Telephone Support During Overseas Deployment for Military Spouses

• ClinicalTrials.gov Identifier: NCT01828983
• Recruitment Status: Completed
• First Posted: April 11, 2013
• Results First Posted: October 23, 2017
• Last Update Posted: November 24, 2017
• Sponsor: Memphis VA Medical Center
• Collaborator: United States Department of Defense
• Information provided by (Responsible Party): Linda O. Nichols, Ph.D., Memphis VA Medical Center

Tracking Information

• First Submitted Date: April 4, 2013
• First Posted Date: April 11, 2013
• Results First Submitted Date: June 1, 2017
• Results First Posted Date: October 23, 2017
• Last Update Posted Date: November 24, 2017
• Study Start Date: April 2011
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 1, 2017)

• 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.
• 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.

Original Primary Outcome Measures (submitted: April 8, 2013)

• Change in Resilience [ Time Frame: Baseline, 6 months, 12 months ]
  Connor-Davidson Resilience Scale (CD-RISC) measured at baseline, 6 and 12 months. Scores range from 0-100. Higher scores equal greater resilience.
• Change in Anxiety [ Time Frame: baseline, 6 and 12 months ]
  Generalized Anxiety Disorder (GAD-7) measured at baseline, 6 and 12 months. Scores range from 0 to 21; higher scores equal more anxiety.
• Change in Depression [ Time Frame: Baseline, 6 and 12 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.
• Change in Coping [ Time Frame: Baseline, 6 and 12 months ]
  Personal/Family Coping Scale measured at baseline, 6 and 12 months. Personal Coping is items 1-8 ranging from 8-40. Family Coping (children) includes items 9-14 with scores from 6-30. Higher scores indicate greater personal/family coping.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Telephone Support During Overseas Deployment for Military Spouses
• Official Title: Telephone Support During Overseas Deployment for Military Spouses
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Military Personnel
• Family Members
• Resilience, Psychological
• Deployment

Intervention

• Behavioral: Telephone support groups
• Other: Education webinars

Study Arms

• Experimental: Telephone support groups
  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: Behavioral: Telephone support groups
• Active Comparator: Education webinars
  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: Other: Education webinars

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 1, 2017): 161
• Original Estimated Enrollment (submitted: April 8, 2013): 160
• Actual Study Completion Date: June 2015
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01828983
• Other Study ID Numbers: W81XWH-11-2-0087
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Linda O. Nichols, Ph.D., Memphis VA Medical Center
• Study Sponsor: Memphis VA Medical Center
• Collaborators: United States Department of Defense

Investigators

• Principal Investigator: Linda O Nichols, PhD; Memphis VA Medical Center and University of Tennessee Health Science Center
• Principal Investigator: Jennifer L Martindale-Adams, EdD; University of Tennessee Health Science Center and Memphis VA Medical Center

• PRS Account: Memphis VA Medical Center
• Verification Date: October 2017