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: April 3, 2013
Last verified: April 2013

May 7, 2010
April 3, 2013
October 2009
December 2013   (final data collection date for primary outcome measure)
Depression symptoms from the PHQ-9 (Patient Health Questionnaire) scale [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Depression symptoms from the PHQ-9 scale [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01121250 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Spouse READI (Resilience Education And Deployment Information) Post Deployment Telephone Support Groups
Spouse READI (Resilience Education And Deployment Information) Post Deployment Telephone Support Groups

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
  • Spouses
  • Military Personnel
  • Coping Skills
  • 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).
  • 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.
  • Experimental: Telephone Discussion Groups
    Intervention: Behavioral: Telephone Discussion Groups
  • Active Comparator: Education only
    Intervention: Behavioral: Education sessions
  • No Intervention: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
225
February 2014
December 2013   (final data collection date for primary outcome measure)

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.
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01121250
W81XWH-09-1-0242
No
Linda O. Nichols, Ph.D., Memphis VA Medical Center
Memphis VA Medical Center
U.S. Army Medical Research and Materiel Command
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
Memphis VA Medical Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP