Project description:Anxiety disorders are found to be the most prevalent psychological problems among children and adolescents. Cognitive behaviour therapy (CBT) was found to be effective at reducing anxiety. The purpose of this study was to assess the effectiveness of a universal school-based intervention for reducing anxiety among Grade 9 schoolchildren. A randomized controlled cluster trial was conducted by randomly assigning 36 schools in the Colombo district in Sri Lanka into study and control arms, each comprising 18 schools with 360 students. The levels of anxiety, self-esteem and depression status were assessed using the validated Screen for Child Anxiety Related Disorders (SCARED) tool and the Rosenberg self-esteem scale, respectively, and the Depression, Anxiety and Stress Scale 21 (DASS-21) at baseline, after intervention, and after 3 months. A CBT-based universal intervention package was administered weekly by a trained teacher for eight weeks with a one-month self-practice period to a randomly selected Grade 9 class in each school in the study arm. The control arm received routine care. Anxiety and self-esteem scores and depression status were compared between the two arms after the intervention and at 3 months of follow-up using the generalized estimation equation (GEE), controlling for confounding and clustering. The nonresponse and loss to follow-up rates were < 1%. When comparing the study arm with the control arm using GEE, anxiety levels were significantly lower [β = (-0.096), 95% CI = (-0.005) - (-0.186), p = 0.038] at follow-up but not postintervention [β = (-0.024), 95% CI = 0.006 - (-0.055), p = 0.115]. There were no significant differences in depression status after intervention (OR = 0.257, 95% CI =0.052-1.286; p = 0.098) or follow-up (OR = 0.422, 95% CI 0.177-1.008; p = 0.052), and self-esteem significantly increased after intervention (β = 0.811, 95% CI = 0.314-1.309; p = 0.001) but not at follow-up [β=0.435, 95% CI=(-0.276)-1.145, p=0.231]. This study revealed that the universal package based on CBT is effective at reducing anxiety and improving self-esteem among adolescents. The trial registration number and date were SLCTR/2018/018 and 19th of June 2018 respectively.
Project description:Fatigue is one of the most common and disabling symptoms in end-stage kidney disease, particularly among in-centre haemodialysis patients. This two-arm parallel group feasibility randomised controlled trial will determine whether a fully powered efficacy trial is achievable by examining the feasibility of recruitment, acceptability and potential benefits of a cognitive-behavioural therapy (CBT)-based intervention for fatigue among in-centre haemodialysis patients.We aim to recruit 40 adult patients undergoing in-centre haemodialysis at secondary care outpatient dialysis units, who meet clinical levels of fatigue. Patients will be randomised individually (using a 1:1 ratio) to either a 4-6 weeks' CBT-based intervention (intervention arm) or to a waiting-list control (control arm). The primary feasibility outcomes include descriptive data on numbers within each recruiting centre meeting eligibility criteria, rates of recruitment, numbers retained postrandomisation and treatment adherence. To assess the potential benefits of the cognitive-behavioural therapy for renal fatigue intervention, secondary self-report outcomes include measures of fatigue severity (Chalder Fatigue Questionnaire), fatigue-related functional impairment (Work and Social Adjustment Scale), sleep quality (Pittsburgh Sleep Quality Index), depression (Patient Health Questionnaire-9) and anxiety (Generalised Anxiety Disorder-7). Changes in fatigue perceptions (Brief Illness Perception Questionnaire), cognitive and behavioural responses to fatigue (Cognitive and Behavioural Responses to Symptoms Questionnaire), sleep hygiene behaviours (Sleep Hygiene Index) and physical activity (International Physical Activity Questionnaire-short form) will also be explored. These self-report measures will be collected at baseline and 3 months postrandomisation. Nested qualitative interviews will be conducted postintervention to explore the acceptability of the intervention and identify any areas in need of improvement. The statistician and assessor will be blinded to treatment allocation.A National Health Service (NHS) Research Ethics Committee approved the study. Any amendments to the protocol will be submitted to the NHS Committee and study sponsor.ISRCTN91238019;Pre-results.
