Cognitive bias modification for paranoia, feasibility study: Main and interim datasets 2015-2017

DOI

The study was a feasibility, double-blind randomized controlled trial of CBM-pa treatment for clinical paranoia compared to an active text reading control, both given in addition to treatment as usual. CBM-pa is a cognitive intervention that targets negatively biased interpretation of emotional ambiguity of the sort specifically related to paranoid thinking. It is self-administered on a computer without the need for a therapist to be involved. Participants were people suffering persistent, distressing paranoid symptoms at clinical levels. All participants visited the laboratory weekly for six weeks to receive either CBM-pa or the active control. Assessments comprised clinical interview, experimental measures of interpretation (online and pen/ paper), self-report measures of clinical symptoms, and behavioural/ real life measures of stress, distress and vulnerability. Assessments were conducted as follows: baseline assessment (T0); Interim assessments (I1-4); post treatment assessment (T1); postal/telephone follow-ups at 1-and 3-months (4 and 12 weeks from end of last session, respectively). The main dataset comprises: Feasibility trial assessment data for baseline (T0), post treatment (T1) and Follow up (T2, T3). The interim dataset comprises: Feasibility trial assessment data for interim sessions (I1-4).Many people with psychosis continue to have paranoid beliefs, despite the best treatments available. We will examine a new computer therapy, ‘Cognitive Bias Modification for paranoia’ (CBM-pa). CBM encourages people to develop alternative ways of interpreting difficult thoughts (i.e. “someone is watching me”), leading participants to change their understanding of what these situations might mean. CBM is used in anxiety 62,21, but has not been appropriately applied together disorders. Our version, CBM-pa, was developed with service user input. It is based on new research into the biases that people with paranoia have when interpreting events 61. It involves participants reading stories on a computer screen, completing missing words and answering questions about each story in a way that encourages more helpful beliefs about themselves and others. After one session of CBM-pa, people with paranoia displayed a range of helpful effects, including significant belief change, and less distress in ambiguous social situations. This study will test whether, in addition to usual treatment, six sessions of CBM-pa produces significant benefit for patients (for example by reducing symptoms and distress) immediately, and at 1 and 3 month follow-up, compared to reading passages of text alone. Eight participants will be interviewed in more depth about their experiences. The overall aim is to test whether CBM-pa could be an effective treatment for paranoia. If so, CBM-pa would have a number of potential advantages over other approaches, including, minimal effort to complete, no homework, no therapist, and portability.

The study was a feasibility, double-blind randomized controlled trial of CBM-pa treatment for paranoid compared to an active text reading control. CBM-pa is a cognitive intervention that targets negatively biased interpretation of emotional ambiguity of the sort specifically related to paranoid thinking. Participants were those who suffer from persistent, distressing paranoid symptoms and met a range of other inclusion and exclusion criteria. Both arms were conducted in addition to Treatment as Usual (TAU) which comprised individualised combinations of medication and care coordination. Participants were randomized to either CBM-pa or control by the King's Clinical Trials Unit. Participants visited the Institute of Psychiatry, Psychology and Neuroscience, King’s College London, or the NIHR/Wellcome Trust King’s Clinical Research Facility, for six sessions (Baseline assessment plus first session: T0; Interim sessions: I1-4; final session plus post treatment assessment, T1) and received postal/telephone follow-ups at 1-and 3-months (4 and 12 weeks from end of last session, respectively). The intervention was delivered on laboratory-owned laptops. Assessments comprised clinical interview, experimental measures of interpretation (online and pen/ paper), self report measures of clinical, and behavioural/ real life measures of stress, distress and vulnerability.

Identifier
DOI https://doi.org/10.5255/UKDA-SN-853978
Metadata Access https://datacatalogue.cessda.eu/oai-pmh/v0/oai?verb=GetRecord&metadataPrefix=oai_ddi25&identifier=0b0700ea196732d41f27193437dc1c146dcaff4863b9870e1d1924897f06a8ec
Provenance
Creator Yiend, J, King's College London
Publisher UK Data Service
Publication Year 2020
Funding Reference NIHR Research for Patient Benefit
Rights Jenny Yiend, King's College London; The Data Collection is available for download to users registered with the UK Data Service.
OpenAccess true
Representation
Resource Type Numeric; Text
Discipline Psychology; Social and Behavioural Sciences
Spatial Coverage London; United Kingdom