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Completed

NCT Number: NCT03964246

Compassion Meditation for Older Adults

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.

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Key information

Conditions

Anxiety and Mood Disorders Anxiety Disorders Mental Disorders Mood Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.]

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.]

Primary outcomes

  1. Enrollment Rate

    Time frame: 36 months

    The proportion of consented subjects among all screened and eligible patients.

  2. Initiation Rate

    Time frame: 4 months

    The proportion of subjects who initiate the intervention among all consented subjects.

  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.

  4. Practice Time at Home

    Time frame: 12 weeks

    Unanticipated COVID-related restrictions necessitated changing certain outcome measures. Data was not collected for this measure

Secondary outcomes

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

    Time frame: Baseline and 14 weeks

    Social Connectedness Scale (SCS-R), 20-items scores, possible range = 20 to 120, higher scores reflect more connectedness

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

    Time frame: Baseline and 14 weeks

    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.

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

    Time frame: Baseline and 14 weeks

    Satisfaction With Life Scale (SWLS); 5-items, range 5 to 35, higher scores represent greater satisfaction

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

    Time frame: Baseline and 14 weeks

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 28, 2019
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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