Mindfulness Training in Military Spouses
Primary Purpose
Psychological Stress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness training
Sponsored by
About this trial
This is an interventional basic science trial for Psychological Stress
Eligibility Criteria
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.
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
Experimental
Arm Label
Spouse Trainers (MT-ST)
Wait-list control
Mindfulness Expert (MT-ME)
Arm Description
Participants will engage in a short-form mindfulness training delivered by their peers who underwent an extensive training practicum.
Participants will be tested before and after a no-training interval and may receive training at a later time.
Participants will engage in a short-form mindfulness training delivered by an expert mindfulness trainer.
Outcomes
Primary Outcome Measures
Change in Sustained Attention to Response Task (SART)
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 in Working Memory task (WM)
WMMW is used to assess working memory performance
Secondary Outcome Measures
Change in Positive and Negative Affect Scale (PANAS)
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.
Change in Perceived Stress Scale (PSS)
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 in Self-Compassion Scale (SCQ)
SCQ assesses self-compassion.
Change in Center for Epidemiological Studies Depression Scale (CES-D)
This 20-item scale measures the major components of depressive symptomatology in the general population (i.e., nonpsychiatric persons older than 18).
Change in Anxiety Sensitivity Index (ASI)
ASI assesses the construct of anxiety sensitivity.
Change in Perseverative Thoughts Questionnaire (PTQ)
PTQ assesses stress due to reoccurring thoughts
Change in Marital Satisfaction
Marital Satisfaction questionnaire assesses the level of marital satisfaction.
Practice Logs
Practice logs will be used to keep track of participants' daily mindfulness practice.
Demographic Questions
General demographic questions will be asked to gather information about the participants, i.e. gender, age, partner ranking, partner deployment status etc.
Change in Cognitive Failures Questionnaire (CFQ)
CFQ assesses one's attention and awareness.
Feedback regarding the training
If participants were part of any of the training groups, they will be asked to provide feedback of the training.
Feedback regarding the testing
A 10-item questionnaire for participants to express their views and motivations about the tasks completed during the testing session.
General questions regarding life tendencies
General questions regarding life tendencies in a variety of situations during the past two weeks.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03308344
Brief Title
Mindfulness Training in Military Spouses
Official Title
Promoting Wellbeing in Military Spouses With Training
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project aims to contextualize the delivery of mindfulness training for military spouses and evaluate its effectiveness on measures of executive functions and psychological well-being.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned into three groups: (i) a mindfulness training with spouse trainers (MT-ST, n = 60) that will receive the training from peers who underwent an extensive training practicum; (ii) a mindfulness training with mindfulness expert trainer group (MT-ME, n = 30) that will receive the training from a mindfulness expert trainer; and (ii) a wait-list control group (WLC, n = 30) that will be tested before and after a no-training interval and may receive MT at a later time after their second testing if they are interested.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spouse Trainers (MT-ST)
Arm Type
Experimental
Arm Description
Participants will engage in a short-form mindfulness training delivered by their peers who underwent an extensive training practicum.
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
Participants will be tested before and after a no-training interval and may receive training at a later time.
Arm Title
Mindfulness Expert (MT-ME)
Arm Type
Experimental
Arm Description
Participants will engage in a short-form mindfulness training delivered by an expert mindfulness trainer.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness training
Intervention Description
The present MT program includes topics related to mindfulness, emotion regulation, and connection. It will be delivered in short, weekly sessions.
Primary Outcome Measure Information:
Title
Change in Sustained Attention to Response Task (SART)
Description
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.
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.
Title
Change in Working Memory task (WM)
Description
WMMW is used to assess working memory performance
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.
Secondary Outcome Measure Information:
Title
Change in Positive and Negative Affect Scale (PANAS)
Description
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.
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.
Title
Change in Perceived Stress Scale (PSS)
Description
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.
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.
Title
Change in Self-Compassion Scale (SCQ)
Description
SCQ assesses self-compassion.
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.
Title
Change in Center for Epidemiological Studies Depression Scale (CES-D)
Description
This 20-item scale measures the major components of depressive symptomatology in the general population (i.e., nonpsychiatric persons older than 18).
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.
Title
Change in Anxiety Sensitivity Index (ASI)
Description
ASI assesses the construct of anxiety sensitivity.
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.
Title
Change in Perseverative Thoughts Questionnaire (PTQ)
Description
PTQ assesses stress due to reoccurring thoughts
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.
Title
Change in Marital Satisfaction
Description
Marital Satisfaction questionnaire assesses the level of 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.
Title
Practice Logs
Description
Practice logs will be used to keep track of participants' daily mindfulness practice.
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.
Title
Demographic Questions
Description
General demographic questions will be asked to gather information about the participants, i.e. gender, age, partner ranking, partner deployment status etc.
Time Frame
Demographic questions will only be asked at the pre-intervention baseline (testing 1).
Title
Change in Cognitive Failures Questionnaire (CFQ)
Description
CFQ assesses one's attention and awareness.
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.
Title
Feedback regarding the training
Description
If participants were part of any of the training groups, they will be asked to provide feedback of 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.
Title
Feedback regarding the testing
Description
A 10-item questionnaire for participants to express their views and motivations about the tasks completed during the testing session.
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.
Title
General questions regarding life tendencies
Description
General questions regarding life tendencies in a variety of situations during the past two weeks.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amishi Jha, Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25671579
Citation
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.
Results Reference
background
PubMed Identifier
20141302
Citation
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.
Results Reference
background
PubMed Identifier
20071699
Citation
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.
Results Reference
background
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Mindfulness Training in Military Spouses
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