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| ID | Type | Description | Link |
|---|---|---|---|
| RX003186-01 | Other Grant/Funding Number | VA Rehabilitation R&D |
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Some older Veterans with psychological distress may under-utilize mental health services due to perceived stigma of symptom-focused interventions. This study was designed to examine the feasibility of a strengths-based compassion training intervention with Veterans ages > 55 years with anxiety or depressive symptoms. Although this study was focused on feasibility if successful, this line of research could open the door to a novel and effective treatment that widens acceptance by older Veterans with psychological distress.
Many older Veterans in VA primary care clinics experience anxiety and depressive symptoms, but only a minority of these Veterans seek care through VA mental health services. Research suggests that some older Veterans with psychological distress under-utilize mental health services due to perceived stigma of treatments focused on mental health symptoms. However, prior research with civilians, including one study of Veterans with PTSD, suggests a strengths-focused intervention that provides group training in compassion meditation may be effective in reducing negative emotions and increasing positive emotions and well-being. This project was designed to examine the feasibility of this approach with Veterans ages > 55 years with anxiety or depression. The study was designed to guide and support development of a future larger-size, more definitive follow-up project. . If successful, this line of research could open the door to a novel and effective treatment that widens acceptance by older Veterans with psychological distress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compassion Meditation (CM) intervention group | Experimental | 10-week group intervention consisting of compassion meditation training. |
|
| Psychoeducational healthy aging group | Active Comparator | 10-week group focused on review and discussion of psychoeducational videos related to healthy aging topics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compassion Meditation (CM) intervention | Behavioral | 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 initiation of cohort 1, the investigators had to retool the intervention for telehealth delivery.] |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment Rate | The proportion of consented subjects among all screened and eligible patients. | 36 months |
| Initiation Rate | The proportion of subjects who initiate the intervention among all consented subjects. | 4 months |
| Completion Rate | 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. | 12 weeks |
| Practice Time at Home | Unanticipated COVID-related restrictions necessitated changing certain outcome measures. Data was not collected for this measure | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Social Connection (SCS-R) From Baseline to Post-intervention | Social Connectedness Scale (SCS-R), 20-items scores, possible range = 20 to 120, higher scores reflect more connectedness | Baseline and 14 weeks |
| Mean (and SD) Change Scores for Each Inflammatory Biomarker (Hs-CRP, IL-6, and TNF- ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barton W. Palmer, PhD | VA San Diego Healthcare System, San Diego, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38409790 | Derived | Malaktaris A, McLean CL, Casmar P, Kangas J, Myers H, Chu G, Phillips RC, Maglione JE, Palmer BW, Lang AJ. Compassion Meditation for Distressed Older Veterans: A Feasibility Study. Clin Gerontol. 2025 Jul-Sep;48(4):816-827. doi: 10.1080/07317115.2024.2322056. Epub 2024 Feb 26. |
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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)
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Due to unanticipated COVID social distancing restrictions, we had to switch to a telehealth format with which the available videos for the psychoeducational sessions was too dry for a credible attention control. We began identifying more engaging videos from other sources, but with other COVID-related delays we were unable to complete this process during the study period.
25 participants enrolled and were assigned to the CM intervention, but 3 withdrew before the first intervention session.
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| ID | Title | Description |
|---|---|---|
| BG000 | Compassion Meditation (CM) Intervention Group | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Enrollment Rate | The proportion of consented subjects among all screened and eligible patients. | Participants who were successfully contacted and verbally consented to formal telephone screening | Posted | Count of Participants | Participants | No | 36 months |
|
12 weeks (baseline evaluation to final study visit)
Clinicaltrials.gov definitions are used.
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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 | Compassion Meditation (CM) Intervention Group | 10-week group intervention consisting of compassion meditation training. |
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Unanticipated COVID-related social distancing restrictions necessitated changing to remote assessment and intervention during the first intervention cohort and throughout the remainder of the trial. The lessons learned are valuable in the context of this as a feasibility study, could potentially help future studies of the intervention focused on Veterans with transportation or geographic distance limitations, but hindered our completion of some of the originally planned components of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barton W. Palmer | Veterans Affairs San Diego Healthcare System | 8582460765 | bpalmer@ucsd.edu |
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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 | Sep 21, 2020 | Aug 22, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 28, 2021 | Apr 28, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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This non-randomized feasibility study was designed to collect pilot data to establish feasibility for a future randomized controlled trial (RCT) of manualized compassion meditation (CM) group intervention for older Veterans identified through VA Primary Care clinics as having clinically significant psychological distress. The plan was to enroll 20 to 30 participants 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, the investigators also planned to enroll up to 10 additional participants in a 10-session psychoeducational group focused on topics in healthy aging. The intent for the latter was to examine the feasibility and appropriateness of employing this as a control condition in a follow-up RCT.
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|
| Healthy Aging Psychoeducation | Other | The investigators planned to administer a 10-week psychoeducational in-person group 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.] |
|
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. |
| 14 weeks |
| Change in Depression and Anxiety From Baseline to Post-intervention | 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. | Baseline and 14 weeks |
| Satisfaction With Life (SWLS) From Baseline to Post-intervention | Satisfaction With Life Scale (SWLS); 5-items, range 5 to 35, higher scores represent greater satisfaction | Baseline and 14 weeks |
| Change in Positive Emotions (mDES) From Baseline to Post-intervention | 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. | Baseline and 14 weeks |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Initiation Rate | The proportion of subjects who initiate the intervention among all consented subjects. | Participants who enrolled. | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Primary | Completion Rate | 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. | 22 people who attended at least the first intervention session | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Primary | Practice Time at Home | Unanticipated COVID-related restrictions necessitated changing certain outcome measures. Data was not collected for this measure | Participants with data available on minutes practiced at home | Posted | 12 weeks |
|
|
| Secondary | Change in Social Connection (SCS-R) From Baseline to Post-intervention | Social Connectedness Scale (SCS-R), 20-items scores, possible range = 20 to 120, higher scores reflect more connectedness | Participants with pre- to post-intervention scores on the SCS-R | Posted | Mean | Standard Deviation | score on a scale | Baseline and 14 weeks |
|
|
|
| Secondary | Mean (and SD) Change Scores for Each Inflammatory Biomarker (Hs-CRP, IL-6, and TNF- ) | 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. | 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. | Posted | 14 weeks |
|
|
| Secondary | Change in Depression and Anxiety From Baseline to Post-intervention | 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. | Participants with pre- and post-intervention data for BSI-GSI | Posted | Mean | Standard Deviation | score on a scale | Baseline and 14 weeks |
|
|
|
| Secondary | Satisfaction With Life (SWLS) From Baseline to Post-intervention | Satisfaction With Life Scale (SWLS); 5-items, range 5 to 35, higher scores represent greater satisfaction | Participants with pre-post scores on the SWLS. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 14 weeks |
|
|
|
| Secondary | Change in Positive Emotions (mDES) From Baseline to Post-intervention | 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. | Participants with pre- and post-intervention scores on the mDES positive emotions subscale | Posted | Mean | Standard Deviation | score on a scale | Baseline and 14 weeks |
|
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|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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