Mindfulness and Support Group to Improve Patient and Caregiver Burden in Cirrhosis
Condition: Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis; Caregiver Burden
Study type: Interventional

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
    

Intervention name(s): Mindfulness and Support Groups
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment