Category
»
Primary study
Registry of Trials»SLCTR
Year
»
2024
INTERVENTION: Study setting: Faculty of Medicine, University of Colombo, Sri Lanka and the National Hospital of Sri Lanka (NHSL), Colombo Randomization: Selected participants (i.e. stage IV and V CKD patients who are at a non‐renal replacement therapy stage and attending renal care clinics at the National Hospital of Sri Lanka, Colombo) will be divided into two groups; intervention/treatment group and the active control/non‐treatment group, randomly (i.e., using block randomization with 1:1 allocation ratio, 5 blocks) using an online automatic random number generator (link to random number generator: http://www.randomizer.org/). Intervention: The proposed meditation‐based psychotherapeutic intervention (MBPI) will consist of eight weekly (1 per week) sessions through which three meditation techniques (i.e., walking meditation, body scan meditation, and loving‐kindness meditation) will be gradually introduced to the participants by trained meditators. Intervention group participants (n=56) will be instructed to maintain a home‐based meditation practice of 40 minutes in between sessions and their practice will be aided by weekly recordings. The participants will be asked to record their practice time and experience in a booklet/journal, and this will be used as a means of monitoring their home based practice. Furthermore, the data from the journals will be analyzed post‐intervention to further analyze the meditation experience of the participants. Each session will further include a brief introductory psychoeducation component at the beginning (approximately 10 min). At the end of the session, the participants will engage in a discussion (approximately 20 min) with the researchers and the meditation trainers where they will be able to discuss their questions, concerns and experience CONDITION: Perceived health related quality of life and psychological distress in stage IV and V chronic kidney disease (non‐renal replacement therapy stage) PRIMARY OUTCOME: Improvement/increase of health‐related quality of associated with experiences, beliefs, and expectations in terms of kidney disease specific components related to quality of life and general health related to quality of life in the intervention group at the end of the intervention. This outcome will be measured using the Sinhala version of the Kidney Disease Quality of Life (KD‐QoL) questionnaire. [These primary outcomes will be measured at 3‐time points: baseline / pre‐intervention (prior to the commencement of the intervention), post‐intervention, and after a 3‐month follow‐up period.]; Decrease in psychological distress, namely in levels of depression, anxiety, and stress in the intervention group at the end of the intervention. This outcome will be measured using the Sinhala version of the Depression Anxiety Stress – 21 (DASS‐21) scale. [These primary outcomes will be measured at 3‐time points: baseline / pre‐intervention (prior to the commencement of the intervention), post‐intervention, and after a 3‐month follow‐up period.]; SECONDARY OUTCOME: Improvement/increase of levels of self‐compassion in the intervention group at the end of the intervention. This outcome will be measured using the Sinhala version of the Self‐compassion scale. [The secondary outcomes will be measured at 3‐time points: baseline / pre‐intervention (prior to the commencement of the intervention), post‐intervention, and after a 3‐month follow‐up period.]; Improvement/increase of psychological resilience in the intervention group at the end of the intervention. This outcome will be measured using the Sinhala version of the Resilience Scale. [ The secondary outcomes will be measured at 3‐time points: baseline / pre‐intervention (prior to the commencement of the intervention), post‐intervention, and after a 3‐month follow‐up period.]; Improvement/increase of adaptive coping in the intervention group at the end of the intervention. This outcome will be measured using the Sinhala version of the BRIEF‐COPE questionnaire. [ The secondary outcomes will be measured at 3‐time points: baseline / pre‐intervention (prior to the commencement of the intervention), post‐intervention, and after a 3‐month follow‐up period.]; Improvement/increase of levels of mindfulness in the intervention group at the end of the intervention. This outcome will be measured using the Sinhala version of the Five Facet Mindfulness Questionnaire (FFMQ‐39). [ The secondary outcomes will be measured at 3‐time points: baseline / pre‐intervention (prior to the commencement of the intervention), post‐intervention, and after a 3‐month follow‐up period.]; INCLUSION CRITERIA: 1. Chronic Kidney Disease (CKD) patients who are in stage IV and V of illness, as identified by a Consultant Nephrologist/senior registrar of nephrology/consultant physician or through the estimated Glomeular Filtration Rate (eGFR) blood test where eGFR levels are less than 30 ml/min. 2. Stage IV and V CKD patients who are not currently going through dialysis procedures /(i.e., non‐renal replacement therapy (non‐RRT) patients) 3. Stage IV or V CKD patients who show mild – severe pretreatment scores for depression (10‐27) and / or anxiety (08‐19) as measured through the Sinhala version of the Depression, Anxiety, Stress Scale (DASS‐21) during participant screening (Participants who show extreme severity in these domains will be referred for psychiatric assessment). 4. 18‐70 years old, males and females 5. Participants who are conversant in Sinhala and show the ability to understand the Sinhala language in order to complete study measures, to understand th
Epistemonikos ID: 7b96dc2b10887946f1977b967b2b083b51345406
First added on: Aug 28, 2024