Effectiveness of an amygdala and insula retraining program combined with mindfulness training to improve the quality of life in patients with long COVID: a randomized controlled trial protocol.

BACKGROUND: There has been growing clinical awareness in recent years of the long-term physical and psychological consequences of the SARS-CoV-2 virus, known as Long COVID. The prevalence of Long COVID is approximately 10% of those infected by the virus. Long COVID is associated with physical and neuropsychological symptoms, including those related to mental health, psychological wellbeing, and cognition. However, research on psychological interventions is still in its early stages, in which means that available results are still limited. The main objective of this study is to evaluate the effects of a program based on amygdala and insula retraining (AIR) combined with mindfulness training (AIR + Mindfulness) on the improvement of quality of life, psychological well-being, and cognition in patients with Long COVID. METHODS: This study protocol presents a single-blind randomized controlled trial (RCT) that encompasses baseline, post-treatment, and six-month follow-up assessment time points. A total of 100 patients diagnosed with Long COVID by the Spanish National Health Service will be randomly assigned to either AIR + Mindfulness (n = 50) or relaxation intervention (n = 50), the latter as a control group. The primary outcome will be quality of life assessed using the Short Form-36 Health Survey (SF-36). Additional outcomes such as fatigue, pain, anxiety, memory, and sleep quality will also be evaluated. Mixed effects regression models will be used to estimate the effectiveness of the program, and effect size calculations will be made. DISCUSSION: Long COVID syndrome is a clinical condition characterized by the persistence of symptoms for at least 12 weeks after the onset of COVID-19 that significantly affects people's quality of life. This will be the first RCT conducted in Spain to apply a psychotherapy program for the management of symptoms derived from Long COVID. Positive results from this RCT may have a significant impact on the clinical context by confirming the beneficial effect of the intervention program being evaluated on improving the symptoms of Long COVID syndrome and aiding the development of better action strategies for these patients. TRIAL REGISTRATION: Clinical Trials.gov NCT05956405. Registered on July 20, 2023.

Effectiveness of attachment-based compassion therapy to reduce psychological distress in university students: a randomised controlled trial protocol.

Introduction: Higher education, particularly university, is a challenge for many students that can lead to their mental health being seriously affected. The stress to which they are subject throughout their time at university can lead to anxiety and depression. "Third wave" psychotherapies, including compassion-based therapy, have been used to improve psychological outcomes, such as stress, anxiety, emotional distress and well-being. There are some signs that third wave psychotherapies reduce psychological distress in university students, but more and higher-quality studies are needed. In this randomised controlled trial (RCT), we hypothesise that the provision of attachment-based compassion therapy (ABCT) will be more effective than an active control group based on relaxation therapy for improving psychological distress in university students. Methods and analysis: A two-arm RCT will be conducted involving 140 university undergraduate and postgraduate students from the University of Zaragoza and the National University of Distance Education (UNED) who reside in the autonomous community of Aragon, Spain. Interventions with either ABCT or relaxation therapy will be implemented, with an allocation ratio of 1:1 between groups. Both interventions will last six weeks and consist of six weekly group sessions lasting 1.5 h each. Data will be collected before and after the intervention, and there will be a follow-up at six months. The primary outcome will be psychological distress at post-intervention. Secondary outcomes will be depression, anxiety, stress and burnout symptoms, affectivity and emotional regulation. Attachment style, experiential avoidance, compassion (for others/oneself) and mindfulness skills will be measured as potential mechanistic variables. Intention-to-treat analysis will be performed using linear mixed regression models. The clinical significance of improvements will be calculated. Potential side effects will be monitored by an independent clinical psychologist. Ethics and dissemination: This study was approved by the Clinical Research Ethics Committee of Aragón. Participant data will remain anonymous, and results will be submitted to peer-reviewed open-access journals and disseminated via conferences. Clinical Trial Registration: ClinicalTrials.gov, identifier NCT05197595.

Effectiveness and implementation of an online intervention (MINDxYOU) for reducing stress and promote mental health among healthcare workers in Spain: a study protocol for a stepped-wedge cluster randomized trial.

