Evidence map›Paper›PMID 28007034›Full record

Trial reportBMC psychiatry2016

Online psycho-education to the treatment of bipolar disorder: protocol of a randomized controlled trial.

Itxaso González-Ortega, Amaia Ugarte, Sonia Ruiz de Azúa, Nuria Núñez, Marta Zubia, Sara Ponce, Patricia Casla, Josu Xabier Llano, Ángel Faria, Ana González-Pinto

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC psychiatry, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02924415 (Future Internet Social and Technological Alignment Research), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 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.

NCT02924415 nacompletednot on this map

Future Internet Social and Technological Alignment Research (FISTAR)

TypeinterventionalSponsorBasque Health ServiceRan2013 to 2015Enrolled50ConditionsBipolar DisorderArmsTele-care support, Control group
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Review
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

10 authors.

Itxaso González-OrtegaCenter for Biomedical Research in the Mental Health Network (CIBERSAM), Department of Psychiatry, Araba University Hospital, University of the Basque Country, Olaguibel Street 29, 01004, Vitoria, Spain. itxaso.gonzalezortega@osakidetza.eus.
Amaia UgarteCenter for Biomedical Research in the Mental Health Network (CIBERSAM), Department of Psychiatry, Araba University Hospital, University of the Basque Country, Olaguibel Street 29, 01004, Vitoria, Spain.
Sonia Ruiz de AzúaCenter for Biomedical Research in the Mental Health Network (CIBERSAM), Department of Psychiatry, Araba University Hospital, University of the Basque Country, Olaguibel Street 29, 01004, Vitoria, Spain.
Nuria NúñezCenter for Biomedical Research in the Mental Health Network (CIBERSAM), Department of Psychiatry, Araba University Hospital, University of the Basque Country, Olaguibel Street 29, 01004, Vitoria, Spain.
Marta ZubiaCenter for Biomedical Research in the Mental Health Network (CIBERSAM), Department of Psychiatry, Araba University Hospital, University of the Basque Country, Olaguibel Street 29, 01004, Vitoria, Spain.
Sara PonceCentro de Investigación en Cronicidad-Kronikgune, Barakaldo, Spain.
Patricia CaslaIK4-Tekniker, Gipuzkoa, Spain.
Josu Xabier LlanoOsatek, Bilbo, Spain.
Ángel FariaSubdirección de Informática, Sistemas de Información-Osakidetza, Vitoria, Spain.
Ana González-PintoCenter for Biomedical Research in the Mental Health Network (CIBERSAM), Department of Psychiatry, Araba University Hospital, University of the Basque Country, Olaguibel Street 29, 01004, Vitoria, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBipolar disorder patients frequently present recurrent episodes and often experience subsyndromal symptoms, cognitive impairment and difficulties in functioning, with a low quality of life, illness relapses and recurrent hospitalization. Early diagnosis and appropriate intervention may play a role in preventing neuroprogression in this disorder. New technologies represent an opportunity to develop standardized psychological treatments using internet-based tools that overcome some of the limitations of face-to-face treatments, in that they are readily accessible and the timing of therapy can be tailored to user needs and availability. However, although many psychological programs are offered through the web and mobile devices for bipolar disorder, there is a lack of high quality evidence concerning their efficacy and effectiveness due to the great variability in measures and methodology used.

methodsThis clinical trial is a simple-blind randomized trial within a European project to compare an internet-based intervention with treatment as usual. Bipolar disorder patients are to be included and randomly assigned to one of two groups: 1) the experimental group (tele-care support) and 2) the control group. Participants in both groups will be evaluated at baseline (pre-treatment) and post-treatment. DISCUSSION: This study describes the design of a clinical trial based on psychoeducation intervention that may have a significant impact on both prognosis and treatment in bipolar disorder. Specifically, bringing different services together (service aggregation), it is hoped that the approach proposed will significantly increase the impact of information and communication technologies on access and adherence to treatment, quality of the service, patient safety, patient and professional satisfaction, and quality of life of patients.

trial registrationNCT02924415 . Retrospectively registered 27 September 2016.

Indexed as

InternetResearch DesignBipolar DisorderClinical ProtocolsEuropeFemaleHumansMaleMiddle AgedPatient Education as TopicQuality of LifeSelf CareSingle-Blind MethodTelemedicineTreatment OutcomeBipolar disorderPsychoeducationTelemedicine

Identifiers

PMID28007034
PMCPMC5178094

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.