Mindfulness Training in Military Spouses

Study Overview
=================
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.

Official Title
-----------------
Promoting Wellbeing in Military Spouses With Training

Conditions
-----------------
Psychological Stress

Intervention / Treatment
-----------------
* Behavioral: Mindfulness training


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spouse Trainers (MT-ST)<br>Participants will engage in a short-form mindfulness training delivered by their peers who underwent an extensive training practicum. | Behavioral: Mindfulness training<br>* The present MT program includes topics related to mindfulness, emotion regulation, and connection. It will be delivered in short, weekly sessions.<br>|
| No Intervention: Wait-list control<br>Participants will be tested before and after a no-training interval and may receive training at a later time. | |
| Experimental: Mindfulness Expert (MT-ME)<br>Participants will engage in a short-form mindfulness training delivered by an expert mindfulness trainer. | Behavioral: Mindfulness training<br>* The present MT program includes topics related to mindfulness, emotion regulation, and connection. It will be delivered in short, weekly sessions.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline. | 
| Change in Working Memory task (WM) | 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) | 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 from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline. | 
| 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 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) | 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) | This 20-item scale measures the major components of depressive symptomatology in the general population (i.e., nonpsychiatric persons older than 18). | 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) | ASI assesses the construct of anxiety sensitivity. | 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 Perseverative Thoughts Questionnaire (PTQ) | PTQ assesses stress due to reoccurring thoughts | 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 | Marital Satisfaction questionnaire assesses the level of marital satisfaction. | Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline. | 
| Practice Logs | Practice logs will be used to keep track of participants' daily mindfulness practice. | 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. | 
| Demographic Questions | General demographic questions will be asked to gather information about the participants, i.e. gender, age, partner ranking, partner deployment status etc. | Demographic questions will only be asked at the pre-intervention baseline (testing 1). | 
| Change in Cognitive Failures Questionnaire (CFQ) | 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. | 
| 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 questions will be asked only at the second testing session (testing 2), which is an average of 5 weeks from the baseline. | 
| Feedback regarding the testing | A 10-item questionnaire for participants to express their views and motivations about the tasks completed during the testing session. | Feedback questions will be asked only at the second testing session (testing 2), which is an average of 5 weeks from the baseline. | 
| General questions regarding life tendencies | 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. |