Table 3.
Scores for the primary and secondary outcome measures
|
CBT group |
Standard care alone group |
Adjusted mean difference (95% CI) | Effect size (d) | ||||
|---|---|---|---|---|---|---|---|
| n | Mean (SD) | n | Mean (SD) | ||||
| Primary outcome measure | |||||||
| Insomnia (ISI) | |||||||
| 0 weeks | 24 | 18·6 (3·2) | 26 | 18·8 (3·3) | .. | .. | |
| 12 weeks | 22 | 9·3 (5·5) | 25 | 15·4 (5·4) | 6·1 (3·0 to 9·22) | 1·9 | |
| 24 weeks | 23 | 11·0 (5·6) | 25 | 15·0 (5·7) | 3·9 (0·9 to 6·8) | 1·2 | |
| Delusions (PSYRATS) | |||||||
| 0 weeks | 24 | 16·1 (3·2) | 26 | 15·3 (4·9) | .. | .. | |
| 12 weeks | 22 | 13·9 (4·8) | 25 | 13·8 (4·1) | 0·3 (−2·0 to 2·6) | 0·1 | |
| 24 weeks | 23 | 14·0 (4·7) | 25 | 12·7 (5·7) | −0·8 (−3·6 to 2·1) | −0·2 | |
| Hallucinations (PSYRATS) | |||||||
| 0 weeks | 24 | 25·1 (12·1) | 26 | 26·7 (9·2) | .. | .. | |
| 12 weeks | 22 | 27·5 (9·2) | 25 | 25·9 (8·1) | −1·9 (−6·5 to 2·7) | −0·2 | |
| 24 weeks | 23 | 24·6 (11·6) | 25 | 22·0 (10·2) | −3·4 (−9·2 to 2·3) | −0·3 | |
| Sleep secondary outcome measures | |||||||
| Sleep quality (PSQI) | |||||||
| 0 weeks | 23 | 11·9 (3·2) | 23 | 11·6 (2·9) | .. | .. | |
| 12 weeks | 21 | 8·7 (3·8) | 23 | 10·5 (4·8) | 1·9 (−0·4 to 4·1) | 0·6 | |
| 24 weeks | 23 | 6·9 (4·4) | 23 | 9·6 (4·8) | 2·8 (0·2 to 5·4) | 0·9 | |
| Time to sleep onset (min)* | |||||||
| 0 weeks | 21 | 61·5 (51·4) | 25 | 61·1 (32·7) | .. | .. | |
| 12 weeks | 22 | 34·6 (40·3) | 19 | 46·6 (37·0) | 18·3 (−1·5 to 38·2) | 0·4 | |
| 24 weeks | 20 | 33·3 (29·6) | 21 | 57·9 (41·7) | 26·4 (2·5 to 50·3) | 0·6 | |
| Total sleep time (min)* | |||||||
| 0 weeks | 18 | 393·7 (127·8) | 21 | 403·4 (146·3) | .. | .. | |
| 12 weeks | 17 | 456·4 (107·7) | 18 | 437·5 (118·1) | 33·0 (−17·9 to 83·8) | 0·2 | |
| 24 weeks | 18 | 465·9 (117·1) | 20 | 412·4 (128·2) | 46·6 (−15·1 to 108·3) | 0·3 | |
| Waking in night (min)* | |||||||
| 0 weeks | 19 | 43·5 (40·2) | 22 | 59·1 (63·3) | .. | .. | |
| 12 weeks | 18 | 19·9 (22·2) | 18 | 47·6 (52·1) | 16·9 (−4·7 to 38·5) | 0·3 | |
| 24 weeks | 18 | 32·7 (35·7) | 20 | 42·7 (46·6) | 14·6 (−11·1 to 40·3) | 0·3 | |
| Total sleep time (min)† | |||||||
| 0 weeks | 20 | 396·3 (141·7) | 23 | 470·0 (128·7) | .. | .. | |
