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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 7, 2010

Last Updated Date

April 3, 2013

Start Date ^ICMJE

October 2009

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Depression symptoms from the PHQ-9 (Patient Health Questionnaire) scale [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Depression symptoms from the PHQ-9 scale [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT01121250 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research

Condition ^ICMJE

Spouses
Military Personnel
Coping Skills

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Telephone Discussion Groups
Intervention: Behavioral: Telephone Discussion Groups
Active Comparator: Education only
Intervention: Behavioral: Education sessions
No Intervention: Usual Care

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

225

Estimated Completion Date

February 2014

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01121250

Other Study ID Numbers ^ICMJE

W81XWH-09-1-0242

Has Data Monitoring Committee

Responsible Party

Linda O. Nichols, Ph.D., Memphis VA Medical Center

Study Sponsor ^ICMJE

Memphis VA Medical Center

Collaborators ^ICMJE

U.S. Army Medical Research and Materiel Command

Investigators ^ICMJE

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

Information Provided By

Memphis VA Medical Center

Verification Date

April 2013

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

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