Military SpousesNCT00870545

Reintegration: The Role of Spouse Telephone BATTLEMIND Pilot Study

A study testing Telephone support groups in people with Military Spouses and Support Groups, 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?: Any age
Conditions the study is for: Military Spouses, Support Groups, Stress Disorders
What is being tested?: Telephone support groups
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 86 participants
Where: 1 siteUnited States
Study dates: Sep 2009to Nov 2011
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
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

have a spouse who participated in OEF/OIF and is at least 1 month post-deployment;
if not married, must have lived as married for at least one year;
live with the service member when not deployed;
have been a spouse/significant other throughout the service member's deployment period;
and have a telephone.

Who cannot join

current diagnosis of schizophrenia or other major mental illness;
auditory impairment that would make telephone use difficult; or
service member refusal of assent for spouse to participate.

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

This study will expand the Department of Defense (DoD) one time, face-to-face post deployment BATTLEMIND training for spouses of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Guard/Reserve service members into year-long, telephone groups focusing on education, skills building and support. The goal is to build spouses' resilience to cope with reintegration, help them serve as a support system for returning service members, and ease the transition for families post-deployment.

Conditions: Military Spouses, Support Groups, Stress Disorders, Combat Disorders
Being tested: Telephone support groups
Keywords: spouses, social support, reintegration, families, military, post deployment, OEF/OIF
Medical subject headings: Stress Disorders, Traumatic, Combat Disorders

What participants receive

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

Telephone support groupsBehavioural
There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.

Study groups in NCT00870545
Study group	Role	What they receive
Telephone support	Experimental	12 telephone support group sessions based on the letters of the word BATTLEMIND Receives: Behavioral: Telephone support groups

What is being measured

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

Spouse Self-report of Depression
Depression measured with the Patient Health Questionnaire (PHQ)-9 at baseline, six and 12 months. Scores range from 0-27 with lower scores indicating less depressive symptoms.
Measured: Baseline, 6 months, and 12 months
Anxiety
Anxiety measured with the Generalized Anxiety Disorder -7 (GAD-7)measured at baseline, six and 12 months. Scores range from 0-21, with lower scores indicating fewer anxiety symptoms.
Measured: baseline, 6 months and 12 months
Quality of Marriage
Measure of marriage quality using Quality Marriage Index at baseline, six and 12 months. Scores range from 6-45 with higher scores indicating better quality of marriage.
Measured: Baseline, 6 and 12 months

Secondary outcomes (3)

Family Coping
Family problem solving measured at baseline, six and 12 months with the F-COPES measure. Scores range from 29-145 with higher scores indicating better coping.
Measured: Baseline, 6 months and 12 months
Spouse Social Support
Support measured with the Social Support Index at baseline, six and 12 months. Scores range from 0-68 with higher scores indicating better social support.
Measured: baseline, 6 months, and 12 months
Family Communication
Family communication measured with the Family Problem Solving Communication scale at baseline, six and 12 months. Scores range from 0-30 with higher scores indicating better communication.
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.

Sep 2009Nov 2011

First posted27 Mar 2009 (estimated)
Study startSep 2009
Primary completionJul 2011
Study completionNov 2011

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 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00870545
Sponsor's protocol ID: PT074804
Status last verified: Jun 2017
First submitted: 25 Mar 2009
Last updated: 28 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reintegration: The Role of Spouse Telephone BATTLEMIND Pilot Study
ClinicalTrials.gov ID: NCT00870545
Acronym / sponsor ID: PT074804
Conditions: Military Spouses, Support Groups, Stress Disorders, Combat Disorders
Keywords: spouses, social support, reintegration, families, military, post deployment, OEF/OIF
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: Memphis VA Medical CenterUS federal agency
Collaborators: United States Department of Defense
Study start: Sep 2009
Primary completion: Jul 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 27 Mar 2009 (estimated)
Results: Posted 4 Jun 2013

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Telephone support	Experimental	Behavioral: Telephone support groups12 telephone support group sessions based on the letters of the word BATTLEMIND

Who may qualify

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

Key inclusion criteria (5 listed)

have a spouse who participated in OEF/OIF and is at least 1 month post-deployment;
if not married, must have lived as married for at least one year;
live with the service member when not deployed;
have been a spouse/significant other throughout the service member's deployment period;
and have a telephone.

Key exclusion criteria (3 listed)

current diagnosis of schizophrenia or other major mental illness;
auditory impairment that would make telephone use difficult; or
service member refusal of assent for spouse to participate.

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 groupsThere was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.	Behavioural	Telephone support

Primary outcome

Spouse Self-report of Depression
Time frame: Baseline, 6 months, and 12 months
Depression measured with the Patient Health Questionnaire (PHQ)-9 at baseline, six and 12 months. Scores range from 0-27 with lower scores indicating less depressive symptoms.
Anxiety
Time frame: baseline, 6 months and 12 months
Anxiety measured with the Generalized Anxiety Disorder -7 (GAD-7)measured at baseline, six and 12 months. Scores range from 0-21, with lower scores indicating fewer anxiety symptoms.
Quality of Marriage
Time frame: Baseline, 6 and 12 months
Measure of marriage quality using Quality Marriage Index at baseline, six and 12 months. Scores range from 6-45 with higher scores indicating better quality of marriage.

3 secondary outcomes

Family Coping
Time frame: Baseline, 6 months and 12 months
Spouse Social Support
Time frame: baseline, 6 months, and 12 months
Family Communication
Time frame: baseline, 6 months, and 12 months

Results and safety

Results posted to the registry on 4 Jun 2013, 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	86	69

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 Support n = 86
Depression score at baseline (n=86)	8.9 (5.9)
Depression score at 6 months (n=77)	7.4 (5.6)
Depression score at 12 months (n=70)	6.9 (5.7)

Telephone Support: p = .003, Mixed Models Analysis

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

Primary outcome: Anxiety

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

Measure	Telephone Support n = 86
Anxiety score at baseline (n=86)	8.9 (5.7)
Anxiety score at 6 months (n=77)	6.7 (5.1)
Anxiety score at 12 months (n=70)	6.7 (5.6)

Telephone Support: p <.001, Mixed Models Analysis

Population analysed: All participants with anxiety scores at 12 months

Primary outcome: Quality of Marriage

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

Measure	Telephone Support n = 86
Marriage quality score at baseline (n=86)	32.7 (8.0)
Marriage quality score at 6 months (n=77)	31.6 (9.9)
Marriage quality score at 12 months (n=70)	31.9 (9.8)

Telephone Support: p = .26, Mixed Models Analysis

Population analysed: All participants with quality marriage index scores at the three time points

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telephone Support	0 of 86 (0%)	0 of 86 (0%)	0 of 86

Limitations and caveats (from the sponsor): Small sample size, some of the Wounded Warrior Project spouses knew each other, pilot feasibility study and not a randomized controlled trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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

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 in people with Military Spouses and Support Groups, 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 5 inclusion and 3 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 28 Jun 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 4 Jun 2013). 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 Depression (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 NCT00870545.

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 28 Jun 2017.