scholarly journals Guided internet-based intervention for people with HIV and depressive symptoms: a randomised controlled trial in the Netherlands

2018 ◽  
Vol 5 (9) ◽  
pp. e488-e497 ◽  
Author(s):  
Sanne van Luenen ◽  
Nadia Garnefski ◽  
Philip Spinhoven ◽  
Vivian Kraaij
Keyword(s):  
Depressive Symptoms ◽  
Randomised Controlled Trial ◽  
The Netherlands ◽  
Controlled Trial ◽  
Randomised Controlled ◽  
Internet Based Intervention

scholarly journals Improving Depressive Symptoms through Personalised Exercise and Activation (IDEA): Study Protocol for a Randomised Controlled Trial

2021 ◽  
Vol 18 (12) ◽  
pp. 6306
Author(s):  
Aitana García-Estela ◽  
Natalia Angarita-Osorio ◽  
Sandra Alonso ◽  
Maria Polo ◽  
Maria Roldán-Berengué ◽  
...  
Keyword(s):  
Physical Activity ◽  
Depressive Symptoms ◽  
Randomised Controlled Trial ◽  
Physical Health ◽  
Controlled Trial ◽  
Exercise Group ◽  
Global Functioning ◽  
Motivational Messages ◽  
Randomised Controlled ◽  
Group Programme

Individuals who suffer from depressive symptoms experience a substantial impact on psychosocial functioning, physical health, mortality, and quality of life. In the search for therapeutic strategies, exercise has been found to play a relevant part in its treatment. However, the promotion of exercise entails adherence difficulties that arose out of the tendency towards sedentarism led by symptomatology. Personalised exercise plans on top of usual care have the potential to enhance behavioural changes and mental health. The present study aims at evaluating the changes in functioning deriving from a blended intervention merging a psychological intervention with a personalised exercise programme based on medical assessment. We will conduct a three-arm randomised controlled trial in which 172 participants suffering from mild–moderate depressive symptoms will be allocated to Intervention A (personalised exercise group programme + app with motivational messages), B (personalised exercise group programme + app with no motivational messages) or control group (app with no motivational messages). Data regarding global functioning, well-being, symptoms, physical activity, and exercise capacity will be collected at baseline, 4, 12, and 36 weeks. The results of this trial will provide information about whether this physical activity support programme may be efficient for improving mental and physical health outcomes. Trial registration: ClinicalTrials.gov NCT04857944 (accessed on 15 April 2021). Registered April 2021.

scholarly journals Platelet-Rich plasma Injection Management for Ankle osteoarthritis study (PRIMA): protocol of a Dutch multicentre, stratified, block-randomised, double-blind, placebo-controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e030961
Author(s):  
LDA Paget ◽  
SMA Bierma-Zeinstra ◽  
S Goedegebuure ◽  
GMMJ Kerkhoffs ◽  
R Krips ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
The Netherlands ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Foot And Ankle ◽  
Ankle Osteoarthritis ◽  
Knee Oa ◽  
Plasma Injection ◽  
Pain Subscale ◽  
Randomised Controlled

IntroductionPlatelet-rich plasma (PRP) is a potentially efficacious treatment for ankle osteoarthritis (OA), but its use has not been examined in high-quality studies. Systematic reviews show that PRP injections significantly decrease pain and improve function in patients with knee OA. Ankle OA is more common than hip or knee OA in the young active population; with a prevalence of 3.4%.PRP injections in ankle OA are shown to be safe and improve quality of life over time, but no randomised controlled trial has been conducted. Our randomised controlled trial will evaluate the efficacy of PRP injections for symptom reduction and functional improvement, compared with placebo, in the treatment of ankle (talocrural) OA.Methods and analysisWe will conduct the Platelet-Rich plasma Injection Management for Ankle OA study: a multicentre, randomised, placebo-controlled trial. One hundred patients suffering from ankle OA will be randomised into two treatment groups: PRP injection or placebo (saline) injection. Both groups will receive two injections of PRP or placebo at an interval of 6 weeks. Primary outcome is the American Orthopaedic Foot and Ankle Society score at 26 weeks. Secondary outcomes determined at several follow-up moments up to 5 years, include Ankle Osteoarthritis Score, Foot and Ankle Outcome Score, pain subscale of (0–40), Visual Analogue Scale score (0–100), Ankle Activity Score (0–10), subjective patient satisfaction Short Form Health Survey-36, Global Attainment Scaling and the EuroQol-5 dimensions-3 levels utility score. A cost-effectiveness analysis will be performed at 1 year.Ethics and disseminationThe study is approved by the Medical Ethics Review Committee Amsterdam Medical Center, the Netherlands (ABR 2018–042, approved 23 July 2018) and registered in the Netherlands trial register (NTR7261). Results and new knowledge will be disseminated through the Dutch Arthritis Association (ReumaNederland), Dutch patient federation, conferences and published in a scientific peer-reviewed journal.Trial registration numberNTR7261.

scholarly journals Acceptability and feasibility of two interventions in the MooDFOOD Trial: a food-related depression prevention randomised controlled trial in overweight adults with subsyndromal symptoms of depression

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e034025
Author(s):  
Matthew Owens ◽  
Edward Watkins ◽  
Mariska Bot ◽  
Ingeborg Annemarie Brouwer ◽  
Miquel Roca ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Depression Prevention ◽  
History Of ◽  
Randomised Controlled ◽  
Subsyndromal Symptoms ◽  
Overweight Adults ◽  
History Of Depression

ObjectivesWe report on the acceptability, feasibility, dose-response relationship and adherence of two nutritional strategies to improve mood (multinutrient supplements; food-related behavioural activation (F-BA)) studied in a randomised controlled depression prevention trial (the Multi‐country cOllaborative project on the rOle of Diet, Food‐related behaviour, and Obesity in the prevention of Depression (MooDFOOD) Trial). We also assessed baseline determinants of adherence and assessed whether better adherence resulted in lower depressive symptoms.DesignRandomised controlled trial with a 2×2 factorial design conducted between 2015 and 2017.SettingGermany, the Netherlands, UK and Spain.ParticipantsCommunity sample of 1025 overweight adults with elevated depressive symptoms without a current episode of major depressive disorder. Main eligibility criteria included age (18–75 years), being overweight or obese, and having at least mild depressive symptoms, shown by a Patient Health Questionnaire Score of ≥5. A total of 76% of the sample was retained at the 12-month follow-up.InterventionsDaily nutritional supplements versus pill placebo or an F-BA therapy, delivered in individual and group sessions versus no behavioural intervention over a 1-year period.Primary and secondary outcome measuresPrimary outcome: self-reported acceptability of the interventions. Secondary outcomes: adherence and self-reported depressive symptoms.ResultsMost participants reported that the F-BA was acceptable (83.61%), feasible to do (65.91%) and would recommend it to a friend (84.57%). Individual F-BA sessions (88.10%) were significantly more often rated as positive than group F-BA sessions (70.17%) and supplements (28.59%). There were statistically significant reductions in depressive symptoms for those who both adhered to the F-BA intervention and had a history of depression (B=−0.08, SE=0.03, p=0.012) versus those who had no history of depression. Supplement intake had no effect on depressive symptoms irrespective of adherence.ConclusionsF-BA may have scope for development as a depression prevention intervention and public health strategy but further refinement and testing are needed.Trial registration numberNCT02529423.

scholarly journals A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with severe somatic conditions

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Vladimir Carli ◽  
Danuta Wasserman ◽  
Gergö Hadlaczky ◽  
Nuhamin Gebrewold Petros ◽  
Sara Carletto ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Physiological Data ◽  
Control Group ◽  
Evidence Based ◽  
Treatment As Usual ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Abstract Background Depressive symptoms are common in individuals suffering from severe somatic conditions. There is a lack of interventions and evidence-based interventions aiming to reduce depressive symptoms in patients with severe somatic conditions. The aim of the NEVERMIND project is to address these issues and provide evidence by testing the NEVERMIND system, designed to reduce and prevent depressive symptoms in comparison to treatment as usual. Methods The NEVERMIND study is a parallel-groups, pragmatic randomised controlled trial to assess the effectiveness of the NEVERMIND system in reducing depressive symptoms among individuals with severe somatic conditions. The NEVERMIND system comprises a smart shirt and a user interface, in the form of a mobile application. The system is a real-time decision support system, aiming to predict the severity and onset of depressive symptoms by modelling the well-being condition of patients based on physiological data, body movement, and the recurrence of social interactions. The study includes 330 patients who have a diagnosis of myocardial infarction, breast cancer, prostate cancer, kidney failure, or lower limb amputation. Participants are randomised in blocks of ten to either the NEVERMIND intervention or treatment as usual as the control group. Clinical interviews and structured questionnaires are administered at baseline, at 12 weeks, and 24 weeks to assess whether the NEVERMIND system is superior to treatment as usual. The endpoint of primary interest is Beck Depression Inventory II (BDI-II) at 12 weeks defined as (i) the severity of depressive symptoms as measured by the BDI-II. Secondary outcomes include prevention of the onset of depressive symptoms, changes in quality of life, perceived stigma, and self-efficacy. Discussion There is a lack of evidence-based interventions aiming to reduce and prevent depressive symptoms in patients with severe somatic conditions. If the NEVERMIND system is effective, it will provide healthcare systems with a novel and innovative method to attend to depressive symptoms in patients with severe somatic conditions. Trial registration DRKS00013391. Registered 23 November 2017.

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