Evidence map›Paper›PMID 25873137›Full record

Trial reportTrials2015

Treatment of depression and anxiety with internet-based cognitive behavior therapy in patients with a recent myocardial infarction (U-CARE Heart): study protocol for a randomized controlled trial.

Fredrika Norlund, Erik M G Olsson, Gunilla Burell, Emma Wallin, Claes Held

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01504191 (A Randomized Controlled Study of the Effects of Internet-based Cognitive Behavior Therapy on Depression and Anxiety in Patients With a Previous Myocardial Infarction), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT01504191 nacompletednot on this map

A Randomized Controlled Study of the Effects of Internet-based Cognitive Behavior Therapy on Depression and Anxiety in Patients With a Previous Myocardial Infarction

TypeinterventionalSponsorUppsala UniversityRan2013 to 2017Enrolled239ConditionsDepression, Anxiety, Myocardial InfarctionArmsInternet-based CBT
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Psychological interventions for coronary heart disease.The Cochrane database of systematic reviews · 2017
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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

5 authors.

Fredrika NorlundDepartment of Public Health and Caring Sciences, Uppsala University, Box 564, Uppsala, SE-751 22, Sweden. fredrika.norlund@pubcare.uu.se.
Erik M G OlssonDepartment of Public Health and Caring Sciences, Uppsala University, Box 564, Uppsala, SE-751 22, Sweden. erik.olsson@pubcare.uu.se.
Gunilla BurellDepartment of Public Health and Caring Sciences, Uppsala University, Box 564, Uppsala, SE-751 22, Sweden. gunilla.burell@pubcare.uu.se.
Emma WallinDepartment of Psychology, Uppsala University, Box 562 S-75122, Uppsala, Sweden. emma.wallin@psyk.uu.se.
Claes HeldDepartment of Medical Sciences, Cardiology, Uppsala Clinical Research Center Uppsala University, Dag Hammarskjölds väg 14B, S-752 37, Uppsala, Sweden. claes.held@ucr.uu.se.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMajor depression and depressive symptoms are common in patients with a recent myocardial infarction (MI), and depression is associated with adverse cardiovascular outcomes. Anxiety post-MI is less studied, but occurs commonly in patients with heart disease, and is also considered a risk factor for recurrence of cardiac events. Cognitive behavior therapy (CBT) is an established therapy for depression and anxiety disorders. To the best of our knowledge, there have not been any studies to determine if internet-based CBT (iCBT) can reduce the symptoms of depression and anxiety in patients with a recent MI. The main aim of the U-CARE Heart trial is to evaluate an iCBT intervention for patients with a recent MI. METHODS/

designThis is a randomized, controlled, prospective study with a multicenter design. A total of 500 participants will be randomized at a 1:1 ratio, around two months after an acute MI, to either iCBT or to a control group. Both groups will receive an optimal standard of care according to guidelines. The intervention consists of a self-help program delivered via the internet with individual online support from a psychologist. Treatment duration is 14 weeks. The primary outcome is change in patients' self-rated anxiety and depression symptoms from baseline to end of treatment. An internal pilot study was conducted indicating sufficient levels of study acceptability and engagement in treatment. DISCUSSION: The present study is designed to evaluate an iCBT intervention targeting symptoms of depression and anxiety in a post-MI population. If effective, iCBT has several advantages, and will potentially be implemented as an easily accessible treatment option added to modern standard of care.

trial registrationThis trial was registered with Clinicaltrials.gov (identifier: NCT01504191 ) on 19 December 2011.

Indexed as

Cognitive Behavioral TherapyInternetAgedAnxietyClinical ProtocolsDepressionFemaleHumansMaleMiddle AgedMyocardial InfarctionProspective StudiesResearch DesignSelf ReportSwedenTelemedicine

Identifiers

PMID25873137
PMCPMC4404081

What OpenQuestion holds

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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.