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Telephone Support During Overseas Deployment for Military Spouses

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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:
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  ICMJE April 4, 2013
First Posted Date  ICMJE April 11, 2013
Results First Submitted Date  ICMJE June 1, 2017
Results First Posted Date  ICMJE October 23, 2017
Last Update Posted Date November 24, 2017
Study Start Date  ICMJE April 2011
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telephone Support During Overseas Deployment for Military Spouses
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Military Personnel
  • Family Members
  • Resilience, Psychological
  • Deployment
Intervention  ICMJE
  • Behavioral: Telephone support groups
  • Other: Education webinars
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 1, 2017)
161
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2013)
160
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01828983
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Linda O. Nichols, Ph.D., Memphis VA Medical Center
Study Sponsor  ICMJE Memphis VA Medical Center
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP