The effects of a brief CBT intervention, delivered by frontline mental health staff, to promote recovery in people with psychosis and comorbid anxiety or depression (the GOALS study):study protocol for a randomized controlled trial

BACKGROUND: NICE guidance states that cognitive behavioural therapy (CBT) should be offered to all patients with psychosis. However, there is a need to improve access to therapeutic interventions. We aim to train frontline mental health staff to deliver brief, structured CBT-based therapies. We have developed and piloted a manualized intervention to support people with psychosis and anxious avoidance or depression to work towards a personal recovery goal. METHODS/DESIGN: The ‘GOALS Study’ is a pilot randomized controlled trial comparing usual care plus an 8-week intervention with usual care alone. The key objective is to assess clinical feasibility (recruitment and randomization; compliance with the treatment manual; acceptability and satisfaction; progress towards goals). A secondary objective is a preliminary evaluation of efficacy. Sixty-six participants with a diagnosis of psychosis, plus symptoms of depression or anxiety will be recruited from adult mental health services. Those currently refusing medication, in receipt of CBT, or with a primary diagnosis of an organic mental health problem or substance dependency will be excluded. Following informed consent, randomization will be independent of the trial team, at a 50:50 ratio, at the level of the individual and stratified by main problem focus. Following randomization, participants allocated to the intervention group will begin the 8-week intervention with a local, trained member of staff, supervised by the study coordinator. Outcomes will be assessed blind to treatment condition at 0, 12 and 18 weeks post-randomization. The primary outcome measure for the efficacy analysis will be activity levels at 12 weeks. Secondary outcome measures include mood, psychotic symptoms, quality of life and clinical distress. A health economic analysis comparing service use in each condition will also be performed. Recruitment began in March, 2013 and is ongoing until December, 2014. DISCUSSION: This is the first trial of the GOALS intervention. The approach is brief and staff can be readily trained in its delivery: there is therefore potential to develop a cost-effective intervention that could be widely disseminated. If the trial proves clinically feasible and demonstrates preliminary evidence of efficacy, a large multi-site trial will be warranted. TRIAL REGISTRATION: Current Controlled Trials ISRCTN: 73188383. http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=1353

Cognitive bias and unusual experiences in childhood

Cognitive therapy is recommended for children with psychotic-like, or unusual, experiences associated with distress or impairment (UEDs; UK National Institute for Health and Care Excellence, 2013 [1]). Accurate models of the psychological underpinnings of childhood UEDs are required to effectively target therapies. Cognitive biases, such as the jumping to conclusions data-gathering bias (JTC), are implicated in the development and maintenance of psychosis in adults. In this study, we aimed to establish the suitability for children of a task developed to assess JTC in adults. Eighty-six participants (aged 5–14 years) were recruited from Child and Adolescent Mental Health Service (CAMHS) and community (school) settings, and completed the probabilistic reasoning (‘Beads’) task, alongside measures of intellectual functioning, general psychopathology, and UEDs. Self-reported reasoning strategy was coded as ‘probabilistic’ or ‘other’. Younger children (5–10 years) were more likely than older children (11–14 years) to JTC (OR = 2.7, 95 % CI = 1.1–6.5, p = 0.03); and to use non-probabilistic reasoning strategies (OR = 9.4, 95 % CI = 1.7–48.8, p = 0.008). Both UED presence (OR = 5.1, 95 % CI = 1.2–21.9, p = 0.03) and lower IQ (OR = 0.9, 95 % CI = 0.9–1.0, p = 0.02) were significantly and independently associated with JTC, irrespective of age and task comprehension. Findings replicate research in adults, indicating that the ‘Beads’ task can be reliably employed in children to assess cognitive biases. Psychological treatments for children with distressing unusual experiences might usefully incorporate reasoning interventions

TRIALS STUDY PROTOCOL Open Access

The effects of a brief CBT intervention, delivered by frontline mental health staff, to promote recovery in people with psychosis and comorbid anxiety or depression (the GOALS study): study protocol for a randomized controlled tria

Modelling psychosocial influences on the distress and impairment caused by psychotic-like experiences in children and adolescents

Abstract Psychological understanding of psychotic-like experiences (PLEs) occurring in childhood is limited, with no recognised conceptual framework to guide appropriate intervention. We examined the contribution to PLE severity of emotional, cognitive and socio-environmental mechanisms thought to influence the development and maintenance of psychosis. Forty 8–14 year olds referred to a community Child and Adolescent Mental Health Service completed a battery of questionnaires and assessments measuring severity of PLEs, emotional problems, cognitive biases, and negative life events. 85 % of children assessed reported having experienced a PLE over the previous year, and 55 % reported more than one. 60 % had experienced at least one in the previous fortnight. Multiple linear regression demonstrated that each of the variables made a significant and independent contribution to PLE severity, after adjusting for verbal ability and age, accounting together for more than half of the variance (reasoning B = 6.324, p = .049, emotion B = 1.807, p = .005, life events B = 4.039, p = .001). PLEs were common in this clinical sample of children. Psychological factors implicated in the development and maintenance of psychosis in adults were also associated with PLE severity in these children. PLE severity may be reduced by targeting each of these factors in cognitive therapy, at this very early stage. Any improvements in emotional wellbeing and functioning may then increase future resilience

Variation in psychosocial influences according to the dimensions and content of children's unusual experiences: Potential routes for the development of targeted interventions

The psychosocial processes implicated in the development and maintenance of psychosis differ according to both the dimensional attributes (conviction, frequency, associated distress, adverse life impact) and the content or type (e.g. grandiosity, hallucinations, paranoia) of the psychotic symptoms experienced. This has informed the development of ‘targeted’ cognitive behavioural therapy for psychosis (CBTp): interventions focusing on specific psychological processes in the context of particular symptom presentations. In adults, larger effect sizes for change in primary outcomes are typically reported in trials of targeted interventions, compared to those for trials of generic CBTp approaches with multiple therapeutic foci. We set out to test the theoretical basis for developing targeted CBTp interventions for young people with distressing psychotic-like, or unusual, experiences (UEs). We investigated variations in the psychosocial processes previously associated with self-reported UE severity (reasoning, negative life events, emotional problems) according to UE dimensional attributes and content/type (using an established five-factor model) in a clinically referred sample of 72 young people aged 8–14 years. Regression analyses revealed associations of conviction and grandiosity with reasoning; of frequency, and hallucinations and paranoia, with negative life events; and of distress/adverse life impact, and paranoia and hallucinations, with emotional problems. We conclude that psychological targets for intervention differ according to particular characteristics of childhood UEs in much the same way as for psychotic symptoms in adults. The development of targeted interventions is therefore indicated, and tailoring therapy according to presentation should further improve clinical outcomes for these young people