- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01828983
Telephone Support During Overseas Deployment for Military Spouses
October 20, 2017 updated by: Linda O. Nichols, Ph.D., Memphis VA Medical Center
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
161
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Memphis, Tennessee, United States, 38104
- Memphis VA Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 6 months
|
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.
|
baseline, and 6 months
|
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.
|
Baseline, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
April 4, 2013
First Submitted That Met QC Criteria
April 8, 2013
First Posted (Estimate)
April 11, 2013
Study Record Updates
Last Update Posted (Actual)
November 24, 2017
Last Update Submitted That Met QC Criteria
October 20, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- W81XWH-11-2-0087
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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