Spouse READI (Resilience Education And Deployment Information) Post Deployment Telephone Support Groups

• Sponsor: Memphis VA Medical Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01121250
• Collaborator: U.S. Army Medical Research and Development Command (U.S. Fed)
• Enrollment: 228
• Location: 1
• Arms: 3
• Duration (Months): 64
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

This 12-month study is for spouses or significant others of service members who have returned from Afghanistan or Iraq. This study will determine if participating in a telephone discussion group, offering education, skills building, and support, will help increase post-deployment adjustment. There will be 225 spouses recruited for this study.

Condition or Disease	Intervention/Treatment	Phase
Spouses; Military Personnel; Coping Skills	Behavioral: Telephone Discussion Groups; Behavioral: Education sessions	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 228 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Spouse READI (Resilience Education And Deployment Information) Post Deployment Telephone Support Groups
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telephone Discussion Groups Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury).	Behavioral: Telephone Discussion Groups; Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury).
Active Comparator: Education sessions Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook.	Behavioral: Education sessions; Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook.
No Intervention: Usual Care Participants do not receive any services.

Outcome Measures

Primary Outcome Measures

1. Spouse Self-report of Anxiety [Baseline, 6 months, and 12 months]

   Anxiety symptoms from the Generalized Anxiety Disorder-7 (GAD-7) scale, measured from 0-21, higher scores indicate greater anxiety

2. Spouse Self-report of Depression [Baseline, 6 months, and 12 months]

   Depression symptoms as measured on the Patient Health Questionnaire (PHQ-9), measured from 0-27, with higher numbers indicating more depression

3. Spouse Self-report of Resilience [Baseline, 6 months, and 12 months]

   Resilience as measured on the Connor-Davidson Resilience Scale, measured from 0-100; higher scores show greater resilience

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. have a spouse who participated in a deployment to Iraq and Afghanistan and is at least 1 month post-deployment

2. if not married, must have lived as married for at least one year

3. must be committed to the relationship

4. have a telephone.

Exclusion Criteria:

1. known deployment of spouse in the next six months

2. auditory impairment that would make telephone use difficult.

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
• U.S. Army Medical Research and Development Command

Investigators

• Principal Investigator: Linda O Nichols, Ph.D., Memphis VA Medical Center and University of Tennessee Health Science Center
• Principal Investigator: Jennifer L Martindale-Adams, Ed.D., University of Tennessee Health Science Center and VA Medical Center Memphis

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Linda O. Nichols, Ph.D., Healthcare education specialist/Health Services Researcher, Memphis VA Medical Center
• ClinicalTrials.gov Identifier: NCT01121250
• Other Study ID Numbers: W81XWH-09-1-0242
• First Posted: May 12, 2010
• Last Update Posted: Jul 30, 2018
• 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: Combat disorders; Spouses; Support; Military personnel

Study Results

Participant Flow

Arm/Group Title	Telephone Discussion Groups	Education Sessions	Usual Care
Arm/Group Description	Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury).	Education sessions: Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook.	Participants do not receive any services.
Period Title: Overall Study
STARTED	76	76	76
COMPLETED	76	76	75
NOT COMPLETED	0	0	1

Baseline Characteristics

Arm/Group Title	Telephone Discussion Groups	Education Sessions	Usual Care	Total
Arm/Group Description	Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury).	Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook.	Participants do not receive any services.	Total of all reporting groups
Overall Participants	76	76	75	227
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.4 (8.6)	38.0 (8.3)	35.1 (8.7)	36.5 (8.6)
Sex: Female, Male (Count of Participants)
Female	74 97.4%	75 98.7%	75 100%	224 98.7%
Male	2 2.6%	1 1.3%	0 0%	3 1.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 13.2%	7 9.2%	10 13.3%	27 11.9%
Not Hispanic or Latino	66 86.8%	69 90.8%	65 86.7%	200 88.1%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.3%	0 0%	3 4%	4 1.8%
Asian	0 0%	1 1.3%	3 4%	4 1.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	10 13.2%	13 17.1%	5 6.7%	28 12.3%
White	61 80.3%	60 78.9%	59 78.7%	180 79.3%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	4 5.3%	2 2.6%	5 6.7%	11 4.8%
Region of Enrollment (Count of Participants)
United States	76 100%	76 100%	75 100%	227 100%

