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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01121250
Other study ID # W81XWH-09-1-0242
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2009
Est. completion date February 2015

Study information

Verified date October 2017
Source Memphis VA Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 228
Est. completion date February 2015
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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).
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.

Locations

Country Name City State
United States Memphis VA Medical Center Memphis Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Memphis VA Medical Center U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

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

Outcome

Type Measure Description Time frame Safety issue
Primary Spouse Self-report of Anxiety 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
Primary Spouse Self-report of Depression 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
Primary Spouse Self-report of Resilience Resilience as measured on the Connor-Davidson Resilience Scale, measured from 0-100; higher scores show greater resilience Baseline, 6 months, and 12 months
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