NCT03308344

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

1.8 years

First QC Date

October 6, 2017

Last Update Submit

August 2, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (13)

  • Change in Positive and Negative Affect Scale (PANAS)

    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)

    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)

    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)

    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)

    Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.

  • +8 more secondary outcomes

Study Arms (3)

Spouse Trainers (MT-ST)

EXPERIMENTAL

Participants will engage in a short-form mindfulness training delivered by their peers who underwent an extensive training practicum.

Behavioral: Mindfulness training

Wait-list control

NO INTERVENTION

Participants will be tested before and after a no-training interval and may receive training at a later time.

Mindfulness Expert (MT-ME)

EXPERIMENTAL

Participants will engage in a short-form mindfulness training delivered by an expert mindfulness trainer.

Behavioral: Mindfulness training

Interventions

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

Mindfulness Expert (MT-ME)Spouse Trainers (MT-ST)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English-speaking
  • Being in a relationship or married to U.S. Army active-duty member or veteran.

You may not qualify if:

  • A non-controlled severe medical disease that might interfere with the performance in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

Related 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.

    PMID: 25671579BACKGROUND
  • 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.

    PMID: 20141302BACKGROUND
  • 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.

    PMID: 20071699BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Amishi Jha, Ph.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 6, 2017

First Posted

October 12, 2017

Study Start

October 2, 2017

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

August 6, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations