Trial Outcomes & Findings for Primary Care Brief Mindfulness Training for Veterans With PTSD (NCT NCT03352011)

NCT ID: NCT03352011

Last Updated: 2022-12-22

Results Overview

rate of participants who complete all assessment time points

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 55 participants
• Primary outcome timeframe: enrollment to 24 week follow-up
• Results posted on: 2022-12-22

Participant Flow

Participant milestones

Measure	Primary Care Brief Mindfulness Training Primary Care Brief Mindfulness Training: Primary Care Brief Mindfulness Training consists of four 90-minute group classes that teach sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go.	PTSD Psychoeducational Class PTSD Psychoeducational Class: The PTSD Psychoeducational Class is designed to provide a supportive environment for learning about PTSD-related issues and to help Veterans determine what recovery strategies will be most helpful for them. Session themes include "Civilian Readjustment and PTSD," "Trust, Safety, and Healing" and "Treatment Strategies."
Overall Study STARTED	28	27
Overall Study COMPLETED	21	20
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Primary Care Brief Mindfulness Training for Veterans With PTSD

Baseline characteristics by cohort

Measure	Primary Care Brief Mindfulness Training n=28 Participants Primary Care Brief Mindfulness Training: Primary Care Brief Mindfulness Training consists of four 90-minute group classes that teach sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go.	PTSD Psychoeducational Class n=27 Participants PTSD Psychoeducational Class: The PTSD Psychoeducational Class is designed to provide a supportive environment for learning about PTSD-related issues and to help Veterans determine what recovery strategies will be most helpful for them. Session themes include "Civilian Readjustment and PTSD," "Trust, Safety, and Healing" and "Treatment Strategies."	Total n=55 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=93 Participants	16 Participants n=4 Participants	32 Participants n=27 Participants
Age, Categorical >=65 years	12 Participants n=93 Participants	11 Participants n=4 Participants	23 Participants n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Male	24 Participants n=93 Participants	24 Participants n=4 Participants	48 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=93 Participants	25 Participants n=4 Participants	52 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) White	26 Participants n=93 Participants	21 Participants n=4 Participants	47 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: enrollment to 24 week follow-up

rate of participants who complete all assessment time points

Outcome measures

Measure	Primary Care Brief Mindfulness Training n=28 Participants Primary Care Brief Mindfulness Training: Primary Care Brief Mindfulness Training consists of four 90-minute group classes that teach sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go.	PTSD Psychoeducational Class n=27 Participants PTSD Psychoeducational Class: The PTSD Psychoeducational Class is designed to provide a supportive environment for learning about PTSD-related issues and to help Veterans determine what recovery strategies will be most helpful for them. Session themes include "Civilian Readjustment and PTSD," "Trust, Safety, and Healing" and "Treatment Strategies."
Number of Participants With Assessment Retention Assessment Retention	24 Participants	25 Participants

PRIMARY outcome

Timeframe: enrollment to 24 week follow-up

rate of participants who complete assigned intervention

Outcome measures

Measure	Primary Care Brief Mindfulness Training n=28 Participants Primary Care Brief Mindfulness Training: Primary Care Brief Mindfulness Training consists of four 90-minute group classes that teach sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go.	PTSD Psychoeducational Class n=27 Participants PTSD Psychoeducational Class: The PTSD Psychoeducational Class is designed to provide a supportive environment for learning about PTSD-related issues and to help Veterans determine what recovery strategies will be most helpful for them. Session themes include "Civilian Readjustment and PTSD," "Trust, Safety, and Healing" and "Treatment Strategies."
Intervention Retention	21 Participants	20 Participants

PRIMARY outcome

Timeframe: enrollment to 8 week follow-up

Population: Data were not collected for the "PTSD Psychoeducational Class Arm/ Group"

Number of essential components of the Primary Care Brief Mindfulness Training curriculum delivered across all 5 cohorts of PCBMT. Number of essential components 0-90. Higher scores indicate more components delivered and better fidelity.

Outcome measures

Measure	Primary Care Brief Mindfulness Training n=28 Participants Primary Care Brief Mindfulness Training: Primary Care Brief Mindfulness Training consists of four 90-minute group classes that teach sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go.	PTSD Psychoeducational Class PTSD Psychoeducational Class: The PTSD Psychoeducational Class is designed to provide a supportive environment for learning about PTSD-related issues and to help Veterans determine what recovery strategies will be most helpful for them. Session themes include "Civilian Readjustment and PTSD," "Trust, Safety, and Healing" and "Treatment Strategies."
Primary Care Brief Mindfulness Fidelity Assessment	85 number of essential components delivered	—

PRIMARY outcome

Timeframe: 8 week follow-up

measured by the Client Satisfaction Questionnaire, scale range 1-32 with 32 indicating highest satisfaction.

Outcome measures

Measure	Primary Care Brief Mindfulness Training n=27 Participants Primary Care Brief Mindfulness Training: Primary Care Brief Mindfulness Training consists of four 90-minute group classes that teach sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go.	PTSD Psychoeducational Class n=25 Participants PTSD Psychoeducational Class: The PTSD Psychoeducational Class is designed to provide a supportive environment for learning about PTSD-related issues and to help Veterans determine what recovery strategies will be most helpful for them. Session themes include "Civilian Readjustment and PTSD," "Trust, Safety, and Healing" and "Treatment Strategies."
Client Satisfaction Scale	19.07 units on a scale Standard Deviation 1.174	19.36 units on a scale Standard Deviation 1.287

SECONDARY outcome

Timeframe: 24 week follow-up

PTSD Checklist-5. Scale range 0-63 with 63 indicating highest PTSD severity.

