Mindfulness and Support Group to Improve Patient and Caregiver Burden in Cirrhosis
Primary Purpose
Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness and Support Groups
Sponsored by
About this trial
This is an interventional treatment trial for Cirrhosis
Eligibility Criteria
Patients
Inclusion Criteria:
- Cirrhosis proven by radiology, endoscopy (esophageal varices present) or biopsy
- Able to give informed consent as determined by the study staff
- Have a family member or caregiver who lives with them that is willing to participate
Exclusion Criteria:
- Unable to give consent
- Active psychosis
- Acute suicidal ideation
- No identified family member or caregiver
Caregivers/Family members:
Inclusion Criteria:
- Sharing living space with cirrhotic patient for at least 3 years
- Able and willing to participate in the groups
Exclusion Criteria:
- Unfamiliar with patient's routines and does not live in the same space
- Unwilling to consent or participate
Sites / Locations
- Hunter Holmes McGuire VA Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active group
Arm Description
Will get the mindfulness and support groups
Outcomes
Primary Outcome Measures
Beck Depression Inventory (patients)
Secondary Outcome Measures
Beck Anxiety Inventory (patients)
Zarit Burden Interview (caregivers only)
Sickness Impact Profile (patients)
Pittsburgh Sleep Quality Index (patients)
Epworth Sleepiness Scale (patients)
Full Information
NCT ID
NCT02944643
First Posted
October 24, 2016
Last Updated
January 11, 2017
Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02944643
Brief Title
Mindfulness and Support Group to Improve Patient and Caregiver Burden in Cirrhosis
Official Title
Mindfulness and Support Group to Improve Patient and Caregiver Burden in Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic liver disease and cirrhosis pose a huge financial burden to the health care system. This includes the cost of medical care, employment, disability-related issues and reduced survival. Specifically, the complication of cirrhosis known as hepatic encephalopathy (HE) especially hinders quality of life, the performance of activities of daily living and the ability to drive a motor vehicle in affected subjects. The hidden burden to family members and caregivers of these subjects, however, has been all but ignored to date. Evaluation of family members and caregivers is essential. The burden of caring for someone with liver disease can result in added cost for health care for family members and caregivers and is typically not recognized. The importance of the burden to families and family members or caregivers resulting from other neurological diseases such as Alzheimer's has been well evaluated and specific strategies to educate and counsel family members and caregivers have been elaborated. This is important because as the findings of this study have emerged, we have found that both Veterans and non-Veterans with cirrhosis and HE have a poor quality of life, worse socio-economic status and place a significantly higher burden on their family members or caregivers than those without HE
Detailed Description
The initial intake visit will include an overall assessment of the situation with the subject and family members or caregivers by the study physician and description of the group therapy. If the subjects and family members or caregivers want to continue, they will be asked to visit with the psychologist individually (subject first, then family member or caregiver, then both) in order to confirm their insight into the disease process and assess their readiness and appropriateness for the group therapy.
All concerns regarding confidentiality and details to be discussed during the group therapy sessions will be reiterated to subjects and family members or caregivers individually. They can then choose to participate or not. If they choose not to participate, they will be seen in 1- 3 months to complete the all tests / questionnaires detailed as in the measurements section
Subjects and family members or caregivers agreeing to participate in group therapy will be required to attend four weekly group therapy sessions in order for them to be considered as group therapy recipients. If they choose to terminate the group at any time, they will be free to do so and will be asked to complete all tests / questionnaires detailed as in the measurements section
GROUP INTERVENTION FORMAT:
Group therapy sessions will be conducted on a weekly basis over a four week period. The group therapy sessions will last approximately one hour. The group will not have a rolling admission meaning members will be required to attend all scheduled group sessions.
Measurements used:
QOL assessment using Sickness Impact Profile (a 136 item questionnaire)
Sleep assessment using Pittsburgh Sleep Quality Questionnaire (PQSI) and Epworth Sleepiness Scale (ESS)
Assessment of Depression and Anxiety using the Beck Questionnaires
Structure of the Groups:
Each group will begin with a review of what was learned in the group before and a review of the concrete goals/homework that the participants set from the last group. The group can work together to identify barriers and strategies.
Second portion of the group will focus on acquiring specific skills. These skills include Qigong (gentle movements), body scan, progressive relaxation, and loving-kindness meditation At the conclusion of the session, subjects, family members or caregivers core skills to be targeted as detailed below will be evaluated by the psychologists running the group.
Core Skills to be Targeted:
I. Stress Management II. Dealing with Depression III. Adjusting to Anxiety IV. Family Health and Changes in Roles
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active group
Arm Type
Experimental
Arm Description
Will get the mindfulness and support groups
Intervention Type
Other
Intervention Name(s)
Mindfulness and Support Groups
Primary Outcome Measure Information:
Title
Beck Depression Inventory (patients)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Beck Anxiety Inventory (patients)
Time Frame
4 weeks
Title
Zarit Burden Interview (caregivers only)
Time Frame
4 weeks
Title
Sickness Impact Profile (patients)
Time Frame
4 weeks
Title
Pittsburgh Sleep Quality Index (patients)
Time Frame
4 weeks
Title
Epworth Sleepiness Scale (patients)
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients
Inclusion Criteria:
Cirrhosis proven by radiology, endoscopy (esophageal varices present) or biopsy
Able to give informed consent as determined by the study staff
Have a family member or caregiver who lives with them that is willing to participate
Exclusion Criteria:
Unable to give consent
Active psychosis
Acute suicidal ideation
No identified family member or caregiver
Caregivers/Family members:
Inclusion Criteria:
Sharing living space with cirrhotic patient for at least 3 years
Able and willing to participate in the groups
Exclusion Criteria:
Unfamiliar with patient's routines and does not live in the same space
Unwilling to consent or participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jasmohan S Bajaj, MD
Organizational Affiliation
Mcguire VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Mindfulness and Support Group to Improve Patient and Caregiver Burden in Cirrhosis
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