Compassion Meditation for Older Adults

NCT03964246 | Completed Results

• 2 other identifiers: E3186-PRX003186-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety and Mood Disorders

Keywords

Feasibility Studies; Meditation, psychology

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (5)

• Change in Social Connection (SCS-R) From Baseline to Post-intervention

  Baseline and 14 weeks

• Mean (and SD) Change Scores for Each Inflammatory Biomarker (Hs-CRP, IL-6, and TNF- )

  14 weeks

• Change in Depression and Anxiety From Baseline to Post-intervention

  Baseline and 14 weeks

• Satisfaction With Life (SWLS) From Baseline to Post-intervention

  Baseline and 14 weeks

• Change in Positive Emotions (mDES) From Baseline to Post-intervention

  Baseline and 14 weeks

Study Arms (2)

Compassion Meditation (CM) intervention group

EXPERIMENTAL

10-week group intervention consisting of compassion meditation training.

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

Other: Healthy Aging Psychoeducation

Interventions

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. \[These were planned as in-person groups but due to the COVID-19 social distancing requirements that started after initiation of cohort 1, the investigators had to retool the intervention for telehealth delivery.\]

Compassion Meditation (CM) intervention group

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. \[Unfortunately, with the switch to telehealth format necessitated by the COVID-19 social distancing requirements, the consensus of the investigators and staff was that these proved too be too dry/"dull/academic" to be a credible attention control in a telehealth format for the target population.\]

Psychoeducational healthy aging group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Mood Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Limitations and Caveats

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.

Results Point of Contact

• Title: Barton W. Palmer
• Organization: Veterans Affairs San Diego Healthcare System

bpalmer@ucsd.edu

8582460765

Study Officials

• Barton W. Palmer, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 28, 2019
• Study Start: October 1, 2019
• Primary Completion: April 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 5, 2024
• Results First Posted: July 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)