NCT05406531 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Black DS, Slavich GM
Mindfulness meditation and the immune system: a systematic review of randomized controlled trials. Ann N Y Acad Sci. 2016 Jun;1373(1):13-24. doi: 10.1111/nyas.12998. Epub 2016 Jan 21.
Heiss S, Vaschillo B, Vaschillo EG, Timko CA, Hormes JM
Heart rate variability as a biobehavioral marker of diverse psychopathologies: A review and argument for an "ideal range". Neurosci Biobehav Rev. 2021 Feb;121:144-155. doi: 10.1016/j.neubiorev.2020.12.004. Epub 2020 Dec 9.
Sanada K, Alda Diez M, Salas Valero M, Perez-Yus MC, Demarzo MM, Montero-Marin J, Garcia-Toro M, Garcia-Campayo J
Effects of mindfulness-based interventions on biomarkers in healthy and cancer populations: a systematic review. BMC Complement Altern Med. 2017 Feb 23;17(1):125. doi: 10.1186/s12906-017-1638-y.

The Effectiveness of Mobile-based Psychological Interventions in Reducing Psychological Distress and Preventing Stress-related Changes in Psycho-neuroendocrine-immune Network in Breast Cancer Survivors- Randomized Controlled Trial

Details for clinical trial NCT05406531

Clinical trial NCT05406531 - References