المؤلفون: Stephen Benjamin Peckham, Emily Ionson, Marouane Nassim, Kevin Ojha, Lena Palaniyappan, Joe Gati, Jean Thebérge, Andrea Lazosky, Mark Speechley, Imants Barušs, Soham Rej, Akshya Vasudev

المصدر: Trials, Vol 20, Iss 1, Pp 1-16 (2019)

مصطلحات موضوعية: Late-life depression, Treatment-resistant late-life depression, Executive functioning, Sahaj Samadhi meditation, Health Enhancement Program, Randomized controlled trial, Medicine (General), R5-920

الوصف: Abstract Background Recent estimates suggest an 11% prevalence of current late-life depression (LLD) and a lifetime prevalence of 16–20%. LLD leads to cognitive disturbance as well as a nearly two to three times increased risk of dementia. We conducted a recent randomized controlled trial (RCT) which demonstrated that Sahaj Samadhi meditation (SSM), an easy-to-implement, meditation-based augmentation strategy, led to higher rates of symptom remission when compared to treatment as usual (40.0 vs 16.3%; odds ratio, 3.36; 95% CI 1.06–10.64; p = 0.040). Here we present a protocol describing a two-site, blinded, RCT, comparing an SSM arm to an active-control arm – a Health Enhancement Program (HEP) intervention – in their ability to reduce depressive symptoms and improve executive functioning, among several other exploratory outcomes. Methods/design One hundred and ninety-two (n = 192) participants with LLD will be recruited at two sites (London, ON, Canada, and Montreal, QC, Canada). Participants will undergo stratified randomization with regards to site and the presence of treatment-resistant-LLD (TR-LLD) or not, to either SSM or HEP. We will assess change in (1) depression severity using the Hamilton Depression Rating Scale (HAM-D), (2) executive functioning, and (3) other exploratory physiological and mood-based measures, at baseline (0 weeks), post intervention (12 weeks), and 26 weeks after baseline. Raters, clinicians, and care providers will be blinded to group allocation while participants will be blinded to the study hypotheses. Discussion This study should more definitively assess whether SSM can be used as an augmentation strategy in routine clinical care for patients suffering from LLD and TR-LLD. If the effects of SSM are significantly better than HEP, it will offer support for the routine use of this intervention to manage LLD/TR-LLD and comorbid declines in executive dysfunction. The results of this study could also inform whether SSM can improve/prevent cognitive decline in LLD. Trial registration ClinicalTrials.gov, ID: NCT03564041. Registered on 20 June 2018.

وصف الملف: electronic resource

العلاقة: http://link.springer.com/article/10.1186/s13063-019-3682-zTest; https://doaj.org/toc/1745-6215Test

الوصول الحر: https://doaj.org/article/149c90b4861744ab888bc1d20b2063c5Test

المؤلفون: Joseph S. Gati, Marouane Nassim, Akshya Vasudev, Kevin Ojha, Imants Barušs, Mark Speechley, Emily Ionson, Jean Théberge, Soham Rej, Lena Palaniyappan, Andrea Lazosky, Stephen Benjamin Peckham

المصدر: Brain and Mind Institute Researchers' Publications
Trials, Vol 20, Iss 1, Pp 1-16 (2019)
Trials

مصطلحات موضوعية: Male, Time Factors, Medicine (miscellaneous), Severity of Illness Index, Late-life depression, law.invention, Study Protocol, Executive Function, 0302 clinical medicine, Randomized controlled trial, law, Multicenter Studies as Topic, Medicine, Pharmacology (medical), Cognitive decline, Depression (differential diagnoses), Randomized Controlled Trials as Topic, Aged, 80 and over, Ontario, lcsh:R5-920, Depression, Age Factors, Quebec, Sahaj Samadhi meditation, Middle Aged, Treatment-resistant late-life depression, Late life depression, 3. Good health, Meditation, Treatment Outcome, Female, lcsh:Medicine (General), Health Enhancement Program, medicine.medical_specialty, 03 medical and health sciences, Rating scale, Humans, Dementia, Aged, business.industry, Odds ratio, medicine.disease, 030227 psychiatry, Affect, Physical therapy, Executive functioning, business, 030217 neurology & neurosurgery, Executive dysfunction

