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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telephone support | Experimental | 12 telephone support group sessions based on the letters of the word BATTLEMIND |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone support groups | Behavioral | 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 | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Spouse Social Support |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda O Nichols, PhD | Memphis VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memphis VA Medical Center | Memphis | Tennessee | 38104 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Telephone Support | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants with depression data at baseline, six and twelve months | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months, and 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telephone Support | 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. |
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Small sample size, some of the Wounded Warrior Project spouses knew each other, pilot feasibility study and not a randomized controlled trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Linda Nichols | Memphis VAMC | 901 523-8990 | 5082 | linda.nichols@va.gov |
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| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D003130 | Combat Disorders |
| ID | Term |
|---|---|
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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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 |
| 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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | All participants with family coping data at baseline, six and 12 months. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months and 12 months |
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| 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. | All participants with anxiety scores at 12 months | Posted | Mean | Standard Deviation | units on a scale | baseline, 6 months and 12 months |
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| 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. | All participants with quality marriage index scores at the three time points | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 and 12 months |
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| 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. | All participants with social support data at baseline, six and 12 months. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6 months, and 12 months |
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| 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. | All participants with family communication data at baseline, six and 12 months. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6 months, and 12 months |
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| 0 |
| 86 |
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| 86 |
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| 86 |
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