Evidence map›Paper›PMID 22943627›Full record

Trial reportTrials2012

WELL.ME - Wellbeing therapy based on real-time personalized mobile architecture, vs. cognitive therapy, to reduce psychological distress and promote healthy lifestyle in cardiovascular disease patients: study protocol for a randomized controlled trial.

Angelo Compare, Vassilis Kouloulias, Vontas Apostolos, Wendy Moreno Peña, Enrico Molinari, Enzo Grossi, Efstathopoulos Efstathios, Michele Carenini

Retracted Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialRetracted Publication
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It has been retracted, and should not be counted. It is linked to trial NCT01543815 (Well-Being Therapy for Psychological Distress and Enhancing Healthy Behaviors With Personalized Mobile Technology in Cardiac Patients), 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
0.6field-weighted citation impact, top 27% 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.

NCT01543815 nacompletednot on this map

Well-Being Therapy for Psychological Distress and Enhancing Healthy Behaviors With Personalized Mobile Technology in Cardiac Patients: a Randomized Controlled-trial Study Protocol

TypeinterventionalSponsorUniversity of BergamoRan2006 to 2010Enrolled400ConditionsPsychological DistressArmsWell-Being Therapy based on Web Mobile Technology, Cognitive Behavior Therapy, Standardized Care Management
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 3 countries.

Angelo CompareHuman Factors and Technologies for Health - HTC Centre; Dept. of Human and Social Sciences, University of Bergamo, Piazzale S. Agostino 2, 24129, Bergamo, BG, Italy. angelo.compare@unibg.it
Vassilis Kouloulias
Vontas Apostolos
Wendy Moreno Peña
Enrico Molinari
Enzo Grossi
Efstathopoulos Efstathios
Michele Carenini
National and Kapodistrian University of Athens · GRHuman Factors (Norway) · NOIULM University · ITUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is compelling evidence that psychological factors may have the same or even greater impact on the possibility of adverse events on cardiac diseases (CD) than other traditional clinical risk factors. Anxiety and depression are predictors of short- and long-term adverse outcomes, increased risk for higher rates of in-hospital complications, re-infarction, malignant arrhythmias, and mortality in CD patients. Despite researchers finding that cognitive behavior therapy (CBT) reduced depressive and anxiety symptoms, the fact that such results are maintained only in the short term and the lack of maintenance of the long-term affects the absence of changes in lifestyles, preventing the possibility of a wide generalization of results. Recently wellbeing therapy (WBT) has been proposed as a useful approach to improve healthy lifestyle behaviors and reduce psychological distress. METHODS/

designThe present randomized controlled study will test WBT, in comparison with CBT, as far as the reduction of symptoms of depression, anxiety and psychological distress, and the improvement of lifestyle behaviors and quality of life in cardiac patients are concerned. Moreover, innovations in communication technologies allow patients to be constantly followed in real life. Therefore WBT based on personalized mobile technology will allow the testing of its effectiveness in comparison with usual WBT. DISCUSSION: The present study is a large outpatient study on the treatment of co-morbid depression, anxiety, and psychological distress in cardiac patients. The most important issues of this study are its randomized design, the focus on promotion of health-related behaviors, and the use of innovative technologies supporting patients' wellbeing in real life and in a continuous way. First results are expected in 2012.

trial registrationClinicalTrials.gov Identifier: NCT01543815.

Indexed as

Computers, HandheldAnxietyCardiovascular DiseasesCognitive Behavioral TherapyComorbidityDepressionHealth BehaviorHealth PromotionHumansLife StyleProgram EvaluationQuality of LifeResearch DesignRisk FactorsRisk Reduction BehaviorStress, Psychological

Identifiers

PMID22943627
PMCPMC3492018
OpenAlexW2119283153

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.