Digital cognitive behavioural therapy for insomnia versus digital sleep education control in an Australian community-based sample: a randomised controlled trial.

Insomnia is a prevalent condition in Australia that increases the risk of depression and anxiety symptoms. Cognitive behaviour therapy for insomnia (CBT-i) is the recommended 'first line' treatment but is accessed by a minority of people with insomnia. To improve CBT-i access in Australia, we aimed to develop and test a self-guided interactive digital CBT-i program. An online randomised controlled trial was conducted from August 2022 to August 2023 to investigate the effect of digital CBT-i, versus digital sleep education control, on symptoms of insomnia (ISI), depression (PHQ-9), anxiety (GAD-7), fatigue, sleepiness and maladaptive beliefs about sleep at 8-week follow-up. The control group accessed the intervention after the 8-week follow-up. Questionnaires were additionally administered at 16 and 24 weeks. Intent-to-treat mixed models and complete-case chi-squared analyses were used. Participants included 62 adults with insomnia symptoms (age M (SD) = 52.5 (16.3), 82% female, ISI = 18.6 (2.9)). There were no between-group differences in baseline characteristics or missing 8-week data (14.5%). After adjusting for baseline scores, CBT-i was associated with lower insomnia (Diffadj (95% CI) = 7.32 (5.0-9.6), P < 0.001, d = 1.64), depression (3.36 (1.3-5.4), p = 0.002, d = 0.84), fatigue (5.2 (2.5-7.9), P < 0.001, d = 1.00) and maladaptive beliefs about sleep (11.0 (4.1-18.0), P = 0.002, d = 0.82), but not anxiety symptoms at 8 weeks (1.84 (-0.1 to 3.8), p = 0.060, d = 0.50). Compared to control, CBT-i was associated with greater rates of insomnia remission (ISI <8; 0.0%, vs 40.0%, P < 0.001) and response at 8 weeks (ISI reduction ≥6; 7.1% vs 72.0%, P < 0.001). Improvements in insomnia and depression were maintained at 24 weeks in the CBT-i group. This interactive digital CBT-i program resulted in large and sustained improvements in symptoms of insomnia, depression, fatigue and maladaptive beliefs about sleep in Australian adults with insomnia symptoms. Implementation programs are required to increase digital CBT-i access and uptake.

Sweetman A ，Reynolds C ，Richardson C 《-》

Erratum: Eyestalk Ablation to Increase Ovarian Maturation in Mud Crabs.

《Jove-Journal of Visualized Experiments》

Exercise therapy for chronic fatigue syndrome.

