Anxiety and Mood DisordersNCT03964246

Compassion Meditation for Older Adults

A study testing Compassion Meditation (CM) intervention and Healthy Aging Psychoeducation in people with Anxiety and Mood Disorders, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 years and older
Conditions the study is for: Anxiety and Mood Disorders
What is being tested?: Compassion Meditation (CM) intervention and Healthy Aging Psychoeducation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2019to 30 Jun 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

VA San Diego Healthcare System (VASDHS) patient
current mild-to-moderate anxiety or depressive symptoms as defined by scores between 5 and 14 on the Patient Health Questionnaire (PHQ-9) and or Generalized Anxiety Disorders scale (GAD-7).
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

Who cannot join

no active suicidality/homicidality in the preceding six months
untreated alcohol or substance use disorders
changes to psychiatric medications within six months prior to the baseline evaluation
medical and/or psychiatric instability interfering with current ability to engage in the group sessions and outside homework assignments

Trial locations and contacts

1 site in 1 country.

United States1 site

VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161

Other trials in United States

About this study

Official title: Feasibility Study of Compassion Meditation Intervention for Older Veterans in Primary Care With Anxiety or Mood Disorders

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.

Read the detailed description

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.

Conditions: Anxiety and Mood Disorders
Being tested: Compassion Meditation (CM) intervention, Healthy Aging Psychoeducation
Keywords: Feasibility Studies, Meditation, psychology
Medical subject headings: Anxiety Disorders, Mood Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Compassion Meditation (CM) interventionBehavioural
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.]
Healthy Aging PsychoeducationOther
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.]

Study groups in NCT03964246
Study group	Role	What they receive
Compassion Meditation (CM) intervention group	Experimental	10-week group intervention consisting of compassion meditation training. Receives: Behavioral: Compassion Meditation (CM) intervention
Psychoeducational healthy aging group	Active comparator	10-week group focused on review and discussion of psychoeducational videos related to healthy aging topics Receives: Other: Healthy Aging Psychoeducation

What is being measured

The primary outcome is the main question the study is designed to answer.

Enrollment Rate
The proportion of consented subjects among all screened and eligible patients.
Measured: 36 months
Initiation Rate
The proportion of subjects who initiate the intervention among all consented subjects.
Measured: 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.
Measured: 12 weeks
Practice Time at Home
Unanticipated COVID-related restrictions necessitated changing certain outcome measures. Data was not collected for this measure
Measured: 12 weeks

Secondary outcomes (5)

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
Measured: Baseline and 14 weeks
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline and 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201930 Jun 2022

First posted28 May 2019
Study start1 Oct 2019
Primary completion30 Apr 2022
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Anxiety and Mood DisordersStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03964246
Sponsor's protocol ID: E3186-P
Other IDs: RX003186-01
Status last verified: Mar 2024
First submitted: 23 May 2019
Last updated: 5 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 38409790

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Study of Compassion Meditation Intervention for Older Veterans in Primary Care With Anxiety or Mood Disorders
ClinicalTrials.gov ID: NCT03964246
Acronym / sponsor ID: E3186-P
Conditions: Anxiety and Mood Disorders
Keywords: Feasibility Studies, Meditation, psychology
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 Oct 2019 (actual)
Primary completion: 30 Apr 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 28 May 2019 (actual)
Results: Posted 5 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Compassion Meditation (CM) intervention group	Experimental	Behavioral: Compassion Meditation (CM) intervention10-week group intervention consisting of compassion meditation training.
Psychoeducational healthy aging group	Active comparator	Other: Healthy Aging Psychoeducation10-week group focused on review and discussion of psychoeducational videos related to healthy aging topics

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

VA San Diego Healthcare System (VASDHS) patient
current mild-to-moderate anxiety or depressive symptoms as defined by scores between 5 and 14 on the Patient Health Questionnaire (PHQ-9) and or Generalized Anxiety Disorders scale (GAD-7).
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

Key exclusion criteria (4 listed)

no active suicidality/homicidality in the preceding six months
untreated alcohol or substance use disorders
changes to psychiatric medications within six months prior to the baseline evaluation
medical and/or psychiatric instability interfering with current ability to engage in the group sessions and outside homework assignments

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Compassion Meditation (CM) intervention10 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.]	Behavioural	Compassion Meditation (CM) intervention group
Healthy Aging PsychoeducationThe 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.]	Other	Psychoeducational healthy aging group

Primary outcome

Enrollment Rate
Time frame: 36 months
The proportion of consented subjects among all screened and eligible patients.
Initiation Rate
Time frame: 4 months
The proportion of subjects who initiate the intervention among all consented subjects.
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.
Practice Time at Home
Time frame: 12 weeks
Unanticipated COVID-related restrictions necessitated changing certain outcome measures. Data was not collected for this measure

5 secondary outcomes

Change in Social Connection (SCS-R) From Baseline to Post-intervention
Time frame: Baseline and 14 weeks
Mean (and SD) Change Scores for Each Inflammatory Biomarker (Hs-CRP, IL-6, and TNF- )
Time frame: 14 weeks
Change in Depression and Anxiety From Baseline to Post-intervention
Time frame: Baseline and 14 weeks
Satisfaction With Life (SWLS) From Baseline to Post-intervention
Time frame: Baseline and 14 weeks
Change in Positive Emotions (mDES) From Baseline to Post-intervention
Time frame: Baseline and 14 weeks

Results and safety

Results posted to the registry on 5 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Compassion Meditation (CM) Intervention Group	22	13
Psychoeducational Healthy Aging Group	0	0

Primary outcome: Enrollment Rate

Time frame: 36 months. Count of participants. Unit: Participants

Measure	Compassion Meditation (CM) Intervention Group n = 33	Psychoeducational Healthy Aging Group n = 0
Value	25	0

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

Primary outcome: Initiation Rate

Time frame: 4 months. Count of participants. Unit: Participants

Measure	Compassion Meditation (CM) Intervention Group n = 25	Psychoeducational Healthy Aging Group n = 0
Value	22	–

Population analysed: Participants who enrolled.

Primary outcome: Completion Rate

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	Compassion Meditation (CM) Intervention Group n = 22	Psychoeducational Healthy Aging Group n = 0
Value	13	–

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

Primary outcome: Practice Time at Home

Time frame: 12 weeks

Population analysed: Participants with data available on minutes practiced at home

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks (baseline evaluation to final study visit). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Compassion Meditation (CM) Intervention Group	0 of 22 (0%)	0 of 22 (0%)	0 of 22
Psychoeducational Healthy Aging Group	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38409790Malaktaris 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Barton W. Palmer, PhD principal investigator

VA San Diego Healthcare System, San Diego, CA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enrollment Rate (time frame: 36 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03964246, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.