SpousesSpouse READINCT01121250

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

A study testing Telephone Discussion Groups and Education sessions in people with Spouses and Military Personnel, 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

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. Read more about this study

Who is it for?: Any age, women only
Conditions the study is for: Spouses, Military Personnel, Coping Skills
What is being tested?: Telephone Discussion Groups and Education sessions
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 228 participants
Where: 1 siteUnited States
Study dates: Oct 2009to Feb 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 Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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

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

Conditions: Spouses, Military Personnel, Coping Skills
Being tested: Telephone Discussion Groups, Education sessions
Keywords: Combat disorders, Spouses, Support, Military personnel
Medical subject headings: Combat Disorders

What participants receive

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

Telephone Discussion GroupsBehavioural
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 sessionsBehavioural
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 groups in NCT01121250
Study group	Role	What they receive
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). Receives: 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. Receives: Behavioral: Education sessions
Usual Care	No intervention	Participants do not receive any services.

What is being measured

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

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
Measured: 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
Measured: 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
Measured: Baseline, 6 months, and 12 months

Timeline

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

Oct 2009Feb 2015

First posted12 May 2010 (estimated)
Study startOct 2009
Primary completionDec 2013
Study completionFeb 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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for SpousesStudies 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 228 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01121250
Sponsor's protocol ID: W81XWH-09-1-0242
Acronym: Spouse READI
Status last verified: Oct 2017
First submitted: 7 May 2010
Last updated: 30 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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
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

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?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Spouse READI (Resilience Education And Deployment Information) Post Deployment Telephone Support Groups
ClinicalTrials.gov ID: NCT01121250
Acronym / sponsor ID: Spouse READI / W81XWH-09-1-0242
Conditions: Spouses, Military Personnel, Coping Skills
Keywords: Combat disorders, Spouses, Support, Military personnel
Study type: Interventional
Recruitment status: Completed
Enrolment: 228 participants (actual)
Lead sponsor: Memphis VA Medical CenterUS federal agency
Collaborators: U.S. Army Medical Research and Development Command
Study start: Oct 2009
Primary completion: Dec 2013 (actual)
Study completion: Feb 2015 (actual)
First posted: 12 May 2010 (estimated)
Results: Posted 30 Jul 2018

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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Telephone Discussion Groups	Experimental	Behavioral: Telephone Discussion GroupsEach 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	Active comparator	Behavioral: Education sessionsParticipants 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.
Usual Care	No intervention	–Participants do not receive any services.

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (2 listed)

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

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 Discussion GroupsEach 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).	Behavioural	Telephone Discussion Groups
Education sessionsParticipants 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.	Behavioural	Education sessions

Primary outcome

Spouse Self-report of Anxiety
Time frame: Baseline, 6 months, and 12 months
Anxiety symptoms from the Generalized Anxiety Disorder-7 (GAD-7) scale, measured from 0-21, higher scores indicate greater anxiety
Spouse Self-report of Depression
Time frame: Baseline, 6 months, and 12 months
Depression symptoms as measured on the Patient Health Questionnaire (PHQ-9), measured from 0-27, with higher numbers indicating more depression
Spouse Self-report of Resilience
Time frame: Baseline, 6 months, and 12 months
Resilience as measured on the Connor-Davidson Resilience Scale, measured from 0-100; higher scores show greater resilience

Results and safety

Results posted to the registry on 30 Jul 2018, 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 Discussion Groups	76	76
Education Sessions	76	76
Usual Care	76	75

Primary outcome: Spouse Self-report of Anxiety

Time frame: Baseline, 6 months, and 12 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Telephone Discussion Groups n = 76	Education Sessions n = 76	Usual Care n = 75
Anxiety score at baseline	7.9 (5.5)	7.1 (5.1)	7.9 (4.8)
Anxiety score at 6 months	5.5 (4.0)	5.2 (4.4)	6.2 (4.4)
Anxiety score at 12 months	6.0 (4.8)	6.1 (4.9)	5.5 (4.8)

Population analysed: All participants with anxiety data at baseline, six months, and twelve months

Primary outcome: Spouse Self-report of Depression

Time frame: Baseline, 6 months, and 12 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Telephone Discussion Groups n = 76	Education Sessions n = 76	Usual Care n = 75
Depression symptoms at baseline	6.6 (5.8)	5.8 (5.2)	6.4 (4.7)
Depression symptoms at 6 months	4.5 (4.6)	4.4 (4.8)	5.3 (4.1)
Depression symptoms at 12 months	4.8 (5.1)	5.3 (4.8)	5.0 (4.7)

Population analysed: All participations with depression data at baseline, six and 12 months

Primary outcome: Spouse Self-report of Resilience

Time frame: Baseline, 6 months, and 12 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Telephone Discussion Groups n = 76	Education Sessions n = 76	Usual Care n = 75
Resilience scores at baseline	75.8 (10.0)	78.8 (10.6)	76.4 (9.5)
Resilience scores at 6 months	78.1 (12.4)	77.9 (13.0)	77.7 (10.7)
Resilience scores at 12 months	78.1 (11.0)	76.3 (12.5)	78.0 (10.2)

Population analysed: All participants with resilience data at baseline, 6 and 12 months

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telephone Discussion Groups	0 of 76 (0%)	0 of 76 (0%)	0 of 76
Education Sessions	0 of 76 (0%)	0 of 76 (0%)	0 of 76
Usual Care	0 of 75 (0%)	0 of 75 (0%)	0 of 75

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationNichols, 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
Results publicationNichols 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
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, Ph.D. principal investigator

Memphis VA Medical Center and University of Tennessee Health Science Center

Jennifer L Martindale-Adams, Ed.D. principal investigator

University of Tennessee Health Science Center and VA Medical Center Memphis

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 Discussion Groups and Education sessions in people with Spouses and Military Personnel, 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 4 inclusion and 2 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 30 Jul 2018. 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 30 Jul 2018). 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 Anxiety (time frame: Baseline, 6 months, and 12 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 NCT01121250, which also lists 2 linked publications.

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 30 Jul 2018.