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Completed

NCT Number: NCT03308344

Mindfulness Training in Military Spouses

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Coral Gables, Florida, 33146, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness Training

Behavioral

The present MT program includes topics related to mindfulness, emotion regulation, and connection. It will be delivered in short, weekly sessions.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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

  7. 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.

  8. 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.

    Practice logs will be used to keep track of participants' daily mindfulness practice.

  9. Demographic Questions

    Time frame: Demographic questions will only be asked at the pre-intervention baseline (testing 1).

    General demographic questions will be asked to gather information about the participants, i.e. gender, age, partner ranking, partner deployment status etc.

  10. 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.

  11. 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.

    If participants were part of any of the training groups, they will be asked to provide feedback of the training.

  12. 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.

  13. 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Promoting Wellbeing in Military Spouses With Training

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 12, 2017
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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