Psychological StressNCT03308344
Mindfulness Training in Military Spouses
A study testing Mindfulness training in people with Psychological Stress, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress
- What is being tested?
- Mindfulness training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2017to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking
- Being in a relationship or married to U.S. Army active-duty member or veteran.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Wellbeing in Military Spouses With Training
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.
Read the 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.
- Conditions
- Psychological Stress
- Being tested
- Mindfulness training
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness trainingBehavioural
The present MT program includes topics related to mindfulness, emotion regulation, and connection. It will be delivered in short, weekly sessions.
| Study group | Role | What they receive |
|---|---|---|
| Spouse Trainers (MT-ST) | Experimental | Participants will engage in a short-form mindfulness training delivered by their peers who underwent an extensive training practicum. Receives: 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. Receives: Behavioral: Mindfulness training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start2 Oct 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amishi Jha, University of Miami
- Investigators
- Amishi Jha, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308344
- Sponsor's protocol ID
- 20120295
- Status last verified
- Aug 2019
- First submitted
- 6 Oct 2017
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25671579Jha 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.
PubMed 20141302Mansfield 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.
PubMed 20071699
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Wellbeing in Military Spouses With Training
- ClinicalTrials.gov ID
- NCT03308344
- Acronym / sponsor ID
- 20120295
- Conditions
- Psychological Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 12 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Spouse Trainers (MT-ST) | Experimental | Behavioral: Mindfulness trainingParticipants will engage in a short-form mindfulness training delivered by their peers who underwent an extensive training practicum. |
| 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 | Behavioral: Mindfulness trainingParticipants will engage in a short-form mindfulness training delivered by an expert mindfulness trainer. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English-speaking
- Being in a relationship or married to U.S. Army active-duty member or veteran.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness trainingThe present MT program includes topics related to mindfulness, emotion regulation, and connection. It will be delivered in short, weekly sessions. | Behavioural | Mindfulness Expert (MT-ME), Spouse Trainers (MT-ST) |
Primary outcome
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.
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
13 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
Demographic Questions
Time frame: Demographic questions will only be asked at the pre-intervention baseline (testing 1).
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Background: PubMed 25671579Jha 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.
- Background: PubMed 20141302Jha 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.
- Background: PubMed 20071699Mansfield 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.
- Individual participant dataSharing planned: No
Related trials for Psychological Stress
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Recruiting
Heat and Mental Health - PART 2
Depressed Mood, Young Adults
Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Active, not recruiting
AI Ambient Scribe in Psychiatry
Therapeutic Alliance, Empathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amishi Jha, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness training in people with Psychological Stress, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03308344, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.