Telephone Support During Overseas Deployment for Military Spouses

• Sponsor: Memphis VA Medical Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01828983
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 161
• Location: 1
• Arms: 2
• Duration (Months): 50
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Military Personnel; Family Members; Resilience, Psychological; Deployment	Behavioral: Telephone support groups; Other: Education webinars	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 161 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Telephone Support During Overseas Deployment for Military Spouses
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Telephone support groups
Active Comparator: 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.	Other: Education webinars

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memphis VA Medical Center	Memphis	Tennessee	United States	38104

Sponsors and Collaborators

• Memphis VA Medical Center
• United States Department of Defense

Investigators

• Principal Investigator: Linda O Nichols, PhD, Memphis VA Medical Center and University of Tennessee Health Science Center
• Principal Investigator: Jennifer L Martindale-Adams, EdD, University of Tennessee Health Science Center and Memphis VA Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Linda O. Nichols, Ph.D., Healthcare education specialist/Health Services Researcher, Memphis VA Medical Center
• ClinicalTrials.gov Identifier: NCT01828983
• Other Study ID Numbers: W81XWH-11-2-0087
• First Posted: Apr 11, 2013
• Last Update Posted: Nov 24, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Linda O. Nichols, Ph.D., Healthcare education specialist/Health Services Researcher, Memphis VA Medical Center: Telephone; Support groups; Social support; Depression

Study Results

Participant Flow

Arm/Group Title	Telephone Support Groups	Education Webinars
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

Baseline Characteristics

Arm/Group Title	Telephone Support Groups	Education Webinars	Total
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 Participants	80	81	161
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.6 (8.4)	35.5 (8.4)	35.6 (8.2)
Sex: Female, Male (Count of Participants)
Female	78 97.5%	79 97.5%	157 97.5%
Male	2 2.5%	2 2.5%	4 2.5%
Ethnicity (NIH/OMB) (Count of 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%
Race (NIH/OMB) (Count of 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%
Black or African American	8 10%	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%
Unknown or Not Reported	5 6.3%	6 7.4%	11 6.8%
Region of Enrollment (Count of Participants)
United States	80 100%	81 100%	161 100%

Outcome Measures

1. Primary Outcome

Title	Spouse Self-report of Resilience
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

Outcome Measure Data

Analysis Population Description

Participants who had data at baseline and 6 months

Arm/Group Title	Telephone Support Groups	Education Webinars
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.
Measure Participants	80	81
Resilience scores at baseline	75.4 (1.3)	75.9 (1.3)
Resilience scores at 6 months	78.5 (1.1)	81.0 (1.1)

2. Primary Outcome

Title	Spouse Self Report of Anxiety
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

Outcome Measure Data

Analysis Population Description

Participants who had data at baseline and 6 months

Arm/Group Title	Telephone Support Groups	Education Webinars
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.
Measure Participants	80	81
Participants 'Anxiety baseline baseline scores	6.0 (0.5)	7.3 (0.5)
Participants' Anxiety scores at 6 months	5.3 (0.6)	4.9 (0.6)

3. Primary Outcome

Title	Spouse Self Report of Depression
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

Outcome Measure Data

Analysis Population Description

Participants with data at baseline and 6 months

Arm/Group Title	Telephone Support Groups	Education Webinars
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.
Measure Participants	80	81
Participants' baseline scores	5.5 (0.6)	6.6 (0.6)
Participants' scores at 6 months	3.8 (0.5)	3.8 (0.5)

Adverse Events

Arm/Group Title	Telephone Support Groups		Education Webinars
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/80 (0%)		0/81 (0%)
Serious Adverse Events
	Telephone Support Groups		Education Webinars
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/80 (0%)		0/81 (0%)
Other (Not Including Serious) Adverse Events
	Telephone Support Groups		Education Webinars
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/80 (0%)		0/81 (0%)

Limitations/Caveats

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.

More Information

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.