Mindfulness Training in Military Spouses

Psychological Stress Clinical Trial

Official title:

Promoting Wellbeing in Military Spouses With Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03308344
• Other study ID #: 20120295
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychological Stress
• Stress, Psychological

Intervention

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

Locations

Country	Name	City	State
United States	University of Miami	Coral Gables	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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).
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.