A randomized, controlled clinical trial: the effect of mindfulness-based cognitive therapy on generalized anxiety disorder among Chinese community patients: protocol for a randomized trial

<b>Background</b> Research suggests that an eight-week Mindfulness-Based Cognitive Therapy (MBCT) program may be effective in the treatment of generalized anxiety disorders. Our objective is to compare the clinical effectiveness of the MBCT program with a psycho-education programme and usual care in reducing anxiety symptoms in people suffering from generalized anxiety disorder.<p></p> <b>Methods and Design</b> A three armed randomized, controlled clinical trial including 9-month post-treatment follow-up is proposed. Participants screened positive using the Structure Clinical Interview for DSM-IV (SCID) for general anxiety disorder will be recruited from community-based clinics. 228 participants will be randomly allocated to the MBCT program plus usual care, psycho-education program plus usual care or the usual care group. Validated Chinese version of instruments measuring anxiety and worry symptoms, depression, quality of life and health service utilization will be used. Our primary end point is the change of anxiety and worry score (Beck Anxiety Inventory and Penn State Worry Scale) from baseline to the end of intervention. For primary analyses, treatment outcomes will be assessed by ANCOVA, with change in anxiety score as the baseline variable, while the baseline anxiety score and other baseline characteristics that significantly differ between groups will serve as covariates.<p></p> <b>Discussion</b> This is a first randomized controlled trial that compare the effectiveness of MBCT with an active control, findings will advance current knowledge in the management of GAD and the way that group intervention can be delivered and inform future research

Time-Dependent Changes in Depressive Symptoms Among Control Participants in Digital-Based Psychological Intervention Studies: Meta-analysis of Randomized Controlled Trials

BackgroundDigital-based psychological interventions (DPIs) have been shown to be efficacious in many randomized controlled trials (RCTs) in dealing with depression in adults. However, the effects of control comparators in these DPI studies have been largely overlooked, and they may vary in their effects on depression management. ObjectiveThis meta-analytical study aimed to provide a quantitative estimate of the within-subject effects of control groups across different time intervals and explore the moderating effects of control types and symptom severity at baseline. MethodsA systematic literature search was conducted in late September 2021 on selected electronic databases: PubMed; ProQuest; Web of Science; and the Ovid system with MEDLINE, PsycINFO, and Embase. The control conditions in 107 RCTs with a total of 11,803 adults with depressive symptoms were included in the meta-analysis, and effect sizes (Hedges g) were calculated using the standardized mean difference approach. Study quality was assessed using the Cochrane risk-of-bias tool for randomized trials version 2. ResultsThe control conditions collectively yielded small to moderate effects in reducing depressive symptoms within 8 weeks since the baseline assessment (g=−0.358, 95% CI −0.434 to −0.281). The effects grew to moderate within 9 to 24 weeks (g=−0.549, 95% CI −0.638 to −0.460) and peaked at g=−0.810 (95% CI −0.950 to −0.670) between 25 and 48 weeks. The effects were maintained at moderate to large ranges (g=−0.769, 95% CI −1.041 to −0.498) beyond 48 weeks. The magnitude of the reduction differed across the types of control and severity of symptoms. Care as usual was the most powerful condition of all and produced a large effect (g=−0.950, 95% CI −1.161 to −0.739) in the medium term. The findings showed that waitlist controls also produced a significant symptomatic reduction in the short term (g=−0.291, 95% CI −0.478 to −0.104), refuting the previous suspicion of a nocebo effect. In addition, a large effect on depressive symptom reduction in the long term (g=−1.091, 95% CI −1.210 to −0.972) was noted among participants with severe levels of depressive symptoms at baseline. ConclusionsThis study provided evidence that depressive symptoms generally reduced over time among control conditions in research trials of DPIs. Given that different control conditions produce variable and significant levels of symptomatic reduction, future intervention trials must adopt an RCT design and should consider the contents of control treatments when investigating the efficacy of DPIs. The results of waitlist controls confirmed previous findings of spontaneous recovery among people with mild to moderate depressive symptoms in face-to-face studies. Researchers may adopt watchful waiting as participants wait for the availability of digital-based psychological services

Delivering Mindfulness-Based Interventions for Insomnia, Pain, and Dysfunctional Eating Through a Text Messaging App: Three Randomized Controlled Trials Investigating the Effectiveness and Mediating Mechanisms

