Evidence map›Paper›PMID 37498415›Full record

Trial reportDigestive diseases and sciences2023

CAREGIVER Randomized Trial of Two Mindfulness Methods to Improve the Burden and Distress of Caring for Persons with Cirrhosis.

Elliot B Tapper, Zachary M Saleh, Sofia Lizza, Xi Chen, Samantha Nikirk, Marina Serper

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Digestive diseases and sciences, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04205396 (CAREGIVER), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04205396 nacompletednot on this map

CAREGIVER: An Randomized Clinical Trial (RCT) to Improve the Burden and Distress of Caring for Persons With Decompensated Cirrhosis

TypeinterventionalSponsorUniversity of MichiganRan2020 to 2022Enrolled87ConditionsCaregiversArmsWritten emotional disclosure, Resilience training, No treatment
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Guideline
  2. The RELAX randomized controlled trial: Stretching versus meditation for nocturnal muscle cramps.Liver international : official journal of the International Association for the Study of the Liver · 2024
    Trial
  3. Longitudinal changes in physical and psychological outcomes in spousal vs. non-spousal caregivers for patients with end-stage liver disease.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Elliot B TapperDivision of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI, USA. etapper@umich.edu.ORCID 0000-0002-0839-1515
Zachary M SalehDivision of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI, USA.
Sofia LizzaDivision of Gastroenterology and Hepatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
Xi ChenDivision of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI, USA.
Samantha NikirkDivision of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI, USA.
Marina SerperDivision of Gastroenterology and Hepatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
University of Michigan · USUniversity of Pennsylvania · US

Funding

Optimizing Measures for Clinical Trials in Covert Hepatic EncephalopathyK23DK117055 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI TAPPER, ELLIOT · 2019 to 2022
$776k
NIDDK NIH HHS K23 DK117055
6 · The paper itself

Abstract

backgroundPatient caregivers experience burden and distress that negatively impacts health-related quality of life (HRQOL). Mindfulness may alleviate caregiver burden but randomized trials of mindfulness activities on caregiver burden and distress are lacking.

methodsCaregivers for patients with advanced liver disease were recruited from the Universities of Michigan and Pennsylvania (12/2019-12/2021) and followed for 8 weeks. Participants were randomized 1:1:1 to: written emotional disclosure for 4 weeks, resilience training for 4 weeks, or control (no active intervention). All completed assessments at baseline, week 4 and 8. The primary outcome was change in the Zarit Caregiver Burden Index-12 (ZBI) at week 8. Secondary outcomes included changes at week 4 and 8 in the ZBI, distress thermometer (DT), HRQOL visual analog scale (VAS), and caregiver captivity index (CCI).

resultsEighty seven caregivers were enrolled, 59(72%) completed the study. In unadjusted analyses at week 4, the burden measured by ZBI was not significantly different between arms, increasing by 0.6 ± 5.7 and 2.5 ± 5.2 points, for the written emotional disclosure and resilience training study arms, respectively, and by 2.9 ± 6.1 points in the control arm. At week 8, the non-significant ZBI change was - 1.0 ± 8.9, 2.8 ± 6.1, and 1.5 ± 7.4 for written emotional disclosure, resilience training, at week 8, respectively. The DT and VAS worsened in all arms, however, it worsened the least in the written emotional disclosure arm. In analyses adjusted for differences in baseline characteristics, the ZBI declined by - 4.21 ± 2.03(p = 0.04) in the emotional disclosure arm at week 4. This decrease was attenuated week 8, - 1.13 ± 2.6(p = 0.67). There were no significant differences in secondary outcomes save for resilience training reducing the CCI at week 4 by 1.36 ± 0.67(p = 0.04).

conclusionWritten emotional disclosure may reduce caregiver burden in the short term among caregivers for patients with cirrhosis. REGISTRATION: NCT04205396.

Indexed as

CaregiversMindfulnessCost of IllnessEmotionsHumansLiver CirrhosisQuality of LifeAscitesHepatic encephalopathyLiver diseaseResilience

Identifiers

PMID37498415
PMCPMC10833499
OpenAlexW4385294786

What OpenQuestion holds

Textmetadata
LicenceTDM
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.