Perceived health related quality of life and psychological distress in stage IV and V chronic kidney disease (non-renal replacement therapy stage)
Conditions
Interventions
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
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 generato
Sponsors
World Bank – AHEAD operations
Eligibility
Inclusion criteria
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 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).
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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.] | — |
Countries
Sri Lanka
Contacts
Public ContactNicholene Omella Outschoorn
Clinical Psychologist and PhD Candidate
Outcome results
None listed