Fiorentino 2008.
Methods | Design: crossover‐experimental. Follow‐up: 6 and 12 weeks from baseline. | |
Participants | Major inclusion criteria: Survivors of breast cancer who had finished their breast cancer treatment and met the DSM IV criteria for insomnia N = 14 (E: 11, C: 10) Mean age: 61 ± 11.6 years Stage of breast cancer: Stage 1 (7), Stage 2 (3), stage 3 (2) and advanced stage 3 (2) |
|
Interventions | E: educational + psychology (behavioural) Education + Psychology (behavioural): 1‐hour session per week for 6 week; educational component covered sleep stages, processes regulating sleep , sleep throughout life, sleep in cancer patients, Spielman et al.’s (1987) insomnia 3‐P model and cognitive behavioral therapy basics; psychological (behavioural) component included entailed sleep restriction, stimulus control, adhering to the sleep hygiene rules, and training in progressive muscle relaxation techniques; conducted by a graduate level therapist trained in CBT‐I, and supervised by a licensed clinical psychologist C: usual care |
|
Outcomes | Quality of life: SF‐36 Others: actigraphy, PSQI, ISI, Sleep Diaries, MFSI‐SF, FOSQ, CESD,BSI‐18, GCS |
|
Notes | C: comparison, E: experimental, SF‐36: Short Form (36) Health Survey ISI: Insomnia, PSQI: Pittsburgh Sleep Quality Index, ISI: Insomnia Severity Index, Severity Index, MFSI‐SF: Multidimensional Fatigue Symptom Inventory, FOSQ: Functional Outcomes of Sleep Questionnaire, BSI‐18: Brief Symptom Inventory, GCS: Greene Climacteric Scale. Dropouts or missing data where reported: 5 in experimental and 2 in comparison lost to follow‐up |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants randomly assigned through a computer‐generated random list |
Allocation concealment (selection bias) | Unclear risk | Study did not provide enough information to allow judgment as concealment was not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants could be aware of allocated interventions since they had to go through the intervention. Study did not provide enough information to allow judgment whether personnel were blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Participants could be aware of allocated interventions since they had to go through the intervention. Study did not provide enough information to allow judgment whether outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 women dropped out, 1 reported study was too much and another realised in therapy that the root of her insomnia would be addressed with a more comprehensive psychotherapy addressing psychological events and traumas experienced in childhood |
Selective reporting (reporting bias) | Unclear risk | Study protocol was not available. Study did not provide enough information to allow conclusion if all expected outcome measures were reported |
Other bias | High risk | Sampling bias likely present as non‐probability sampling method used. Participation rate was about 58.3% |