Summary of findings 1. CBT plus standard care compared to standard care for persistent aggressive behaviour or agitation in people with schizophrenia.
| CBT plus standard care compared to standard care for persistent aggressive behaviour or agitation in people with schizophrenia | |||
| Patient or population: persistent aggressive behaviour or agitation in people with schizophrenia Setting: any clinical setting Intervention: CBT plus standard care Comparison: standard care | |||
| Outcomes | Impact | № of participants (studies) | Certainty of the evidence (GRADE) |
| Aggression ‐ frequency of physical violence. Assessed with: frequency of aggressive episodes over person‐time. Follow up: median 6 months. | Rate ratio 0.52 (0.23 to 1.18) amongst 84 participants included in one RCT. Data was reported as incidence rate ratios with 95% CI. Absolute effect estimation was not allowed due that frequencies of aggressions were not reported. CBT may result in little to no difference in the frequency of physical violence, but the evidence is very uncertain. Participants allocated to CBT had 0.52 times the rate of events compared to participants allocated to standard care (0.23 times fewer to 1.18 times more). |
84 (1 RCT) | ⨁◯◯◯ VERY LOW 1 2 |
| Agitation ‐ frequency of agitation | No study reported on this important outcome. | 0 (0 RCTs) |
Not estimable |
| Clinically important adverse effect or event. Assessed with: number of adverse effects recorded. Follow up: 6 months. |
Absolute and relative effect sizes are not estimable. No serious adverse effects or events were recorded in both arms. | 100 (1 RCT) |
Not estimable |
| Self harm ‐ frequency of self harm | No study reported on this important outcome. | 0 (0 RCTs) |
Not estimable |
| Mental state ‐ clinically important change in mental state | No study reported on this important outcome. | 0 (0 RCTs) |
Not estimable |
| Leaving the study early for any reason. Follow‐up: range 3 to 6 months. |
Risk ratio 1.04 (0.53 to 2.00) amongst 184 participants included in two RCTs. CBT may result in little to no difference in leaving the study early for any reason. |
184 (2 RCTs) |
⨁⨁◯◯ LOW 3 4 |
| Quality of life ‐ clinically important change in overall quality of life | No study reported on this important outcome. | 0 (0 RCTs) |
Not estimable |
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | |||
1 We downgraded two levels due to very serious risk of bias for lack of blinding of participants and personnel (open trial), and for lack of blinding of outcome assessment (clinical notes from clinicians involved in the treatment or self‐reported scales from unblinded participants).
2 We downgraded one level due to information based on only one study with a total of 84 participants.
3 We downgraded one level due to serious risk of bias for lack of blinding of participants and personnel (open trial).
4 We downgraded one level due to information based on two studies with a total of 184 participants.