BACKGROUND: The World Health Organization has formally recognized that healthcare professionals are at risk of developing mental health problems; finding ways to reduce their stress is mandatory to improve both their quality of life and, indirectly, their job performance. In recent years, particularly since the COVID-19 pandemic outbreak, there has been a proliferation of online interventions with promising results. The purpose of the present study is twofold: to test the effectiveness of an online, self-guided intervention, MINDxYOU, to reduce the stress levels of healthcare workers; and to conduct an implementation study of this intervention. Additionally, an economic evaluation of the intervention will be conducted. METHODS: The current study has a hybrid effectiveness-implementation type 2 design. A stepped wedge cluster randomized trial design will be used, with a cohort of 180 healthcare workers recruited in two Spanish provinces (Malaga and Zaragoza). The recruitment stage will commence in October 2022. Frontline health workers who provide direct care to people in a hospital, primary care center, or nursing home setting in both regions will participate. The effectiveness of the intervention will be studied, with perceived stress as the main outcome (Perceived Stress Scale), while other psychopathological symptoms and process variables (e.g., mindfulness, compassion, resilience, and psychological flexibility) will be also assessed as secondary outcomes. The implementation study will include analysis of feasibility, acceptability, adoption, appropriateness, fidelity, penetration, and sustainability. The incremental costs and benefits, in terms of quality-adjusted life years, will be examined by means of cost-utility and cost-effectiveness analyses. DISCUSSION: MINDxYOU is designed to reduce healthcare workers' stress levels through the practice of mindfulness, acceptance, and compassion, with a special focus on how to apply these skills to healthy habits and considering the particular stressors that these professionals face on a daily basis. The present study will show how implementation studies are useful for establishing the framework in which to address barriers to and promote facilitators for acceptability, appropriateness, adoption, feasibility, fidelity, penetration, and sustainability of online interventions. The ultimate goal is to reduce the research-to-practice gap. TRIAL REGISTRATION: This study was registered in ClinicalTrials.gov on 29/06/2022; registration number: NCT05436717.

Attachment-Based Compassion Therapy for Reducing Anxiety and Depression in Fibromyalgia.

Fibromyalgia patients often experience anxiety and depressive symptoms; however, validated interventions show only limited efficacy. This pilot study analyzed the effects of a 16-session version of attachment-based compassion therapy (ABCT-16) for improving anxiety and depressive symptomatology, as well as self-compassion and decentering, in 11 fibromyalgia patients. Scales were assessed at four time points: baseline, after sessions 8 and 16, and 3.5 months after the completion of the program. Significant improvements were found in all outcomes after the program, and most remained significant in the follow-up assessment. Our preliminary results suggest that ABCT-16 can be effective for improving anxiety and depressive symptomatology in fibromyalgia patients. Nonetheless, further studies with larger samples and control groups are necessary to confirm these results.

Efficacy of a mindfulness-based programme with and without virtual reality support to reduce stress in university students: A randomized controlled trial.

OBJECTIVES: To evaluate the efficacy of a mindfulness-based programme (MBP) for reducing stress in university students and its action mechanisms and to explore the capacity of virtual reality (VR) exposure to enhance adherence to the intervention. METHODS: This randomized controlled trial (RCT) involved assessment time points of baseline, posttreatment, and 6-month follow-up. A total of 280 students from two Spanish universities were randomly assigned to 'MBP', 'MBP + VR', or 'Relaxation' (active controls). Perceived stress posttreatment was the primary outcome; wellbeing and academic functional outcomes were assessed as well. Multilevel mixed-effects models were performed to estimate the efficacy of the programme. RESULTS: Both 'MBP' (B = -2.77, d = -0.72, p = .006) and 'MBP + VR' (B = -2.44, d = -0.59, p = .014) were superior to 'Relaxation' in improving stress, as well as most of the secondary outcomes, with medium-to-large effects posttreatment and at follow-up. The long-term effects of MBPs on stress were mediated by mindfulness and self-compassion in parallel. Treatment adherence was improved in the 'MBP + VR' group, with higher retention rates and session attendance (p < .001). CONCLUSIONS: This RCT supports the efficacy of an MBP compared to relaxation for reducing stress in university students through mindfulness and self-compassion as mechanisms of change. VR exposure may enhance treatment adherence. TRIAL REGISTRATION: ClinicalTrials.gov NCT03771300.

Testing the Efficacy of 'Unlearning', a Mindfulness and Compassion-Based Programme for Cultivating Nonviolence in Teenagers: A Randomised Controlled Trial.

Background: Most programmes developed to reduce aggressive attitudes among teenagers are based on cultivating nonviolence, a construct that has been related to compassion and, more indirectly, mindfulness. This study aims at testing the efficacy of 'Unlearning', a mindfulness and compassion-based programme, for reducing aggressive attitudes in adolescents. Method: A sample of 164 students from three high schools in Zaragoza (Spain) participated in the study. They were randomly assigned to (1) 'Unlearning', or (2) relaxation programme. Three assessment points were established: baseline, post-treatment and a 4-month follow-up. The outcome variables were the subscales of the 'Attitudes Toward Social Aggression Scale'. Mindfulness and compassion were assessed as secondary outcomes. Results: 'Unlearning' did not produce changes in the primary outcomes, but significant effects were observed post-treatment in self-compassion; and in the follow-up, in self-compassion and mindfulness. The control group did not experience any change post-treatment, but a significant effect in mindfulness was observed in the follow-up. The intergroup analyses indicated that 'Unlearning' improved self-compassion, both post-treatment (t = -2.48, p = 0.014) and after 4-months (t = -2.03, p = 0.044), although these results were not statistically significant after correcting for multiple comparisons. Conclusion: 'Unlearning' did not produce significant reductions in aggressive attitudes compared to the control group. The low baseline levels may have hindered the efficacy of the interventions. 'Unlearning' showed potential to improve self-compassion, which is related to nonviolence, and this may have positive implications for the adolescents. Future interventions should include teachers and families to enhance the effectiveness of the programmes.