Grawe 2006.
| Methods | Allocation: randomised Blinding: Assessor was blinded, however, it was unclear if the trialists and the participants were also blinded. Location: Norway Length of follow‐up: 2 years |
|
| Participants | Diagnosis: schizophrenia (DSM‐IV) N = 50 Sex: male and female (numbers not reported) Age: ˜ 25.4 years, SD ˜4.6 years Included: length of illness: mean ˜ 2 years; recent onset, no substance abuse, no mental retardation, has shown period of recovery from an initial psychotic episode Excluded: not reported |
|
| Interventions | 1. CBT group*: N = 30 Content: integrated treatment provided by multi‐disciplinary team, including pharmacotherapy and case management. Structured family psychoeducation, cognitive behavioural family education, problem‐solving skills training, individual cognitive behavioural strategies for residual symptoms Delivered by: not reported Frequency: one hour per week for the first two months; and then every third week for an hour for the first year; monthly for the second year Treatment duration: 2 years 2. Standard care group: N = 20 Content: antipsychotic medication, supportive house and day care, crisis inpatient treatment, rehabilitation, brief psychoeducation and supportive psychotherapy Delivered by: not reported Frequency: not reported Treatment duration: not reported |
|
| Outcomes | Global state: relapse, clinically important change (no improvement)**, rehospitalisation Adverse event: suicidal attempts Satisfaction with treatment: leaving the study early Unable to use: Mental state: general (BPRS scores) ‐ unable to extract data from graph Functioning: general (GAF scores) ‐ data not reported by groups |
|
| 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: "...random numbers provided by the central Optimal Treatment project administration. Blocks were of variable size (8 ‐ 12), stratified according to sex and with a ratio of IT to ST of 3:2 to ensure that the majority of cases received the experimental treatment." Comment: Block and stratified randomisation was used. |
| Allocation concealment (selection bias) | Low risk | Quote: ''...random numbers provided by the central Optimal Treatment project administration. Blocks were of variable size (8 ‐ 12), stratified according to sex and with a ratio of IT to ST of 3:2 to ensure that the majority of cases received the experimental treatment..." Comment: Allocation was concealed via Optimal Treatment Project administration. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: Neither participants, nor therapists were blinded. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Ratings were made by an independent rater who was blind to treatment conditions..." Comment: Assessor was blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no incomplete outcome data |
| Selective reporting (reporting bias) | Low risk | Comment: no selective reporting identified |
| Other bias | Low risk | Comment: no other bias identified |