Anxiety and Mood Disorders Clinical Trial
Official title:
Feasibility Study of Compassion Meditation Intervention for Older Veterans inPrimary Care With Anxiety or Mood Disorders
| Verified date | October 2022 |
| Source | VA Office of Research and Development |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | June 30, 2022 |
| Est. primary completion date | April 30, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 55 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | VA San Diego Healthcare System, San Diego, CA | San Diego | California |
| Lead Sponsor | Collaborator |
|---|---|
| VA Office of Research and Development |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 |