Compassion Meditation for Older Adults
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ClinicalTrials.gov Identifier: NCT03964246 |
Recruitment Status :
Enrolling by invitation
First Posted : May 28, 2019
Last Update Posted : January 19, 2022
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Condition or disease | Intervention/treatment | Phase |
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Anxiety and Mood Disorders | Behavioral: Compassion Meditation (CM) intervention Other: Heathy Aging Psychoeducation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | The proposed non-randomized feasibility study will collect pilot data to establish feasibility for a future randomized controlled trial (RCT) of manualized compassion meditation (CM) group intervention to restore functioning in older Veterans identified through VA Primary Care clinics as having clinically significant psychological distress. Twenty to 30 participants will be enrolled in a 10-week CM training group (with 8-10 participants in each group). As part of establishing feasibility for a subsequent large-scale RCT, 10 additional participants will be enrolled in a 10-session manualized psychoeducational group focused on topics in healthy aging. The latter group will be conducted to examine the feasibility and appropriateness of employing this as a control condition in a follow-up RCT. |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Feasibility Study of Compassion Meditation Intervention for Older Veterans inPrimary Care With Anxiety or Mood Disorders |
Actual Study Start Date : | October 1, 2019 |
Estimated Primary Completion Date : | April 30, 2022 |
Estimated Study Completion Date : | June 30, 2022 |

Arm | Intervention/treatment |
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Experimental: Compassion Meditation (CM) intervention group
Thee CBCT-Vet includes 10 90-minute sessions that will be led by certified CBCT therapist with significant experience in administering CBCT-Vet. Sessions 1 - 4 assist participants in basic mindfulness breathing practices; sessions 4 - 8 focus on personal analysis of factors underlying difficulties with compassion for self or others; the final two sessions (9 and 10) review content and assist with relapse prevention. Session by session topics are: (1) Introduction and learning breathing meditation, (2) Focused attention, (3) Creating space, (4) Mindful awareness, (5) Re-engaging with heroic spirit, (6) Seeing ourselves in others, (7) Appreciation and gratitude, (8) Empathy and engaged compassion, (9) "Putting it all together," and (10) "Putting it all together 2."
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Behavioral: Compassion Meditation (CM) intervention
Thee CBCT-Vet includes 10 90-minute sessions that will be led by certified CBCT therapist with significant experience in administering CBCT-Vet. Sessions 1 - 4 assist participants in basic mindfulness breathing practices; sessions 4 - 8 focus on personal analysis of factors underlying difficulties with compassion for self or others; the final two sessions (9 and 10) review content and assist with relapse prevention. Session by session topics are: (1) Introduction and learning breathing meditation, (2) Focused attention, (3) Creating space, (4) Mindful awareness, (5) Re-engaging with heroic spirit, (6) Seeing ourselves in others, (7) Appreciation and gratitude, (8) Empathy and engaged compassion, (9) "Putting it all together," and (10) "Putting it all together 2." |
Active Comparator: Psychoeducational healthy aging group
The investigators will develop and test a 10-week psychoeducational group focused on topics in healthy aging to examine its feasibility as a control condition for a subsequent VA Merit-supported randomized controlled trial. This will include multiple resources for community education regarding healthy aging, including a library of videotaped community-focused talks, such as increasing happiness, mental resilience and health, nutrition, and physical activity. These resources will be incorporated into 90-minute sessions wherein the key information from talks is shown to participants, with a follow-up discussion and review period led by the group facilitator. In the context of the present feasibility study, the investigators anticipate modifying and refining the content and format of the group in response to participant feedback.
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Other: Heathy Aging Psychoeducation
The investigators will develop and test a 10-week psychoeducational group focused on topics in healthy aging to examine its feasibility as a control condition for a subsequent VA Merit-supported randomized controlled trial. This will include multiple resources for community education regarding healthy aging, including a library of videotaped community-focused talks, such as increasing happiness, mental resilience and health, nutrition, and physical activity. These resources will be incorporated into 90-minute sessions wherein the key information from talks is shown to participants, with a follow-up discussion and review period led by the group facilitator. In the context of the present feasibility study, the investigators anticipate modifying and refining the content and format of the group in response to participant feedback. |
- Enrollment rate [ Time Frame: 18 months ]The proportion of consented subjects among all screened and eligible patients. The mean (and SD) or percentage will be calculated and the 95% confidence interval will be estimated.
- Initiation rate [ Time Frame: 4 months ]The proportion of subjects who initiate the intervention among all consented subjects. The mean (and SD) or percentage will be calculated and the 95% confidence interval will be estimated.
- Completion rate [ Time Frame: 12 weeks ]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. The mean (and SD) or percentage will be calculated and the 95% confidence interval will be estimated.
- Practice time at home [ Time Frame: 12 weeks ]Average minutes that subjects practice at home each week. The mean (and SD) or percentage will be calculated and the 95% confidence interval will be estimated.
- Improvement in depression and anxiety (BSI), social connection (SCS-R), satisfaction with life (SWLS) and positive emotions (mDES) from baseline to post-intervention [ Time Frame: 14 weeks ]The investigators will evaluate the improvement in depression and anxiety (Brief Symptom Inventory-18; BSI), social connection (Social Connectedness Scale; SCS-R), satisfaction with life (Satisfaction with Life Scale; SWLS) and positive emotions (modified Differential Emotions Scale; mDES) from baseline to post-intervention using a linear random effect model and time will be included as a main effect in the model. The random effects model is suitable for examining changes in outcomes in longitudinal studies. It will include all available data, minimizing the effects of missing data on the analyses.
- Mean (and SD) change scores for each inflammatory biomarker (hs-CRP, IL-6, and TNF- ) [ Time Frame: 14 weeks ]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.
- Improvement in depression and anxiety from baseline to post-intervention [ Time Frame: 14 weeks ]Brief Symptom Inventory-18 (BSI; depression, anxiety, and somatization) using a linear random effect model and time will be included as a main effect in the model.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- VA San Diego Healthcare System (VASDHS) patient
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current mild-to-moderate anxiety or depressive symptoms
- (as defined below)
- stated intention to attend the 10 group sessions at the scheduled times at the VASDHS in addition to the baseline and follow-up study assessment visits, as well as to complete the outside homework assignments
- provides written informed consent for participation
Exclusion Criteria:
- no active suicidality/homicidality in the preceding six months
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untreated alcohol or substance use disorders
- those co-enrolled in the VASDHS Alcohol and Drug Treatment Program will be eligible
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changes to psychiatric medications within six months of baseline evaluation
- changes to medications during the course of the study will be permitted as determined appropriate by Veteran's treating clinicians, but changes will be recorded to further describe the sample
- medical and/or psychiatric instability interfering with current ability to engage in the group sessions and outside homework assignments

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964246
United States, California | |
VA San Diego Healthcare System, San Diego, CA | |
San Diego, California, United States, 92161 |
Principal Investigator: | Barton W. Palmer, PhD | VA San Diego Healthcare System, San Diego, CA |
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT03964246 |
Other Study ID Numbers: |
E3186-P RX003186-01 ( Other Grant/Funding Number: VA Rehabilitation R&D ) |
First Posted: | May 28, 2019 Key Record Dates |
Last Update Posted: | January 19, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Feasibility Studies Meditation, psychology |
Mood Disorders Mental Disorders |