Military PersonnelNCT01828983

Telephone Support During Overseas Deployment for Military Spouses

A study testing Telephone support groups and Education webinars in people with Military Personnel and Family Members, run by Memphis VA Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Military Personnel, Family Members, Resilience, Psychological
What is being tested?: Telephone support groups and Education webinars
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 161 participants
Where: 1 siteUnited States
Study dates: Apr 2011to Jun 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

living as married for at least one year before deployment

Trial locations and contacts

1 site in 1 country.

United States1 site

Memphis VA Medical Center
Memphis, Tennessee, 38104

Other trials in United States

About this study

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.

Conditions: Military Personnel, Family Members, Resilience, Psychological, Deployment
Being tested: Telephone support groups, Education webinars
Keywords: Telephone, Support groups, Social support, Depression
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Telephone support groupsBehavioural
Education webinarsOther

Study groups in NCT01828983
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Education webinars

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Jun 2015

First posted11 Apr 2013 (estimated)
Study startApr 2011
Primary completionDec 2014
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Military PersonnelStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 161 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01828983
Sponsor's protocol ID: W81XWH-11-2-0087
Status last verified: Oct 2017
First submitted: 4 Apr 2013
Last updated: 24 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Telephone Support During Overseas Deployment for Military Spouses
ClinicalTrials.gov ID: NCT01828983
Acronym / sponsor ID: W81XWH-11-2-0087
Conditions: Military Personnel, Family Members, Resilience, Psychological, Deployment
Keywords: Telephone, Support groups, Social support, Depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 161 participants (actual)
Lead sponsor: Memphis VA Medical CenterUS federal agency
Collaborators: United States Department of Defense
Study start: Apr 2011
Primary completion: Dec 2014 (actual)
Study completion: Jun 2015 (actual)
First posted: 11 Apr 2013 (estimated)
Results: Posted 23 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Telephone support groups	Experimental	Behavioral: Telephone support groupsTelephone 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.
Education webinars	Active comparator	Other: Education webinarsEducation 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

living as married for at least one year before deployment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Telephone support groups	Behavioural	Telephone support groups
Education webinars	Other	Education webinars

Primary outcome

Spouse Self-report of Resilience
Time frame: Baseline, 6 months
Connor-Davidson Resilience Scale (CD-RISC) measured at baseline, 6 and 12 months. Scores range from 0-100. Higher scores equal greater resilience.
Spouse Self Report of Anxiety
Time frame: baseline, and 6 months
Generalized Anxiety Disorder (GAD-7) measured at baseline, 6 and 12 months. Scores range from 0 to 21; higher scores equal more anxiety.
Spouse Self Report of Depression
Time frame: Baseline, 6 months
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.

Results and safety

Results posted to the registry on 23 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Telephone Support Groups	80	80
Education Webinars	81	81

Primary outcome: Spouse Self-report of Resilience

Time frame: Baseline, 6 months. Mean (Standard Error). Unit: units on a scale

Measure	Telephone Support Groups n = 80	Education Webinars n = 81
Resilience scores at baseline	75.4 (1.3)	75.9 (1.3)
Resilience scores at 6 months	78.5 (1.1)	81.0 (1.1)

Population analysed: Participants who had data at baseline and 6 months

Primary outcome: Spouse Self Report of Anxiety

Time frame: baseline, and 6 months. Mean (Standard Error). Unit: units on a scale

Measure	Telephone Support Groups n = 80	Education Webinars n = 81
Participants 'Anxiety baseline baseline scores	6.0 (0.5)	7.3 (0.5)
Participants' Anxiety scores at 6 months	5.3 (0.6)	4.9 (0.6)

Population analysed: Participants who had data at baseline and 6 months

Primary outcome: Spouse Self Report of Depression

Time frame: Baseline, 6 months. Mean (Standard Error). Unit: units on a scale

Measure	Telephone Support Groups n = 80	Education Webinars n = 81
Participants' baseline scores	5.5 (0.6)	6.6 (0.6)
Participants' scores at 6 months	3.8 (0.5)	3.8 (0.5)

Population analysed: Participants with data at baseline and 6 months

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telephone Support Groups	0 of 80 (0%)	0 of 80 (0%)	0 of 80
Education Webinars	0 of 81 (0%)	0 of 81 (0%)	0 of 81

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Linda O Nichols, PhD principal investigator

Memphis VA Medical Center and University of Tennessee Health Science Center

Jennifer L Martindale-Adams, EdD principal investigator

University of Tennessee Health Science Center and Memphis VA Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Telephone support groups and Education webinars in people with Military Personnel and Family Members, run by Memphis VA Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spouse Self-report of Resilience (time frame: Baseline, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01828983.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017.