2 Research recommendations

The Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future. The Guideline Development Group's full set of research recommendations is detailed in the full guideline.

2.1 Peer support interventions

What is the clinical and cost effectiveness of peer support interventions in people with psychosis and schizophrenia?

Why this is important

Service users have supported the development of peer support interventions, which have recently proliferated in the UK, but current evidence for these interventions in people with psychotic disorders is not strong and the studies are mainly of very low quality. Moreover the content of the programmes has varied considerably, some using structured interventions, others providing more informal support. There is therefore an urgent need for high-quality evidence in this area.

The programme of research would be in several stages. First, there should be development work to establish what specifically service users want from peer support workers, as opposed to what they want from professionals, and what the conditions are for optimal delivery of the intervention. This development work should be co-produced by exploring the views of service users, experienced peer support workers and developers of peer support interventions, and suitable outcome measures should be identified reflecting the aims of peer support. Second, the intervention, delivered as far as possible under the optimal conditions, should be tested in a high-quality trial. Further research should test structured and manualised formats versus unstructured formats (in which service user and peer decide together what to cover in the session). Benefits and adverse effects experienced by peer support workers should also be measured.

2.2 People who choose not to take antipsychotic medication

What is the clinical and cost effectiveness of psychological intervention alone, compared with treatment as usual, in people with psychosis or schizophrenia who choose not to take antipsychotic medication?

Why this is important

The development of alternative treatment strategies is important for the high proportion of people with psychosis and schizophrenia who choose not to take antipsychotic medication, or discontinue it because of adverse effects or lack of efficacy. There is evidence that psychological interventions (CBT and family intervention) as an adjunct to antipsychotic medication are effective in the treatment of psychosis and schizophrenia and are cost saving. However, there is little evidence for family intervention or CBT alone, without antipsychotic medication.

The programme of research should compare the clinical and cost effectiveness of psychological intervention alone (CBT and/or family intervention) with treatment as usual for people with psychosis or schizophrenia who choose not to take antipsychotic medication, using an adequately powered study with a randomised controlled design. Key outcomes should include symptoms, relapse rates, quality of life, treatment acceptability, social functioning and the cost effectiveness of the interventions.

2.3 The physical health benefits of discontinuing antipsychotic medication

What are the short- and long-term benefits to physical health of guided medication discontinuation and/or reduction in first episode psychosis and can this be achieved without major risks?

Why this is important

There is growing concern about the long-term health risks, increased mortality and cortical grey matter loss linked to cumulative neuroleptic exposure in people with psychosis. The majority of young adults discontinue their medication in an unplanned way because of these risks. A Dutch moderately-sized open trial has reported successful discontinuation of medication in 20% of people without serious relapse; at 7-year follow-up there was continuous benefit for guided reduction in terms of side effects, functioning and employment, with no long-term risks. If replicated, this would mark a significant breakthrough in reducing the long-term physical health risks associated with antipsychotic treatment and improving outcomes.

The programme of research should use an adequately powered, multicentre, double-blind, randomised controlled design to test the physical health benefits, risks and costs of discontinuing or reducing antipsychotic medication among young adults with first episode psychosis who have achieved remission. The primary outcomes should be quality of life and metabolic disorder, including weight gain; secondary outcomes should include side effects, serious relapse, acceptability and user preference.

2.4 Maintaining the benefits of early intervention in psychosis services after discharge

How can the benefits of early intervention in psychosis services be maintained once service users are discharged after 3 years?

Why this is important

Early intervention in psychosis services deliver evidence-based interventions in a positive, youth-friendly setting, improve outcomes, are cost effective and have high service user acceptability and engagement. Once people are transferred to primary care or community mental health services these gains are diminished. The guideline recommends that trusts consider extending these services. However, the extent to which gains would be maintained and who would benefit most is not known. The successful element of early intervention in psychosis services might be incorporated into mainstream services for psychosis, but how this would function, and its cost effectiveness, needs to be determined.

The suggested programme of research should use an adequately powered, multi-centre randomised trial comparing extending early intervention in psychosis services (for example, for 2 years) versus providing augmented (step-down) care in community mental health services versus treatment as usual to determine whether the gains of early intervention can be maintained and which service users would benefit most under each condition. The primary outcome should be treatment/service engagement and secondary outcomes should include relapse, readmission, functioning and user preference.

2.5 Interventions for PTSD symptoms in people with psychosis and schizophrenia

What is the benefit of a CBT-based trauma reprocessing intervention on PTSD symptoms in people with psychosis and schizophrenia?

Why this is important

PTSD symptoms have been documented in approximately one-third of people with psychosis and schizophrenia. The absence of PTSD symptoms in this context predicts better mental health outcomes, lower service use and improved life satisfaction. Two-thirds of the traumatic intrusions, observed in first episode and established psychosis, relate to symptoms of psychosis and its treatment (including detention). One study has demonstrated proof-of-principle in first episode psychosis for trauma reprocessing, focusing on psychosis-related intrusions. Replication of the study will fill a major gap in treatment for this population and may have other benefits on psychotic symptoms and service use.

The suggested programme of research would use an adequately powered, multi-centre randomised trial to test whether a CBT-based trauma reprocessing intervention can reduce PTSD symptoms and related distress in people with psychosis and schizophrenia. The trial should be targeted at those with high levels of PTSD symptoms, particularly traumatic intrusions, following first episode psychosis. The follow-up should be up to 2 years and the intervention should include 'booster' elements, extra sessions of CBT-based trauma reprocessing interventions, and a health economic evaluation.

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