Trial Outcomes & Findings for Groups for Regaining Our Wellbeing (NCT NCT03058952)

NCT ID: NCT03058952

Last Updated: 2024-06-21

Results Overview

A validated measure of pain, minimum value: 0, maximum value: 222, higher scores indicate worse outcomes.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 245 participants
• Primary outcome timeframe: Change from baseline to 6 months after completing the intervention
• Results posted on: 2024-06-21

Participant Flow

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.

Of 258 enrolled participants, 245 met inclusion criteria and were randomized to treatment.

Participant milestones

Measure	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.	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).
Overall Study STARTED	123	122
Overall Study Completed Intervention	65	65
Overall Study Completed Immediate Post-assessment	99	96
Overall Study Completed 3-month Post-intervention Assessment	97	89
Overall Study COMPLETED	100	96
Overall Study NOT COMPLETED	23	26

Reasons for withdrawal

Measure	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.	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).
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	15	15
Overall Study Withdrawal by Subject	7	11

Baseline Characteristics

Groups for Regaining Our Wellbeing

Baseline characteristics by cohort

Measure	Mindfulness-Based Stress Reduction n=115 Participants 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.	Chronic Disease Self-Management Program n=114 Participants 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).	Total n=229 Participants Total of all reporting groups
Age, Continuous	57.4 years STANDARD_DEVIATION 9.4 • n=5 Participants	55.6 years STANDARD_DEVIATION 8.7 • n=7 Participants	56.5 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex/Gender, Customized Gender · Female	14 Participants n=5 Participants	18 Participants n=7 Participants	32 Participants n=5 Participants
Sex/Gender, Customized Gender · Male	101 Participants n=5 Participants	95 Participants n=7 Participants	196 Participants n=5 Participants
Sex/Gender, Customized Gender · Transgender	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	106 Participants n=5 Participants	103 Participants n=7 Participants	209 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	30 Participants n=5 Participants	23 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) White	69 Participants n=5 Participants	55 Participants n=7 Participants	124 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	17 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Gulf-War Veteran Status	44 Participants n=5 Participants	43 Participants n=7 Participants	87 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to 6 months after completing the intervention

Population: Intent-to-treat population with complete data on the measure

A validated measure of pain, minimum value: 0, maximum value: 222, higher scores indicate worse outcomes.

Outcome measures

Measure	Mindfulness-Based Stress Reduction n=108 Participants 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.	Chronic Disease Self-Management Program n=105 Participants 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).
Short Form McGill Pain Questionnaire (SF-MPQ-2) Total Score Baseline	69.2 score on scale Standard Deviation 42.1	64.9 score on scale Standard Deviation 34.9
Short Form McGill Pain Questionnaire (SF-MPQ-2) Total Score final 6-month post-intervention	62.3 score on scale Standard Deviation 43.4	55.5 score on scale Standard Deviation 38.7

PRIMARY outcome

Timeframe: Change from baseline to 6 months after completing the intervention

Population: Intent-to-treat population with complete data on the measure

A measure of general fatigue symptoms. Minimum value: 0, maximum value: 80, higher scores indicate worse outcomes.

Outcome measures

Measure	Mindfulness-Based Stress Reduction n=114 Participants 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.	Chronic Disease Self-Management Program n=109 Participants 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).
General Fatigue Subscale of the Multidimensional Fatigue Inventory (MFI) Baseline	15.1 score on a scale Standard Deviation 3.7	14.8 score on a scale Standard Deviation 3.6
General Fatigue Subscale of the Multidimensional Fatigue Inventory (MFI) final 6-month post-intervention	14.2 score on a scale Standard Deviation 4.1	13.6 score on a scale Standard Deviation 4.0

PRIMARY outcome

Timeframe: Change from baseline to 6 months after completing the intervention

Population: Intent-to-treat population with complete data on measure

A measure of concentration and memory disturbances. Minimum value: 0, maximum value: 100, higher scores indicate worse outcomes.

Outcome measures

Measure	Mindfulness-Based Stress Reduction n=111 Participants 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.	Chronic Disease Self-Management Program n=111 Participants 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).
Cognitive Failures Questionnaire (CFQ) Baseline	47.0 score on a scale Standard Deviation 18.6	49.5 score on a scale Standard Deviation 15.3
Cognitive Failures Questionnaire (CFQ) final 6-month post-intervention	43.5 score on a scale Standard Deviation 17.3	43.5 score on a scale Standard Deviation 14.7

PRIMARY outcome

Timeframe: report at post-intervention assessment, 3-4 months after baseline

Population: participants who completed at least 1 intervention session

A measure of satisfaction with the interventions. Minimum value: 8, maximum value: 32, higher scores indicate higher satisfaction.

