Abstract
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.
Highlights
NICE guidelines state cognitive behavioural therapy (CBT) is a front-line psychological treatment for people presenting with depression in primary care
Since 2008, patients presenting to the UK National Health Service (NHS) with a primary condition of mild, moderate and severe depression are typically treated within Improving Access to Psychological Therapies (IAPT) services
The PRaCTICED trial is a large-scale randomised trial investigating the efficacy of Counselling for Depression (CfD) against CBT
Summary
NICE guidelines state cognitive behavioural therapy (CBT) is a front-line psychological treatment for people presenting with depression in primary care. Since 2008, patients presenting to the UK National Health Service (NHS) with a primary condition of mild, moderate and severe depression are typically treated within Improving Access to Psychological Therapies (IAPT) services. These services are premised on a stepped care model and built on the argument for improved access to, in particular, cognitive behaviour therapy (CBT), which resulted in a large investment in training a new workforce in this particular psychological approach [1]. While the implementation of IAPT at step 2 and step 3 originally focused only on training and delivering CBT-based personnel and interventions, more latterly the provision of psychological approaches at step 3 has been extended to include bona fide psychological therapies in addition to CBT, namely interpersonal psychotherapy, dynamic interpersonal therapy, couples counselling, and counselling for depression (CfD), with the latter being the focus of the present article
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