Trial Outcomes & Findings for Reintegration: The Role of Spouse Telephone BATTLEMIND Pilot Study (NCT NCT00870545)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

86 participants

Primary outcome timeframe

Baseline, 6 months, and 12 months

Results posted on

2017-06-28

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 milestones

Participant milestones
Measure	Telephone Support 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.
Overall Study STARTED	86
Overall Study COMPLETED	69
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reintegration: The Role of Spouse Telephone BATTLEMIND Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telephone Support n=86 Participants 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.
Age, Continuous	37.4 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	86 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months, and 12 months

Population: All participants with depression data at baseline, six and twelve 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.

Outcome measures

Outcome measures
Measure	Telephone Support n=86 Participants 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.
Spouse Self-report of Depression Depression score at baseline (n=86)	8.9 units on a scale Standard Deviation 5.9
Spouse Self-report of Depression Depression score at 6 months (n=77)	7.4 units on a scale Standard Deviation 5.6
Spouse Self-report of Depression Depression score at 12 months (n=70)	6.9 units on a scale Standard Deviation 5.7

PRIMARY outcome

Timeframe: baseline, 6 months and 12 months

Population: All participants with anxiety scores at 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.

Outcome measures

Outcome measures
Measure	Telephone Support n=86 Participants 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.
Anxiety Anxiety score at baseline (n=86)	8.9 units on a scale Standard Deviation 5.7
Anxiety Anxiety score at 6 months (n=77)	6.7 units on a scale Standard Deviation 5.1
Anxiety Anxiety score at 12 months (n=70)	6.7 units on a scale Standard Deviation 5.6

PRIMARY outcome

Timeframe: Baseline, 6 and 12 months

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

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.

Outcome measures

Outcome measures
Measure	Telephone Support n=86 Participants 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.
Quality of Marriage Marriage quality score at baseline (n=86)	32.7 units on a scale Standard Deviation 8.0
Quality of Marriage Marriage quality score at 6 months (n=77)	31.6 units on a scale Standard Deviation 9.9
Quality of Marriage Marriage quality score at 12 months (n=70)	31.9 units on a scale Standard Deviation 9.8

SECONDARY outcome

Timeframe: Baseline, 6 months and 12 months

Population: All participants with family coping data at baseline, six 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.

Outcome measures

Outcome measures
Measure	Telephone Support n=85 Participants 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.
Family Coping Family coping score at baseline (n=85)	104.3 units on a scale Standard Deviation 13.8
Family Coping Family coping score at 6 months (n=77)	104.7 units on a scale Standard Deviation 13.7
Family Coping Family coping score at 12 months (n=70)	105.7 units on a scale Standard Deviation 14.5

SECONDARY outcome

Timeframe: baseline, 6 months, and 12 months

Population: All participants with social support data at baseline, six 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.

Outcome measures

Outcome measures
Measure	Telephone Support n=86 Participants 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.
Spouse Social Support Social Support score at baseline (n=86)	44.0 units on a scale Standard Deviation 8.6
Spouse Social Support Social Support score at 6 months (n=77)	46.0 units on a scale Standard Deviation 10.2
Spouse Social Support Social Support score at 12 months (n=70)	45.5 units on a scale Standard Deviation 10.1

SECONDARY outcome

Timeframe: baseline, 6 months, and 12 months

Population: All participants with family communication data at baseline, six 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.

Outcome measures

Outcome measures
Measure	Telephone Support n=85 Participants 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.
Family Communication Family communication score at baseline (n=85)	19.9 units on a scale Standard Deviation 6.2
Family Communication Family communication score at 6 months (n=77)	20.9 units on a scale Standard Deviation 6.4
Family Communication Family communication score at 12 months (n=70)	20.9 units on a scale Standard Deviation 6.2

Adverse Events

Telephone Support

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Linda Nichols

Memphis VAMC

Phone: 901 523-8990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place