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Telephone Support During Overseas Deployment for Military Spouses

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ClinicalTrials.gov Identifier: NCT01828983
Recruitment Status : Completed
First Posted : April 11, 2013
Results First Posted : October 23, 2017
Last Update Posted : November 24, 2017
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Linda O. Nichols, Ph.D., Memphis VA Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Military Personnel
Family Members
Resilience, Psychological
Deployment
Interventions Behavioral: Telephone support groups
Other: Education webinars
Enrollment 161
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Telephone Support Groups Education Webinars
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 80 81
Completed 80 81
Not Completed 0 0
Arm/Group Title Telephone Support Groups Education Webinars Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 80 81 161
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 81 participants 161 participants
35.6  (8.4) 35.5  (8.4) 35.6  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 161 participants
Female
78
  97.5%
79
  97.5%
157
  97.5%
Male
2
   2.5%
2
   2.5%
4
   2.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 161 participants
Hispanic or Latino
15
  18.8%
10
  12.3%
25
  15.5%
Not Hispanic or Latino
65
  81.3%
71
  87.7%
136
  84.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 161 participants
American Indian or Alaska Native
2
   2.5%
1
   1.2%
3
   1.9%
Asian
2
   2.5%
4
   4.9%
6
   3.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  10.0%
5
   6.2%
13
   8.1%
White
63
  78.8%
65
  80.2%
128
  79.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
   6.3%
6
   7.4%
11
   6.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 80 participants 81 participants 161 participants
80
 100.0%
81
 100.0%
161
 100.0%
1.Primary Outcome
Title Spouse Self-report of Resilience
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had data at baseline and 6 months
Arm/Group Title Telephone Support Groups Education Webinars
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 80 81
Mean (Standard Error)
Unit of Measure: units on a scale
Resilience scores at baseline Number Analyzed 80 participants 81 participants
75.4  (1.3) 75.9  (1.3)
Resilience scores at 6 months Number Analyzed 72 participants 65 participants
78.5  (1.1) 81.0  (1.1)
2.Primary Outcome
Title Spouse Self Report of Anxiety
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had data at baseline and 6 months
Arm/Group Title Telephone Support Groups Education Webinars
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 80 81
Mean (Standard Error)
Unit of Measure: units on a scale
Participants 'Anxiety baseline baseline scores Number Analyzed 80 participants 81 participants
6.0  (0.5) 7.3  (0.5)
Participants' Anxiety scores at 6 months Number Analyzed 72 participants 65 participants
5.3  (0.6) 4.9  (0.6)
3.Primary Outcome
Title Spouse Self Report of Depression
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with data at baseline and 6 months
Arm/Group Title Telephone Support Groups Education Webinars
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 80 81
Mean (Standard Error)
Unit of Measure: units on a scale
Participants' baseline scores Number Analyzed 80 participants 81 participants
5.5  (0.6) 6.6  (0.6)
Participants' scores at 6 months Number Analyzed 72 participants 81 participants
3.8  (0.5) 3.8  (0.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Telephone Support Groups Education Webinars
Hide Arm/Group Description 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 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.
All-Cause Mortality
Telephone Support Groups Education Webinars
Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   0/81 (0.00%) 
Hide Serious Adverse Events
Telephone Support Groups Education Webinars
Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   0/81 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Telephone Support Groups Education Webinars
Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   0/81 (0.00%) 

There was no control arm where participants received no services. Participants were at various stages of the deployment process.

Lack of participation in the intervention was a study limitation.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Linda Nichols
Organization: Memphis VA Medical Center
Phone: 901 523-8990 ext 5082
EMail: linda.nichols@va.gov
Layout table for additonal information
Responsible Party: Linda O. Nichols, Ph.D., Memphis VA Medical Center
ClinicalTrials.gov Identifier: NCT01828983    
Other Study ID Numbers: W81XWH-11-2-0087
First Submitted: April 4, 2013
First Posted: April 11, 2013
Results First Submitted: June 1, 2017
Results First Posted: October 23, 2017
Last Update Posted: November 24, 2017