Project description:Background:Cognitive-behavioural therapy (CBT) is the treatment of choice for generalised anxiety disorder (GAD), yielding significant improvements in approximately 50% of patients. There is significant room for improvement in the outcomes of treatment, especially in recovery. Aims:We aimed to compare metacognitive therapy (MCT) with the gold standard treatment, CBT, in patients with GAD (clinicaltrials.gov identifier: NCT00426426). Method:A total of 246 patients with long-term GAD were assessed and 81 were randomised into three conditions: CBT (n = 28), MCT (n = 32) and a wait-list control (n = 21). Assessments were made at pre-treatment, post-treatment and at 2 year follow-up. Results:Both CBT and MCT were effective treatments, but MCT was more effective (mean difference 9.762, 95% CI 2.679-16.845, P = 0.004) and led to significantly higher recovery rates (65% v. 38%). These differences were maintained at 2 year follow-up. Conclusions:MCT seems to produce recovery rates that exceed those of CBT. These results demonstrate that the effects of treatment cannot be attributed to non-specific therapy factors. Declaration of interest:A.W. wrote the treatment protocol in MCT and several books on CBT and MCT, and receives royalties from these. T.D.B. wrote the protocol in CBT and has published several articles and chapters on CBT and receives royalties from these. All other authors declare no competing interests.
Project description:Background: Internet-delivered Cognitive Behavioural Therapy (i-CBT) offers potential as an alternative, accessible, clinically and cost-effective treatment for post-traumatic stress disorder (PTSD), but little is known about its acceptability. Objective: To review the available evidence to understand the acceptability of i-CBT for PTSD. Method: We undertook a mixed-methods systematic review according to Cochrane Collaboration Guidelines, of randomised controlled trials (RCTs) of i-CBT for adults with PTSD. We examined included studies for measures of acceptability, and possible proxy indicators of acceptability, including dropout rates, which were meta-analysed as risk ratios (RRs). Results: Ten studies with 720 participants were included. We found i-CBT to be acceptable according to specific acceptability measures, and suggestions for acceptability according to some proxy measures of i-CBT programme usage. There was, however, evidence of greater dropout from i-CBT than waitlist (RR 1.39, CI 1.03-1.88; 8 studies; participants = 585) and no evidence of a difference in dropout between i-CBT and i-non-CBT (RR 2.14, CI 0.97-4.73; participants = 132; 2 studies). Conclusion: i-CBT appears a potentially acceptable intervention for adults with PTSD. We identified clinical and research questions, including the status of proxy indicators, and call for standardised, consistent treatment acceptability measurement.
Project description:BackgroundLittle is known about the association between stressors (especially positive stressors) during pregnancy and postpartum depression and anxiety.AimsWe investigated the association between positive and negative stress events during different stages of pregnancy and postpartum mental health outcomes among low-income pregnant women with symptoms of anxiety in Pakistan and evaluated whether an intervention based on cognitive-behavioural therapy (CBT) had a regulatory effect.MethodsParticipants were 621 pregnant Pakistani women with mild anxiety. Using the Pregnancy Experience Scale-Brief Version, six scores were created to assess positive and negative stressors. We performed a multivariate linear regression to examine whether these six scores, measured both at baseline and in the third trimester, were associated with postpartum anxiety and depressive symptoms. The effect of the intervention on this relationship was examined by adding an interaction term to the regression model.ResultsHassles frequency measured in the third trimester was positively associated with depression (B=0.22, 95% confidence interval (CI): 0.09 to 0.36) and anxiety (B=0.19, 95% CI: 0.08to 0.30). At the same timepoint, uplifts intensity was negatively associated with symptoms of depression (B=-0.82, 95% CI: -1.46 to -0.18) and anxiety (B=-0.70, 95% CI: -1.25 to -0.15), whereas hassles intensity was positively related to symptoms of depression (B=1.02, 95% CI: 0.36 to 1.67) and anxiety (B=0.90, 95% CI: 0.34 to 1.47). The intensity ratio of hassles to uplifts reported in the third trimester was positively related to both depression (B=1.40, 95% CI: 0.59 to 2.20) and anxiety (B=1.26, 95% CI: 0.57 to 1.96). The intervention strengthened the overall positive effects of uplifts and the negative effects of hassles. Pregnancy experiences at baseline during early pregnancy to mid-pregnancy were not associated with mental health outcomes.ConclusionsStressors in the third trimester but not earlier in pregnancy were associated with postpartum symptoms of anxiety and depression. The CBT intervention modified the association between pregnancy stressors and postpartum mental health outcomes. Programmes that promote positive experiences and reduce negative experiences, especially in late pregnancy, may mitigate postpartum mental health consequences.Trial registration numberNCT03880032.
