It is estimated that over half a million people in the UK alone suffer from psychosis. For many, recovery is impeded by high levels of distress, often resulting from persisting psychotic symptoms, stigma and social exclusion [1, 2]. There is evidence for an increased prevalence of anxiety and depression in people with psychosis, in comparison with the general population [3, 4]. These difficulties can prevent people from engaging in meaningful activity and from achieving valued goals. Helping people to overcome these obstacles and achieve their goals should promote recovery.
There is evidence that cognitive behavioural therapy (CBT), in conjunction with antipsychotic medication, is effective in reducing distressing symptoms and hospitalizations, in comparison with medication alone [5, 6]. Consequently, the latest National Institute for Health and Care Excellence (NICE) guidance  states that CBT should be offered to all people with psychosis or schizophrenia. New cognitive behavioural approaches for psychosis have been developed to focus specifically on recovery-oriented outcomes, such as increased activity levels and hopefulness about the future . However, given the large number of patients with psychosis and the limited availability of CBT-trained professionals, there is a need to consider ways of improving access.
Brief, evidence-based CBT approaches are available, as adopted in the UK ‘Improving Access to Psychological Therapies’ programme; namely, graded exposure and behavioural activation. These interventions are effective in reducing anxiety and depression [9–11], and are often applied in CBT for psychosis, to help with concurrent difficulties with mood, and to help manage persisting psychotic symptoms . Importantly, the approaches can be readily disseminated: ‘nonspecialist’ staff can be trained to deliver behavioural activation effectively, following brief training [13, 14]. However, little evidence is available regarding their efficacy in this group. Based on these evidence-based methods, we have developed a new intervention designed to help people meet valued, personal goals and improve recovery, which can be delivered by frontline mental health staff as part of the team’s package of care.
We have completed a small pre-pilot study to evaluate the feasibility of the model of delivery, and the effectiveness of the intervention . Six staff members, including nurses and occupational therapists, completed training over four half-days, with ongoing group supervision from a clinical psychologist. They delivered the intervention to 12 service users, all of whom were outpatients attending early-intervention or community mental health services. All participants showed increased activity and clinical improvement, and were able to meet their goals. Both staff and service users gave positive feedback on the intervention. Participant and staff feedback was sought following completion of the study , which informed a number of changes to the treatment manual and training package.
Pilot randomized controlled trial
The aim of the study is to run a pilot randomized controlled trial of this intervention, specifically designed for people with psychosis: the GOALS study (‘Getting On top of Anxiety and Low mood’). Following the same structure as the pre-pilot study, therapy will be delivered over eight weekly sessions by frontline mental health staff, after receiving brief training (2 days) and fortnightly case supervision from a clinical psychologist, to provide ongoing support and to ensure fidelity to the treatment protocol. Staff will come from a range of professional backgrounds, including nursing, occupational therapy and psychology (assistants) and are likely to have little or no previous experience in delivering CBT-based therapy. The manualized intervention aims to improve recovery, social inclusion and social functioning and reduce distress, and will be evaluated in comparison to a treatment-as-usual (TAU) control group, which will be standard community mental health care. This will inform the further development of the intervention and training and will provide information for a larger multicentre trial.
The main objective of the study is to assess the clinical feasibility of delivering the therapy package to patients with a diagnosis of psychosis and concurrent anxiety or depression. We will assess this on the basis of successful recruitment and randomization, therapist and participant compliance with the treatment manual and good levels of acceptability and satisfaction with the treatment and progress towards participants’ chosen goals. A secondary objective is a preliminary evaluation of efficacy. For this, the primary outcome is activity levels at post-intervention; our assessment time point of interest. In addition we will examine a range of secondary outcomes at both post-intervention (12 weeks) and follow-up (18 weeks). These include assessments of mood, psychotic symptoms, well-being and clinical distress. A health economic analysis, assessing service use, will also be performed, to assess the cost effectiveness of the intervention.