Effects of a meditation-based psychotherapeutic intervention (online-based) on perceived health related quality of life and psychological distress in Sinhala-conversant non-renal replacement therapy patients diagnosed with stages IV and V chronic kidney disease: A Parallel-group, Randomized Controlled Trial using a series of illness related education sessions as the active comparator.
- Conditions
- Perceived health related quality of life and psychological distress in stage IV and V chronic kidney disease (non-renal replacement therapy stage)
- Registration Number
- SLCTR/2024/002
- Lead Sponsor
- World Bank – AHEAD operations
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
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 the content and material delivered through the programme and to engage in discussions conducted in Sinhala.
6.Participants who have a smart phone/desktop computer or laptop at home and an internet connection that is available to be used for zoom sessions held once a week (data cards will be provided and technical guidance will be provided if/when needed).
1.CKD patients expecting to receive RRTs (i.e., dialysis and renal transplant) within the next six months from the time of recruitment.
2.CKD patients who present with rapid progressive renal disease
3.CKD patients who have comorbidities such as severe anemia conditions, severe edema and severe arthritis.
4.Obtaining psychological treatment and/or psychotropic medication at the moment or have obtained within the past five years.
5.Presenting with suicidal ideation as identified by a psychologist (i.e., the primary researcher) during participant selection/screening.
6.Following alternative treatment modalities including Ayurveda medicine, indigenous medicine, and homeopathy medicine.
7.Engaging in regular meditation practices (including yoga and relaxation techniques) for more than once/twice a month for the past five years.
8.Experiencing difficulties in reading and/or writing and having only completed mid-secondary education (i.e., grade 11 or lower in local and/or international education syllabus)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method