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临床试验/NCT03964246
NCT03964246已完成不适用

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

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Completion Rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Completion Rate

时间窗: 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.

Enrollment Rate

时间窗: 36 months

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

Initiation Rate

时间窗: 4 months

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

Practice Time at Home

时间窗: 12 weeks

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

次要结局

  • Change in Social Connection (SCS-R) From Baseline to Post-intervention(Baseline and 14 weeks)
  • Change in Depression and Anxiety From Baseline to Post-intervention(Baseline and 14 weeks)
  • Mean (and SD) Change Scores for Each Inflammatory Biomarker (Hs-CRP, IL-6, and TNF- )(14 weeks)
  • Satisfaction With Life (SWLS) From Baseline to Post-intervention(Baseline and 14 weeks)
  • Change in Positive Emotions (mDES) From Baseline to Post-intervention(Baseline and 14 weeks)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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