Telephone Support During Overseas Deployment for Military Spouses

• 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: Memphis VA Medical Center
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

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 Number of Baseline Participants		80	81	161
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%

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.
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
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.
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
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.
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
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 (%)	Affected / at Risk (%)
Total	0/80 (0.00%)	0/81 (0.00%)
Serious Adverse Events
	Telephone Support Groups	Education Webinars
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/80 (0.00%)	0/81 (0.00%)
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%)

Limitations and 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.

Results Point of Contact

• Name/Title: Dr. Linda Nichols
• Organization: Memphis VA Medical Center
• Phone: 901 523-8990 ext 5082
• EMail: linda.nichols@va.gov

• 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