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The Veteran Caregiver Reducing Stress Time (VetCareReST) Study (VetCareReST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02852174
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Sandraluz Lara-Cinisomo, University of Illinois at Urbana-Champaign

Tracking Information
First Submitted Date  ICMJE July 28, 2016
First Posted Date  ICMJE August 2, 2016
Last Update Posted Date May 1, 2018
Actual Study Start Date  ICMJE May 2016
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
Stress [ Time Frame: 8 weeks ]
Perceived levels of stress
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
Depressed mood [ Time Frame: 8 weeks ]
Depressive symptoms
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 28, 2018)
  • Anxiety [ Time Frame: 8 weeks ]
    Anxious symptoms
  • Worry [ Time Frame: 8 weeks ]
    Worried feelings
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Veteran Caregiver Reducing Stress Time (VetCareReST) Study
Official Title  ICMJE Mindfulness-Based Stress Reduction for Wounded Warrior Caregivers
Brief 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, 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stress, Depression, Anxiety and Worry
Intervention  ICMJE Behavioral: Mindfulness meditation training
Mindfulness meditation training
Study Arms  ICMJE
  • Experimental: Mindfulness group
    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.
    Intervention: Behavioral: Mindfulness meditation training
  • No Intervention: Control
    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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2018)
30
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2016)
136
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • The presence of significant psychiatric disorders other than depression or anxiety (e.g., bipolar disorder, substance abuse, actively suicidal)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02852174
Other Study ID Numbers  ICMJE 16648
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sandraluz Lara-Cinisomo, University of Illinois at Urbana-Champaign
Study Sponsor  ICMJE Sandraluz Lara-Cinisomo
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Illinois at Urbana-Champaign
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP