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.
Study Goal
The researchers aimed to evaluate the effects of a combined amygdala and insula retraining (AIR) and mindfulness program on quality of life, psychological well-being, and cognition in Long COVID patients.
Results Summary
The study protocol outlines a randomized controlled trial to assess the effectiveness of AIR + Mindfulness compared to relaxation, but results are not yet available as the abstract describes the study design rather than outcomes.
Population
100 patients diagnosed with Long COVID by the Spanish National Health Service.
Effective Dosage
Not specified
Duration
Post-treatment and six-month follow-up assessments are planned, but intervention duration is not explicitly stated.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
amygdala and insula retraining (AIR) combined with mindfulness training (AIR + Mindfulness) | increase | quality of life, psychological well-being, and cognition | patients with Long COVID | - | evaluate the effects on the improvement | #1 |
amygdala and insula retraining (AIR) combined with mindfulness training (AIR + Mindfulness) | increase | quality of life | patients with Long COVID | - | evaluate the effects on the improvement | #2 |
amygdala and insula retraining (AIR) combined with mindfulness training (AIR + Mindfulness) | increase | psychological well-being | patients with Long COVID | - | evaluate the effects on the improvement | #3 |
amygdala and insula retraining (AIR) combined with mindfulness training (AIR + Mindfulness) | increase | cognition | patients with Long COVID | - | evaluate the effects on the improvement | #4 |
amygdala and insula retraining (AIR) combined with mindfulness training (AIR + Mindfulness) | neutral | fatigue | patients with Long COVID | - | will be evaluated | #5 |
amygdala and insula retraining (AIR) combined with mindfulness training (AIR + Mindfulness) | neutral | pain | patients with Long COVID | - | will be evaluated | #6 |
amygdala and insula retraining (AIR) combined with mindfulness training (AIR + Mindfulness) | neutral | anxiety | patients with Long COVID | - | will be evaluated | #7 |
amygdala and insula retraining (AIR) combined with mindfulness training (AIR + Mindfulness) | neutral | memory | patients with Long COVID | - | will be evaluated | #8 |
amygdala and insula retraining (AIR) combined with mindfulness training (AIR + Mindfulness) | neutral | sleep quality | patients with Long COVID | - | will be evaluated | #9 |
amygdala and insula retraining (AIR) combined with mindfulness training (AIR + Mindfulness) | decrease | symptoms of Long COVID syndrome | patients with Long COVID | - | may have a significant impact on the clinical context by confirming the beneficial effect | #10 |
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.