CompletedNCT01121250Spouse READIUpdated Jul 30, 2018Results posted

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

An interventional study of Telephone Discussion Groups and Education sessions in Spouses, Military Personnel and Coping Skills, sponsored by Memphis VA Medical Center. Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2018-07-30.

Sponsored by Memphis VA Medical Center · Not applicable, Interventional, and Health services research

Phase: Not applicable
Study type: Interventional
Enrollment: 228
Allocation: Randomized
Sex: Female

Study 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.

Conditions studied

Spouses
Military Personnel
Coping Skills

Keywords

Combat disorders
Spouses
Support
Military personnel

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

have a spouse who participated in a deployment to Iraq and Afghanistan and is at least 1 month post-deployment
if not married, must have lived as married for at least one year
must be committed to the relationship
have a telephone.

Exclusion criteria

Exclusion Criteria:

known deployment of spouse in the next six months
auditory impairment that would make telephone use difficult.

Study design

Phase: Not applicable
Primary purpose: Health services research
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 228 participants (actual)

Study arms

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
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
No intervention
Usual Care
Participants do not receive any services.

Interventions

BehavioralTelephone 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).
BehavioralEducation 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.

What researchers measure

Primary outcomes

Spouse Self-report of Anxiety
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
Spouse Self-report of Depression
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
Spouse Self-report of Resilience
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

Results

Posted Jul 30, 2018

Limitations and 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.

Participant flow

Participant flow — Overall Study
Milestone	Telephone Discussion Groups	Education Sessions	Usual Care
Started	76	76	76
Completed	76	76	75
Not completed	0	0	1

Outcome measures

PrimarySpouse Self-report of Anxiety

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
Reported as:: Mean · units on a scale

Spouse Self-report of Anxiety
units on a scale	Telephone Discussion Groups	Education Sessions	Usual Care
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

PrimarySpouse Self-report of Depression

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
Reported as:: Mean · units on a scale

Spouse Self-report of Depression
units on a scale	Telephone Discussion Groups	Education Sessions	Usual Care
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

PrimarySpouse Self-report of Resilience

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
Reported as:: Mean · units on a scale

Spouse Self-report of Resilience
units on a scale	Telephone Discussion Groups	Education Sessions	Usual Care
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

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Telephone Discussion Groups	0/76 (0%)	0/76 (0%)	0/76 (0%)
Education Sessions	0/76 (0%)	0/76 (0%)	0/76 (0%)
Usual Care	0/75 (0%)	0/75 (0%)	0/75 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Telephone Discussion Groups	Education Sessions	Usual Care	Total
Mean	36.4 ± 8.6	38.0 ± 8.3	35.1 ± 8.7	36.5 ± 8.6

Sex: Female, Male
Sex: Female, Male(Participants)	Telephone Discussion Groups	Education Sessions	Usual Care	Total
Female	74	75	75	224
Male	2	1	0	3

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Telephone Discussion Groups	Education Sessions	Usual Care	Total
Hispanic or Latino	10	7	10	27
Not Hispanic or Latino	66	69	65	200
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Telephone Discussion Groups	Education Sessions	Usual Care	Total
American Indian or Alaska Native	1	0	3	4
Asian	0	1	3	4
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	10	13	5	28
White	61	60	59	180
More than one race	0	0	0	0
Unknown or Not Reported	4	2	5	11

Region of Enrollment
Region of Enrollment(Participants)	Telephone Discussion Groups	Education Sessions	Usual Care	Total
United States	76	76	75	227

Study locations

1 site

Memphis VA Medical Center
Memphis, Tennessee 38104, United States

References and documents

Publications

Nichols, L.O., Martindale-Adams, J., Zuber, J., Graney, M., Burns, R., & Clark, C. Support for Spouses of Post Deployment Service Members. Military Behavioral Health, Published online: 30 Jan 2015. DOI:10.1080/21635781.2015.1009210
Nichols L.O., Martindale-Adams, J., Zuber, J., & Graney, M. Service Member Need and Supportive Services Use of Military/Veteran Spouses. Military Behavioral Health, Published online: 09 Feb 2015, DOI:10.1080/21635781.2014.995251

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT01121250
Lead sponsor: Memphis VA Medical Center
Collaborators: U.S. Army Medical Research and Development Command
Responsible party: Linda O. Nichols, Ph.D. (Healthcare education specialist/Health Services Researcher, Memphis VA Medical Center) — Principal investigator
First posted: May 12, 2010
Start date: Oct 2009
Primary completion: Dec 2013
Completion: Feb 2015
Results posted: Jul 30, 2018
Last update: Jul 30, 2018

Study contacts

Linda O Nichols, Ph.D.

principal investigator · Memphis VA Medical Center and University of Tennessee Health Science Center

Jennifer L Martindale-Adams, Ed.D.

principal investigator · University of Tennessee Health Science Center and VA Medical Center Memphis

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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