The effects of a digital lifestyle intervention in patients with hypertension: Results of a pilot randomized controlled trial.

In this pilot study, the authors investigated the preliminary effectiveness of the digital lifestyle intervention, actensio (mementor DE GmbH), in treating arterial hypertension. Adults with arterial hypertension were randomly assigned to an intervention group (actensio + standard care) or a control group (waiting list + standard care) in a 1:1 ratio. Primary and secondary endpoints were assessed at baseline (t0) and 3 months post-randomization (t1). The primary endpoint was average systolic blood pressure, measured at home for 1 week. Secondary endpoints included patient engagement (measured using the "patient activation measure"; PAM-13), average diastolic blood pressure, and heart rate. All endpoints were analyzed using ANCOVA models, following an intention-to-treat approach, while adjusting for baseline values. Missing data were estimated using multiple imputation models. A total of N = 102 participants (f = 59, age = 52.94 ± 9.01) were randomized to either the intervention (IG; N = 52) or the control group (CG; N = 50), of which N = 80 completed the blood pressure diary, and N = 81 the PAM-13 at t1. Between-group comparisons showed an average group difference in systolic blood pressure of -5.06 mm Hg (95% CI = -8.71 to -1.41, p = .013) between the intervention group (M = 137.37 ± 10.13) and the control group (M = 142.35 ± 11.23). Average group difference for patient engagement was 3.35 points with a trend towards statistical significance (95% CI = -018 to 6.89, p = .064), favoring the intervention group (MIG = 79.38 ± 9.44 vs. MCG = 75.45 ± 10.62). There were no group differences in diastolic blood pressure (-1.78 mm Hg; 95% CI = -4.50 to 0.95, p = .402) and heart rate (-0.684; 95% CI = -3.73 to 2.36, p = 0.683). The results of the present pilot study confirm the preliminary effectiveness of the digital lifestyle intervention, actensio, in reducing high blood pressure in patients with hypertension.

Investigating the efficacy of digital cognitive behavioural therapy in comparison to a sleep-monitoring application via integrated diary and actigraphy: A randomised-controlled trial.

Dissemination of digital cognitive behavioural therapy is a promising approach for treating insomnia in the broad population. Current evidence supports the effectiveness of the digital format, but clinical findings are often limited by the choice of control group and lack of in-depth therapeutic measures. This study was designed to investigate the specific effects of digital cognitive behavioural therapy in comparison to a self-monitoring application. Participants meeting criteria for insomnia were randomly allocated (1:1) to 8 weeks of digital cognitive behavioural therapy or 8 weeks of digital sleep monitoring (control application). The primary outcome, insomnia severity, was assessed at baseline, 8- and 16-weeks post-randomisation. Secondary outcomes included the assessment of sleep via application-integrated sleep diaries and actigraphy. Linear-mixed models were fitted to assess between-group differences. Fifty-six participants (48 females, mean age: M = 45.55 ± 13.70 years) were randomised to either digital cognitive behavioural therapy (n = 29) or digital sleep monitoring (n = 27). At 8- and 16-weeks post-randomisation, large treatment effects (d = 0.87-1.08) indicated robust reductions (-3.70 and -2.97, respectively; p ≤ 0.003) in insomnia severity in the digital cognitive behavioural therapy arm, relative to digital sleep monitoring. Treatment effects in favour of digital cognitive behavioural therapy were also found for self-reported and actigraphy-derived sleep continuity variables, indicating that sleep improved throughout the 8-week intervention period. Our study reinforces the role of digital cognitive behavioural therapy in achieving clinical improvements for patients with insomnia, affirming previous findings and supporting the specific effects of cognitive behavioural therapy.

The effect of single-component sleep restriction therapy on depressive symptoms: A systematic review and meta-analysis.

Sleep restriction therapy is a behavioural component within cognitive behavioural therapy for insomnia and is an effective standalone treatment for insomnia, but its effect on depressive symptoms remains unclear. This review aimed to synthesise and evaluate the impact of single-component sleep restriction therapy on depressive symptoms relative to a control intervention. We searched electronic databases and sleep-related journals for randomised controlled trials and uncontrolled clinical trials, published from 1 January 1986 until 19 August 2023, that delivered sleep restriction therapy to adults with insomnia. Random-effects meta-analysis of standardised mean differences and Cochrane risk of bias assessment were performed on randomised controlled trials, while uncontrolled clinical trials were discussed narratively. The meta-analysis was pre-registered on PROSPERO (ID: CRD42020191803). We identified seven randomised controlled trials (N = 1102) and two uncontrolled clinical trials (N = 22). Findings suggest that sleep restriction therapy is associated with a medium effect for improvement in depressive symptoms at post-treatment (Nc = 6, g = -0.45 [95% confidence interval = -0.70 to -0.21], p < 0.001) and a small effect at follow-up (Nc = 4, g = -0.31 [95% confidence interval = -0.45 to -0.16], p < 0.001). Five of the seven included randomised controlled trials were judged to have a high risk of bias. Standalone sleep restriction therapy appears to be efficacious for improving depressive symptoms at post-treatment and follow-up. However, conclusions are tentative due to the small number of trials and because none of the trials was performed in a population with clinically defined depression. Large-scale trials are needed to test the effect of sleep restriction therapy in patients experiencing depression and insomnia. Findings also highlight the need to improve the standardisation and reporting of sleep restriction therapy procedures, and to design studies with more rigorous control arms to reduce potential bias.

