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Cognitive Bias Modification for paranoia (CBM-pa): study protocol for a randomised controlled trial.

ABSTRACT: BACKGROUND:Persecutory delusions are the most common type of delusions in psychosis and present in around 10-15% of the general population. Persecutory delusions are thought to be sustained by biased cognitive and emotional processes. Recent advances favour targeted interventions, focussing on specific symptoms or mechanisms. Our aim is to test the clinical feasibility of a novel psychological intervention, which manipulates biased interpretations toward more adaptive processing, in order to reduce paranoia in patients. METHODS:The 'Cognitive Bias Modification for paranoia' (CBM-pa) study is a feasibility, double-blind, randomised controlled trial (RCT) for 60 stabilised outpatients with persistent, distressing paranoid symptoms. Patients will be randomised at a 50:50 ratio, to computerised CBM-pa or a text-reading control intervention, receiving one 40-min session per week, for 6 weeks. CBM-pa 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. Treatment as Usual will continue for patients in both groups. Patients will be assessed by a researcher blind to allocation, at baseline, each interim session, post treatment and 1- and 3-month follow-up post treatment. The primary outcome is the feasibility parameters (trial design, recruitment rate and acceptability) of the intervention. The secondary outcomes are clinical symptoms (including severity of paranoia) as assessed by a clinical psychologist, and 'on-line' measurement of interpretation bias and stress/distress. The trial is funded by the NHS National Institute for Health Research. DISCUSSION:This pilot study will test whether CBM-pa has the potential to be a cost-effective, accessible and flexible treatment. If the trial proves feasible and demonstrates preliminary evidence of efficacy, a fully powered RCT will be warranted. TRIAL REGISTRATION:Current Controlled Trials ISRCTN: 90749868 . Retrospectively registered on 12 May 2016.

SUBMITTER: Yiend J

PROVIDER: S-EPMC5492504 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Cognitive Bias Modification for paranoia (CBM-pa): study protocol for a randomised controlled trial.

Yiend Jenny J Trotta Antonella A Meek Christopher C Dzafic Ilvana I Baldus Nora N Crane Bryony B Kabir Thomas T Stahl Daniel D Heslin Margaret M Shergill Sukhwinder S McGuire Philip P Peters Emmanuelle E

Trials 20170629 1

<h4>Background</h4>Persecutory delusions are the most common type of delusions in psychosis and present in around 10-15% of the general population. Persecutory delusions are thought to be sustained by biased cognitive and emotional processes. Recent advances favour targeted interventions, focussing on specific symptoms or mechanisms. Our aim is to test the clinical feasibility of a novel psychological intervention, which manipulates biased interpretations toward more adaptive processing, in orde ...[more]

PMID: 28662715

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Project description:BACKGROUND:Cognitive Bias Modification (CBM) has been used successfully as a computer-based intervention in disorders such as anxiety. However, CBM to modify interpretations of ambiguous information relevant to paranoia has not yet been tested. We conducted a qualitative investigation of a novel intervention called CBM for paranoia (CBM-pa) to examine its acceptability in patients with psychosis. METHODS:Eight participants with psychosis who completed CBM-pa were identified by purposive sampling and invited for a semi-structured interview to explore the facilitators and barriers to participation, optimum form of delivery, perceived usefulness of CBM-pa and their opinions on applying CBM-pa as a computerised intervention. The interviews were transcribed and analysed using thematic analysis by researchers working in collaboration with service users. RESULTS:Themes emerged relating to participants' perception about delivery, engagement, programme understanding, factors influencing experience, perceived impact and application of CBM-pa. CBM-pa was regarded as easy, straightforward and enjoyable. It was well-accepted among those we interviewed, who understood the procedure as a psychological intervention. Patients reported that it increased their capacity for adopting alternative interpretations of emotionally ambiguous scenarios. Although participants all agreed on the test-like nature of the current CBM-pa format, they considered that taking part in sessions had improved their overall wellbeing. Most of them valued the computer-based interface of CBM-pa but favoured the idea of combining CBM-pa with some form of human interaction. CONCLUSIONS:CBM-pa is an acceptable intervention that was well-received by our sample of patients with paranoia. The current findings reflect positively on the acceptability and experience of CBM-pa in the target population. Patient opinion supports further development and testing of CBM-pa as a possible adjunct treatment for paranoia. TRIAL REGISTRATION:Current Controlled Trials ISRCTN: 90749868 . Retrospectively registered on 12 May 2016.

Project description:IntroductionPrevious studies indicate that computerised trainings implementing cognitive bias modification (CBM) for interpretation bias might be promising treatments for trauma-related cognitive distortions and symptoms. However, results are mixed, which might be related to the implemented task (sentence completion task), setting, or training duration. Within the present study, we aim to evaluate the efficacy and safety of an app-based intervention for interpretation bias using standardised imagery audio scripts, which is designed as a standalone treatment.Methods and analysisThe study is a randomised controlled trial, implementing two parallel arms. 130 patients diagnosed with post-traumatic stress disorder (PTSD) will be allocated to either the intervention group or the waiting-list control group receiving treatment as usual. The intervention consists of 3 weeks of an app-based CBM training for interpretation bias using mental imagery, with three training sessions (20 min) per week. Two months after the last training session, 1 week of booster CBM treatment will be implemented, consisting of three additional training sessions. Outcome assessments will be conducted pretraining, 1 week post-training, 2 months post-training, as well as 1 week after the booster session (approximately 2.5 months after initial training termination). The primary outcome is interpretation bias. Secondary outcomes include PTSD-related cognitive distortions and symptom severity, as well as negative affectivity. Outcome assessment will be conducted by intention-to-treat analysis, as well as per-protocol analysis using linear mixed models.Ethics and disseminationThe study was approved by the Ethics Committee of the State Chamber of Physicians in Baden-Wuerttemberg, Germany (number of approval: F-2022-080). Scientific findings will be published in peer-reviewed journals informing future clinical studies, which focus on the reduction of PTSD-related symptoms using CBM.Trial registration numberGerman Clinical Trials Register (DRKS00030285; https://drks.de/search/de/trial/DRKS00030285).

Project description:The current randomised controlled trial will evaluate the efficacy of an internet-delivered positive imagery cognitive bias modification (CBM) intervention for depression when compared with an active control condition and help establish the additive benefit of positive imagery CBM when delivered in combination with internet cognitive behavioural therapy for depression.Patients meeting diagnostic criteria for a current major depressive episode will be recruited through the research arm of a not-for-profit clinical and research unit in Australia. The minimum sample size for each group (? set at 0.05, power at 0.80) was identified as 29, but at least 10% more will be recruited to hedge against expected attrition. We will measure the impact of CBM on primary measures of depressive symptoms (Beck Depression Inventory-second edition (BDI-II), Patient Health Questionnaire (PHQ9)) and interpretive bias (ambiguous scenarios test-depression), and on a secondary measure of psychological distress (Kessler-10 (K10)) following the 1-week CBM intervention. Secondary outcome measures of psychological distress (K10), as well as disability (WHO disability assessment schedule-II), repetitive negative thinking (repetitive thinking questionnaire), and anxiety (state trait anxiety inventory-trait version) will be evaluated following completion of the 11-week combined intervention, in addition to the BDI-II and PHQ9. Intent-to-treat marginal and mixed effect models using restricted maximum likelihood estimation will be used to evaluate the primary hypotheses. Clinically significant change will be defined as high-end state functioning (a BDI-II score <14) combined with a total score reduction greater than the reliable change index score. Maintenance of gains will be assessed at 3-month follow-up.The current trial protocol has been approved by the Human Research Ethics Committee of St Vincent's Hospital and the University of New South Wales, Sydney.Australian New Zealand Clinical Trials Registry: ACTRN12613000139774 and Clinicaltrials.gov: NCT01787513. This trial protocol is written in compliance with the Standard Protocol Items: recommendations for Interventional Trials (SPIRIT) guidelines.

Project description:INTRODUCTION:Binge eating disorder (BED) is a common mental disorder, closely associated with obesity. Existing treatments are only moderately effective with high relapse rates, necessitating novel interventions. This paper describes the rationale for, and protocol of, a feasibility randomised controlled trial (RCT), evaluating the combination of transcranial direct current stimulation (tDCS) and a computerised cognitive training, namely approach bias modification training (ABM), in patients with BED who are overweight or obese. The aim of this trial is to obtain information that will guide decision-making and protocol development in relation to a future large-scale RCT of combined tDCS+ABM treatment in this group of patients, and also to assess the preliminary efficacy of this intervention. METHODS AND ANALYSIS:66 participants with Diagnostic and Statistical Manual-5 diagnosis of BED and a body mass index (BMI) of ?25?kg/m2 will be randomly allocated to one of three groups: ABM+real?tDCS; ABM+sham?tDCS or a wait-list control group. Participants in both intervention groups will receive six sessions of ABM+real/sham tDCS over 3 weeks; engaging in the ABM task while simultaneously receiving bilateral tDCS to the dorsolateral prefrontal cortex. ABM is based on an implicit learning paradigm in which participants are trained to enact an avoidance behaviour in response to visual food cues. Assessments will be conducted at baseline, post-treatment (3 weeks) and follow-up (7 weeks post-randomisation). Feasibility outcomes assess recruitment and retention rates, acceptability of random allocation, blinding success (allocation concealment), completion of treatment sessions and research assessments. Other outcomes include eating disorder psychopathology and related neurocognitive outcomes (ie, delay of gratification and inhibitory control), BMI, other psychopathology (ie, mood), approach bias towards food and surrogate endpoints (ie, food cue reactivity, trait food craving and food intake). ETHICS AND DISSEMINATION:This study has been approved by the North West-Liverpool East Research Ethics Committee. Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:ISRCTN35717198.

Project description:IntroductionInfluential theories of post-traumatic stress disorder (PTSD) suggest that dysfunctional appraisals of trauma play a key role in the maintenance of symptoms, and this suggestion is increasingly supported by research. Experimental studies have indicated that a simple computerised cognitive training procedure, here termed cognitive bias modification-appraisals (CBM-App), can modify trauma-relevant appraisals and reduce analogue trauma symptoms among healthy volunteers. This suggests the possibility that CBM-App could improve outcomes in PTSD via targeting the key process of dysfunctional appraisals, for example, if applied as an adjunct to treatment.Methods and analysisThe study is a randomised controlled trial with two parallel arms. It is planned to randomise 80 patients admitted for treatment for PTSD to an inpatient treatment clinic to complete either sessions of CBM-App or a sham-training control condition, the peripheral vision task. Both interventions comprise eight sessions scheduled over a 2-week period and are completed in addition to the standard treatment programme in the clinic. Outcome assessment occurs pretraining, after 1 week of training, post-training, at discharge from the inpatient clinic and 6 weeks and 3 months postdischarge. The primary outcome is dysfunctional trauma-relevant appraisals at post-training, measured using a scenario completion task. Secondary outcomes include symptom measures and hair cortisol. Outcome analyses will be primarily via mixed linear models and conducted with both intention to treat and per protocol samples.Ethics and disseminationThe trial has been approved by the Ethics Committee for the Faculty of Psychology, Ruhr-Universität Bochum (approval no 204) and the Ethics Committee for the Faculty of Medicine, Ruhr-Universität Bochum (approval no 15-5477). Results will be published in peer-reviewed journals and will inform future clinical and experimental studies into targeting maladaptive appraisals for the reduction of PTSD symptoms.Trial registration numberNCT02687555.

