Home » Trials » SLCTR/2024/002


A Randomized Controlled Trial of 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

-

SLCTR Registration Number

SLCTR/2024/002


Date of Registration

07 Feb 2024

The date of last modification

Feb 07, 2024



Application Summary


Scientific Title of Trial

A Randomized Controlled Trial of 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


Public Title of Trial

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.


Disease or Health Condition(s) Studied

Perceived health related quality of life and psychological distress in stage IV and V chronic kidney disease (non-renal replacement therapy stage)


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1291-4927


Any other number(s) assigned to the trial and issuing authority

EC-22-088


Trial Details


What is the research question being addressed?

Will a meditation-based psychotherapeutic intervention (online-based), compared to a series of illness-related education sessions with similar group support, therapeutic alliance and instructor attention, increase perceived health related quality of life and reduce psychological distress in Sinhala-conversant, non-renal replacement-therapy patients diagnosed with stage IV and V chronic kidney disease (CKD)?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Active


Assignment

Parallel


Purpose

Supportive care


Study Phase

Not Applicable


Intervention(s) planned

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 experiences. Each session will be conducted for a period of 1 – 1.5 hours. The intervention will be delivered in a hybrid mode where sessions 1 and 8 will be conducted onsite and sessions 2-7 will be conducted online. Participants will be asked to have their mobile phone / computer cameras switched on (they will be informed of this during the recruitment and informed consent process), thus enabling the researchers and the trainer to observe and guide them.

Active control condition: The participants chosen for the active control condition (n=56) will be delivered with illness-related education sessions parallel to the intervention group. This active control condition will follow the design of an active control group with a non-specific treatment component. This design is also named as an attention placebo group. As placebo effects are often attributed to clinical interactions and contextual factors that affect the expectations of the patient about the treatment and result in symptom change, complying by this design, we hope to provide the control group with similar time and attention from a professional figure compared to the intervention group. This will be done by providing illness-related education to the control group through 8 weeks similar to the intervention group. They too will engage in a discussion with professional facilitators who will be medical doctors, where their questions, concerns, and experiences will be discussed. These sessions will also run parallel to the sessions with the intervention group and this group will also participate in eight sessions conducted in a hybrid manner; 1st and 8th session onsite and sessions 2-7 online. This group will be waitlisted to receive the MBPI after its completion with the intervention group.

Standard treatment/care: as usual (non-specific) for CKD populations include regular dialysis (only for Renal Replacement Therapy patients), supplements of vitamins and micronutrients, nutritional advice, and drugs to improve the hemoglobin levels.

Note: at the end of the intervention period the intervention group too will be given leaflets with this helpful illness related education content printed on them.


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

  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)


Primary outcome(s)

1.

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.

]
2.

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(s)

1.

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.

]
2.

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.

]
3.

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.

]
4.

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.

]

Target number/sample size

112 (56 participants per group)


Countries of recruitment

Sri Lanka


Anticipated start date

2024-03-01


Anticipated end date

2024-11-30


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

World Bank Group - AHEAD


Regulatory approvals

N/A



State of Ethics Review Approval


Status

Approved


Date of Approval

2022-09-15


Approval number

EC-22-088


Details of Ethics Review Committee

Name: Ethics Review Committee of the Faculty of Medicine, University of Colombo, Sri Lanka
Institutional Address:Ethics Review Committee, Faculty of Medicine, University of Colombo, PO Box 271, Kynsey Road, Colombo 08, Sri Lanka
Telephone:+94112695300 (Ext. 240)
Email: ethicscommitteemfc@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Nicholene Omella Outschoorn
Clinical Psychologist and PhD Candidate
Research Promotion and Facilitation Centre (RPFC), Faculty of Medicine, No. 25, Kynsey Road, Colombo 08, Sri Lanka
+94112695 300 (Ext. 106)
+94770717720

omella@med.cmb.ac.lk; nicholenho@gmail.com

Contact Person for Public Queries

Dr. Santushi D. Amarasuriya,
Senior Lecturer,
Department of Medical Humanities, Faculty of Medicine, No. 25, Kynsey Road, Colombo 08, Sri Lanka
+94112695 300 (Ext. 256)


santushi@med.cmb.ac.lk


Primary study sponsor/organization

World Bank – AHEAD operations

79/1, 5th Lane, Colombo 03



Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

Yes


IPD sharing plan description

Individual participant data that underlie the results being reported will be shared after de-identification (text, tables, figures and appendices). The study protocol will also be shared. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, including for individual participant data meta-analysis. Proposals should be directed to omella@med.cmb.ac.lk / nicholenho@gmail.com. To gain access, data requesters will need to sign a data access agreement.


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results