CClinicalTrials.gg
CompletedNCT00870545Updated Jun 28, 2017Results posted

Reintegration: The Role of Spouse Telephone BATTLEMIND Pilot Study

An interventional study of Telephone support groups in Military Spouses, Support Groups and Stress Disorders, sponsored by Memphis VA Medical Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2017-06-28.

Sponsored by Memphis VA Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Not applicable
Sex
All
01

Study 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.

02

Conditions studied

  • Military Spouses
  • Support Groups
  • Stress Disorders
  • Combat Disorders

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Keywords

  • spouses
  • social support
  • reintegration
  • families
  • military
  • post deployment
  • OEF/OIF
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    Telephone support

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

    Behavioral: Telephone support groups

Interventions

  • BehavioralTelephone 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 6 months, and 12 months

  2. 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.

    Time frame: baseline, 6 months and 12 months

  3. 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.

    Time frame: Baseline, 6 and 12 months

Secondary outcomes

  1. 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.

    Time frame: Baseline, 6 months and 12 months

  2. 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.

    Time frame: baseline, 6 months, and 12 months

  3. 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.

    Time frame: baseline, 6 months, and 12 months

06

Results

Posted Jun 4, 2013
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.

Participant flow

April 2009 - January 2010 and April 2010 - June 2010. There were 86 spouses enrolled in 14 groups. Spouses were recruited nationally through online methods such as websites and emails, mailings, and referrals from military, advocacy groups and veterans facilities. Twenty-six were referrals from the national Wounded Warrior Project office.

Participant flow — Overall Study
MilestoneTelephone Support
Started86
Completed69
Not completed17

Outcome measures

PrimarySpouse 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.

Time frame:
Baseline, 6 months, and 12 months
Reported as:
Mean · units on a scale
Spouse Self-report of Depression
units on a scaleTelephone Support
Depression score at baseline (n=86)8.9 ± 5.9
Depression score at 6 months (n=77)7.4 ± 5.6
Depression score at 12 months (n=70)6.9 ± 5.7
Statistical analysis
  • Telephone Support · Mixed Models Analysis · p = .003 (P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.)
SecondaryFamily 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.

Time frame:
Baseline, 6 months and 12 months
Reported as:
Mean · units on a scale
Family Coping
units on a scaleTelephone Support
Family coping score at baseline (n=85)104.3 ± 13.8
Family coping score at 6 months (n=77)104.7 ± 13.7
Family coping score at 12 months (n=70)105.7 ± 14.5
Statistical analysis
  • Telephone Support · Mixed Models Analysis · p = .20 (P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.)
PrimaryAnxiety

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
Reported as:
Mean · units on a scale
Anxiety
units on a scaleTelephone Support
Anxiety score at baseline (n=86)8.9 ± 5.7
Anxiety score at 6 months (n=77)6.7 ± 5.1
Anxiety score at 12 months (n=70)6.7 ± 5.6
Statistical analysis
  • Telephone Support · Mixed Models Analysis · p = <.001 (P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.)
PrimaryQuality 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.

Time frame:
Baseline, 6 and 12 months
Reported as:
Mean · units on a scale
Quality of Marriage
units on a scaleTelephone Support
Marriage quality score at baseline (n=86)32.7 ± 8.0
Marriage quality score at 6 months (n=77)31.6 ± 9.9
Marriage quality score at 12 months (n=70)31.9 ± 9.8
Statistical analysis
  • Telephone Support · Mixed Models Analysis · p = .26 (P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.)
SecondarySpouse 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.

Time frame:
baseline, 6 months, and 12 months
Reported as:
Mean · units on a scale
Spouse Social Support
units on a scaleTelephone Support
Social Support score at baseline (n=86)44.0 ± 8.6
Social Support score at 6 months (n=77)46.0 ± 10.2
Social Support score at 12 months (n=70)45.5 ± 10.1
Statistical analysis
  • Telephone Support · Mixed Models Analysis · p = .04 (P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.)
SecondaryFamily 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.

Time frame:
baseline, 6 months, and 12 months
Reported as:
Mean · units on a scale
Family Communication
units on a scaleTelephone Support
Family communication score at baseline (n=85)19.9 ± 6.2
Family communication score at 6 months (n=77)20.9 ± 6.4
Family communication score at 12 months (n=70)20.9 ± 6.2
Statistical analysis
  • Telephone Support · Mixed Models Analysis · p = .10 (P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.)

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Telephone Support0/86 (0%)0/86 (0%)0/86 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Telephone Support
Mean37.4 ± 9.0
Sex: Female, Male
Sex: Female, Male(Participants)Telephone Support
Female86
Male0
Region of Enrollment
Region of Enrollment(participants)Telephone Support
United States86
07

Study locations

1 site
  • Memphis VA Medical Center
    Memphis, Tennessee 38104, United States
08

References and documents

09

Registry details

Key details

Study ID
NCT00870545
Lead sponsor
Memphis VA Medical Center
Collaborators
United States Department of Defense
Responsible party
Linda O. Nichols, Ph.D. (Healthcare Education Specialist/Health Services Researcher, Memphis VA Medical Center) — Principal investigator
First posted
Mar 27, 2009
Start date
Sep 2009
Primary completion
Jul 2011
Completion
Nov 2011
Results posted
Jun 4, 2013
Last update
Jun 28, 2017

Study contacts

Linda O Nichols, PhD
principal investigator · Memphis VA Medical Center

Oversight

Data monitoring committee
No
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