Reintegration: The Role of Spouse Telephone BATTLEMIND Pilot Study

Combat Disorders Clinical Trial

Official title:

Reintegration: The Role of Spouse Telephone BATTLEMIND Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870545
• Other study ID #: PT074804
• Status: Completed
• Phase: N/A
• First received: March 25, 2009
• Last updated: June 3, 2013
• Start date: September 2009
• Est. completion date: November 2011

Study information

• Verified date: June 2013
• Source: Memphis VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: November 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Combat Disorders
• Disease
• Military Spouses
• Stress Disorders
• Stress Disorders, Traumatic
• Support Groups

Intervention

Behavioral:
• Telephone support groups
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.

Locations

Country	Name	City	State
United States	Memphis VA Medical Center	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Memphis VA Medical Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 6 months, and 12 months	Yes
Primary	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.	baseline, 6 months and 12 months	No
Primary	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.	Baseline, 6 and 12 months	No
Secondary	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.	Baseline, 6 months and 12 months	No
Secondary	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.	baseline, 6 months, and 12 months	No
Secondary	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.	baseline, 6 months, and 12 months	No

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