Compassion Meditation for Older Adults

• ClinicalTrials.gov Identifier: NCT03964246
• Recruitment Status: Enrolling by invitation
• First Posted: May 28, 2019
• Last Update Posted: November 20, 2020
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Anxiety and Mood Disorders	Behavioral: Compassion Meditation (CM) intervention; Other: Heathy Aging Psychoeducation	Not Applicable

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 Design

• 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: May 30, 2021
• Estimated Study Completion Date: June 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States, 92161

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Barton W. Palmer, PhD; VA San Diego Healthcare System, San Diego, CA

More Information

• 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
• Last Update Posted: November 20, 2020
• Last Verified: November 2020

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

Keywords provided by VA Office of Research and Development:

Feasibility Studies; Meditation, psychology

Additional relevant MeSH terms:

Mood Disorders; Mental Disorders