Trial Outcomes & Findings for Compassion Meditation for Older Adults (NCT NCT03964246)

Results Overview

The proportion of consented subjects among all screened and eligible patients.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

36 months

Results posted on

2024-07-05

Participant Flow

25 participants enrolled (signed the ICF) and were assigned to the CM intervention, but 3 of the 25 withdrew from the study before the first intervention session. Thus 22 participants started the CM intervention (attended at least first intervention session)

Participant milestones

Participant milestones
Measure	Compassion Meditation (CM) Intervention Group 10 weekly 90-minute sessions. Sessions 1-3 assist participants in basic mindfulness breathing practices; sessions 4-8 focus on personal analysis of factors underlying difficulties with compassion for self or others; sessions 9 and 10 review content and assist with relapse prevention. These were planned as in-person groups but due to the COVID-19 social distancing requirements that started after session 3 of the cohort 1, the investigators had to retool the intervention for telehealth delivery.	Psychoeducational Healthy Aging Group The investigators planned to examine one 10-week psychoeducational in-person group (with up to 10 participants) focused on topics in healthy aging to examine its feasibility as a control condition for a subsequent randomized controlled trial. This would include use of an existing library of videotaped community-focused talks, such as increasing happiness, mental resilience and health, nutrition, and physical activity. Unfortunately, with the switch to telehealth format necessitated by the COVID-19 social distancing requirements, the consensus of the investigators and staff was that these proved too be too dry/"dull/academic" to be a credible attention control in a telehealth format for the target population.
Overall Study STARTED	22	0
Overall Study COMPLETED	13	0
Overall Study NOT COMPLETED	9	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Compassion Meditation for Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Compassion Meditation (CM) Intervention Group n=25 Participants Ten 90-minute group sessions: Sessions 1-3 assist participants in basic mindfulness breathing practices; sessions 4-8 focus on personal analysis of factors underlying difficulties with compassion for self or others; sessions 9 and 10 review content and assist with relapse prevention.	Psychoeducational Healthy Aging Group This would have been one 10-week psychoeducational in-person group (with up to 10 participants) focused on topics in healthy aging to examine its feasibility as a control condition for a subsequent randomized controlled trial. This would include use of an existing library of videotaped community-focused talks, such as increasing happiness, mental resilience and health, nutrition, and physical activity. Unfortunately, with the switch to telehealth format necessitated by the COVID-19 social distancing requirements, the consensus of the investigators and staff was that these proved too be too dry/"dull/academic" to be a credible attention control in a telehealth form	Total n=25 Participants Total of all reporting groups
Age, Continuous	69.0 years STANDARD_DEVIATION 10.6 • n=99 Participants	—	69.0 years STANDARD_DEVIATION 10.6 • n=206 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	—	3 Participants n=206 Participants
Sex: Female, Male Male	22 Participants n=99 Participants	—	22 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants	—	3 Participants n=206 Participants
Race (NIH/OMB) White	22 Participants n=99 Participants	—	22 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	—	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: 36 months

Population: Participants who were successfully contacted and verbally consented to formal telephone screening

The proportion of consented subjects among all screened and eligible patients.

Outcome measures

Outcome measures
Measure	Psychoeducational Healthy Aging Group The investigators planned to examine one 10-week psychoeducational in-person group (with up to 10 participants) focused on topics in healthy aging to examine its feasibility as a control condition for a subsequent randomized controlled trial. This would include use of an existing library of videotaped community-focused talks, such as increasing happiness, mental resilience and health, nutrition, and physical activity. Unfortunately, with the switch to telehealth format necessitated by the COVID-19 social distancing requirements, the consensus of the investigators and staff was that these proved too be too dry/"dull/academic" to be a credible attention control in a telehealth format for the target population.	Compassion Meditation (CM) Intervention Group n=33 Participants 10-week group intervention consisting of compassion meditation training.
Enrollment Rate	0 Participants	25 Participants

PRIMARY outcome

Timeframe: 4 months

Population: Participants who enrolled.

