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临床试验/NCT01828983
NCT01828983已完成不适用

Telephone Support During Overseas Deployment for Military Spouses

Memphis VA Medical Center2 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2011年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
161
试验地点
2
主要终点
Spouse Self Report of Depression

研究概览

简要总结

Deployment impacts both service member and family, and the cost can be high. Spouses' reactions to deployment may include emotional distress, loneliness, anticipatory fear or grief, somatic complaints, and depression. The goal is to help spouses learn ways to manage stress and solve problems related to deployment and reintegration, communication, managing long distance relationships, and other common problems. The study will compare telephone support groups to online education sessions. The study will enroll 160 spouses. In the Telephone Support groups, a group leader and participants will meet 12 times over six months to focus on education, skills building and support. Education Only online sessions will provide the same education content, without skills building or support. Content includes strategies to reduce or eliminate communication difficulties during deployment, how to find help; practical concerns during deployment; fostering resilience and decreasing stress; fostering relationships while apart, negotiating roles and relationships; changes during deployment; strategies to support the spouse and the service member; and cues to alert spouses when to seek mental health services for the family or themselves. Outcomes will include resilience, depression, anxiety and coping behaviors. Telephone data collection will be conducted at baseline, six and twelve months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • spouse or significant other (living as married for at least one year before deployment) of an overseas deployed military service member
  • deployed at least six months

排除标准

  • living as married for at least one year before deployment

研究组 & 干预措施

Telephone support groups

Experimental

Telephone support groups, each with participants and a trained group leader. Each hour-long telephone group will meet bi-monthly for six months for a total of 12 meetings. Groups are structured with education, skills building, and support. Participants will receive and use a Spouse Workbook with information and activities.

干预措施: Telephone support groups (Behavioral)

Education webinars

Active Comparator

Education Webinar session topics are the same that are covered in the intervention arm without telephone interaction/support and skills building components. Each session is 30-minutes. Each participant receives a Spouse Workbook with information and activities.

干预措施: Education webinars (Other)

结局指标

主要结局

Spouse Self Report of Depression

时间窗: Baseline, 6 months

Patient Health Questionnaire - Depression (PHQ)-9 measured at baseline, 6 and 12 months. Scores range from 0-27 with higher scores indicating more depressive symptoms.

Spouse Self-report of Resilience

时间窗: Baseline, 6 months

Connor-Davidson Resilience Scale (CD-RISC) measured at baseline, 6 and 12 months. Scores range from 0-100. Higher scores equal greater resilience.

Spouse Self Report of Anxiety

时间窗: baseline, and 6 months

Generalized Anxiety Disorder (GAD-7) measured at baseline, 6 and 12 months. Scores range from 0 to 21; higher scores equal more anxiety.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Linda O. Nichols, Ph.D.

Healthcare education specialist/Health Services Researcher

Memphis VA Medical Center

研究点 (2)

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