The effect of sleep restriction therapy for insomnia on REM sleep fragmentation: A secondary analysis of a randomised controlled trial.

Rapid eye movement sleep fragmentation is hypothesised to be a reliable feature of insomnia, which may contribute to emotion dysregulation. Sleep restriction therapy, an effective intervention for insomnia, has the potential to reduce rapid eye movement sleep fragmentation through its manipulation of basic sleep-wake processes. We performed secondary data analysis of a randomised controlled trial to examine whether sleep restriction therapy reduces rapid eye movement sleep fragmentation in comparison to a matched control arm. Participants (n = 56; 39 female, mean age = 40.78 ± 9.08 years) were randomly allocated to 4 weeks of sleep restriction therapy or 4 weeks of time in bed regularisation. Ambulatory polysomnographic recordings were performed at baseline, week 1 and week 4. Arousals during rapid eye movement and non-rapid eye movement sleep were scored blind to group allocation. The following rapid eye movement sleep fragmentation index was the primary outcome: index 1 = (rapid eye movement arousals + rapid eye movement awakenings + non-rapid eye movement intrusions)/rapid eye movement duration in hours. Secondary outcomes were two further indices of rapid eye movement sleep fragmentation: index 2 = (rapid eye movement arousals + rapid eye movement awakenings)/rapid eye movement duration in hours; and index 3 = rapid eye movement arousals/rapid eye movement duration in hours. A non-rapid eye movement fragmentation index was also calculated (non-rapid eye movement arousals/non-rapid eye movement duration in hours). Linear-mixed models were fitted to assess between-group differences. There was no significant group difference for the primary rapid eye movement fragmentation index at week 1 (p = 0.097, d = -0.31) or week 4 (p = 0.741, d = -0.06). There was some indication that secondary indices of rapid eye movement fragmentation decreased more in the sleep restriction therapy group relative to control at week 1 (index 2: p = 0.023, d = -0.46; index 3: p = 0.051, d = -0.39), but not at week 4 (d ≤ 0.13). No group effects were found for arousals during non-rapid eye movement sleep. We did not find clear evidence that sleep restriction therapy modifies rapid eye movement sleep fragmentation. Small-to-medium effect sizes in the hypothesised direction, across several indices of rapid eye movement fragmentation during early treatment, demand further investigation in future studies.

Isolating the role of time in bed restriction in the treatment of insomnia: a randomized, controlled, dismantling trial comparing sleep restriction therapy with time in bed regularization.

STUDY OBJECTIVES: Sleep restriction therapy (SRT) is one of the most effective treatments for insomnia. Restriction of time in bed (TIB) is assumed to be the central mechanism through which SRT improves sleep consolidation and reduces insomnia symptoms. This hypothesis has never been directly tested. We designed a randomized, controlled, dismantling trial in order to isolate the role of TIB restriction in driving both clinical and polysomnographic sleep outcomes. METHODS: Participants aged 25-55 who met diagnostic criteria for insomnia disorder were block-randomized (1:1) to 4 weeks of SRT or time in bed regularization (TBR), a treatment that involves the prescription of a regular but not reduced TIB. The primary outcome was assessed with the insomnia severity index (ISI) at baseline, 4-, and 12-weeks post-randomization. Secondary outcomes included sleep continuity (assessed via polysomnography, actigraphy, and diary) and quality of life. We performed intention-to-treat analyses using linear mixed models. RESULTS: Fifty-six participants (39 females, mean age = 40.78 ± 9.08) were assigned to SRT (n = 27) or TBR (n = 29). Daily monitoring of sleep via diaries and actigraphy confirmed large group differences in TIB (d range = 1.63-1.98). At 4-weeks post-randomization, the adjusted mean difference for the ISI was -4.49 (d = -1.40) and -4.35 at 12 weeks (d = -1.36), indicating that the SRT group reported reduced insomnia severity relative to TBR. Robust treatment effects in favor of SRT were also found for objective and self-reported sleep continuity variables (d range = 0.40-0.92) and sleep-related quality of life (d = 1.29). CONCLUSIONS: For the first time, we demonstrate that TIB restriction is superior to the regularization of TIB on its own. Our results underscore the centrality of the restriction component in reducing insomnia symptoms and consolidating sleep.