Jackson 2009.
Methods | Allocation: randomised Blinding: assessor blind Location: four Mental Health Services throughout the West Midlands in the UK Length of follow‐up: 12 months |
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Participants | Diagnosis: first episode of non‐affective* psychosis (ICD‐10) N = 76 Sex: 49 M, 17 F Age: 16 ‐ 35 years, mean ˜ 24.1 years, SD ˜4.7 years Included: length of illness: mean ˜ 17.4 weeks, SD ˜ 25.4 weeks; experienced a first episode of psychosis within the previous 6 ‐ 18 months Excluded: non English speakers; unable to give informed consent |
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Interventions | 1. CBT group**: N = 36 Content: The cognitive therapy‐based recovery intervention (CRI) was designed to be delivered on a weekly basis over a 6 month period (i.e. it was limited to a maximum of 26 sessions) and followed a protocol‐based modular approach. There were three key components: (a) engagement and formulation; (b) trauma processing; and (c) appraisals of psychotic illness (shame, loss, and entrapment). The intervention, therefore, is not just designed for those who could be described as 'traumatised' by their experiences of psychosis. It is intended to be helpful for all first episode patients adjusting to and recovering from a first episode of psychosis. Delivered by: four clinical psychologists and a cognitive behavioural psychotherapist Freqency: a weekly basis over a 6‐month period Treatment duration: 6 months 2. Standard care group: N = 30 Content: Those assigned to the standard care group received treatment‐as‐usual from their local mental health services. Standard care consisted of a combination of case management and antipsychotic medication. Delivered by: not reported Frequency: not reported Treatment duration: 6 months |
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Outcomes | Mental state: depression (CDS scores), self‐esteem (RSCQ scores) Satisfaction with treatment: leaving the study early Unable to use: Post‐traumatic phenomena: IES score ‐ not predefined outcome for this review Attraction, worth, auto self‐regulation, comp, value of existence: RSCQ scores ‐ not predefined outcomes for this review |
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Notes | *We think 'non‐affective' could be schizophrenia, but not necessarily 100%. In this case, we have given this trial the benefit of the doubt and decided to include it. **The term 'Treatment‐as‐usual (TAU)' was used in this paper. Participants in the CBT group also received the standard care intervention. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Participants were randomly assigned to CBT or Standard care by means of a computerised random number generator administered by the Birmingham University Clinical Trials Unit independent of the research team." (p.455) Comments: Randomisation was well conducted. |
Allocation concealment (selection bias) | Low risk | Quote: "...random number generator administered by the Birmingham University Clinical Trials Unit independent of the research team." (p.455) Comments: Participants and investigators enrolling participants could not foresee assignment |
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: "In addition, to maintain blindness, therapists and clients were asked not to discuss with the research associates which group they were allocated to and research staff did not attend treatment meetings or access case notes following randomisation. Assessors were asked to record any loss of masking to treatment allocation. " (p.455) Comments: The outcome assessor was blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comments: intention‐to‐treat analysis undertaken |
Selective reporting (reporting bias) | Low risk | Comments: All measured outcomes were reported. |
Other bias | Low risk | Comments: none obvious |