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The effects of Cognitive Bias Modification training and oxytocin administration on trust in maternal support: study protocol for a randomized controlled trial.

ABSTRACT: Lack of trust in parental support is a transdiagnostic risk factor for the development of psychological problems throughout the lifespan. Research suggests that children's cognitive attachment representations and related information processing biases could be an important target for interventions aiming to build trust in the parent-child relationship. A paradigm that can alter these biases and increase trust is that of Cognitive Bias Modification (CBM), during which a target processing bias is systematically trained. Trust-related CBM training effects could possibly be enhanced by oxytocin, a neuropeptide that has been proposed to play an important role in social information processing and social relationships. The present article describes the study protocol for a double-blind randomized controlled trial (RCT) aimed at testing the individual and combined effects of CBM training and oxytocin administration on trust in maternal support.One hundred children (aged 8-12 years) are randomly assigned to one of four intervention conditions. Participants inhale a nasal spray that either contains oxytocin (OT) or a placebo. Additionally, they receive either a CBM training aimed at positively modifying trust-related information processing bias or a neutral placebo training aimed to have no trust-related effects. Main and interaction effects of the interventions are assessed on three levels of trust-related outcome measures: trust-related interpretation bias; self-reported trust; and mother-child interactional behavior. Importantly, side-effects of a single administration of OT in middle childhood are monitored closely to provide further information on the safety of OT administration in this age group.The present RCT is the first study to combine CBM training with oxytocin to test for individual and combined effects on trust in mother. If effective, CBM training and oxytocin could be easily applicable and nonintrusive additions to interventions that target trust in the context of the parent-child relationship.ClinicalTrials.gov, ID: NCT02737254 . Registered on 23 March 2016.

SUBMITTER: Verhees MWFT

PROVIDER: S-EPMC5513044 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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The effects of Cognitive Bias Modification training and oxytocin administration on trust in maternal support: study protocol for a randomized controlled trial.

Verhees Martine W F T MWFT Ceulemans Eva E Bakermans-Kranenburg Marian J MJ van IJzendoorn Marinus H MH de Winter Simon S Bosmans Guy G

Trials 20170714 1

<h4>Background</h4>Lack of trust in parental support is a transdiagnostic risk factor for the development of psychological problems throughout the lifespan. Research suggests that children's cognitive attachment representations and related information processing biases could be an important target for interventions aiming to build trust in the parent-child relationship. A paradigm that can alter these biases and increase trust is that of Cognitive Bias Modification (CBM), during which a target p ...[more]

PMID: 28709470

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Project description:BackgroundPersecutory 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.MethodsThe '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.DiscussionThis 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 registrationCurrent Controlled Trials ISRCTN: 90749868 . Retrospectively registered on 12 May 2016.

Project description:Cognitive biases refer to automatic attentional and interpretational tendencies, which could be retained by cognitive bias modification interventions. Cristea et al and Jones et al have published reviews (in 2016 and 2017 respectively) on the effectiveness of such interventions. The advancement of technologies such as electronic health (eHealth) and mobile health (mHealth) has led to them being harnessed for the delivery of cognitive bias modification. To date, at least eight studies have demonstrated the feasibility of mobile technologies for the delivery of cognitive bias modification. Most of the studies are limited to a description of the conventional cognitive bias modification methodology that has been adopted. None of the studies shared the developmental process for the methodology involved, such that future studies could adopt it in the cost-effective replication of such interventions.It is important to have a common platform that could facilitate the design and customization of cognitive bias modification interventions for a variety of psychiatric and addictive disorders. It is the aim of the current research protocol to describe the design of a research platform that allows for customization of cognitive bias modification interventions for addictive disorders.A multidisciplinary team of 2 addiction psychiatrists, a psychologist with expertise in cognitive bias modification, and a computer engineer, were involved in the development of the intervention. The proposed platform would comprise of a mobile phone version of the cognitive bias task which is controlled by a server that could customize the algorithm for the tasks and collate the reaction-time data in realtime. The server would also allow the researcher to program the specific set of images that will be present in the task. The mobile phone app would synchronize with the backend server in real-time. An open-sourced cross-platform gaming software from React Native was used in the current development.Multimedia Appendix 1 contains a video demonstrating the operation of the app, as well as a sample dataset of the reaction times (used for the computation of attentional biases) captured by the app.The current design can be utilized for cognitive bias modification across a spectrum of disorders and is not limited to one disorder. It will be of value for future research to utilize the above platform and compare the efficacy of mHealth approaches, such as the one described in this study, with conventional Web-based approaches in the delivery of attentional bias modification interventions.RR1-10.2196/9740.

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.

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The effects of Cognitive Bias Modification training and oxytocin administration on trust in maternal support: study protocol for a randomized controlled trial.

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The effects of Cognitive Bias Modification training and oxytocin administration on trust in maternal support: study protocol for a randomized controlled trial.

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