- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01121250
Spouse READI (Resilience Education And Deployment Information) Post Deployment Telephone Support Groups (Spouse READI)
October 20, 2017 updated by: Linda O. Nichols, Ph.D., Memphis VA Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
228
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Memphis, Tennessee, United States, 38104
- Memphis VA Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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:
- known deployment of spouse in the next six months
- auditory impairment that would make telephone use difficult.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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).
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spouse Self-report of Anxiety
Time Frame: 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
|
Baseline, 6 months, and 12 months
|
|
Spouse Self-report of Depression
Time Frame: 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
|
Baseline, 6 months, and 12 months
|
|
Spouse Self-report of Resilience
Time Frame: Baseline, 6 months, and 12 months
|
Resilience as measured on the Connor-Davidson Resilience Scale, measured from 0-100; higher scores show greater resilience
|
Baseline, 6 months, and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
May 7, 2010
First Submitted That Met QC Criteria
May 11, 2010
First Posted (Estimate)
May 12, 2010
Study Record Updates
Last Update Posted (Actual)
July 30, 2018
Last Update Submitted That Met QC Criteria
October 20, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- W81XWH-09-1-0242
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coping Skills
-
Saglik Bilimleri UniversitesiCompleted
-
National Health Promotion Associates, Inc.United States Air ForceCompletedSexual Behavior | Skills, Social | Skills, CopingUnited States
-
Klein Buendel, Inc.National Institute on Alcohol Abuse and Alcoholism (NIAAA); University of New...CompletedCoping Skills | Family RelationsUnited States
-
University of California, Los AngelesNational Institute on Drug Abuse (NIDA); American Academy of Child Adolescent...CompletedCoping Skills | Family RelationshipUnited States
-
University of OsnabrueckCompletedStress | Coping Skills | Oxytocin
-
Marmara University Pendik Training and Research...Haydarpasa Numune Training and Research HospitalCompleted
-
University of PittsburghWithdrawn
-
Seattle Children's HospitalUniversity of Pittsburgh Medical CenterRecruitingCancer | Coping Skills | Psychosocial Functioning | Social FunctioningUnited States
-
Erzincan Binali Yildirim UniversitesiActive, not recruitingCoping Skills | Youth Mental Health | Stress ManagementTurkey (Türkiye)
-
Duke UniversityCompletedMobile Pain Coping Skills Training | In Person Pain Coping Skills TrainingUnited States
Clinical Trials on Telephone Discussion Groups
-
Queen's University, BelfastCompletedAge Related Macular DegenerationUnited Kingdom
-
University of SheffieldUniversity of Southampton; Bangor University; Northumbria University; Age UK; Community...TerminatedLoneliness | Self EfficacyUnited Kingdom
-
Memphis VA Medical CenterUnited States Department of DefenseCompletedCombat Disorders | Stress Disorders | Support Groups | Military SpousesUnited States
-
Memphis VA Medical CenterUnited States Department of DefenseCompletedResilience, Psychological | Family Members | Military Personnel | DeploymentUnited States
-
Medical Research CouncilNHS Greater Glasgow and ClydeTerminatedParenting | Child Behaviour Problems | Parent Mental HealthUnited Kingdom
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingStage III Uterine Corpus Cancer AJCC v8 | Stage IV Uterine Corpus Cancer AJCC v8 | Malignant Female Reproductive System Neoplasm | Stage III Cervical Cancer AJCC v8 | Stage IV Cervical Cancer AJCC v8 | Stage IV Vulvar Cancer AJCC v8 | Stage III Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC... and other conditionsUnited States
-
University of Michigan Rogel Cancer CenterNational Cancer Institute (NCI)Not yet recruitingLynch Syndrome | Hereditary Neoplastic Syndrome | BRCA1-Related Hereditary Breast and Ovarian Cancer Syndrome | BRCA2-Related Hereditary Breast and Ovarian Cancer SyndromeUnited States
-
Chelsea and Westminster NHS Foundation TrustKing's College Hospital NHS Trust; Public Health England; Department of Health... and other collaboratorsCompleted
-
GlaxoSmithKlineICON plcCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom
-
University of California, MercedCompletedParents of Children Ages 10 to 17 Years OldUnited States