Project description:IntroductionBeing physically active is associated with a wide range of health benefits in patients. However, many patients do not engage in the recommended levels of physical activity (PA). To date, interventions promoting PA in patients mainly rely on providing knowledge about the benefits associated with PA to develop their motivation to be active. Yet, these interventions focusing on changing patients' conscious goals have proven to be rather ineffective in changing behaviours. Recent research on automatic factors (eg, automatic approach tendencies) may provide additional targets for interventions. However, the implementation and evaluation of intervention designed to change these automatic bases of PA are rare. Consequently, little is known about whether and how interventions that target automatically activated processes towards PA can be effective in changing PA behaviours. The Improving Physical Activity (IMPACT) trial proposes to fill this knowledge gap by investigating the effect of a cognitive-bias modification intervention aiming to modify the automatic approach towards exercise-related stimuli on PA among patients.Methods and analysisThe IMPACT trial is a single-centre, placebo (sham controlled), triple-blinded, phase 3 randomised controlled trial that will recruit 308 patients enrolled in a rehabilitation programme in the Division of General Medical Rehabilitation at the University Hospital of Geneva (Switzerland) and intends to follow up them for up to 1 year after intervention. Immediately after starting a rehabilitation programme, patients will be randomised (1:1 ratio) to receive either the cognitive-bias modification intervention consisting of a 12-session training programme performed over 3 weeks or a control condition (placebo). The cognitive-bias modification intervention aims to improve PA levels through a change in automatic approach tendencies towards PA and sedentary behaviours. The primary outcome is the sum of accelerometer-based time spent in light-intensity, moderate-intensity and vigorous-intensity PA over 1 week after the cognitive-bias modification intervention (in minutes per week). Secondary outcomes are related to changes in (1) automatic approach tendencies and self-reported motivation to be active, (2) physical health and (3) mental health. Sedentary behaviours and self-reported PA will also be examined. The main time point of the analysis will be the week after the end of the intervention. These outcomes will also be assessed during the rehabilitation programme, as well as 1, 3, 6 and 12 months after the intervention for secondary analyses.Ethics and disseminationThe study will be conducted in accordance with the Declaration of Helsinki. This trial was approved by the Ethics Committee of Geneva Canton, Switzerland (reference number: CCER2019-02257). All participants will give an informed consent to participate in the study. Results will be published in relevant scientific journals and be disseminated in international conferences.Trial registration detailsThe clinical trial was registered at the German clinical trials register (reference number: DRKS00023617); Pre-results.

Project description:IntroductionDepressive symptoms are common and undermine the quality of life of people with Alzheimer's disease (AD). Cholinesterase inhibitors and antidepressants have all but no effect on the mood of patients, and their use increases adverse events. Cognitive bias modification (CBM) targets attentional and interpretative biases associated with anxiety, dysphoria and depression and may be useful to treat depression in AD (DAD). This trial aims to determine the effect of CBM on depression scores and the quality of life of people with DAD.Methods and analysisRandomised, double-blind, parallel, controlled trial of CBM (1:1 allocation ratio). Participants will be 80 adults with probable AD living in the Western Australian community who score 8 or more on the Cornell Scale for Depression in Dementia (CSDD). They will have mild to moderate dementia (Mini-Mental State Examination-MMSE score ?15) and will be free of severe sensory impairment or suicidal intent. The intervention will consist of 10 40?min sessions of CBM delivered over 2?weeks using a high-resolution monitor using a local computer station at the Western Australian Centre for Health and Ageing. The primary outcomes of interest are the 2-week change, from baseline, in the severity of CSDD scores and the Quality of Life AD (QoL-AD) scores. Secondary outcomes include changes in the CSDD, QoL-AD after 12?weeks, and changes in MMSE scores, negative attentional and interpretative bias and the proportion of participants with CSDD <8 after 2 and 12?weeks.Ethics and disseminationThe study will comply with the principles of the Declaration of Helsinki and participants will provide written informed consent. The Ethics Committee of the Royal Perth Hospital will approve and oversee the study (REG14-036). The results of this trial will provide level 2 evidence of efficacy for CBM as a treatment of DAD.Trial registration numberAustralian and New Zealand Clinical Trials Registry number ACTRN12614000420640, date registered 06/04/2014.

Dataset Information

Cognitive Bias Modification for paranoia (CBM-pa): study protocol for a randomised controlled trial.

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Cognitive Bias Modification for paranoia (CBM-pa): study protocol for a randomised controlled trial.

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