Editorial note (19 December 2024; amended 31 January 2025): Larun L, Brurberg KG, Odgaard‐Jensen J, Price JR. Exercise therapy for chronic fatigue syndrome. Cochrane Database of Systematic Reviews 2019, Issue 10. Art. No.: CD003200. DOI: 10.1002/14651858.CD003200.pub8. Accessed 18 December 2024. This Editorial Note is for the above article, published online on 2 October 2019 on the Cochrane Library (https://www.cochranelibrary.com/), and has been issued by the Publisher, John Wiley & Sons Ltd, in agreement with the Cochrane Collaboration. The Editorial note has been agreed to inform readers that Cochrane is ceasing the production of a full update of this Cochrane review. A pilot project for engaging interest holders in the development of this Cochrane review was initiated on 2 October 2019 (see Editorial Note below) and has now been disbanded. Cochrane maintains its decision to publish this Cochrane review in 2019, which includes studies from searches up to 9 May 2014. Editorial note (2 October 2019): A statement from the Editor in Chief about this review and its planned update is available at https://www.cochrane.org/news/cfs Chronic fatigue syndrome (CFS) or myalgic encephalomyelitis (ME) is a serious disorder characterised by persistent postexertional fatigue and substantial symptoms related to cognitive, immune and autonomous dysfunction. There is no specific diagnostic test, therefore diagnostic criteria are used to diagnose CFS. The prevalence of CFS varies by type of diagnostic criteria used. Existing treatment strategies primarily aim to relieve symptoms and improve function. One treatment option is exercise therapy. The objective of this review was to determine the effects of exercise therapy for adults with CFS compared with any other intervention or control on fatigue, adverse outcomes, pain, physical functioning, quality of life, mood disorders, sleep, self-perceived changes in overall health, health service resources use and dropout. We searched the Cochrane Common Mental Disorders Group controlled trials register, CENTRAL, and SPORTDiscus up to May 2014, using a comprehensive list of free-text terms for CFS and exercise. We located unpublished and ongoing studies through the World Health Organization International Clinical Trials Registry Platform up to May 2014. We screened reference lists of retrieved articles and contacted experts in the field for additional studies. We included randomised controlled trials (RCTs) about adults with a primary diagnosis of CFS, from all diagnostic criteria, who were able to participate in exercise therapy. Two review authors independently performed study selection, 'Risk of bias' assessments and data extraction. We combined continuous measures of outcomes using mean differences (MDs) or standardised mean differences (SMDs). To facilitate interpretation of SMDs, we re-expressed SMD estimates as MDs on more common measurement scales. We combined dichotomous outcomes using risk ratios (RRs). We assessed the certainty of evidence using GRADE. We included eight RCTs with data from 1518 participants. Exercise therapy lasted from 12 weeks to 26 weeks. The studies measured effect at the end of the treatment and at long-term follow-up, after 50 weeks or 72 weeks. Seven studies used aerobic exercise therapies such as walking, swimming, cycling or dancing, provided at mixed levels in terms of intensity of the aerobic exercise from very low to quite rigorous, and one study used anaerobic exercise. Control groups consisted of passive control, including treatment as usual, relaxation or flexibility (eight studies); cognitive behavioural therapy (CBT) (two studies); cognitive therapy (one study); supportive listening (one study); pacing (one study); pharmacological treatment (one study) and combination treatment (one study). Most studies had a low risk of selection bias. All had a high risk of performance and detection bias. Exercise therapy compared with 'passive' control Exercise therapy probably reduces fatigue at end of treatment (SMD -0.66, 95% CI -1.01 to -0.31; 7 studies, 840 participants; moderate-certainty evidence; re-expressed MD -3.4, 95% CI -5.3 to -1.6; scale 0 to 33). We are uncertain if fatigue is reduced in the long term because the certainty of the evidence is very low (SMD -0.62, 95 % CI -1.32 to 0.07; 4 studies, 670 participants; re-expressed MD -3.2, 95% CI -6.9 to 0.4; scale 0 to 33). We are uncertain about the risk of serious adverse reactions because the certainty of the evidence is very low (RR 0.99, 95% CI 0.14 to 6.97; 1 study, 319 participants). Exercise therapy may moderately improve physical functioning at end of treatment, but the long-term effect is uncertain because the certainty of the evidence is very low. Exercise therapy may also slightly improve sleep at end of treatment and at long term. The effect of exercise therapy on pain, quality of life and depression is uncertain because evidence is missing or of very low certainty. Exercise therapy compared with CBT Exercise therapy may make little or no difference to fatigue at end of treatment (MD 0.20, 95% CI -1.49 to 1.89; 1 study, 298 participants; low-certainty evidence), or at long-term follow-up (SMD 0.07, 95% CI -0.13 to 0.28; 2 studies, 351 participants; moderate-certainty evidence). We are uncertain about the risk of serious adverse reactions because the certainty of the evidence is very low (RR 0.67, 95% CI 0.11 to 3.96; 1 study, 321 participants). The available evidence suggests that there may be little or no difference between exercise therapy and CBT in physical functioning or sleep (low-certainty evidence) and probably little or no difference in the effect on depression (moderate-certainty evidence). We are uncertain if exercise therapy compared to CBT improves quality of life or reduces pain because the evidence is of very low certainty. Exercise therapy compared with adaptive pacing Exercise therapy may slightly reduce fatigue at end of treatment (MD -2.00, 95% CI -3.57 to -0.43; scale 0 to 33; 1 study, 305 participants; low-certainty evidence) and at long-term follow-up (MD -2.50, 95% CI -4.16 to -0.84; scale 0 to 33; 1 study, 307 participants; low-certainty evidence). We are uncertain about the risk of serious adverse reactions (RR 0.99, 95% CI 0.14 to 6.97; 1 study, 319 participants; very low-certainty evidence). The available evidence suggests that exercise therapy may slightly improve physical functioning, depression and sleep compared to adaptive pacing (low-certainty evidence). No studies reported quality of life or pain. Exercise therapy compared with antidepressants We are uncertain if exercise therapy, alone or in combination with antidepressants, reduces fatigue and depression more than antidepressant alone, as the certainty of the evidence is very low. The one included study did not report on adverse reactions, pain, physical functioning, quality of life, sleep or long-term results. Exercise therapy probably has a positive effect on fatigue in adults with CFS compared to usual care or passive therapies. The evidence regarding adverse effects is uncertain. Due to limited evidence it is difficult to draw conclusions about the comparative effectiveness of CBT, adaptive pacing or other interventions. All studies were conducted with outpatients diagnosed with 1994 criteria of the Centers for Disease Control and Prevention or the Oxford criteria, or both. Patients diagnosed using other criteria may experience different effects.