Outcome Measures

1. Primary Outcome

Title	Spouse Self-report of Anxiety
Description	Anxiety symptoms from the Generalized Anxiety Disorder-7 (GAD-7) scale, measured from 0-21, higher scores indicate greater anxiety
Time Frame	Baseline, 6 months, and 12 months

Outcome Measure Data

Analysis Population Description

All participants with anxiety data at baseline, six months, and twelve months

Arm/Group Title	Telephone Discussion Groups	Education Sessions	Usual Care
Arm/Group Description	Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury).	Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook.	Participants do not receive any services.
Measure Participants	76	76	75
Anxiety score at baseline	7.9 (5.5)	7.1 (5.1)	7.9 (4.8)
Anxiety score at 6 months	5.5 (4.0)	5.2 (4.4)	6.2 (4.4)
Anxiety score at 12 months	6.0 (4.8)	6.1 (4.9)	5.5 (4.8)

2. Primary Outcome

Title	Spouse Self-report of Depression
Description	Depression symptoms as measured on the Patient Health Questionnaire (PHQ-9), measured from 0-27, with higher numbers indicating more depression
Time Frame	Baseline, 6 months, and 12 months

Outcome Measure Data

Analysis Population Description

All participations with depression data at baseline, six and 12 months

Arm/Group Title	Telephone Discussion Groups	Education Sessions	Usual Care
Arm/Group Description	Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury).	Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook.	Participants do not receive any services.
Measure Participants	76	76	75
Depression symptoms at baseline	6.6 (5.8)	5.8 (5.2)	6.4 (4.7)
Depression symptoms at 6 months	4.5 (4.6)	4.4 (4.8)	5.3 (4.1)
Depression symptoms at 12 months	4.8 (5.1)	5.3 (4.8)	5.0 (4.7)

3. Primary Outcome

Title	Spouse Self-report of Resilience
Description	Resilience as measured on the Connor-Davidson Resilience Scale, measured from 0-100; higher scores show greater resilience
Time Frame	Baseline, 6 months, and 12 months

Outcome Measure Data

Analysis Population Description

All participants with resilience data at baseline, 6 and 12 months

Arm/Group Title	Telephone Discussion Groups	Education Sessions	Usual Care
Arm/Group Description	Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury).	Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook.	Participants do not receive any services.
Measure Participants	76	76	75
Resilience scores at baseline	75.8 (10.0)	78.8 (10.6)	76.4 (9.5)
Resilience scores at 6 months	78.1 (12.4)	77.9 (13.0)	77.7 (10.7)
Resilience scores at 12 months	78.1 (11.0)	76.3 (12.5)	78.0 (10.2)

Adverse Events

Time Frame	1 year
Arm/Group Title	Telephone Discussion Groups		Education Sessions		Usual Care
Arm/Group Description	Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury).		Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook.		Participants do not receive any services.
All Cause Mortality
	Telephone Discussion Groups		Education Sessions		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/76 (0%)		0/75 (0%)
Serious Adverse Events
	Telephone Discussion Groups		Education Sessions		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/76 (0%)		0/75 (0%)
Other (Not Including Serious) Adverse Events
	Telephone Discussion Groups		Education Sessions		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/76 (0%)		0/75 (0%)

Limitations/Caveats

Spouses were not screened for distress and did not exhibit high levels of anxiety or depression or low levels of resilience at baseline. Participants discontinued or were lost to follow up. Less than half of participants attended > six sessions.

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.