الوصف: Background Recent estimates suggest an 11% prevalence of current late-life depression (LLD) and a lifetime prevalence of 16–20%. LLD leads to cognitive disturbance as well as a nearly two to three times increased risk of dementia. We conducted a recent randomized controlled trial (RCT) which demonstrated that Sahaj Samadhi meditation (SSM), an easy-to-implement, meditation-based augmentation strategy, led to higher rates of symptom remission when compared to treatment as usual (40.0 vs 16.3%; odds ratio, 3.36; 95% CI 1.06–10.64; p = 0.040). Here we present a protocol describing a two-site, blinded, RCT, comparing an SSM arm to an active-control arm – a Health Enhancement Program (HEP) intervention – in their ability to reduce depressive symptoms and improve executive functioning, among several other exploratory outcomes. Methods/design One hundred and ninety-two (n = 192) participants with LLD will be recruited at two sites (London, ON, Canada, and Montreal, QC, Canada). Participants will undergo stratified randomization with regards to site and the presence of treatment-resistant-LLD (TR-LLD) or not, to either SSM or HEP. We will assess change in (1) depression severity using the Hamilton Depression Rating Scale (HAM-D), (2) executive functioning, and (3) other exploratory physiological and mood-based measures, at baseline (0 weeks), post intervention (12 weeks), and 26 weeks after baseline. Raters, clinicians, and care providers will be blinded to group allocation while participants will be blinded to the study hypotheses. Discussion This study should more definitively assess whether SSM can be used as an augmentation strategy in routine clinical care for patients suffering from LLD and TR-LLD. If the effects of SSM are significantly better than HEP, it will offer support for the routine use of this intervention to manage LLD/TR-LLD and comorbid declines in executive dysfunction. The results of this study could also inform whether SSM can improve/prevent cognitive decline in LLD. Trial registration ClinicalTrials.gov, ID: NCT03564041. Registered on 20 June 2018.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::89efdc9cc07e2e16e67a51f89d01e159Test
https://doi.org/10.1186/s13063-019-3682-zTest

المؤلفون: Jayanthi Raman, Evelyn Smith, Phillipa Hay

المصدر: Trials

مصطلحات موضوعية: Research design, Questionnaires, Male, obesity, Time Factors, medicine.medical_treatment, Medicine (miscellaneous), Neuropsychological Tests, law.invention, Body Mass Index, Executive Function, Study Protocol, Randomized controlled trial, Clinical Protocols, Weight loss, law, Surveys and Questionnaires, binge-eating, Pharmacology (medical), Cognition, Middle Aged, Treatment Outcome, Cognitive Therapy, Cognitive remediation therapy, Research Design, Female, medicine.symptom, New South Wales, executive functioning, Clinical psychology, Adult, medicine.medical_specialty, Adolescent, Cognitive Remediation Therapy, Young Adult, Physical medicine and rehabilitation, Quality of life (healthcare), Intervention (counseling), General & Internal Medicine, Weight Loss, medicine, Humans, Obesity, Psychiatric Status Rating Scales, Cognitive Behavioral Therapy, business.industry, Waist-Hip Ratio, Feeding Behavior, Cardiovascular System & Hematology, Cognitive therapy, Quality of Life, business

الوصف: © 2014 Raman et al. Background: Research has shown that obese individuals have cognitive deficiencies in executive function, leading to poor planning and impulse control, and decision-making difficulties. An intervention that could help reduce these deficits and in turn help weight loss maintenance is Cognitive Remediation Therapy for Obesity (CRT-O). We aim to examine the efficacy of manualised CRT-O, which is intended to improve executive function, enhance reflective practice and help weight loss maintenance. Methods/Design: A randomised controlled trial (registered with the Australian New Zealand Clinical Trials Registry) will be conducted. First, 90 obese adults (body mass index >30 kg/m2) in the community will receive three weekly sessions of a group Behaviour Weight Loss Treatment (BWLT), and then will be randomised either to receive CRT-O or to enter a no-treatment control group. CRT-O training will comprise twice-weekly sessions of 45 minutes over a 4 to 6 week period, for a total of eight sessions. Measurement points will be at baseline, post CRT-O (or 4 to 6 weeks after BWLT for the no-treatment control), 3 months post treatment and 1 year post treatment. The primary outcome will be executive function and secondary outcome measures will include participants' body mass index, hip to waist ratio, eating behaviours and quality of life. Discussion: This is the first study of its kind to examine the efficacy of Cognitive Remediation Therapy for obese adults through a randomised controlled trial. Trial Registration: Australian New Zealand Clinical Trials Registry number: 12613000537752. Date of registration: 14 May 2013.

وصف الملف: application/pdf

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9699ea399c1ace5ba78c11335bcb6779Test
https://pubmed.ncbi.nlm.nih.gov/25370364Test