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Clinical Trials/NCT01828983
NCT01828983CompletedNot Applicable

Telephone Support During Overseas Deployment for Military Spouses

Memphis VA Medical Center2 sites in 1 country161 target enrollmentStarted: April 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
161
Locations
2
Primary Endpoint
Spouse Self Report of Depression

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • living as married for at least one year before deployment

Arms & Interventions

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.

Intervention: 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.

Intervention: Education webinars (Other)

Outcomes

Primary Outcomes

Spouse Self Report of Depression

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Fed
Responsible Party
Principal Investigator
Principal Investigator

Linda O. Nichols, Ph.D.

Healthcare education specialist/Health Services Researcher

Memphis VA Medical Center

Study Sites (2)

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