NCT01121250

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

July 30, 2018

Completed
Last Updated

July 30, 2018

Status Verified

October 1, 2017

Enrollment Period

4.2 years

First QC Date

May 7, 2010

Results QC Date

June 1, 2017

Last Update Submit

October 20, 2017

Conditions

Keywords

Combat disordersSpousesSupportMilitary personnel

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (3)

Telephone Discussion Groups

EXPERIMENTAL

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: Telephone Discussion Groups

Education sessions

ACTIVE COMPARATOR

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.

Behavioral: Education sessions

Usual Care

NO INTERVENTION

Participants do not receive any services.

Interventions

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).

Telephone Discussion Groups

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.

Education sessions

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • known deployment of spouse in the next six months
  • auditory impairment that would make telephone use difficult.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memphis VA Medical Center

Memphis, Tennessee, 38104, United States

Location

Related Publications (2)

  • 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

    RESULT
  • 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

    RESULT

Related Links

MeSH Terms

Conditions

Combat Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Limitations and Caveats

Spouses were not screened for distress and did not exhibit high levels of anxiety or depression or low levels of resilience at baseline. Participants discontinued or were lost to follow up. Less than half of participants attended \> six sessions.

Results Point of Contact

Title
Dr. Linda Nichols
Organization
Memphis VA Medical Center

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Healthcare education specialist/Health Services Researcher

Study Record Dates

First Submitted

May 7, 2010

First Posted

May 12, 2010

Study Start

October 1, 2009

Primary Completion

December 1, 2013

Study Completion

February 1, 2015

Last Updated

July 30, 2018

Results First Posted

July 30, 2018

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations