Deployment, Family Members, Military Personnel, Resilience, Psychological
Conditions
Keywords
Telephone, Support groups, Social support, Depression
Brief summary
Deployment impacts both service member and family, and the cost can be high. Spouses' reactions to deployment may include emotional distress, loneliness, anticipatory fear or grief, somatic complaints, and depression. The goal is to help spouses learn ways to manage stress and solve problems related to deployment and reintegration, communication, managing long distance relationships, and other common problems. The study will compare telephone support groups to online education sessions. The study will enroll 160 spouses. In the Telephone Support groups, a group leader and participants will meet 12 times over six months to focus on education, skills building and support. Education Only online sessions will provide the same education content, without skills building or support. Content includes strategies to reduce or eliminate communication difficulties during deployment, how to find help; practical concerns during deployment; fostering resilience and decreasing stress; fostering relationships while apart, negotiating roles and relationships; changes during deployment; strategies to support the spouse and the service member; and cues to alert spouses when to seek mental health services for the family or themselves. Outcomes will include resilience, depression, anxiety and coping behaviors. Telephone data collection will be conducted at baseline, six and twelve months.
Interventions
BEHAVIORALTelephone support groups
OTHEREducation webinars
Sponsors
United States Department of Defense
Memphis VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* spouse or significant other (living as married for at least one year before deployment) of an overseas deployed military service member * deployed at least six months
Exclusion criteria
* living as married for at least one year before deployment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spouse Self-report of Resilience | Baseline, 6 months | Connor-Davidson Resilience Scale (CD-RISC) measured at baseline, 6 and 12 months. Scores range from 0-100. Higher scores equal greater resilience. |
| Spouse Self Report of Anxiety | baseline, and 6 months | Generalized Anxiety Disorder (GAD-7) measured at baseline, 6 and 12 months. Scores range from 0 to 21; higher scores equal more anxiety. |
| Spouse Self Report of Depression | Baseline, 6 months | Patient Health Questionnaire - Depression (PHQ)-9 measured at baseline, 6 and 12 months. Scores range from 0-27 with higher scores indicating more depressive symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telephone Support Groups Telephone support groups, each with participants and a trained group leader. Each hour-long telephone group will meet bi-monthly for six months for a total of 12 meetings. Groups are structured with education, skills building, and support. Participants will receive and use a Spouse Workbook with information and activities. | 80 |
| Education Webinars Education Webinar session topics are the same that are covered in the intervention arm without telephone interaction/support and skills building components. Each session is 30-minutes. Each participant receives a Spouse Workbook with information and activities. | 81 |
| Total | 161 |
Baseline characteristics
| Characteristic | Telephone Support Groups | Total | Education Webinars |
|---|---|---|---|
| Age, Continuous | 35.6 years STANDARD_DEVIATION 8.4 | 35.6 years STANDARD_DEVIATION 8.2 | 35.5 years STANDARD_DEVIATION 8.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 25 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 65 Participants | 136 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 13 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 11 Participants | 6 Participants |
| Race (NIH/OMB) White | 63 Participants | 128 Participants | 65 Participants |
| Region of Enrollment United States | 80 Participants | 161 Participants | 81 Participants |
| Sex: Female, Male Female | 78 Participants | 157 Participants | 79 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 81 |
| other Total, other adverse events | 0 / 80 | 0 / 81 |
| serious Total, serious adverse events | 0 / 80 | 0 / 81 |
Outcome results
Primary
Spouse Self Report of Anxiety
Generalized Anxiety Disorder (GAD-7) measured at baseline, 6 and 12 months. Scores range from 0 to 21; higher scores equal more anxiety.
Time frame: baseline, and 6 months
Population: Participants who had data at baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telephone Support Groups | Spouse Self Report of Anxiety | Participants 'Anxiety baseline baseline scores | 6.0 units on a scale | Standard Error 0.5 |
| Telephone Support Groups | Spouse Self Report of Anxiety | Participants' Anxiety scores at 6 months | 5.3 units on a scale | Standard Error 0.6 |
| Education Webinars | Spouse Self Report of Anxiety | Participants 'Anxiety baseline baseline scores | 7.3 units on a scale | Standard Error 0.5 |
| Education Webinars | Spouse Self Report of Anxiety | Participants' Anxiety scores at 6 months | 4.9 units on a scale | Standard Error 0.6 |
Primary
Spouse Self Report of Depression
Patient Health Questionnaire - Depression (PHQ)-9 measured at baseline, 6 and 12 months. Scores range from 0-27 with higher scores indicating more depressive symptoms.
Time frame: Baseline, 6 months
Population: Participants with data at baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telephone Support Groups | Spouse Self Report of Depression | Participants' baseline scores | 5.5 units on a scale | Standard Error 0.6 |
| Telephone Support Groups | Spouse Self Report of Depression | Participants' scores at 6 months | 3.8 units on a scale | Standard Error 0.5 |
| Education Webinars | Spouse Self Report of Depression | Participants' baseline scores | 6.6 units on a scale | Standard Error 0.6 |
| Education Webinars | Spouse Self Report of Depression | Participants' scores at 6 months | 3.8 units on a scale | Standard Error 0.5 |
Primary
Spouse Self-report of Resilience
Connor-Davidson Resilience Scale (CD-RISC) measured at baseline, 6 and 12 months. Scores range from 0-100. Higher scores equal greater resilience.
Time frame: Baseline, 6 months
Population: Participants who had data at baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telephone Support Groups | Spouse Self-report of Resilience | Resilience scores at baseline | 75.4 units on a scale | Standard Error 1.3 |
| Telephone Support Groups | Spouse Self-report of Resilience | Resilience scores at 6 months | 78.5 units on a scale | Standard Error 1.1 |
| Education Webinars | Spouse Self-report of Resilience | Resilience scores at baseline | 75.9 units on a scale | Standard Error 1.3 |
| Education Webinars | Spouse Self-report of Resilience | Resilience scores at 6 months | 81.0 units on a scale | Standard Error 1.1 |