Reintegration: The Role of Spouse Telephone BATTLEMIND Pilot Study

• Sponsor: Memphis VA Medical Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00870545
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 86
• Location: 1
• Arm: 1
• Duration (Months): 26
• Patients Per Site Per Month: 3.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Military Spouses; Support Groups; Stress Disorders; Combat Disorders	Behavioral: Telephone support groups	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 86 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Reintegration: The Role of Spouse Telephone BATTLEMIND Pilot Study
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

1. Spouse Self-report of Depression [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.

2. Anxiety [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.

3. Quality of Marriage [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.

Secondary Outcome Measures

1. Family Coping [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.

2. Spouse Social Support [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.

3. Family Communication [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: 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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memphis VA Medical Center	Memphis	Tennessee	United States	38104

Sponsors and Collaborators

• Memphis VA Medical Center
• United States Department of Defense

Investigators

• Principal Investigator: Linda O Nichols, PhD, Memphis VA Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Information and contacts

Publications

None provided.

• Responsible Party: Linda O. Nichols, Ph.D., Healthcare Education Specialist/Health Services Researcher, Memphis VA Medical Center
• ClinicalTrials.gov Identifier: NCT00870545
• Other Study ID Numbers: PT074804
• First Posted: Mar 27, 2009
• Last Update Posted: Jun 28, 2017
• Last Verified: Jun 1, 2017

• Keywords provided by Linda O. Nichols, Ph.D., Healthcare Education Specialist/Health Services Researcher, Memphis VA Medical Center: spouses; social support; reintegration; families; military; post deployment; OEF/OIF
• Additional relevant MeSH terms: Disease; Combat Disorders

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Telephone Support
Arm/Group 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.
Period Title: Overall Study
STARTED	86
COMPLETED	69
NOT COMPLETED	17

Baseline Characteristics

Arm/Group Title	Telephone Support
Arm/Group Description	12 telephone support groups based on the letters of the word BATTLEMIND Telephone support groups : 12 hour-long structured 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. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND.
Overall Participants	86
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.4 (9.0)
Sex: Female, Male (Count of Participants)
Female	86 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	86 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants with depression data at baseline, six and twelve months

Arm/Group Title	Telephone Support
Arm/Group 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.
Measure Participants	86
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 1

Statistical Analysis Overview	Comparison Group Selection	Telephone Support
	Comments	Change in scores measured across three time points (baseline, 6 and 12 months)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.003
	Comments	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.
	Method	Mixed Models Analysis
	Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants with family coping data at baseline, six and 12 months.

Arm/Group Title	Telephone Support
Arm/Group 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.
Measure Participants	85
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 1

Statistical Analysis Overview	Comparison Group Selection	Telephone Support
	Comments	Analysis was change in score over time (baseline, 6 and 12 months)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.20
	Comments	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.
	Method	Mixed Models Analysis
	Comments

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants with anxiety scores at 12 months

Arm/Group Title	Telephone Support
Arm/Group 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.
Measure Participants	86
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 1

Statistical Analysis Overview	Comparison Group Selection	Telephone Support
	Comments	Change in scores measured across three time points (baseline, 6 and 12 months)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments	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.
	Method	Mixed Models Analysis
	Comments

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants with quality marriage index scores at the three time points

Arm/Group Title	Telephone Support
Arm/Group 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.
Measure Participants	86
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 1

Statistical Analysis Overview	Comparison Group Selection	Telephone Support
	Comments	Analysis was change in score over time (baseline, 6 months, 12 months)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.26
	Comments	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.
	Method	Mixed Models Analysis
	Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants with social support data at baseline, six and 12 months.

Arm/Group Title	Telephone Support
Arm/Group 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.
Measure Participants	86
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 1

Statistical Analysis Overview	Comparison Group Selection	Telephone Support
	Comments	Analysis was change in scores over time (baseline, 6 months, and 12 months)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.04
	Comments	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.
	Method	Mixed Models Analysis
	Comments

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants with family communication data at baseline, six and 12 months.

Arm/Group Title	Telephone Support
Arm/Group 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.
Measure Participants	85
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 1

Statistical Analysis Overview	Comparison Group Selection	Telephone Support
	Comments	Analysis was change in score over time (baseline, 6 months, and 12 months)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.10
	Comments	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.
	Method	Mixed Models Analysis
	Comments

Adverse Events

Arm/Group Title	Telephone Support
Arm/Group Description	12 telephone support groups based on the letters of the word BATTLEMIND Telephone support groups : 12 hour-long structured 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. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND.
All Cause Mortality
	Telephone Support
	Affected / at Risk (%)	# Events
Total	0/86 (0%)
Serious Adverse Events
	Telephone Support
	Affected / at Risk (%)	# Events
Total	0/86 (0%)
Other (Not Including Serious) Adverse Events
	Telephone Support
	Affected / at Risk (%)	# Events
Total	0/86 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.