Trial Outcomes & Findings for Telephone Support During Overseas Deployment for Military Spouses (NCT NCT01828983)
NCT ID: NCT01828983
Last Updated: 2017-11-24
Results Overview
Connor-Davidson Resilience Scale (CD-RISC) measured at baseline, 6 and 12 months. Scores range from 0-100. Higher scores equal greater resilience.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
161 participants
Primary outcome timeframe
Baseline, 6 months
Results posted on
2017-11-24
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
81
|
|
Overall Study
COMPLETED
|
80
|
81
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telephone Support During Overseas Deployment for Military Spouses
Baseline characteristics by cohort
| Measure |
Telephone Support Groups
n=80 Participants
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.
|
Education Webinars
n=81 Participants
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.
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.6 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
35.5 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
35.6 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
80 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsPopulation: Participants who had data at baseline and 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.
Outcome measures
| Measure |
Telephone Support Groups
n=80 Participants
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.
|
Education Webinars
n=81 Participants
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.
|
|---|---|---|
|
Spouse Self-report of Resilience
Resilience scores at baseline
|
75.4 units on a scale
Standard Error 1.3
|
75.9 units on a scale
Standard Error 1.3
|
|
Spouse Self-report of Resilience
Resilience scores at 6 months
|
78.5 units on a scale
Standard Error 1.1
|
81.0 units on a scale
Standard Error 1.1
|
PRIMARY outcome
Timeframe: baseline, and 6 monthsPopulation: Participants who had data at 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.
Outcome measures
| Measure |
Telephone Support Groups
n=80 Participants
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.
|
Education Webinars
n=81 Participants
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.
|
|---|---|---|
|
Spouse Self Report of Anxiety
Participants' Anxiety scores at 6 months
|
5.3 units on a scale
Standard Error 0.6
|
4.9 units on a scale
Standard Error 0.6
|
|
Spouse Self Report of Anxiety
Participants 'Anxiety baseline baseline scores
|
6.0 units on a scale
Standard Error 0.5
|
7.3 units on a scale
Standard Error 0.5
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsPopulation: Participants with data at baseline and 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.
Outcome measures
| Measure |
Telephone Support Groups
n=80 Participants
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.
|
Education Webinars
n=81 Participants
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.
|
|---|---|---|
|
Spouse Self Report of Depression
Participants' baseline scores
|
5.5 units on a scale
Standard Error 0.6
|
6.6 units on a scale
Standard Error 0.6
|
|
Spouse Self Report of Depression
Participants' scores at 6 months
|
3.8 units on a scale
Standard Error 0.5
|
3.8 units on a scale
Standard Error 0.5
|
Adverse Events
Telephone Support Groups
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Education Webinars
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place