Outcome measures

Measure	Mindfulness-Based Stress Reduction n=86 Participants 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.	Chronic Disease Self-Management Program n=83 Participants 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).
Client Satisfaction Questionnaire (CSQ-8)	25.7 score on a scale Standard Deviation 5.5	26.1 score on a scale Standard Deviation 4.6

SECONDARY outcome

Timeframe: Change from baseline to 6 months after completing the intervention

Population: Intent-to-treat

A measure of depression. Minimum value: 0, maximum value: 27, higher scores indicate worse outcomes.

Outcome measures

Measure	Mindfulness-Based Stress Reduction n=115 Participants 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.	Chronic Disease Self-Management Program n=114 Participants 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).
Patient Health Questionnaire (PHQ-9) Baseline	9.8 score on a scale Standard Deviation 5.9	9.7 score on a scale Standard Deviation 5.9
Patient Health Questionnaire (PHQ-9) final 6-month post-intervention	7.8 score on a scale Standard Deviation 6.0	7.1 score on a scale Standard Deviation 5.7

SECONDARY outcome

Timeframe: Change from baseline to 6 months after completing the intervention

Population: Intent-to-treat population with complete data on the measure

A measure of PTSD. Minimum value: 0, maximum value: 80. Higher score indicates worse outcome.

Outcome measures

Measure	Mindfulness-Based Stress Reduction n=112 Participants 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.	Chronic Disease Self-Management Program n=112 Participants 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).
PTSD Checklist - Civilian Version (PCL-C) Baseline	31.7 score on a scale Standard Deviation 19	31.3 score on a scale Standard Deviation 18.3
PTSD Checklist - Civilian Version (PCL-C) final 6-month post-intervention	28.8 score on a scale Standard Deviation 20.5	30.3 score on a scale Standard Deviation 18.1

SECONDARY outcome

Timeframe: Change from baseline to 6 months after completing the intervention

Population: Intent-to-treat population with complete data on the measure

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.

Outcome measures

Measure	Mindfulness-Based Stress Reduction n=110 Participants 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.	Chronic Disease Self-Management Program n=105 Participants 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).
SF-12, Standard (Mental and Physical Component Summary Scores) MCS Baseline	40.3 score on a scale Standard Deviation 11.5	42.3 score on a scale Standard Deviation 11.8
SF-12, Standard (Mental and Physical Component Summary Scores) MCS final 6-month post-intervention	43.5 score on a scale Standard Deviation 12.7	44.2 score on a scale Standard Deviation 12.4
SF-12, Standard (Mental and Physical Component Summary Scores) PCS Baseline	24.7 score on a scale Standard Deviation 8.8	23.4 score on a scale Standard Deviation 7.8
SF-12, Standard (Mental and Physical Component Summary Scores) PCS final 6-month post-intervention	24.9 score on a scale Standard Deviation 8.8	25 score on a scale Standard Deviation 8.3

SECONDARY outcome

Timeframe: Change from baseline to 6 months after completing the intervention

Population: Intent-to-treat population with complete data on the measure

Substance Use Disorder (SUD) symptom severity for alcohol. Minimum score: 0, maximum score: 35. Higher scores indicate worse outcomes.

Outcome measures

Measure	Mindfulness-Based Stress Reduction n=115 Participants 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.	Chronic Disease Self-Management Program n=114 Participants 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).
NIH Patient Reported Outcome Measures Information System (PROMIS) for Alcohol Negative Consequences, Short Form Alcohol Negative Consequences Baseline	4.1 score on a scale Standard Deviation 5.7	4.5 score on a scale Standard Deviation 5.5
NIH Patient Reported Outcome Measures Information System (PROMIS) for Alcohol Negative Consequences, Short Form Alcohol Negative Consequences final 6-month post-intervention	4.7 score on a scale Standard Deviation 6.2	5.2 score on a scale Standard Deviation 5.6

Adverse Events

Mindfulness-Based Stress Reduction

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Chronic Disease Self-Management Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mindfulness-Based Stress Reduction n=123 participants at risk 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.	Chronic Disease Self-Management Program n=122 participants at risk 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).
Surgical and medical procedures Hospitalization not due to intervention	0.81% 1/123 • Number of events 1 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8-9 months.	0.00% 0/122 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8-9 months.
Psychiatric disorders Suicidal ideation requiring care	0.81% 1/123 • Number of events 1 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8-9 months.	0.00% 0/122 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8-9 months.

Additional Information

Dr. Tracy Simpson

VA Puget Sound

Phone: (206) 277-3337

Email: Tracy.Simpson@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place