, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D010146 | Pain |
| D003863 | Depression |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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| Chronic Disease Self-Management Program | Behavioral | The CDSMP is a structured program to teach self-management skills based on self-efficacy theory. CDSMP teaches self-management strategies and attempts to modify illness beliefs, enhance self-management capabilities and reinforce successful management strategies. CDSMP is based on self-efficacy theory, which posits that key determinants of behavior are: 1). self-efficacy (confidence in the ability to carry out an action) and 2). outcome expectancy (expectation that a particular goal will be achieved). |
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A measure of PTSD. Minimum value: 0, maximum value: 80. Higher score indicates worse outcome.
| Change from baseline to 6 months after completing the intervention |
| SF-12, Standard (Mental and Physical Component Summary Scores) | A measure of functional status and wellbeing. Two scores generated: a mental component score (MCS) and a physical component score (PCS). For each measure: minimum value: 0, maximum value: 100. Lower score indicates worse outcome. | Change from baseline to 6 months after completing the intervention |
| NIH Patient Reported Outcome Measures Information System (PROMIS) for Alcohol Negative Consequences, Short Form | Substance Use Disorder (SUD) symptom severity for alcohol. Minimum score: 0, maximum score: 35. Higher scores indicate worse outcomes. | Change from baseline to 6 months after completing the intervention |
| Withdrawal by Subject |
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| BG001 | Chronic Disease Self-Management Program | The CDSMP is a structured program to teach self-management skills based on self-efficacy theory. CDSMP teaches self-management strategies and attempts to modify illness beliefs, enhance self-management capabilities and reinforce successful management strategies. CDSMP is based on self-efficacy theory, which posits that key determinants of behavior are: 1). self-efficacy (confidence in the ability to carry out an action) and 2). outcome expectancy (expectation that a particular goal will be achieved). Chronic Disease Self-Management Program: The CDSMP is a structured program to teach self-management skills based on self-efficacy theory. CDSMP teaches self-management strategies and attempts to modify illness beliefs, enhance self-management capabilities and reinforce successful management strategies. CDSMP is based on self-efficacy theory, which posits that key determinants of behavior are: 1). self-efficacy (confidence in the ability to carry out an action) and 2). outcome expectancy (expectation that a particular goal will be achieved). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Gulf-War Veteran Status | Our definition of Gulf-War Veteran is a Veteran who was deployed to the Gulf War theater of operations any time during August 1990 to August 1991. | Count of Participants | Participants |
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| OG001 | Chronic Disease Self-Management Program | The CDSMP is a structured program to teach self-management skills based on self-efficacy theory. CDSMP teaches self-management strategies and attempts to modify illness beliefs, enhance self-management capabilities and reinforce successful management strategies. CDSMP is based on self-efficacy theory, which posits that key determinants of behavior are: 1). self-efficacy (confidence in the ability to carry out an action) and 2). outcome expectancy (expectation that a particular goal will be achieved). Chronic Disease Self-Management Program: The CDSMP is a structured program to teach self-management skills based on self-efficacy theory. CDSMP teaches self-management strategies and attempts to modify illness beliefs, enhance self-management capabilities and reinforce successful management strategies. CDSMP is based on self-efficacy theory, which posits that key determinants of behavior are: 1). self-efficacy (confidence in the ability to carry out an action) and 2). outcome expectancy (expectation that a particular goal will be achieved). |
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| Primary | General Fatigue Subscale of the Multidimensional Fatigue Inventory (MFI) | A measure of general fatigue symptoms. Minimum value: 0, maximum value: 80, higher scores indicate worse outcomes. | Intent-to-treat population with complete data on the measure | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to 6 months after completing the intervention |
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| Primary | Cognitive Failures Questionnaire (CFQ) | A measure of concentration and memory disturbances. Minimum value: 0, maximum value: 100, higher scores indicate worse outcomes. | Intent-to-treat population with complete data on measure | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to 6 months after completing the intervention |
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| Primary | Client Satisfaction Questionnaire (CSQ-8) | A measure of satisfaction with the interventions. Minimum value: 8, maximum value: 32, higher scores indicate higher satisfaction. | participants who completed at least 1 intervention session | Posted | Mean | Standard Deviation | score on a scale | report at post-intervention assessment, 3-4 months after baseline |
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| Secondary | Patient Health Questionnaire (PHQ-9) | A measure of depression. Minimum value: 0, maximum value: 27, higher scores indicate worse outcomes. | Intent-to-treat | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to 6 months after completing the intervention |
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| Secondary | PTSD Checklist - Civilian Version (PCL-C) | A measure of PTSD. Minimum value: 0, maximum value: 80. Higher score indicates worse outcome. | Intent-to-treat population with complete data on the measure | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to 6 months after completing the intervention |
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| Secondary | SF-12, Standard (Mental and Physical Component Summary Scores) | A measure of functional status and wellbeing. Two scores generated: a mental component score (MCS) and a physical component score (PCS). For each measure: minimum value: 0, maximum value: 100. Lower score indicates worse outcome. | Intent-to-treat population with complete data on the measure | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to 6 months after completing the intervention |
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| Secondary | NIH Patient Reported Outcome Measures Information System (PROMIS) for Alcohol Negative Consequences, Short Form | Substance Use Disorder (SUD) symptom severity for alcohol. Minimum score: 0, maximum score: 35. Higher scores indicate worse outcomes. | Intent-to-treat population with complete data on the measure | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to 6 months after completing the intervention |
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| 0 |
| 123 |
| 0 |
| 123 |
| 2 |
| 123 |
| EG001 | Chronic Disease Self-Management Program | The CDSMP is a structured program to teach self-management skills based on self-efficacy theory. CDSMP teaches self-management strategies and attempts to modify illness beliefs, enhance self-management capabilities and reinforce successful management strategies. CDSMP is based on self-efficacy theory, which posits that key determinants of behavior are: 1). self-efficacy (confidence in the ability to carry out an action) and 2). outcome expectancy (expectation that a particular goal will be achieved). Chronic Disease Self-Management Program: The CDSMP is a structured program to teach self-management skills based on self-efficacy theory. CDSMP teaches self-management strategies and attempts to modify illness beliefs, enhance self-management capabilities and reinforce successful management strategies. CDSMP is based on self-efficacy theory, which posits that key determinants of behavior are: 1). self-efficacy (confidence in the ability to carry out an action) and 2). outcome expectancy (expectation that a particular goal will be achieved). | 0 | 122 | 0 | 122 | 0 | 122 |
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| Suicidal ideation requiring care | Psychiatric disorders | Non-systematic Assessment | Veteran disclosed thoughts of suicide at post-assessment without plan or intent but in need of immediate care, arranged by research staff |
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| D001519 | Behavior |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D004191 |
| Behavioral Disciplines and Activities |
| final 6-month post-intervention |
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| final 6-month post-intervention |
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| final 6-month post-intervention |
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| final 6-month post-intervention |
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| MCS final 6-month post-intervention |
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| PCS Baseline |
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| PCS final 6-month post-intervention |
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| Alcohol Negative Consequences final 6-month post-intervention |
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