Clinical trial NCT03964246: Compassion Meditation for Older Adults
Official title: Feasibility Study of Compassion Meditation Intervention for Older Veterans in Primary Care With Anxiety or Mood Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety and Mood Disorders
Keywords: Feasibility Studies
Meditation, psychology
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-05-28
Enrollment: 25
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Enrollment Rate
timeFrame: 36 months
measure: Initiation Rate
timeFrame: 4 months
measure: Completion Rate
timeFrame: 12 weeks
measure: Practice Time at Home
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Social Connection (SCS-R) From Baseline to Post-intervention
timeFrame: Baseline and 14 weeks
measure: Mean (and SD) Change Scores for Each Inflammatory Biomarker (Hs-CRP, IL-6, and TNF- )
timeFrame: 14 weeks
measure: Change in Depression and Anxiety From Baseline to Post-intervention
timeFrame: Baseline and 14 weeks
measure: Satisfaction With Life (SWLS) From Baseline to Post-intervention
timeFrame: Baseline and 14 weeks
measure: Change in Positive Emotions (mDES) From Baseline to Post-intervention
timeFrame: Baseline and 14 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Barton W. Palmer, PhD
role: PRINCIPAL_INVESTIGATOR
References: