Compassion Meditation for Older Adults

Feasibility Study of Compassion Meditation Intervention for Older Veterans inPrimary Care With Anxiety or Mood Disorders

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. The proposed project is designed to examine the feasibility of this approach with Veterans ages > 55 years with anxiety or depression. The information from the study will guide and support development of a larger-size, more definitive study, planned as the follow-up after this 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.

Study Overview

• Status: Completed
• Conditions: Anxiety and Mood Disorders
• Intervention / Treatment: Behavioral: Compassion Meditation (CM) intervention; Other: Heathy Aging Psychoeducation

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. The proposed project is designed to examine the feasibility of this approach with Veterans ages > 55 years with anxiety or depression. The information from the study will guide and support development of a larger-size, more definitive study, planned as the follow-up after this 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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161
      • VA San Diego Healthcare System, San Diego, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• VA San Diego Healthcare System (VASDHS) patient

• 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

• untreated alcohol or substance use disorders

  • those co-enrolled in the VASDHS Alcohol and Drug Treatment Program will be eligible

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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."	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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment rate	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.	18 months
Initiation rate	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.	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. The mean (and SD) or percentage will be calculated and the 95% confidence interval will be estimated.	12 weeks
Practice time at home	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in depression and anxiety (BSI), social connection (SCS-R), satisfaction with life (SWLS) and positive emotions (mDES) from baseline to post-intervention	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.	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.	14 weeks
Improvement in depression and anxiety from baseline to post-intervention	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.	14 weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Barton W. Palmer, PhD, VA San Diego Healthcare System, San Diego, CA

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2019
• Primary Completion (ACTUAL): April 30, 2022
• Study Completion (ACTUAL): June 30, 2022

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: May 23, 2019
• First Posted (ACTUAL): May 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Feasibility Studies; Meditation, psychology
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders
• Other Study ID Numbers: E3186-P; RX003186-01 (OTHER_GRANT: VA Rehabilitation R&D)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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