Stress, Depression, Anxiety and WorryVetCareReSTNCT02852174
The Veteran Caregiver Reducing Stress Time (VetCareReST) Study
A study testing Mindfulness meditation training in people with Stress, Depression, Anxiety and Worry, run by Sandraluz Lara-Cinisomo at 1 site in United States.
Trial summary
Caring for a disabled adult, particularly those with long-lasting impairment, has been associated with elevated levels of stress, depression and anxiety among caregivers.Recent studies show that veteran caregivers experience higher levels of psychological distress than caregivers in the general population… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Depression, Anxiety and Worry
- What is being tested?
- Mindfulness meditation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Nov 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide unpaid caregiver or support to a veteran
- Must be 18 years of age or older
- Willing to participate for the duration of the project
- Able to track his/her home practice in a handwritten log
- Have no significant psychiatric disorders other than depression or anxiety (e.g., bipolar disorder, substance abuse, actively suicidal)
Who cannot join
- The presence of significant psychiatric disorders other than depression or anxiety (e.g., bipolar disorder, substance abuse, actively suicidal)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Champaign, Illinois, 61820
About this study
Official title: Mindfulness-Based Stress Reduction for Wounded Warrior Caregivers
Caring for a disabled adult, particularly those with long-lasting impairment, has been associated with elevated levels of stress, depression and anxiety among caregivers.Recent studies show that veteran caregivers experience higher levels of psychological distress than caregivers in the general population, highlighting the psychological needs of this population. The Veteran Caregiver Reducing Stress Time (VetCareReST) is a randomized control trial designed to test the effectiveness of a mindfulness at reducing stress, depression and anxiety in veteran caregivers in Champaign and Danville County.
Read the detailed description
Recent estimates indicate that there are 275,000 to one million informal veteran caregivers. Caring for a disabled adult, particularly those with long-lasting impairment, has been associated with elevated levels of stress, depression and anxiety among caregivers. Veteran caregivers are especially vulnerable because of competing demands. For instance, Post 9/11 veteran caregivers are more likely to be the spouse of a veteran, and have experienced the stress of multiple deployments, have a young child in their care, and work outside the home. Recent studies show that veteran caregivers experience higher levels of psychological distress than caregivers in the general population, highlighting the psychological needs of this population. One effective approach at reducing stress, depression and anxiety has been the use of mindfulness training, which has been shown to effectively reduce mood symptoms among professional caregivers. The Veteran Caregiver Reducing Stress Time (VetCareReST) is a randomized control trial designed to test the effectiveness of a mindfulness at reducing stress, depression and anxiety in veteran caregivers in Champaign and Danville County. This study builds on Dr. Lara-Cinisomo's (PI) experience with military spouses. The findings from this trial will serve as pilot data for a large-scale study.
- Conditions
- Stress, Depression, Anxiety and Worry
- Being tested
- Mindfulness meditation training
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditation trainingBehavioural
Mindfulness meditation training
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness group | Experimental | The treatment groups will participate in a mindfulness intervention training that will meet for 2 hours once a week for eight weeks. The 8-week program provides participants with 2-hour weekly instruction designed to teach specific skills and how to apply them during stressful situations (e.g., when caring for or advocating for the veteran).Mindfulness training also requires that participants engage in daily home practice for 30 to 40 minutes. Participants will be required to record the duration of the meditation in log sheets. Receives: Behavioral: Mindfulness meditation training |
| Control | No intervention | Participants in the control may receive the mindfulness training after the wait period ends at which point they may receive the treatment as described above. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress
Perceived levels of stress
Measured: 8 weeks
Secondary outcomes (1)
Depressed mood
Depressive symptoms
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, Depression, Anxiety and WorryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandraluz Lara-Cinisomo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sandraluz Lara-Cinisomo, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852174
- Sponsor's protocol ID
- 16648
- Acronym
- VetCareReST
- Status last verified
- Apr 2018
- First submitted
- 28 Jul 2016
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Stress Reduction for Wounded Warrior Caregivers
- ClinicalTrials.gov ID
- NCT02852174
- Acronym / sponsor ID
- VetCareReST / 16648
- Conditions
- Stress, Depression, Anxiety and Worry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sandraluz Lara-CinisomoUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 2 Aug 2016 (estimated)
- 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.
Caring for a disabled adult, particularly those with long-lasting impairment, has been associated with elevated levels of stress, depression and anxiety among caregivers.Recent studies show that veteran caregivers experience higher levels of psychological distress than caregivers in the general population, highlighting the psychological needs of this population. The Veteran Caregiver Reducing Stress Time (VetCareReST) is a randomized control trial designed to test the effectiveness of a mindfulness at reducing stress, depression and anxiety in veteran caregivers in Champaign and Danville County.
Detailed description
Recent estimates indicate that there are 275,000 to one million informal veteran caregivers. Caring for a disabled adult, particularly those with long-lasting impairment, has been associated with elevated levels of stress, depression and anxiety among caregivers. Veteran caregivers are especially vulnerable because of competing demands. For instance, Post 9/11 veteran caregivers are more likely to be the spouse of a veteran, and have experienced the stress of multiple deployments, have a young child in their care, and work outside the home. Recent studies show that veteran caregivers experience higher levels of psychological distress than caregivers in the general population, highlighting the psychological needs of this population. One effective approach at reducing stress, depression and anxiety has been the use of mindfulness training, which has been shown to effectively reduce mood symptoms among professional caregivers. The Veteran Caregiver Reducing Stress Time (VetCareReST) is a randomized control trial designed to test the effectiveness of a mindfulness at reducing stress, depression and anxiety in veteran caregivers in Champaign and Danville County. This study builds on Dr. Lara-Cinisomo's (PI) experience with military spouses. The findings from this trial will serve as pilot data for a large-scale study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness group | Experimental | Behavioral: Mindfulness meditation trainingThe treatment groups will participate in a mindfulness intervention training that will meet for 2 hours once a week for eight weeks. The 8-week program provides participants with 2-hour weekly instruction designed to teach specific skills and how to apply them during stressful situations (e.g., when caring for or advocating for the veteran).Mindfulness training also requires that participants engage in daily home practice for 30 to 40 minutes. Participants will be required to record the duration of the meditation in log sheets. |
| Control | No intervention | –Participants in the control may receive the mindfulness training after the wait period ends at which point they may receive the treatment as described above. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provide unpaid caregiver or support to a veteran
- Must be 18 years of age or older
- Willing to participate for the duration of the project
- Able to track his/her home practice in a handwritten log
- Have no significant psychiatric disorders other than depression or anxiety (e.g., bipolar disorder, substance abuse, actively suicidal)
Key exclusion criteria (1 listed)
- The presence of significant psychiatric disorders other than depression or anxiety (e.g., bipolar disorder, substance abuse, actively suicidal)
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 meditation trainingMindfulness meditation training | Behavioural | Mindfulness group |
Primary outcome
Stress
Time frame: 8 weeks
Perceived levels of stress
1 secondary outcome
Depressed mood
Time frame: 8 weeks
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 1 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 meditation training in people with Stress, Depression, Anxiety and Worry, run by Sandraluz Lara-Cinisomo 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 5 inclusion and 1 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 1 May 2018. 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?
Stress (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2018.