Evidence map›Paper›PMID 36719886›Full record

Trial reportPLoS medicine2023

Metacognitive therapy home-based self-help for anxiety and depression in cardiovascular disease patients in the UK: A single-blind randomised controlled trial.

Adrian Wells, David Reeves, Calvin Heal, Peter Fisher, Patrick Doherty, Linda Davies, Anthony Heagerty, Lora Capobianco

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

Trial report in PLoS medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03999359 (A Single-Blind Randomised Controlled Trial of Self-Help Metacognitive Therapy for Anxiety and Depression in the Cardiac Rehabilitation Pathway), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
4.8field-weighted citation impact, top 4% 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.

NCT03999359 naterminatednot on this map

A Single-Blind Randomised Controlled Trial of Self-Help Metacognitive Therapy for Anxiety and Depression in the Cardiac Rehabilitation Pathway

TypeinterventionalSponsorUniversity of ManchesterRan2019 to 2020Enrolled242ConditionsDepression, Anxiety, Cardiac Rehabilitation, Psychological DistressArmsHome-based Metacognitive Therapy
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

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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

8 authors at 5 institutions in 1 country.

Adrian WellsFaculty of Biology, Medicine and Health, School of Psychological Sciences, The University of Manchester, Manchester, United Kingdom.ORCID 0000-0001-7713-1592
David ReevesNIHR School for Primary Care Research, Manchester Academic Health Science Centre, The University of Manchester, Manchester, United Kingdom.ORCID 0000-0001-6377-6859
Calvin HealNIHR School for Primary Care Research, Manchester Academic Health Science Centre, The University of Manchester, Manchester, United Kingdom.ORCID 0000-0002-6445-1551
Peter FisherInstitute of Psychology, Health and Society, University of Liverpool, Liverpool, United Kingdom.ORCID 0000-0002-7388-720X
Patrick DohertyDepartment of Health Sciences, University of York, York, United Kingdom.
Linda DaviesCentre for Health Economics, Division of Population Health, Health Services Research and Primary Care, Faculty of Biology Medicine and Health, School of Health Sciences, The University of Manchester, Manchester, United Kingdom.
Anthony HeagertyCore Technology Facility, The University of Manchester School of Medical Sciences, Manchester, United Kingdom.
Lora CapobiancoResearch and Innovation, Greater Manchester Mental Health NHS Foundation Trust, Manchester, United Kingdom.ORCID 0000-0001-6877-8650
Manchester Academic Health Science Centre · GBGreater Manchester Mental Health NHS Foundation Trust · GBManchester Royal Infirmary · GBUniversity of Liverpool · GBUniversity of York · GB

Funding

Department of Health
6 · The paper itself

Abstract

backgroundAnxiety and depression in cardiac rehabilitation (CR) are associated with greater morbidity, mortality, and increased healthcare costs. Current psychological interventions within CR have small effects based on low-quality studies of clinic-based interventions with limited access to home-based psychological support. We tested the effectiveness of adding self-help metacognitive therapy (Home-MCT) to CR in reducing anxiety and depression in a randomised controlled trial (RCT). METHODS AND

findingsWe ran a single-blind, multi-centre, two-arm RCT. A total of 240 CR patients were recruited from 5 NHS-Trusts across North West England between April 20, 2017 and April 6, 2020. Patients were randomly allocated to Home-MCT+CR (n = 118, 49.2%) or usual CR alone (n = 122, 50.8%). Randomisation was 1:1 via randomised blocks within hospital site, balancing arms on sex and baseline Hospital Anxiety and Depression Scale (HADS) scores. The primary outcome was the HADS total score at posttreatment (4-month follow-up). Follow-up data collection occurred between August 7, 2017 and July 20, 2020. Analysis was by intention to treat. The 4-month outcome favoured the MCT intervention group demonstrating significantly lower end of treatment scores (HADS total: adjusted mean difference = -2.64 [-4.49 to -0.78], p = 0.005, standardised mean difference (SMD) = 0.38). Sensitivity analysis using multiple imputation (MI) of missing values supported these findings. Most secondary outcomes also favoured Home-MCT+CR, especially in reduction of post-traumatic stress symptoms (SMD = 0.51). There were 23 participants (19%) lost to follow-up in Home-MCT+CR and 4 participants (3%) lost to follow-up in CR alone. No serious adverse events were reported. The main limitation is the absence of longer term (e.g., 12-month) follow-up data.

conclusionSelf-help home-based MCT was effective in reducing total anxiety/depression in patients undergoing CR. Improvement occurred across most psychological measures. Home-MCT was a promising addition to cardiac rehabilitation and may offer improved access to effective psychological treatment in cardiovascular disease (CVD) patients.

trial registrationNCT03999359.

Indexed as

Cardiovascular DiseasesAnxietyAnxiety DisordersCost-Benefit AnalysisDepressionEnglandHumansQuality of Life

Identifiers

PMID36719886
PMCPMC9888717
OpenAlexW4318671855

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.