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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
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This 12-month study is for spouses or significant others of service members who have returned from Afghanistan or Iraq. This study will determine if participating in a telephone discussion group, offering education, skills building, and support, will help increase post-deployment adjustment. There will be 225 spouses recruited for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telephone Discussion Groups | Experimental | Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury). |
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| Education sessions | Active Comparator | Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook. |
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| Usual Care | No Intervention | Participants do not receive any services. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone Discussion Groups | Behavioral | Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury). |
| Measure | Description | Time Frame |
|---|---|---|
| Spouse Self-report of Anxiety | Anxiety symptoms from the Generalized Anxiety Disorder-7 (GAD-7) scale, measured from 0-21, higher scores indicate greater anxiety | Baseline, 6 months, and 12 months |
| Spouse Self-report of Depression | Depression symptoms as measured on the Patient Health Questionnaire (PHQ-9), measured from 0-27, with higher numbers indicating more depression | Baseline, 6 months, and 12 months |
| Spouse Self-report of Resilience | Resilience as measured on the Connor-Davidson Resilience Scale, measured from 0-100; higher scores show greater resilience | Baseline, 6 months, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda O Nichols, Ph.D. | Memphis VA Medical Center and University of Tennessee Health Science Center | Principal Investigator |
| Jennifer L Martindale-Adams, Ed.D. | University of Tennessee Health Science Center and VA Medical Center Memphis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memphis VA Medical Center | Memphis | Tennessee | 38104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Nichols, L.O., Martindale-Adams, J., Zuber, J., Graney, M., Burns, R., & Clark, C. Support for Spouses of Post Deployment Service Members. Military Behavioral Health, Published online: 30 Jan 2015. DOI:10.1080/21635781.2015.1009210 | ||
| Result | Nichols L.O., Martindale-Adams, J., Zuber, J., & Graney, M. Service Member Need and Supportive Services Use of Military/Veteran Spouses. Military Behavioral Health, Published online: 09 Feb 2015, DOI:10.1080/21635781.2014.995251 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Telephone Discussion Groups | Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury). |
| FG001 | Education Sessions | Education sessions: Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook. |
| FG002 | Usual Care | Participants do not receive any services. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Telephone Discussion Groups | Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury). |
| 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 Anxiety | Anxiety symptoms from the Generalized Anxiety Disorder-7 (GAD-7) scale, measured from 0-21, higher scores indicate greater anxiety | All participants with anxiety data at baseline, six months, and twelve months | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months, and 12 months |
|
1 year
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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 Discussion Groups | Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury). |
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Spouses were not screened for distress and did not exhibit high levels of anxiety or depression or low levels of resilience at baseline. Participants discontinued or were lost to follow up. Less than half of participants attended > six sessions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Linda Nichols | Memphis VA Medical Center | 901 523-8990 | 5082 | linda.nichols@va.gov |
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| ID | Term |
|---|---|
| D003130 | Combat Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Education sessions | Behavioral | Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook. |
|
| BG001 | Education Sessions | Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook. |
| BG002 | Usual Care | Participants do not receive any services. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Education Sessions | Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook. |
| OG002 | Usual Care | Participants do not receive any services. |
|
|
| Primary | Spouse Self-report of Depression | Depression symptoms as measured on the Patient Health Questionnaire (PHQ-9), measured from 0-27, with higher numbers indicating more depression | All participations with depression 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 | Spouse Self-report of Resilience | Resilience as measured on the Connor-Davidson Resilience Scale, measured from 0-100; higher scores show greater resilience | All participants with resilience data at baseline, 6 and 12 months | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months, and 12 months |
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| 0 |
| 76 |
| 0 |
| 76 |
| 0 |
| 76 |
| EG001 | Education Sessions | Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook. | 0 | 76 | 0 | 76 | 0 | 76 |
| EG002 | Usual Care | Participants do not receive any services. | 0 | 75 | 0 | 75 | 0 | 75 |
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| Depression symptoms at 12 months |
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| Resilience scores at 12 months |
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