NCT00870545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

June 4, 2013

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

1.8 years

First QC Date

March 25, 2009

Results QC Date

April 4, 2013

Last Update Submit

June 1, 2017

Conditions

Keywords

spousessocial supportreintegrationfamiliesmilitarypost deploymentOEF/OIF

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Secondary Outcomes (3)

  • Family Coping

    Baseline, 6 months and 12 months

  • Spouse Social Support

    baseline, 6 months, and 12 months

  • Family Communication

    baseline, 6 months, and 12 months

Study Arms (1)

Telephone support

EXPERIMENTAL

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

Behavioral: Telephone support groups

Interventions

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.

Telephone support

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memphis VA Medical Center

Memphis, Tennessee, 38104, United States

Location

Related Links

MeSH Terms

Conditions

Stress Disorders, TraumaticCombat Disorders

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental Disorders

Limitations and Caveats

Small sample size, some of the Wounded Warrior Project spouses knew each other, pilot feasibility study and not a randomized controlled trial.

Results Point of Contact

Title
Dr. Linda Nichols
Organization
Memphis VAMC

Study Officials

  • Linda O Nichols, PhD

    Memphis VA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Healthcare Education Specialist/Health Services Researcher

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 27, 2009

Study Start

September 1, 2009

Primary Completion

July 1, 2011

Study Completion

November 1, 2011

Last Updated

June 28, 2017

Results First Posted

June 4, 2013

Record last verified: 2017-06

Locations