Back to resultsCompassion Meditation for Older Adults
Primary Purpose
Anxiety and Mood Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compassion Meditation (CM) intervention
Heathy Aging Psychoeducation
Sponsored by
About this trial
This is an interventional other trial for Anxiety and Mood Disorders focused on measuring Feasibility Studies, Meditation, psychology
Eligibility 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
Sites / Locations
- VA San Diego Healthcare System, San Diego, CA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Compassion Meditation (CM) intervention group
Psychoeducational healthy aging group
Arm Description
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."
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT03964246
First Posted
May 23, 2019
Last Updated
October 14, 2022
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03964246
Brief Title
Compassion Meditation for Older Adults
Official Title
Feasibility Study of Compassion Meditation Intervention for Older Veterans inPrimary Care With Anxiety or Mood Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety and Mood Disorders
Keywords
Feasibility Studies, Meditation, psychology
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Compassion Meditation (CM) intervention group
Arm Type
Experimental
Arm Description
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."
Arm Title
Psychoeducational healthy aging group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Compassion Meditation (CM) intervention
Intervention Description
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."
Intervention Type
Other
Intervention Name(s)
Heathy Aging Psychoeducation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Enrollment rate
Description
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.
Time Frame
18 months
Title
Initiation rate
Description
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.
Time Frame
4 months
Title
Completion rate
Description
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.
Time Frame
12 weeks
Title
Practice time at home
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Improvement in depression and anxiety (BSI), social connection (SCS-R), satisfaction with life (SWLS) and positive emotions (mDES) from baseline to post-intervention
Description
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.
Time Frame
14 weeks
Title
Mean (and SD) change scores for each inflammatory biomarker (hs-CRP, IL-6, and TNF- )
Description
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.
Time Frame
14 weeks
Title
Improvement in depression and anxiety from baseline to post-intervention
Description
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.
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barton W. Palmer, PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Compassion Meditation for Older Adults
We'll reach out to this number within 24 hrs