IntroductionThe Antidepressant Advisor Study is a feasibility trial of a computerised decision-support tool which uses an algorithm to provide antidepressant treatment guidance for general practitioners (GPs) in the UK primary care service. The tool is the first in the UK to implement national guidelines on antidepressant treatment guidance into a computerised decision-support tool.Methods and analysisThe study is a parallel group, cluster-randomised controlled feasibility trial where participants are blind to treatment allocation. GPs were assigned to two treatment arms: (1) treatment-as-usual (TAU) and (2) computerised decision-support tool to assist with antidepressant choices. The study will assess recruitment and lost to follow-up rates, GP satisfaction with the tool and impact on health service use. A meaningful long-term roll-out unit cost will be calculated for the tool, and service use data will be collected at baseline and follow-up to inform a full economic evaluation of a future trial.Ethics and disseminationThe study has received National Health Service ethical approval from the London—Camberwell St Giles Research Ethics Committee (ref: 17/LO/2074). The trial was pre-registered in the Clinical Trials.gov registry. The results of the study will be published in a pre-publication archive within 1 year of completion of the last follow-up assessment.Trial registration numberNCT03628027.
BackgroundNICE guidelines state cognitive behavioural therapy (CBT) is a front-line psychological treatment for people presenting with depression in primary care. Counselling for Depression (CfD), a form of Person-Centred Experiential therapy, is also offered within Improving Access to Psychological Therapies (IAPT) services for moderate depression but its effectiveness for severe depression has not been investigated. A full-scale randomised controlled trial to determine the efficacy and cost-effectiveness of CfD is required.MethodsPRaCTICED is a two-arm, parallel group, non-inferiority randomised controlled trial comparing CfD against CBT. It is embedded within the local IAPT service using a stepped care service delivery model where CBT and CfD are routinely offered at step 3. Trial inclusion criteria comprise patients aged 18 years or over, wishing to work on their depression, judged to require a step 3 intervention, and meeting an ICD-10 diagnosis of moderate or severe depression. Patients are randomised using a centralised, web-based system to CfD or CBT with each treatment being delivered up to a maximum 20 sessions. Both interventions are manualised with treatment fidelity tested via supervision and random sampling of sessions using adherence/competency scales. The primary outcome measure is the Patient Health Questionnaire-9 collected at baseline, 6 and 12 months. Secondary outcome measures tap depression, generic psychological distress, anxiety, functioning and quality of life. Cost-effectiveness is determined by a patient service receipt questionnaire. Exit interviews are conducted with patients by research assessors blind to treatment allocation. The trial requires 500 patients (250 per arm) to test the non-inferiority hypothesis of −2 PHQ-9 points at the one-sided, 2.5% significance level with 90% power, assuming no underlying difference and a standard deviation of 6.9. The primary analysis will be undertaken on all patients randomised (intent to treat) alongside per-protocol and complier-average causal effect analyses as recommended by the extension to the CONSORT statement for non-inferiority trials.DiscussionThis large-scale trial utilises routinely collected outcome data as well as specific trial data to provide evidence of the comparative efficacy and cost-effectiveness of Counselling for Depression compared with Cognitive Behaviour Therapy as delivered within the UK government’s Improving Access to Psychological Therapies initiative.Trial registrationControlled Trials ISRCTN Registry, ISRCTN06461651. Registered on 14 September 2014. Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1834-6) contains supplementary material, which is available to authorized users.
BackgroundThe UK government's implementation in 2008 of The Improving Access to Psychological Therapies (IAPT) initiative in England provided a huge increase in the availability of cognitive-behavioural therapy (CBT) for the treatment of depression and anxiety in primary care. Counselling for Depression (CfD) -a form of person-centred experiential therapy (PCET) -has since been included as an IAPT-approved therapy but there is no evidence from randomised controlled trials determining its efficacy as required by the National Institute for Clinical and Social Excellence (NICE). Given the high demand for psychological therapies, there is a need for evidence of efficacy to ensure maximum practitioner resources are available to meet this need and to offer patients choice. We aimed to determine the clinical efficacy and cost-effectiveness of PCET compared with CBT in the treatment of moderate and severe depression within the English IAPT delivery service model. MethodsWe conducted a pragmatic, non-inferiority randomised controlled trial of PCET vs. CBT for patients ≥18 years of age who met criteria for either moderate or severe depression as determined by the Clinical Interview Schedule-Revised version. We excluded participants presenting with an organic condition, psychosis, drug or alcohol dependence, or elevated clinical risk. Randomisation was carried out independent of the research team. Ethical approval was granted by the Health Research Authority (REC: 14/YH/0001). The trial registration ID is ISRCTN06461651 and the research protocol has been published. 510 patients were randomised (1:1) to PCET or CBT and were seen by appropriately trained
Background Recent works suggested taking into account the severity and the type of anhedonia when examining suicidal ideation. The present study investigated a moderated mediation model addressing the psychosocial mechanisms that account for the association between state or trait anhedonia and suicidal ideation. Methods State anhedonia was assessed using the Snaith‐Hamilton Pleasure Scale, while trait anhedonia was assessed using the Temporal Experience of Pleasure Scale. A total number of 1,361 of undergraduates completed questionnaires at three different times, with one‐year intervals. Results The direct effect of stress on suicidal ideation was significantly greater for those students who had lower trait anticipatory and consummatory anhedonia, whereas the indirect effect from stress on suicidal ideation through depression was significantly greater for those who had higher state anhedonia. Moreover, trait consummatory anhedonia moderated the relationship between stress and suicidal ideation after one year, and trait anticipatory anhedonia moderated the relationship between stress and suicidal ideation after two years. Conclusions Low levels of trait anhedonia were associated with elevated suicidal ideation, while high levels of state anhedonia were associated with elevated suicidal ideation. Trait consummatory anhedonia was associated with short‐term suicidal ideation, while trait anticipatory anhedonia was associated with long‐term suicidal ideation.
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