Project description:IntroductionCognitive-behavioural therapy (CBT) consists of multiple treatment techniques for each treatment model and is tailored to the patient's characteristics. Randomised controlled trials (RCTs) have reported that CBT is effective for attention-deficit/hyperactivity disorder (ADHD); however, which CBT components are effective is unknown. In order to provide the best treatment technique, it is important to know which therapeutic component or combination thereof is more effective and what the specific effect size is.Methods and analysisWe will perform component network meta-analysis (cNMA). The search will include studies published from database inception up to 31 March 2022, in English. The electronic databases of MEDLINE (via PubMed), EMBASE, PsycINFO, ClinicalTrials.gov and Cochrane Library will be searched. We will systematically identify all RCTs in the treatment of ADHD between the ages of 10 and 60 years, comparing interventions composed of various CBT components with controlled interventions. We will perform pairwise and network meta-analysis with random effects to estimate summary ORs and standardised mean differences. We will assess the risk of bias in selected studies using the Cochrane risk of bias tool.Ethics and disseminationSince we will review published papers, ethical approval is not required. The results from this cNMA will provide a panorama of the CBT-based ADHD studies. The results of this study will be published in a peer-reviewed journal.Prospero registration numberCRD42022323898.
Project description:OBJECTIVE:To assess whether exposure-based internet-delivered cognitive-behavioural therapy (internet-CBT) is a cost-effective treatment for adolescents with irritable bowel syndrome (IBS) compared with a waitlist control, from a societal perspective, based on data from a randomised trial. DESIGN:Within-trial cost-effectiveness analysis. SETTING:Participants were recruited from the whole of Sweden via primary, secondary and tertiary care clinics reached through news media and advertising. PARTICIPANTS:Adolescents (aged 13-17) with a diagnosis of IBS. INTERVENTIONS:Participants were randomised to either an exposure-based internet-CBT, including 10 weekly modules for adolescents and five modules for parents, or a waitlist. OUTCOME MEASURES:The main health outcome was the quality-adjusted life-year (QALY) estimated by mapping Pediatric Quality-of-Life Inventory (PedsQL) scores onto EQ-5D-3L utilities. The secondary outcome was the point improvement on the PedsQL scale. Data on health outcomes and resource use were collected at baseline and 10 weeks post-treatment. Resource use was measured using the Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) . Incremental cost-effectiveness ratios (ICER) were calculated as the difference in average costs by the difference in average outcomes between groups. RESULTS:The base-case results showed that internet-CBT costs were on average US$170.24 (95% CI 63.14 to 315.04) more per participant than the waitlist. Adolescents in the internet-CBT group showed small QALY gains (0.0031; 95% CI 0.0003 to 0.0061), and an average improvement of 5.647 points (95% CI 1.82 to 9.46) on the PedsQL compared with the waitlist. Internet-CBT yielded an ICER of $54 916/QALY gained and a probability of cost-effectiveness of 74% given the Swedish willingness-to-pay threshold. The ICER for the outcome PedsQL was US$85.29/point improvement. CONCLUSIONS:Offering internet-CBT to adolescents with IBS improves health-related quality of life and generates small QALY gains at a higher cost than a waitlist control. Internet-CBT is thus likely to be cost-effective given the strong efficacy evidence, small QALY gains and low cost. TRIAL REGISTRATION NUMBER:NCT02306369; Results.
Project description:INTRODUCTION:Insomnia is associated with a number of adverse consequences that place a substantial economic burden on individuals and society. Cognitive behavioural therapy for insomnia (CBT-I) is a promising intervention that can improve outcomes in people who suffer from insomnia. However, evidence of its cost-effectiveness remains unclear. In this study, we will systematically review studies that report on economic evaluations of CBT-I and investigate the potential economic benefit of CBT-I as a treatment for insomnia. METHODS AND ANALYSIS:The search will include studies that use full economic evaluation methods (ie, cost-effectiveness, cost-utility, cost-benefit, cost-consequences and cost-minimisation analysis) and those that apply partial economic evaluation approaches (ie, cost description, cost-outcome description and cost analysis). We will conduct a preliminary search in MEDLINE, Google Scholar, MedNar and ProQuest dissertation and theses to build the searching terms. A full search strategy using all identified keywords and index terms will then be undertaken in several databases including MEDLINE, Psychinfo, Proquest, Cochrane, Scopus, Cumulative Index of Nursing and Allied Health Literature (CINAHL), Web of Science and EMBASE. We will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for protocol guidelines in this review. Only articles in the English language and those reporting on adult populations will be included. We will use standardised data extraction tools for economic evaluations to retrieve and synthesise information from selected studies into themes and summarised in a Joanna Briggs Institute dominance ranking matrix. ETHICS AND DISSEMINATION:No formal ethics approval will be required as we will not be collecting primary data. Review findings will be disseminated through a peer-reviewed publication, workshops, conference presentations and a media release. PROSPERO REGISTRATION NUMBER:CRD42019133554.