Outcome measures

Measure	Primary Care Brief Mindfulness Training n=24 Participants Primary Care Brief Mindfulness Training: Primary Care Brief Mindfulness Training consists of four 90-minute group classes that teach sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go.	PTSD Psychoeducational Class n=25 Participants PTSD Psychoeducational Class: The PTSD Psychoeducational Class is designed to provide a supportive environment for learning about PTSD-related issues and to help Veterans determine what recovery strategies will be most helpful for them. Session themes include "Civilian Readjustment and PTSD," "Trust, Safety, and Healing" and "Treatment Strategies."
Post-traumatic Stress Checklist for DSM-5	32.99 score on a scale Standard Error 3.27	40.89 score on a scale Standard Error 3.29

SECONDARY outcome

Timeframe: 24 week follow-up

Recovery Orientation Scale-24 measuring recovery from mental health concerns. Range 24-120, with 120 indicating the greatest amount of recovery.

Outcome measures

Measure	Primary Care Brief Mindfulness Training n=24 Participants Primary Care Brief Mindfulness Training: Primary Care Brief Mindfulness Training consists of four 90-minute group classes that teach sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go.	PTSD Psychoeducational Class n=25 Participants PTSD Psychoeducational Class: The PTSD Psychoeducational Class is designed to provide a supportive environment for learning about PTSD-related issues and to help Veterans determine what recovery strategies will be most helpful for them. Session themes include "Civilian Readjustment and PTSD," "Trust, Safety, and Healing" and "Treatment Strategies."
Recovery Orientation Scale- 24	89.53 score on a scale Standard Error 2.88	82.35 score on a scale Standard Error 2.90

SECONDARY outcome

Timeframe: 24 week follow-up

Patient Health Questionnaire-9, range 0-27, with 27 indicating the greatest amount of depression.

Outcome measures

Measure	Primary Care Brief Mindfulness Training n=24 Participants Primary Care Brief Mindfulness Training: Primary Care Brief Mindfulness Training consists of four 90-minute group classes that teach sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go.	PTSD Psychoeducational Class n=25 Participants PTSD Psychoeducational Class: The PTSD Psychoeducational Class is designed to provide a supportive environment for learning about PTSD-related issues and to help Veterans determine what recovery strategies will be most helpful for them. Session themes include "Civilian Readjustment and PTSD," "Trust, Safety, and Healing" and "Treatment Strategies."
Patient Health Questionnaire-9,	9.12 score on a scale Standard Error 1.21	12.98 score on a scale Standard Error 1.21

SECONDARY outcome

Timeframe: 8 week post-treatment

Self Compassion Scale- Short Form, range 0-60, with 60 indicating the greatest amount of self compassion.

Outcome measures

Measure	Primary Care Brief Mindfulness Training n=27 Participants Primary Care Brief Mindfulness Training: Primary Care Brief Mindfulness Training consists of four 90-minute group classes that teach sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go.	PTSD Psychoeducational Class n=25 Participants PTSD Psychoeducational Class: The PTSD Psychoeducational Class is designed to provide a supportive environment for learning about PTSD-related issues and to help Veterans determine what recovery strategies will be most helpful for them. Session themes include "Civilian Readjustment and PTSD," "Trust, Safety, and Healing" and "Treatment Strategies."
Self Compassion Scale- Short Form	32.38 score on a scale Standard Error 1.40	34.34 score on a scale Standard Error 1.98

SECONDARY outcome

Timeframe: 24 week follow-up

Health Promoting Lifestyle Profile II: Health Responsibility. Subscale ranges from 9-36, with 36 indicating the most health responsibility.

Outcome measures

Measure	Primary Care Brief Mindfulness Training n=24 Participants Primary Care Brief Mindfulness Training: Primary Care Brief Mindfulness Training consists of four 90-minute group classes that teach sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go.	PTSD Psychoeducational Class n=25 Participants PTSD Psychoeducational Class: The PTSD Psychoeducational Class is designed to provide a supportive environment for learning about PTSD-related issues and to help Veterans determine what recovery strategies will be most helpful for them. Session themes include "Civilian Readjustment and PTSD," "Trust, Safety, and Healing" and "Treatment Strategies."
Health Promoting Lifestyle Profile II: Health Responsibility Subscale	24.80 score on a scale Standard Error 1.00	21.40 score on a scale Standard Error 1.00

Adverse Events

Primary Care Brief Mindfulness Training

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

PTSD Psychoeducational Class

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Primary Care Brief Mindfulness Training n=27 participants at risk Primary Care Brief Mindfulness Training: Primary Care Brief Mindfulness Training consists of four 90-minute group classes that teach sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go.	PTSD Psychoeducational Class n=25 participants at risk PTSD Psychoeducational Class: The PTSD Psychoeducational Class is designed to provide a supportive environment for learning about PTSD-related issues and to help Veterans determine what recovery strategies will be most helpful for them. Session themes include "Civilian Readjustment and PTSD," "Trust, Safety, and Healing" and "Treatment Strategies."
General disorders ER visit or hospitalization unrelated to study interventions	11.1% 3/27 • Number of events 3 • enrollment to 24 weeks	16.0% 4/25 • Number of events 4 • enrollment to 24 weeks

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kyle Possemato

VA Center for Integrated Heathcare

Phone: 315-425-4400

Email: kyle.possemato@va.gov

Results disclosure agreements

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