NCT02852174

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

1.5 years

First QC Date

July 28, 2016

Last Update Submit

April 28, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stress

    Perceived levels of stress

    8 weeks

Secondary Outcomes (1)

  • Depressed mood

    8 weeks

Other Outcomes (2)

  • Anxiety

    8 weeks

  • Worry

    8 weeks

Study Arms (2)

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.

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.

Interventions

Mindfulness meditation training

Mindfulness group

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • The presence of significant psychiatric disorders other than depression or anxiety (e.g., bipolar disorder, substance abuse, actively suicidal)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana-Champaign

Champaign, Illinois, 61820, United States

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 2, 2016

Study Start

May 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

May 1, 2018

Record last verified: 2018-04

Locations