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

This study is ongoing, but not recruiting participants.
Sponsor:
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: June 5, 2014
Last verified: June 2014
  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 2015
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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 5, 2014
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 August 28, 2014