Evidence map›Paper›PMID 26357943›Full record

Trial reportTrials2015

Using mobile technology to deliver a cognitive behaviour therapy-informed intervention in early psychosis (Actissist): study protocol for a randomised controlled trial.

Sandra Bucci, Christine Barrowclough, John Ainsworth, Rohan Morris, Katherine Berry, Matthew Machin, Richard Emsley, Shon Lewis, Dawn Edge, Iain Buchan and 1 more

Abstract readRandomized 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. Cited by 28 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 6 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Article
  11. Article
  12. Article
  13. mHealth · 2020
    Review
  14. Article
  15. Review
  16. Article
  17. Review
  18. Article
  19. Article
  20. 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

11 authors.

Sandra BucciSchool of Psychological Sciences, The University of Manchester, Zochonis Building, Brunswick Street, M13 9PL, Manchester, UK. sandra.bucci@manchester.ac.uk.
Christine BarrowcloughSchool of Psychological Sciences, The University of Manchester, Zochonis Building, Brunswick Street, M13 9PL, Manchester, UK. christine.barrowclough@manchester.ac.uk.
John AinsworthCentre for Health Informatics, Institute of Population Health, University of Manchester, M13 9PL, Manchester, UK. john.ainsworth@manchester.ac.uk.
Rohan MorrisSchool of Psychological Sciences, The University of Manchester, Zochonis Building, Brunswick Street, M13 9PL, Manchester, UK. rohan.morris@manchester.ac.uk.
Katherine BerrySchool of Psychological Sciences, The University of Manchester, Zochonis Building, Brunswick Street, M13 9PL, Manchester, UK. katherine.berry@manchester.ac.uk.
Matthew MachinCentre for Health Informatics, Institute of Population Health, University of Manchester, M13 9PL, Manchester, UK. matthew.machin@manchester.ac.uk.
Richard EmsleyCentre for Biostatistics, Institute of Population Health, The University of Manchester & Manchester Academic Health Science Centre, Jean McFarlane Building, Oxford Road, M13 9PL, Manchester, UK. richard.emsley@manchester.ac.uk.
Shon LewisInstitute of Brain, Behaviour and Mental Health, Manchester Academic Health Sciences Centre and Manchester Mental Health and Social Care Trust, Manchester, M13 9PL, UK. shon.lewis@manchester.ac.uk.
Dawn EdgeSchool of Psychological Sciences, The University of Manchester, Zochonis Building, Brunswick Street, M13 9PL, Manchester, UK. dawn.edge@manchester.ac.uk.
Iain BuchanCentre for Health Informatics, Institute of Population Health, University of Manchester, M13 9PL, Manchester, UK. buchan@manchester.ac.uk.
Gillian HaddockSchool of Psychological Sciences, The University of Manchester, Zochonis Building, Brunswick Street, M13 9PL, Manchester, UK. gillian.haddock@manchester.ac.uk.

Funding

Medical Research Council MC_PC_13042Medical Research Council MR/K006665/1Medical Research Council MR/L005301/1
6 · The paper itself

Abstract

backgroundCognitive behaviour therapy (CBT) is recommended for the treatment of psychosis; however, only a small proportion of service users have access to this intervention. Smartphone technology using software applications (apps) could increase access to psychological approaches for psychosis. This paper reports the protocol development for a clinical trial of smartphone-based CBT. METHODS/

designWe present a study protocol that describes a single-blind randomised controlled trial comparing a cognitive behaviour therapy-informed software application (Actissist) plus Treatment As Usual (TAU) with a symptom monitoring software application (ClinTouch) plus TAU in early psychosis. The study consists of a 12-week intervention period. We aim to recruit and randomly assign 36 participants registered with early intervention services (EIS) across the North West of England, UK in a 2:1 ratio to each arm of the trial. Our primary objective is to determine whether in people with early psychosis the Actissist app is feasible to deliver and acceptable to use. Secondary aims are to determine whether Actissist impacts on predictors of first episode psychosis (FEP) relapse and enhances user empowerment, functioning and quality of life. Assessments will take place at baseline, 12 weeks (post-treatment) and 22-weeks (10 weeks post-treatment) by assessors blind to treatment condition. The trial will report on the feasibility and acceptability of Actissist and compare outcomes between the randomised arms. The study also incorporates semi-structured interviews about the experience of participating in the Actissist trial that will be qualitatively analysed to inform future developments of the Actissist protocol and app. DISCUSSION: To our knowledge, this is the first controlled trial to test the feasibility, acceptability, uptake, attrition and potential efficacy of a CBT-informed smartphone app for early psychosis. Mobile applications designed to deliver a psychologically-informed intervention offer new possibilities to extend the reach of traditional mental health service delivery across a range of serious mental health problems and provide choice about available care.

trial registrationISRCTN34966555. Date of first registration: 12 June 2014.

Indexed as

Mobile ApplicationsSmartphoneAcute DiseaseClinical ProtocolsCognitive Behavioral TherapyEnglandFeasibility StudiesHumansPatient SatisfactionPower, PsychologicalPsychiatric Status Rating ScalesPsychotic DisordersQuality of LifeRecurrenceResearch DesignSingle-Blind Method

Identifiers

PMID26357943
PMCPMC4566519

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.