- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03308344
Mindfulness Training in Military Spouses
Promoting Wellbeing in Military Spouses With Training
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In addition to psychological and physical health challenges that military service members face, military deployment is known to have deleterious effects on the entire family unit. The January 2010 issue of the New England Journal of Medicine reported medical data from over 250,000 wives of deployed soldiers. These women suffered from clinically significant levels of anxiety, depression, sleep disturbances, and adjustment disorders. Thus, the psychological profile of military spouses sadly parallels that of the military servicemembers. Unfortunately, the effect of deployment on the psychological health in military spouses is largely unstudied, and very few resilience-building programs are available for military families.
Prior research showed that mindfulness training (MT), as a resilience-building program in civilian and military servicemembers, can effectively protect against degradation in of executive functions (i.e., attention, working memory) and benefit psychological well-being over high-demand intervals. While research evidence mounts that MT is beneficial for service members, there is almost no research examining the impact of MT on military spouses' cognitive functioning and psychological well-being.
The present study aims to investigate if MT may successfully benefit cognitive functioning and psychological well-being in military spouses.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Coral Gables, Florida, United States, 33146
- University of Miami
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- English-speaking
- Being in a relationship or married to U.S. Army active-duty member or veteran.
Exclusion Criteria:
- A non-controlled severe medical disease that might interfere with the performance in the study.
- Any other condition that the investigator might deem problematic for the inclusion of the volunteer in a training study of this nature.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Spouse Trainers (MT-ST)
Participants will engage in a short-form mindfulness training delivered by their peers who underwent an extensive training practicum.
|
The present MT program includes topics related to mindfulness, emotion regulation, and connection.
It will be delivered in short, weekly sessions.
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NO_INTERVENTION: Wait-list control
Participants will be tested before and after a no-training interval and may receive training at a later time.
|
|
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EXPERIMENTAL: Mindfulness Expert (MT-ME)
Participants will engage in a short-form mindfulness training delivered by an expert mindfulness trainer.
|
The present MT program includes topics related to mindfulness, emotion regulation, and connection.
It will be delivered in short, weekly sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Sustained Attention to Response Task (SART)
Time Frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
SART is used to assess attentional performance and mind wandering.
The task uses a continuous performance paradigm involving button presses to frequently presented non-targets (numbers 1, 2, 4, 5, 6, 7, 8, and 9) but requires the participants to withhold their motor response to the infrequent target (number 3).
The subjective experience of mind wandering during SART is assessed through experience sampling probes randomly presented throughout the task.
|
Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
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Change in Working Memory task (WM)
Time Frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
WMMW is used to assess working memory performance
|
Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Positive and Negative Affect Scale (PANAS)
Time Frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
PANAS assesses positive and negative affect.
It consists of a list of descriptors of positive (e.g., 'interested', 'enthusiastic') and negative (e.g., 'irritable', 'upset') affects.
Items are rated on a 5-point scale (1 = very slightly or not at all, 5 = extremely), according to how participants feel.
The Positive Affect scale reflects the extent to which a person feels enthusiastic, active, and alert; the Negative Affect scale reflects unpleasant mood states, such as anger, disgust, and fear.
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Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
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|
Change in Perceived Stress Scale (PSS)
Time Frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
PSS assesses the degree to which situations in one's life are viewed as stressful within the past month.
Individual items assess feelings of stress, nervousness, irritation at life's hassles, and perceptions of one's own coping and control over a situation.
|
Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
|
Change in Self-Compassion Scale (SCQ)
Time Frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
SCQ assesses self-compassion.
|
Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
|
Change in Center for Epidemiological Studies Depression Scale (CES-D)
Time Frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
This 20-item scale measures the major components of depressive symptomatology in the general population (i.e., nonpsychiatric persons older than 18).
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Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
|
Change in Anxiety Sensitivity Index (ASI)
Time Frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
ASI assesses the construct of anxiety sensitivity.
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Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
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Change in Perseverative Thoughts Questionnaire (PTQ)
Time Frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
PTQ assesses stress due to reoccurring thoughts
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Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
|
Change in Marital Satisfaction
Time Frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
Marital Satisfaction questionnaire assesses the level of marital satisfaction.
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Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
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Practice Logs
Time Frame: Participants will complete paper practice logs tracking their daily practice (i.e., minutes) from the beginning through the study completion, which is an average of 5 weeks after the beginning of the intervention.
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Practice logs will be used to keep track of participants' daily mindfulness practice.
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Participants will complete paper practice logs tracking their daily practice (i.e., minutes) from the beginning through the study completion, which is an average of 5 weeks after the beginning of the intervention.
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Demographic Questions
Time Frame: Demographic questions will only be asked at the pre-intervention baseline (testing 1).
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General demographic questions will be asked to gather information about the participants, i.e. gender, age, partner ranking, partner deployment status etc.
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Demographic questions will only be asked at the pre-intervention baseline (testing 1).
|
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Change in Cognitive Failures Questionnaire (CFQ)
Time Frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
CFQ assesses one's attention and awareness.
|
Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
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Feedback regarding the training
Time Frame: Feedback questions will be asked only at the second testing session (testing 2), which is an average of 5 weeks from the baseline.
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If participants were part of any of the training groups, they will be asked to provide feedback of the training.
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Feedback questions will be asked only at the second testing session (testing 2), which is an average of 5 weeks from the baseline.
|
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Feedback regarding the testing
Time Frame: Feedback questions will be asked only at the second testing session (testing 2), which is an average of 5 weeks from the baseline.
|
A 10-item questionnaire for participants to express their views and motivations about the tasks completed during the testing session.
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Feedback questions will be asked only at the second testing session (testing 2), which is an average of 5 weeks from the baseline.
|
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General questions regarding life tendencies
Time Frame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
General questions regarding life tendencies in a variety of situations during the past two weeks.
|
Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amishi Jha, Ph.D., University of Miami
Publications and helpful links
General Publications
- Jha AP, Morrison AB, Dainer-Best J, Parker S, Rostrup N, Stanley EA. Minds "at attention": mindfulness training curbs attentional lapses in military cohorts. PLoS One. 2015 Feb 11;10(2):e0116889. doi: 10.1371/journal.pone.0116889. eCollection 2015.
- Jha AP, Stanley EA, Kiyonaga A, Wong L, Gelfand L. Examining the protective effects of mindfulness training on working memory capacity and affective experience. Emotion. 2010 Feb;10(1):54-64. doi: 10.1037/a0018438.
- Mansfield AJ, Kaufman JS, Marshall SW, Gaynes BN, Morrissey JP, Engel CC. Deployment and the use of mental health services among U.S. Army wives. N Engl J Med. 2010 Jan 14;362(2):101-9. doi: 10.1056/NEJMoa0900177.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20120295
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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