Spouse READI (Resilience Education And Deployment Information) Post Deployment Telephone Support Groups
This study is ongoing, but not recruiting participants.
Sponsor:
Memphis VA Medical Center
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Linda O. Nichols, Ph.D., Memphis VA Medical Center
ClinicalTrials.gov Identifier:
NCT01121250
First received: May 7, 2010
Last updated: April 3, 2013
Last verified: April 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Spouses Military Personnel Coping Skills |
Behavioral: Telephone Discussion Groups Behavioral: Education sessions |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | Spouse READI (Resilience Education And Deployment Information) Post Deployment Telephone Support Groups |
Resource links provided by NLM:
Further study details as provided by Memphis VA Medical Center:
Primary Outcome Measures:
- Depression symptoms from the PHQ-9 (Patient Health Questionnaire) scale [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Anxiety symptoms as measured on the Generalized Anxiety Disorders scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Resilience as measured on the Connor-Davidson Resilience Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Family problem solving communication as measured on the Family Problem Solving Communication Index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 225 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Telephone Discussion Groups |
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 only |
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 |
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121250
Locations
| United States, Tennessee | |
| Memphis VA Medical Center | |
| Memphis, Tennessee, United States, 38104 | |
Sponsors and Collaborators
Memphis VA Medical Center
U.S. Army Medical Research and Materiel 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Linda O. Nichols, Ph.D., Healthcare education specialist/Health Services Researcher, Memphis VA Medical Center |
| ClinicalTrials.gov Identifier: | NCT01121250 History of Changes |
| Other Study ID Numbers: | W81XWH-09-1-0242 |
| Study First Received: | May 7, 2010 |
| Last Updated: | April 3, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Memphis VA Medical Center:
|
Combat disorders Spouses Support Military personnel |
ClinicalTrials.gov processed this record on May 22, 2013