BackgroundAlthough text messaging has the potential to be the core intervention modality, it is often used as an adjunct only. To improve health and alleviate the distress related to insomnia, pain, and dysregulated eating of people living in urban areas, text messaging–based mindfulness-based interventions were designed and evaluated in 3 randomized controlled trials. ObjectiveThis study investigated the effectiveness and mediating mechanisms of text messaging–based mindfulness-based interventions for people with distress related to insomnia, pain, or dysregulated eating. MethodsIn these trials, 333, 235, and 351 participants were recruited online and randomized to intervention and wait-list control conditions for insomnia, pain, and dysregulated eating, respectively. Participants experienced 21 days of intervention through WhatsApp Messenger. Participants completed pre-, post-, 1-month follow-up, and 3-month follow-up self-report questionnaires online. The retention rates at postmeasurements were 83.2% (139/167), 77.1% (91/118), and 72.9% (129/177) for intervention groups of insomnia, pain, and dysregulated eating, respectively. Participants’ queries were answered by a study technician. Primary outcomes included insomnia severity, presleep arousal, pain intensity, pain acceptance, and eating behaviors. Secondary outcomes included mindfulness, depression, anxiety, mental well-being, and functional impairments. Mindfulness, dysfunctional beliefs and attitudes about sleep, pain catastrophizing, and reactivity to food cues were hypothesized to mediate the relationship between the intervention and outcomes. ResultsFor all 3 studies, the intervention groups showed significant improvement on most outcomes at 1-month follow-up compared to their respective wait-list control groups; some primary outcomes (eg, insomnia, pain, dysregulated eating indicators) and secondary outcomes (eg, depression, anxiety symptoms) were sustained at 3-month follow-up. Medium-to-large effect sizes were found at postassessments in most outcomes in all studies. In the intervention for insomnia, mediation analyses showed that dysfunctional beliefs and attitudes about sleep mediated the effect of the intervention on all primary outcomes and most secondary outcomes at both 1-month and 3-month follow-ups, whereas mindfulness mediated the intervention effect on presleep arousal at 1-month and 3-month follow-ups. In the intervention for pain, pain catastrophizing mediated the effect of intervention on pain intensity and functioning at both 1-month and 3-month follow-ups, whereas mindfulness only mediated the effect of intervention on anxiety and depressive symptoms. In the intervention for dysregulated eating, power of food mediated the effect of intervention on both uncontrolled and emotional eating at both 1-month and 3-month follow-ups and mindfulness was found to mediate the effect on depressive symptoms at both 1-month and 3-month follow-ups. ConclusionsThese 3 studies converged and provided empirical evidence that mindfulness-based interventions delivered through text messaging are effective in improving distress related to sleep, pain, and dysregulated eating. Text messaging has the potential to be a core intervention modality to improve various common health outcomes for people living a fast-paced lifestyle. Trial RegistrationClinical Research and Biostatistics Clinical Trials Registry CUHK_CCRB00559; https://tinyurl.com/24rkwar

Digital Interventions for Mental Disorders:Key Features, Efficacy, and Potential for Artificial Intelligence Applications

Mental disorders are highly prevalent and often remain untreated. Many limitations of conventional face-to-face psychological interventions could potentially be overcome through Internet-based and mobile-based interventions (IMIs). This chapter introduces core features of IMIs, describes areas of application, presents evidence on the efficacy of IMIs as well as potential effect mechanisms, and delineates how Artificial Intelligence combined with IMIs may improve current practices in the prevention and treatment of mental disorders in adults. Meta-analyses of randomized controlled trials clearly show that therapist-guided IMIs can be highly effective for a broad range of mental health problems. Whether the effects of unguided IMIs are also clinically relevant, particularly under routine care conditions, is less clear. First studies on IMIs for the prevention of mental disorders have shown promising results. Despite limitations and challenges, IMIs are increasingly implemented into routine care worldwide. IMIs are also well suited for applications of Artificial Intelligence and Machine Learning, which provides ample opportunities to improve the identification and treatment of mental disorders. Together with methodological innovations, these approaches may also deepen our understanding of how psychological interventions work, and why. Ethical and professional restraints as well as potential contraindications of IMIs, however, should also be considered. In sum, IMIs have a high potential for improving the prevention and treatment of mental health disorders across various indications, settings, and populations. Therefore, implementing IMIs into routine care as both adjunct and alternative to face-to-face treatment is highly desirable. Technological advancements may further enhance the variability and flexibility of IMIs, and thus even further increase their impact in people’s lives in the future