Larun L ，Brurberg KG ，Odgaard-Jensen J ，Price JR ... -  《Cochrane Database of Systematic Reviews》

Interventions to increase patient and family involvement in escalation of care for acute life-threatening illness in community health and hospital settings.

There is now a rising commitment to acknowledge the role patients and families play in contributing to their safety. This review focuses on one type of involvement in safety - patient and family involvement in escalation of care for serious life-threatening conditions i.e. helping secure a step-up to urgent or emergency care - which has been receiving increasing policy and practice attention. This review was concerned with the negotiation work that patient and family members undertake across the emergency care escalation pathway, once contact has been made with healthcare staff. It includes interventions aiming to improve detection of symptoms, communication of concerns and staff response to these concerns. To assess the effects of interventions designed to increase patient and family involvement in escalation of care for acute life-threatening illness on patient and family outcomes, treatment outcomes, clinical outcomes, patient and family experience and adverse events. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, MEDLINE (OvidSP), Embase (OvidSP), PsycINFO (OvidSP) ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform from 1 Jan 2000 to 24 August 2018. The search was updated on 21 October 2019. We included randomised controlled trials (RCTs) and cluster-randomised controlled trials where the intervention focused on patients and families working with healthcare professionals to ensure care received for acute deterioration was timely and appropriate. A key criterion was to include an interactive element of rehearsal, role play, modelling, shared language, group work etc. to the intervention to help patients and families have agency in the process of escalation of care. The interventions included components such as enabling patients and families to detect changes in patients' conditions and to speak up about these changes to staff. We also included studies where the intervention included a component targeted at enabling staff response. Seven of the eight authors were involved in screening; two review authors independently extracted data and assessed the risk of bias of included studies, with any disagreements resolved by discussion to reach consensus. Primary outcomes included patient and family outcomes, treatment outcomes, clinical outcomes, patient and family experience and adverse events. Our advisory group (four users and four providers) ensured that the review was of relevance and could inform policy and practice. We included nine studies involving 436,684 patients and family members and one ongoing study. The published studies focused on patients with specific conditions such as coronary artery disease, ischaemic stroke, and asthma, as well as pregnant women, inpatients on medical surgical wards, older adults and high-risk patients with a history of poor self-management. While all studies tested interventions versus usual care, for four studies the usual care group also received educational or information strategies. Seven of the interventions involved face-to-face, interactional education/coaching sessions aimed at patients/families while two provided multi-component education programmes which included components targeted at staff as well as patients/families. All of the interventions included: (1) an educational component about the acute condition and preparedness for future events such as stroke or change in fetal movements: (2) an engagement element (self-monitoring, action plans); while two additionally focused on shared language or communication skills. We had concerns about risk of bias for all but one of the included studies in respect of one or more criteria, particularly regarding blinding of participants and personnel. Our confidence in results regarding the effectiveness of interventions was moderate to low. Low-certainty evidence suggests that there may be moderate improvement in patients' knowledge of acute life-threatening conditions, danger signs, appropriate care-seeking responses, and preparedness capacity between interactional patient-facing interventions and multi-component programmes and usual care at 12 months (MD 4.20, 95% CI 2.44 to 5.97, 2 studies, 687 participants). Four studies in total assessed knowledge (3,086 participants) but we were unable to include two other studies in the pooled analysis due to differences in the way outcome measures were reported. One found no improvement in knowledge but higher symptom preparedness at 12 months. The other study found an improvement in patients' knowledge about symptoms and appropriate care-seeking responses in the intervention group at 18 months compared with usual care. Low-certainty evidence from two studies, each using a different measure, meant that we were unable to determine the effects of patient-based interventions on self-efficacy. Self-efficacy was higher in the intervention group in one study but there was no difference in the other compared with usual care. We are uncertain whether interactional patient-facing and multi-component programmes improve time from the start of patient symptoms to treatment due to low-certainty evidence for this outcome. We were unable to combine the data due to differences in outcome measures. Three studies found that arrival times or prehospital delay time was no different between groups. One found that delay time was shorter in the intervention group. Moderate-certainty evidence suggests that multi-component interventions probably have little or no impact on mortality rates. Only one study on a pregnant population was eligible for inclusion in the review, which found no difference between groups in rates of stillbirth. In terms of unintended events, we found that interactional patient-facing interventions to increase patient and family involvement in escalation of care probably have few adverse effects on patient's anxiety levels (moderate-certainty evidence). None of the studies measured or reported patient and family perceptions of involvement in escalation of care or patient and family experience of patient care. Reported outcomes related to healthcare professionals were also not reported in any studies. Our review identified that interactional patient-facing interventions and multi-component programmes (including staff) to increase patient and family involvement in escalation of care for acute life-threatening illness may improve patient and family knowledge about danger signs and care-seeking responses, and probably have few adverse effects on patient's anxiety levels when compared to usual care. Multi-component interventions probably have little impact on mortality rates. Further high-quality trials are required using multi-component interventions and a focus on relational elements of care. Cognitive and behavioural outcomes should be included at patient and staff level.

