- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00870545
Reintegration: The Role of Spouse Telephone BATTLEMIND Pilot Study
June 1, 2017 updated by: Linda O. Nichols, Ph.D., Memphis VA Medical Center
This study will expand the Department of Defense (DoD) one time, face-to-face post deployment BATTLEMIND training for spouses of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Guard/Reserve service members into year-long, telephone groups focusing on education, skills building and support.
The goal is to build spouses' resilience to cope with reintegration, help them serve as a support system for returning service members, and ease the transition for families post-deployment.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
86
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- have a spouse who participated in OEF/OIF and is at least 1 month post-deployment;
- if not married, must have lived as married for at least one year;
- live with the service member when not deployed;
- have been a spouse/significant other throughout the service member's deployment period;
- and have a telephone.
Exclusion Criteria:
- current diagnosis of schizophrenia or other major mental illness;
- auditory impairment that would make telephone use difficult; or
- service member refusal of assent for spouse to participate.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telephone support
12 telephone support group sessions based on the letters of the word BATTLEMIND
|
There was one intervention.
Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions.
The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spouse Self-report of Depression
Time Frame: Baseline, 6 months, and 12 months
|
Depression measured with the Patient Health Questionnaire (PHQ)-9 at baseline, six and 12 months.
Scores range from 0-27 with lower scores indicating less depressive symptoms.
|
Baseline, 6 months, and 12 months
|
Anxiety
Time Frame: baseline, 6 months and 12 months
|
Anxiety measured with the Generalized Anxiety Disorder -7 (GAD-7)measured at baseline, six and 12 months.
Scores range from 0-21, with lower scores indicating fewer anxiety symptoms.
|
baseline, 6 months and 12 months
|
Quality of Marriage
Time Frame: Baseline, 6 and 12 months
|
Measure of marriage quality using Quality Marriage Index at baseline, six and 12 months.
Scores range from 6-45 with higher scores indicating better quality of marriage.
|
Baseline, 6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Family Coping
Time Frame: Baseline, 6 months and 12 months
|
Family problem solving measured at baseline, six and 12 months with the F-COPES measure.
Scores range from 29-145 with higher scores indicating better coping.
|
Baseline, 6 months and 12 months
|
Spouse Social Support
Time Frame: baseline, 6 months, and 12 months
|
Support measured with the Social Support Index at baseline, six and 12 months.
Scores range from 0-68 with higher scores indicating better social support.
|
baseline, 6 months, and 12 months
|
Family Communication
Time Frame: baseline, 6 months, and 12 months
|
Family communication measured with the Family Problem Solving Communication scale at baseline, six and 12 months.
Scores range from 0-30 with higher scores indicating better communication.
|
baseline, 6 months, and 12 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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
September 1, 2009
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
March 25, 2009
First Submitted That Met QC Criteria
March 25, 2009
First Posted (Estimate)
March 27, 2009
Study Record Updates
Last Update Posted (Actual)
June 28, 2017
Last Update Submitted That Met QC Criteria
June 1, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PT074804
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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