Fowler 2009.
Methods | Allocation: randomised Blinding: assessor blind Location: secondary mental health services in the East Anglia region of the UK Length of follow‐up: 9 months |
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Participants | Diagnosis: a diagnosis of affective or non‐affective psychosis (including schizophrenia, schizoaffective disorder, bipolar disorder, and psychotic depression) but not first episode. 65% of participants had non‐affective psychosis. N = 77 Sex: 55 M, 22 F Age: mean ˜ 27.8 years, SD ˜ 6.1 years Included: length of illness: mean ˜ 4.9 years, SD ˜ 2 years; illness duration less than 8 years; positive psychotic symptoms (hallucinations and delusions) in relative remission; unemployed status or currently engaged in < 16 hours paid employment or education Excluded: if psychotic disorder was thought to have an organic basis; acute psychosis present; primary diagnosis was drug dependency on opiates or cocaine |
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Interventions | 1. CBT group*: N = 35 Content: consisted of three stages and combined techniques of CBT with vocational case management Stage 1 involved developing a formulation of the person in social recovery. The focus was on identifying meaningful personal goals that could be linked with achievable day‐to‐day activity targets and thus address motivation and hopelessness. Stage 2 involved identifying and working towards medium‐ to long‐term goals. Where relevant, this included referral to relevant vocational agencies, or alternatively direct liaison with employers or education providers. Cognitive work at this stage involved promoting a sense of agency and addressing hopelessness, feelings of stigma, and negative beliefs about self and others. Stage 3 involved the active promotion of social activity, work, education, and leisure linked to meaningful goals. This involved promotion of activity by behavioural experiments, while managing symptoms of anxiety and low‐level psychotic symptoms. Specific therapeutic procedures used in the study were drawn from existing CBT manuals, especially procedures to focus on self‐regulation of psychotic symptoms and improve social recovery from psychosis. Therapists were also encouraged to use techniques of activity scheduling and reviewing mastery and pleasure and behavioural experiment approaches to manage social anxiety. Delivered by: Therapy in Norfolk was carried out by case managers who had no previous formal training in CBT. Therapy in the Cambridge‐based centre was carried out by CBT therapists. Frequency: not reported Treatment duration: 9 months 2. Standard care group: N = 42 Content: involved active case management by multi‐disciplinary secondary care mental health teams Delivered by: not reported Frequency: nor reported Treatment duration: 9 months |
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Outcomes | Global state: rehospitalisation Mental state: general (PANSS scores), anxiety (BAI scores), depression (BDI scores), hopelessness (BHS scores) Functioning: social (SOFAS scores) Quality of life: general (QLS scores) Satisfaction with treatment: leaving the study early Unable to use: Qualtiy of life: role functioning (QLS scores) ‐ skewed data Service use: Time Use Survey (scale not validated) |
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Notes | *Participants in the CBT group also received the standard care intervention.. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was stratified for diagnosis (affective/non‐affective psychosis was considered a prognostic factor) and administrative centre (Norfolk/Cambridgeshire)." (p.1628) Comments: Randomisation was well conducted. |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization was stratified for diagnosis (affective/non‐affective psychosis was considered a prognostic factor) and administrative centre (Norfolk/Cambridgeshire)." (p.1628) Comments: Randomisation was administrated by centre. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comments: The author did not address this information. However, participants and personnel were not likely to be blinded because participants in the treatment group received CBT, and the control group only received standard care. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Baseline and post‐treatment assessments were conducted by research assistants who were blind to group allocation." (p.1628) "Where blindness was broken, another research assistant conducted the post‐treatment assessment." (p.1631). "The research assistants made allocation guesses after post‐treatment CBT for improving social recovery in psychosis assessments. The result was within the levels that would be expected by chance." (p.1632) Comments: Blinding of the outcome assessor was well conducted. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Primary analyses and significance testing were conducted on an intention‐to‐treat basis." (p.1632) Comments: Missing data have been imputed using appropriate methods. |
Selective reporting (reporting bias) | Low risk | Comments: All measured outcomes were reported. |
Other bias | Low risk | Comments: none obvious |