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

Primary Purpose

Stress, Depression, Anxiety and Worry

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness meditation training
Sponsored by
Sandraluz Lara-Cinisomo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Depression, Anxiety and Worry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Illinois at Urbana-Champaign

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindfulness group

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Stress
Perceived levels of stress

Secondary Outcome Measures

Depressed mood
Depressive symptoms

Full Information

First Posted
July 28, 2016
Last Updated
April 28, 2018
Sponsor
Sandraluz Lara-Cinisomo
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1. Study Identification

Unique Protocol Identification Number
NCT02852174
Brief Title
The Veteran Caregiver Reducing Stress Time (VetCareReST) Study
Acronym
VetCareReST
Official Title
Mindfulness-Based Stress Reduction for Wounded Warrior Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sandraluz Lara-Cinisomo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Depression, Anxiety and Worry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness meditation training
Intervention Description
Mindfulness meditation training
Primary Outcome Measure Information:
Title
Stress
Description
Perceived levels of stress
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Depressed mood
Description
Depressive symptoms
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Anxiety
Description
Anxious symptoms
Time Frame
8 weeks
Title
Worry
Description
Worried feelings
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
University of Illinois at Urbana-Champaign
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States

12. IPD Sharing Statement

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The Veteran Caregiver Reducing Stress Time (VetCareReST) Study

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