Mindfulness and Support Group to Improve Patient and Caregiver Burden in Cirrhosis

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

Study Overview

• Status: Completed
• Conditions: Cirrhosis
• Intervention / Treatment: Other: Mindfulness and Support Groups

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23249
      • Hunter Holmes McGuire VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Patients

Inclusion Criteria:

1. Cirrhosis proven by radiology, endoscopy (esophageal varices present) or biopsy
2. Able to give informed consent as determined by the study staff
3. Have a family member or caregiver who lives with them that is willing to participate

Exclusion Criteria:

1. Unable to give consent
2. Active psychosis
3. Acute suicidal ideation
4. No identified family member or caregiver

Caregivers/Family members:

Inclusion Criteria:

1. Sharing living space with cirrhotic patient for at least 3 years
2. Able and willing to participate in the groups

Exclusion Criteria:

1. Unfamiliar with patient's routines and does not live in the same space
2. Unwilling to consent or participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active group; Will get the mindfulness and support groups	Other: Mindfulness and Support Groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Beck Depression Inventory (patients)	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Beck Anxiety Inventory (patients)	4 weeks
Zarit Burden Interview (caregivers only)	4 weeks
Sickness Impact Profile (patients)	4 weeks
Pittsburgh Sleep Quality Index (patients)	4 weeks
Epworth Sleepiness Scale (patients)	4 weeks

Collaborators and Investigators

• Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Investigators: Principal Investigator: Jasmohan S Bajaj, MD, McGuire VA Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: October 24, 2016
• First Posted (Estimate): October 26, 2016

Study Record Updates

• Last Update Posted (Estimate): January 12, 2017
• Last Update Submitted That Met QC Criteria: January 11, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Digestive System Diseases; Pathologic Processes; Liver Diseases; Stress, Psychological; Fibrosis; Liver Cirrhosis; Caregiver Burden
• Other Study ID Numbers: BAJAJ0019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO