Transition rates from schizotypal disorder to psychotic disorder for first-contact patients included in the opus trial. A randomized clinical trial of integrated treatment and standard treatment

Impaired Theory of Mind (ToM) ability is a core feature of psychotic disorders that challenges psychosis treatment. We aimed to explore the effect of a Mindfulness-Based Intervention (MBI) on ToM ability in a randomized clinical trial (RCT). A sample of 36 participants diagnosed with psychotic disorder were recruited from a community center and randomly allocated to Integrated Rehabilitation Treatment (IRT) or IRT+MBI. ToM skills were assessed through the Hinting Test and the Reading the Mind in the Eyes Test (RMET). IRT+MBI scored higher in RMET than IRT at posttreatment. MBI is a promising tool for improving ToM ability in psychosis.Keywords: psychotic disorders, theory of mind, mindfulness-based-interventions.

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EPA-1525 - Change- it is about life. a randomized clinical trial of two health promoting programs versus standard treatment for patients with schizophrenia

European Psychiatry ◽

10.1016/s0924-9338(14)78697-3 ◽

2014 ◽

Vol 29 ◽

pp. 1

Author(s):

M. Nordentoft ◽

H. Speyer ◽

O. Mors ◽

H.C.B. Norgaard

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Standard Treatment ◽

Health Promoting

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NOn-invasive Vagus nerve stimulation in acute Ischemic Stroke (NOVIS): a study protocol for a randomized clinical trial

Trials ◽

10.1186/s13063-020-04794-1 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Anne van der Meij ◽

Marianne A. A. van Walderveen ◽

Nyika D. Kruyt ◽

Erik W. van Zwet ◽

Eric J. Liebler ◽

...

Keyword(s):

Clinical Trial ◽

Ischemic Stroke ◽

Vagus Nerve ◽

Randomized Clinical Trial ◽

Nerve Stimulation ◽

Vagus Nerve Stimulation ◽

Standard Treatment ◽

Infarct Volume ◽

Non Invasive ◽

Link Type

Abstract Background Secondary damage due to neurochemical and inflammatory changes in the penumbra in the first days after ischemic stroke contributes substantially to poor clinical outcome. In animal models, vagus nerve stimulation (VNS) inhibits these detrimental changes and thereby reduces tissue injury. The aim of this study is to investigate whether non-invasive cervical VNS (nVNS) in addition to the current standard treatment can improve penumbral recovery and limit final infarct volume. Methods NOVIS is a single-center prospective randomized clinical trial with blinded outcome assessment. One hundred fifty patients will be randomly allocated (1:1) within 12 h from clinical stroke onset to nVNS for 5 days in addition to standard treatment versus standard treatment alone. The primary endpoint is the final infarct volume on day 5 assessed with MRI. Discussion We hypothesize that nVNS will result in smaller final infarct volumes as compared to standard treatment due to improved penumbral recovery. The results of this study will be used to assess the viability and approach to power a larger trial to more definitively assess the clinical efficacy of nVNS after stroke. Trial registration ClinicalTrials.govNCT04050501. Registered on 8 August 2019

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When Research Meets Reality–-Lessons Learned from a Pragmatic Multisite Group-Randomized Clinical Trial on Psychosocial Interventions in the Psychiatric and Addiction Field

Substance Abuse Research and Treatment ◽

10.4137/sart.s9245 ◽

2012 ◽

Vol 6 ◽

pp. SART.S9245 ◽

Cited By ~ 1

Author(s):

Linda E. Wüsthoff ◽

Helge Waal ◽

Rolf W. Gråwe

Keyword(s):

Clinical Trial ◽

Substance Use ◽

Randomized Clinical Trial ◽

Substance Use Disorders ◽

Clinical Studies ◽

Psychosocial Interventions ◽

Integrated Treatment ◽

Lessons Learned ◽

Future Research ◽

New Challenges

Research on treatments for patients with co-occurring psychiatric and substance use disorders is of core importance and at the same time highly challenging as it includes patients that are normally excluded from clinical studies. Such research may require methodological adaptations which in turn create new challenges. However, the challenges that arise in such studies are insufficiently discussed in the literature. The aim of this methodology paper is, firstly, to discuss the methodological adaptations that may be required in such research; secondly, to describe how such adaptations created new challenges in a group-randomized clinical trial on Integrated Treatment amongst patients with co-occurring psychiatric and substance use disorders. We also discuss how these challenges might be understood and highlight lessons for future research in this field. Trial registration: NCT00447733.

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Efficacy and safety of novel herbal tablets in COVID-19 patients in hospital stay days, ICU admission and mortality rate thereof: An open-label, single-blind randomized clinical trial

Jundishapur Journal of Natural Pharmaceutical Products ◽

10.5812/jjnpp.117677 ◽

2021 ◽

Vol In Press (In Press) ◽

Author(s):

Mojtaba Varshochi ◽

Mohammad Shahi ◽

Maryam Rahimzadeh ◽

Hasan Amini ◽

Ramin Mohammadzadeh

Keyword(s):

Clinical Trial ◽

Hospital Stay ◽

Randomized Clinical Trial ◽

Standard Treatment ◽

Length Of Hospital Stay ◽

Crocus Sativus ◽

Open Label ◽

Icu Admission ◽

Herbal Compound ◽

Single Blind

Background: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the super-spreading virus, has claimed hundreds of thousands of lives worldwide. Objectives: This study aimed to evaluate the effectiveness of the novel suggested herbal compound, formulated as compressed tablets, in reducing the length of hospital stay (LoS), intensive care unit (ICU) admission, and mortality in confirmed COVID-19 cases. Methods: Following an open-label, single-blind randomized clinical trial design, a total of 200 patients aged 18-65 admitted to Imam Reza hospital in Tabriz, northwest of Iran, were randomized to intervention and control groups in a 1:1 ratio, i.e., 100 subjects in each group. The former received standard treatment along with the compressed herbal tablets, and the latter only received the standard treatment. Adverse reactions incidence within 180 days after the beginning of the intervention was set as the primary safety endpoint. The most important and active ingredients of the tablets were Terminalia chebula, Glycyrrhiza glabra, Anacyclus pyrethrum, Senna alexandrina, Ferrula asafoetida, Pistacia lentiscus, Zizyphus jujuba, Crocus sativus, Echinacea angustifolia, and Hyssopus officinalis. This trial is registered at the Iranian Registry of Clinical Trials (code: IRCT20200522047545N1). Results: Those in the intervention arm had significantly lower rates of LoS (7.38 vs. 9.45, P = 0.030), ICU admission (6 out of 100 vs. 32 out of 100, P = 0.000), and mortality (1 vs. 19 out of 100, P = 0.000). Conclusions: Our observations suggest that adequate improvement is provided by the prepared herbal compound along with substantial savings in hospitalization hoteling costs. While further multi-center studies with a larger sample size are needed to extend our knowledge regarding the effect of this new option, these novel clinical data may well provide a new alternative for the management of COVID-19 disease.

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