| 12 weeks | 18 | 406·2 (100·0) | 19 | 471·0 (124·4) | −15·5 (−78·9 to 47·9) | −0·1 | |
| 24 weeks | 18 | 445·1 (86·7) | 21 | 449·8 (141·1) | 33·1 (−27·0 to 93·3) | 0·2 | |
| Psychiatric secondary measures | |||||||
| Paranoia (GPTS) | |||||||
| 0 weeks | 24 | 90·8 (28·7) | 26 | 90·5 (29·8) | .. | .. | |
| 12 weeks | 22 | 89·6 (36·8) | 24 | 96·2 (37·3) | 6·7 (−10·2 to 23·5) | 0·2 | |
| 24 weeks | 20 | 78·3 (34·8) | 25 | 88·1 (35·0) | 9·8 (−7·5 to 27·2) | 0·3 | |
| Total symptoms (PANSS) | |||||||
| 0 weeks | 24 | 83·6 (16·2) | 26 | 79·7 (14·1) | .. | .. | |
| 12 weeks | 22 | 77·5 (12·1) | 24 | 79·3 (14·6) | 3·4 (−2·3 to 9·0) | 0·2 | |
| 24 weeks | 21 | 74·8 (14·7) | 24 | 75·8 (11·8) | 3·3 (−2·9 to 9·5) | 0·2 | |
| Fatigue (MFI) | |||||||
| 0 weeks | 23 | 43·8 (16·4) | 26 | 47·6 (15·3) | .. | .. | |
| 12 weeks | 22 | 29·1 (19·0) | 24 | 45·4 (19·6) | 10·5 (2·1 to 18·9) | 0·7 | |
| 24 weeks | 21 | 25·9 (21·4) | 25 | 38·4 (18·1) | 9·0 (−1·1 to 19·1) | 0·6 | |
| Patient outcomes (CHOICE) | |||||||
| 0 weeks | 23 | 52·2 (21·1) | 26 | 55·0 (14·4) | .. | .. | |
| 12 weeks | 22 | 58·0 (22·7) | 24 | 49·9 (18·3) | 8·5 (−1·4 to 18·5) | 0·5 | |
| 24 weeks | 21 | 60·0 (22·8) | 23 | 57·5 (21·8) | 3·8 (−7·3 to 14·9) | 0·2 | |
| Quality of life (EQ-5D-5L) | |||||||
| 0 weeks | 24 | 0·55 (0·23) | 26 | 0·60 (0·22) | .. | .. | |
| 12 weeks | 22 | 0·63 (0·25) | 24 | 0·55 (0·22) | 0·11 (0·02 to 0·23) | 0·5 | |
| 24 weeks | 22 | 0·63 (0·27) | 25 | 0·58 (0·20) | 0·08 (−0·05 to 0·21) | 0·4 | |
| Wellbeing (WEMWBS) | |||||||
| 0 weeks | 24 | 35·3 (9·3) | 26 | 37·0 (7·8) | .. | .. | |
| 12 weeks | 22 | 36·1 (10·7) | 24 | 34·0 (8·9) | 2·6 (−2·1 to 7·4) | 0·3 | |
| 24 weeks | 21 | 39·4 (9·9) | 25 | 34·7 (7·9) | 4·8 (−0·5 to 9·3) | 0·6 | |
CBT=cognitive behavioural therapy. ISI=Insomnia Severity Index. PSYRATS=Psychotic Symptoms Rating Scale. PSQI=Pittsburgh Sleep Quality Index. GPTS=Green et al Paranoid Thought Scales. PANSS=Positive and Negative Syndromes Scale. MFI=Multidimensional Fatigue Inventory. CHOICE=CHoice of Outcome In Cbt for psychoses. EQ–5D=Euroqol 5 Dimensions 5 Levels. WEMWBS=Warwick-Edinburgh Mental Well-being Scale.
*
Sleep diary.
†
Actigraphy data.