The proportion of subjects who initiate the intervention among all consented subjects.

Outcome measures

Outcome measures
Measure	Psychoeducational Healthy Aging Group The investigators planned to examine one 10-week psychoeducational in-person group (with up to 10 participants) focused on topics in healthy aging to examine its feasibility as a control condition for a subsequent randomized controlled trial. This would include use of an existing library of videotaped community-focused talks, such as increasing happiness, mental resilience and health, nutrition, and physical activity. Unfortunately, with the switch to telehealth format necessitated by the COVID-19 social distancing requirements, the consensus of the investigators and staff was that these proved too be too dry/"dull/academic" to be a credible attention control in a telehealth format for the target population.	Compassion Meditation (CM) Intervention Group n=25 Participants 10-week group intervention consisting of compassion meditation training.
Initiation Rate	—	22 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 22 people who attended at least the first intervention session

The proportion of subjects who complete 6 or more sessions (out of a total of 10 sessions) of intervention among those who start the intervention.

Outcome measures

Outcome measures
Measure	Psychoeducational Healthy Aging Group The investigators planned to examine one 10-week psychoeducational in-person group (with up to 10 participants) focused on topics in healthy aging to examine its feasibility as a control condition for a subsequent randomized controlled trial. This would include use of an existing library of videotaped community-focused talks, such as increasing happiness, mental resilience and health, nutrition, and physical activity. Unfortunately, with the switch to telehealth format necessitated by the COVID-19 social distancing requirements, the consensus of the investigators and staff was that these proved too be too dry/"dull/academic" to be a credible attention control in a telehealth format for the target population.	Compassion Meditation (CM) Intervention Group n=22 Participants 10-week group intervention consisting of compassion meditation training.
Completion Rate	—	13 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Participants with data available on minutes practiced at home

Unanticipated COVID-related restrictions necessitated changing certain outcome measures. Data was not collected for this measure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 14 weeks

Population: Participants with pre- to post-intervention scores on the SCS-R

Social Connectedness Scale (SCS-R), 20-items scores, possible range = 20 to 120, higher scores reflect more connectedness

Outcome measures

Outcome measures
Measure	Psychoeducational Healthy Aging Group The investigators planned to examine one 10-week psychoeducational in-person group (with up to 10 participants) focused on topics in healthy aging to examine its feasibility as a control condition for a subsequent randomized controlled trial. This would include use of an existing library of videotaped community-focused talks, such as increasing happiness, mental resilience and health, nutrition, and physical activity. Unfortunately, with the switch to telehealth format necessitated by the COVID-19 social distancing requirements, the consensus of the investigators and staff was that these proved too be too dry/"dull/academic" to be a credible attention control in a telehealth format for the target population.	Compassion Meditation (CM) Intervention Group n=11 Participants 10-week group intervention consisting of compassion meditation training.
Change in Social Connection (SCS-R) From Baseline to Post-intervention Pre-intervention SCS-R total	—	74.1 score on a scale Standard Deviation 14.5
Change in Social Connection (SCS-R) From Baseline to Post-intervention Post-intervention SCS-R total	—	74.8 score on a scale Standard Deviation 17.1

SECONDARY outcome

Timeframe: 14 weeks

Population: The COVID-19 pandemic social distancing restrictions began during the first group of participants and thus no follow-up blood samples could be collected for this or subsequent groups. Due to absence of follow-up blood draws for the initial group and an absence of baseline and follow-up data for the remaining participants, the inflammatory biomarker outcomes could not be examined.

The investigators will also examine the mean (and SD) change scores for each inflammatory biomarker (hs-CRP, IL-6, and TNF- ), as well as the association of these changes with practice time.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 14 weeks

Population: Participants with pre- and post-intervention data for BSI-GSI

Brief Symptom Inventory-18 (BSI; depression, anxiety, and somatization) Global Severity Index (GSI). Each of the 18 items range from a score of 0-4; total score ranges from 0-72 with higher scores indicating worse function.

