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Telephone Support During Overseas Deployment for Military Spouses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Military Personnel Family Members Resilience, Psychological Deployment Behavioral: Telephone support groups Other: Education webinars Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telephone Support During Overseas Deployment for Military Spouses
Study Start Date : April 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
 Other: Education webinars


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828983


Locations
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United States, Tennessee
Memphis VA Medical Center
Memphis, Tennessee, United States, 38104
Sponsors and Collaborators
Memphis VA Medical Center
United States Department of Defense
Investigators
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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
More Information
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Responsible Party: Linda O. Nichols, Ph.D., Healthcare education specialist/Health Services Researcher, Memphis VA Medical Center
ClinicalTrials.gov Identifier: NCT01828983    
Other Study ID Numbers: W81XWH-11-2-0087
First Posted: April 11, 2013    Key Record Dates
Results First Posted: October 23, 2017
Last Update Posted: November 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Linda O. Nichols, Ph.D., Memphis VA Medical Center:
Telephone
Support groups
Social support
Depression