Clinical trial NCT03308344: Mindfulness Training in Military Spouses
Official title: Promoting Wellbeing in Military Spouses With Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Stress
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Change in Sustained Attention to Response Task (SART)
timeFrame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
measure: Change in Working Memory task (WM)
timeFrame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
Secondary outcomes:
measure: Change in Positive and Negative Affect Scale (PANAS)
timeFrame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
measure: Change in Perceived Stress Scale (PSS)
timeFrame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
measure: Change in Self-Compassion Scale (SCQ)
timeFrame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
measure: Change in Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
measure: Change in Anxiety Sensitivity Index (ASI)
timeFrame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
measure: Change in Perseverative Thoughts Questionnaire (PTQ)
timeFrame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
measure: Change in Marital Satisfaction
timeFrame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
measure: Practice Logs
timeFrame: 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.
measure: Demographic Questions
timeFrame: Demographic questions will only be asked at the pre-intervention baseline (testing 1).
measure: Change in Cognitive Failures Questionnaire (CFQ)
timeFrame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
measure: Feedback regarding the training
timeFrame: Feedback questions will be asked only at the second testing session (testing 2), which is an average of 5 weeks from the baseline.
measure: Feedback regarding the testing
timeFrame: Feedback questions will be asked only at the second testing session (testing 2), which is an average of 5 weeks from the baseline.
measure: General questions regarding life tendencies
timeFrame: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Amishi Jha, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.