Coping Skills, Military Personnel, Spouses
Conditions
Keywords
Combat disorders, Spouses, Support, Military personnel
Brief summary
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.
Interventions
BEHAVIORALTelephone 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).
BEHAVIORALEducation 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.
Sponsors
U.S. Army Medical Research and Development Command
Memphis VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
1. have a spouse who participated in a deployment to Iraq and Afghanistan and is at least 1 month post-deployment 2. if not married, must have lived as married for at least one year 3. must be committed to the relationship 4. have a telephone.
Exclusion criteria
1. known deployment of spouse in the next six months 2. auditory impairment that would make telephone use difficult.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spouse Self-report of Anxiety | Baseline, 6 months, and 12 months | Anxiety symptoms from the Generalized Anxiety Disorder-7 (GAD-7) scale, measured from 0-21, higher scores indicate greater anxiety |
| Spouse Self-report of Depression | Baseline, 6 months, and 12 months | Depression symptoms as measured on the Patient Health Questionnaire (PHQ-9), measured from 0-27, with higher numbers indicating more depression |
| Spouse Self-report of Resilience | Baseline, 6 months, and 12 months | Resilience as measured on the Connor-Davidson Resilience Scale, measured from 0-100; higher scores show greater resilience |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 76 |
| 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. | 76 |
| Usual Care Participants do not receive any services. | 75 |
| Total | 227 |
Baseline characteristics
| Characteristic | Telephone Discussion Groups | Total | Usual Care | Education Sessions |
|---|---|---|---|---|
| Age, Continuous | 36.4 years STANDARD_DEVIATION 8.6 | 36.5 years STANDARD_DEVIATION 8.6 | 35.1 years STANDARD_DEVIATION 8.7 | 38.0 years STANDARD_DEVIATION 8.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 27 Participants | 10 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants | 200 Participants | 65 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 4 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 4 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 28 Participants | 5 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 11 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 61 Participants | 180 Participants | 59 Participants | 60 Participants |
| Region of Enrollment United States | 76 Participants | 227 Participants | 75 Participants | 76 Participants |
| Sex: Female, Male Female | 74 Participants | 224 Participants | 75 Participants | 75 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 76 | 0 / 75 |
| other Total, other adverse events | 0 / 76 | 0 / 76 | 0 / 75 |
| serious Total, serious adverse events | 0 / 76 | 0 / 76 | 0 / 75 |
Outcome results
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
Time frame: Baseline, 6 months, and 12 months
Population: All participants with anxiety data at baseline, six months, and twelve months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telephone Discussion Groups | Spouse Self-report of Anxiety | Anxiety score at 6 months | 5.5 units on a scale | Standard Deviation 4 |
| Telephone Discussion Groups | Spouse Self-report of Anxiety | Anxiety score at baseline | 7.9 units on a scale | Standard Deviation 5.5 |
| Telephone Discussion Groups | Spouse Self-report of Anxiety | Anxiety score at 12 months | 6.0 units on a scale | Standard Deviation 4.8 |
| Education Sessions | Spouse Self-report of Anxiety | Anxiety score at 6 months | 5.2 units on a scale | Standard Deviation 4.4 |
| Education Sessions | Spouse Self-report of Anxiety | Anxiety score at baseline | 7.1 units on a scale | Standard Deviation 5.1 |
| Education Sessions | Spouse Self-report of Anxiety | Anxiety score at 12 months | 6.1 units on a scale | Standard Deviation 4.9 |
| Usual Care | Spouse Self-report of Anxiety | Anxiety score at baseline | 7.9 units on a scale | Standard Deviation 4.8 |
| Usual Care | Spouse Self-report of Anxiety | Anxiety score at 12 months | 5.5 units on a scale | Standard Deviation 4.8 |
| Usual Care | Spouse Self-report of Anxiety | Anxiety score at 6 months | 6.2 units on a scale | Standard Deviation 4.4 |
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
Time frame: Baseline, 6 months, and 12 months
Population: All participations with depression data at baseline, six and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telephone Discussion Groups | Spouse Self-report of Depression | Depression symptoms at 6 months | 4.5 units on a scale | Standard Deviation 4.6 |
| Telephone Discussion Groups | Spouse Self-report of Depression | Depression symptoms at baseline | 6.6 units on a scale | Standard Deviation 5.8 |
| Telephone Discussion Groups | Spouse Self-report of Depression | Depression symptoms at 12 months | 4.8 units on a scale | Standard Deviation 5.1 |
| Education Sessions | Spouse Self-report of Depression | Depression symptoms at 6 months | 4.4 units on a scale | Standard Deviation 4.8 |
| Education Sessions | Spouse Self-report of Depression | Depression symptoms at baseline | 5.8 units on a scale | Standard Deviation 5.2 |
| Education Sessions | Spouse Self-report of Depression | Depression symptoms at 12 months | 5.3 units on a scale | Standard Deviation 4.8 |
| Usual Care | Spouse Self-report of Depression | Depression symptoms at baseline | 6.4 units on a scale | Standard Deviation 4.7 |
| Usual Care | Spouse Self-report of Depression | Depression symptoms at 12 months | 5.0 units on a scale | Standard Deviation 4.7 |
| Usual Care | Spouse Self-report of Depression | Depression symptoms at 6 months | 5.3 units on a scale | Standard Deviation 4.1 |
Primary
Spouse Self-report of Resilience
Resilience as measured on the Connor-Davidson Resilience Scale, measured from 0-100; higher scores show greater resilience
Time frame: Baseline, 6 months, and 12 months
Population: All participants with resilience data at baseline, 6 and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telephone Discussion Groups | Spouse Self-report of Resilience | Resilience scores at 6 months | 78.1 units on a scale | Standard Deviation 12.4 |
| Telephone Discussion Groups | Spouse Self-report of Resilience | Resilience scores at baseline | 75.8 units on a scale | Standard Deviation 10 |
| Telephone Discussion Groups | Spouse Self-report of Resilience | Resilience scores at 12 months | 78.1 units on a scale | Standard Deviation 11 |
| Education Sessions | Spouse Self-report of Resilience | Resilience scores at 6 months | 77.9 units on a scale | Standard Deviation 13 |
| Education Sessions | Spouse Self-report of Resilience | Resilience scores at baseline | 78.8 units on a scale | Standard Deviation 10.6 |
| Education Sessions | Spouse Self-report of Resilience | Resilience scores at 12 months | 76.3 units on a scale | Standard Deviation 12.5 |
| Usual Care | Spouse Self-report of Resilience | Resilience scores at baseline | 76.4 units on a scale | Standard Deviation 9.5 |
| Usual Care | Spouse Self-report of Resilience | Resilience scores at 12 months | 78.0 units on a scale | Standard Deviation 10.2 |
| Usual Care | Spouse Self-report of Resilience | Resilience scores at 6 months | 77.7 units on a scale | Standard Deviation 10.7 |