Mackintosh NJ ，Davis RE ，Easter A ，Rayment-Jones H ，Sevdalis N ，Wilson S ，Adams M ，Sandall J ... -  《Cochrane Database of Systematic Reviews》

The effectiveness of cognitive behavioral therapy for insomnia on sleep outcomes in the context of pain among older adult veterans.

Cognitive behavioral therapy for insomnia (CBT-I) is the gold-standard treatment for insomnia disorder in adults. Compared to young adults, older adults have increased risk for the development of conditions associated with chronic pain, which may impact the efficacy of CBT-I in improving insomnia symptoms in older adults. This study evaluated the effect of participant-rated pain on sleep-related outcomes of a supervised, non-clinician administered CBT-I program in older adult patients with chronic insomnia disorder. Secondary analysis was conducted using data from a randomized controlled trial among 106 community-dwelling older adult veterans (N = 106; mean age 72.1 years, 96% male, 78.3% White, 6.6% Hispanic, 5.7% African American) with chronic (≥3 months) insomnia disorder. Participants engaged in five sessions of manual-based CBT-I in individual or group format within one Department of Veterans Affairs healthcare system, provided by non-clinician "sleep coaches" who had weekly telephone supervision by behavioral sleep medicine specialists. Insomnia symptoms (Insomnia Severity Index), perceived sleep quality (Pittsburgh Sleep Quality Index), fatigue (Flinder's Fatigue Scale), daytime sleepiness (Epworth Sleepiness Scale), and perceived pain severity (items from the Geriatric Pain Measure) were assessed at 4 time points: baseline, one-week posttreatment, 6-month follow-up, and 12-month follow-up. Mixed effects models with time invariant and time varying predictors were employed for analyses. CBT-I improved insomnia symptoms, perceived sleep quality, fatigue, and daytime sleepiness among older veterans with chronic insomnia. Participant-reported pain was associated with greater improvements in insomnia symptoms following CBT-I. Pain did not affect improvements in other sleep-related outcomes (-0.38 ≤ b ≤ 0.07, p > 0.05). Between-subjects differences in pain, but not within-subject changes in pain over time, appeared to play a central role in insomnia symptom improvement at posttreatment, with individuals with higher-than-average pain showing greater insomnia symptom improvement (ISI score reduction; -0.32 ≤ b ≤ -0.28, p ≤ 0.005). Pain did not meaningfully hinder the effects of CBT-I on sleep outcomes. Among older veterans with chronic insomnia disorder, individuals with higher pain exhibited slightly greater improvement in insomnia than those with lower levels of pain. These findings suggest that experiencing pain does not impair treatment response and should not preclude older adults with insomnia from being offered CBT-I.

Erickson AJ ，Rodriguez JC ，Ravyts SG ，Dzierzewski JM ，Fung CH ，Kelly MR ，Ryden AM ，Carlson GC ，Josephson K ，Mitchell MN ，Martin JL ，Alessi CA ... -  《-》