Dataset Information

Augmenting inpatient treatment for post-traumatic stress disorder with a computerised cognitive bias modification procedure targeting appraisals (CBM-App): protocol for a randomised controlled trial.

ABSTRACT:

Introduction

Influential 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 analysis

The 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 dissemination

The 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 number

NCT02687555.

SUBMITTER: Woud ML

PROVIDER: S-EPMC6042580 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Augmenting inpatient treatment for post-traumatic stress disorder with a computerised cognitive bias modification procedure targeting appraisals (CBM-App): protocol for a randomised controlled trial.

Woud Marcella L ML Blackwell Simon E SE Cwik Jan C JC Margraf Jürgen J Holmes Emily A EA Steudte-Schmiedgen Susann S Herpertz Stephan S Kessler Henrik H

BMJ open 20180630 6

<h4>Introduction</h4>Influential 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 su ...[more]

PMID: 29961004

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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: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.

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: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:ImportanceMore than half of patients with alcohol use disorder who receive inpatient withdrawal treatment relapse within weeks of discharge, hampering subsequent uptake and effectiveness of psychological and pharmacologic interventions. Cognitive bias modification (CBM) improves outcomes after alcohol rehabilitation, but the efficacy of delivering CBM during withdrawal treatment has not yet been established.ObjectiveTo test the hypothesis that CBM would increase the likelihood of abstaining from alcohol during the 2 weeks following discharge from inpatient withdrawal treatment.Design, setting, and participantsIn a randomized clinical trial, 950 patients in 4 inpatient withdrawal units in Melbourne, Australia, were screened for eligibility between June 4, 2017, and July 14, 2019, to receive CBM or sham treatment. Patients with moderate or severe alcohol use disorder aged 18 to 65 years who had no neurologic illness or traumatic brain injury were eligible. Two-week follow-up, conducted by researchers blinded to the participant's condition, was the primary end point. Both per-protocol and intention-to-treat analysis were conducted.InterventionsRandomized to 4 consecutive daily sessions of CBM designed to reduce alcohol approach bias or sham training not designed to modify approach bias.Main outcomes and measuresPrimary outcome was abstinence assessed using a timeline followback interview. Participants were classified as abstinent (no alcohol use in the first 14 days following discharge) or relapsed (any alcohol use during the first 14 days following discharge or lost to follow-up).ResultsOf the 950 patients screened for eligibility, 338 did not meet inclusion criteria, 108 were discharged before being approached, and 192 refused. Of the 312 patients who consented (referred sample), 12 withdrew before being randomized. In the final population of 300 randomized patients (CBM, n = 147; sham, n = 153), 248 completed the intervention and 272 completed the follow-up. Of the 300 participants (173 [57.7%] men; mean [SD] age, 43.47 [10.43] years), 7 patients (3 controls, 4 CBM) withdrew after finding the training uncomfortable. Abstinence rates were 42.5% (95% CI, 34.3%-50.6%) in controls and 54.4% (95% CI, 46.0%-62.8%) in CBM participants, yielding an 11.9% (95% CI, 0.04%-23.8%; P = .04) difference in abstinence rates. In a per-protocol analysis including only those who completed 4 sessions of training and the follow-up, the difference in abstinence rate between groups was 17.0% (95% CI, 3.8%-30.2%; P = .008).Conclusions and relevanceThe findings of this clinical trial support the efficacy of CBM for treatment of alcohol use disorder. Being safe and easy to implement, requiring only a computer and joystick, and needing no specialist staff/training, CBM could be routinely offered as an adjunctive intervention during withdrawal treatment to optimize outcomes.Trial registrationAustralian New Zealand Clinical Trials Registry Identifier: ACTRN12617001241325.

Dataset Information

Augmenting inpatient treatment for post-traumatic stress disorder with a computerised cognitive bias modification procedure targeting appraisals (CBM-App): protocol for a randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Augmenting inpatient treatment for post-traumatic stress disorder with a computerised cognitive bias modification procedure targeting appraisals (CBM-App): protocol for a randomised controlled trial.

Similar Datasets

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