NCT01828983

Brief Summary

Deployment impacts both service member and family, and the cost can be high. Spouses' reactions to deployment may include emotional distress, loneliness, anticipatory fear or grief, somatic complaints, and depression. The goal is to help spouses learn ways to manage stress and solve problems related to deployment and reintegration, communication, managing long distance relationships, and other common problems. The study will compare telephone support groups to online education sessions. The study will enroll 160 spouses. In the Telephone Support groups, a group leader and participants will meet 12 times over six months to focus on education, skills building and support. Education Only online sessions will provide the same education content, without skills building or support. Content includes strategies to reduce or eliminate communication difficulties during deployment, how to find help; practical concerns during deployment; fostering resilience and decreasing stress; fostering relationships while apart, negotiating roles and relationships; changes during deployment; strategies to support the spouse and the service member; and cues to alert spouses when to seek mental health services for the family or themselves. Outcomes will include resilience, depression, anxiety and coping behaviors. Telephone data collection will be conducted at baseline, six and twelve months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

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

April 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

October 23, 2017

Completed
Last Updated

November 24, 2017

Status Verified

October 1, 2017

Enrollment Period

3.7 years

First QC Date

April 4, 2013

Results QC Date

June 1, 2017

Last Update Submit

October 20, 2017

Conditions

Keywords

TelephoneSupport groupsSocial supportDepression

Outcome Measures

Primary Outcomes (3)

  • Spouse Self-report of Resilience

    Connor-Davidson Resilience Scale (CD-RISC) measured at baseline, 6 and 12 months. Scores range from 0-100. Higher scores equal greater resilience.

    Baseline, 6 months

  • Spouse Self Report of Anxiety

    Generalized Anxiety Disorder (GAD-7) measured at baseline, 6 and 12 months. Scores range from 0 to 21; higher scores equal more anxiety.

    baseline, and 6 months

  • Spouse Self Report of Depression

    Patient Health Questionnaire - Depression (PHQ)-9 measured at baseline, 6 and 12 months. Scores range from 0-27 with higher scores indicating more depressive symptoms.

    Baseline, 6 months

Study Arms (2)

Telephone support groups

EXPERIMENTAL

Telephone support groups, each with participants and a trained group leader. Each hour-long telephone group will meet bi-monthly for six months for a total of 12 meetings. Groups are structured with education, skills building, and support. Participants will receive and use a Spouse Workbook with information and activities.

Behavioral: Telephone support groups

Education webinars

ACTIVE COMPARATOR

Education Webinar session topics are the same that are covered in the intervention arm without telephone interaction/support and skills building components. Each session is 30-minutes. Each participant receives a Spouse Workbook with information and activities.

Other: Education webinars

Interventions

Telephone support groups
Education webinars

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • spouse or significant other (living as married for at least one year before deployment) of an overseas deployed military service member
  • deployed at least six months

You may not qualify if:

  • living as married for at least one year before deployment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memphis VA Medical Center

Memphis, Tennessee, 38104, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Limitations and Caveats

There was no control arm where participants received no services. Participants were at various stages of the deployment process. Lack of participation in the intervention was a study limitation.

Results Point of Contact

Title
Dr. Linda Nichols
Organization
Memphis VA Medical Center

Study Officials

  • Linda O Nichols, PhD

    Memphis VA Medical Center and University of Tennessee Health Science Center

    PRINCIPAL INVESTIGATOR
  • Jennifer L Martindale-Adams, EdD

    University of Tennessee Health Science Center and Memphis VA Medical Center

    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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Healthcare education specialist/Health Services Researcher

Study Record Dates

First Submitted

April 4, 2013

First Posted

April 11, 2013

Study Start

April 1, 2011

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

November 24, 2017

Results First Posted

October 23, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations