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Reintegration: The Role of Spouse Telephone BATTLEMIND Pilot Study

Primary Purpose

Military Spouses, Support Groups, Stress Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone support groups
Sponsored by
Memphis VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Military Spouses focused on measuring spouses, social support, reintegration, families, military, post deployment, OEF/OIF

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. have a spouse who participated in OEF/OIF and is at least 1 month post-deployment;
  2. if not married, must have lived as married for at least one year;
  3. live with the service member when not deployed;
  4. have been a spouse/significant other throughout the service member's deployment period;
  5. and have a telephone.

Exclusion Criteria:

  1. current diagnosis of schizophrenia or other major mental illness;
  2. auditory impairment that would make telephone use difficult; or
  3. service member refusal of assent for spouse to participate.

Sites / Locations

  • Memphis VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telephone support

Arm Description

12 telephone support group sessions based on the letters of the word BATTLEMIND

Outcomes

Primary Outcome Measures

Spouse Self-report of Depression
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.
Anxiety
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.
Quality of Marriage
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.

Secondary Outcome Measures

Family Coping
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.
Spouse Social Support
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.
Family Communication
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.

Full Information

First Posted
March 25, 2009
Last Updated
June 1, 2017
Sponsor
Memphis VA Medical Center
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT00870545
Brief Title
Reintegration: The Role of Spouse Telephone BATTLEMIND Pilot Study
Official Title
Reintegration: The Role of Spouse Telephone BATTLEMIND Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Memphis VA Medical Center
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Military Spouses, Support Groups, Stress Disorders, Combat Disorders
Keywords
spouses, social support, reintegration, families, military, post deployment, OEF/OIF

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telephone support
Arm Type
Experimental
Arm Description
12 telephone support group sessions based on the letters of the word BATTLEMIND
Intervention Type
Behavioral
Intervention Name(s)
Telephone support groups
Intervention Description
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.
Primary Outcome Measure Information:
Title
Spouse Self-report of Depression
Description
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.
Time Frame
Baseline, 6 months, and 12 months
Title
Anxiety
Description
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.
Time Frame
baseline, 6 months and 12 months
Title
Quality of Marriage
Description
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.
Time Frame
Baseline, 6 and 12 months
Secondary Outcome Measure Information:
Title
Family Coping
Description
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.
Time Frame
Baseline, 6 months and 12 months
Title
Spouse Social Support
Description
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.
Time Frame
baseline, 6 months, and 12 months
Title
Family Communication
Description
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.
Time Frame
baseline, 6 months, and 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda O Nichols, PhD
Organizational Affiliation
Memphis VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memphis VA Medical Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.memphis.va.gov/spousebattlemind/
Description
Information and contacts

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Reintegration: The Role of Spouse Telephone BATTLEMIND Pilot Study

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