CirrhosisNCT02944643
Mindfulness and Support Group to Improve Patient and Caregiver Burden in Cirrhosis
A study testing Mindfulness and Support Groups in people with Cirrhosis, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Mindfulness and Support Groups
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Sharing living space with cirrhotic patient for at least 3 years
- Able and willing to participate in the groups
Who cannot join
- Unable to give consent
- Active psychosis
- Acute suicidal ideation
- No identified family member or caregiver
- Caregivers/Family members:
- Unfamiliar with patient's routines and does not live in the same space
- Unwilling to consent or participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
About this study
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
Read the 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:
- Stress Management II. Dealing with Depression III. Adjusting to Anxiety IV. Family Health and Changes in Roles
- Conditions
- Cirrhosis
- Being tested
- Mindfulness and Support Groups
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness and Support GroupsOther
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | Will get the mindfulness and support groups Receives: Other: Mindfulness and Support Groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory (patients)
Measured: 4 weeks
Secondary outcomes (5)
Beck Anxiety Inventory (patients)
Measured: 4 weeks
Zarit Burden Interview (caregivers only)
Measured: 4 weeks
Sickness Impact Profile (patients)
Measured: 4 weeks
Pittsburgh Sleep Quality Index (patients)
Measured: 4 weeks
Epworth Sleepiness Scale (patients)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center
- Investigators
- Jasmohan S Bajaj, MD, Principal investigator, Mcguire VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944643
- Sponsor's protocol ID
- BAJAJ0019
- Status last verified
- Jan 2017
- First submitted
- 24 Oct 2016
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness and Support Group to Improve Patient and Caregiver Burden in Cirrhosis
- ClinicalTrials.gov ID
- NCT02944643
- Acronym / sponsor ID
- BAJAJ0019
- Conditions
- Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical CenterUS federal agency
- Study start
- Jun 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Stress Management II. Dealing with Depression III. Adjusting to Anxiety IV. Family Health and Changes in Roles
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Other: Mindfulness and Support GroupsWill get the mindfulness and support groups |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Sharing living space with cirrhotic patient for at least 3 years
- Able and willing to participate in the groups
Key exclusion criteria (7 listed)
- Unable to give consent
- Active psychosis
- Acute suicidal ideation
- No identified family member or caregiver
- Unfamiliar with patient's routines and does not live in the same space
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness and Support Groups | Other | Active group |
Primary outcome
Beck Depression Inventory (patients)
Time frame: 4 weeks
5 secondary outcomes
Beck Anxiety Inventory (patients)
Time frame: 4 weeks
Zarit Burden Interview (caregivers only)
Time frame: 4 weeks
Sickness Impact Profile (patients)
Time frame: 4 weeks
Pittsburgh Sleep Quality Index (patients)
Time frame: 4 weeks
Epworth Sleepiness Scale (patients)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jasmohan S Bajaj, MD principal investigator
Mcguire VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and Support Groups in people with Cirrhosis, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory (patients) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.