Outcome measures

Outcome measures
Measure	Psychoeducational Healthy Aging Group The investigators planned to examine one 10-week psychoeducational in-person group (with up to 10 participants) focused on topics in healthy aging to examine its feasibility as a control condition for a subsequent randomized controlled trial. This would include use of an existing library of videotaped community-focused talks, such as increasing happiness, mental resilience and health, nutrition, and physical activity. Unfortunately, with the switch to telehealth format necessitated by the COVID-19 social distancing requirements, the consensus of the investigators and staff was that these proved too be too dry/"dull/academic" to be a credible attention control in a telehealth format for the target population.	Compassion Meditation (CM) Intervention Group n=10 Participants 10-week group intervention consisting of compassion meditation training.
Change in Depression and Anxiety From Baseline to Post-intervention Pre-Intervention BSI- GSI	—	17.9 score on a scale Standard Deviation 12.0
Change in Depression and Anxiety From Baseline to Post-intervention Post-Intervention BSI-GSI	—	14.9 score on a scale Standard Deviation 10.4

SECONDARY outcome

Timeframe: Baseline and 14 weeks

Population: Participants with pre-post scores on the SWLS.

Satisfaction With Life Scale (SWLS); 5-items, range 5 to 35, higher scores represent greater satisfaction

Outcome measures

Outcome measures
Measure	Psychoeducational Healthy Aging Group The investigators planned to examine one 10-week psychoeducational in-person group (with up to 10 participants) focused on topics in healthy aging to examine its feasibility as a control condition for a subsequent randomized controlled trial. This would include use of an existing library of videotaped community-focused talks, such as increasing happiness, mental resilience and health, nutrition, and physical activity. Unfortunately, with the switch to telehealth format necessitated by the COVID-19 social distancing requirements, the consensus of the investigators and staff was that these proved too be too dry/"dull/academic" to be a credible attention control in a telehealth format for the target population.	Compassion Meditation (CM) Intervention Group n=10 Participants 10-week group intervention consisting of compassion meditation training.
Satisfaction With Life (SWLS) From Baseline to Post-intervention Post-Intervention SWLS total	—	21.0 score on a scale Standard Deviation 8.8
Satisfaction With Life (SWLS) From Baseline to Post-intervention Pre-Intervention SWLS total	—	18.0 score on a scale Standard Deviation 9.7

SECONDARY outcome

Timeframe: Baseline and 14 weeks

Population: Participants with pre- and post-intervention scores on the mDES positive emotions subscale

10-item positive emotions subscale of the 20-item modified Differential Emotions Scale (mDES); scores on this subscale have a potential range of 0 to 40 with higher scores reflecting more positive emotions.

Outcome measures

Outcome measures
Measure	Psychoeducational Healthy Aging Group The investigators planned to examine one 10-week psychoeducational in-person group (with up to 10 participants) focused on topics in healthy aging to examine its feasibility as a control condition for a subsequent randomized controlled trial. This would include use of an existing library of videotaped community-focused talks, such as increasing happiness, mental resilience and health, nutrition, and physical activity. Unfortunately, with the switch to telehealth format necessitated by the COVID-19 social distancing requirements, the consensus of the investigators and staff was that these proved too be too dry/"dull/academic" to be a credible attention control in a telehealth format for the target population.	Compassion Meditation (CM) Intervention Group n=11 Participants 10-week group intervention consisting of compassion meditation training.
Change in Positive Emotions (mDES) From Baseline to Post-intervention Pre-Intervention mDES Positive Emotions subscale total	—	21.7 score on a scale Standard Deviation 7.8
Change in Positive Emotions (mDES) From Baseline to Post-intervention Post-Intervention mDES Positive Emotions subscale total	—	21.0 score on a scale Standard Deviation 7.8

Adverse Events

Compassion Meditation (CM) Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Psychoeducational Healthy Aging Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Barton W. Palmer

Veterans Affairs San Diego Healthcare System

Phone: 8582460765

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place