A Phase 4 interventional study of Cognitive behavioral therapy and Bisoprolol in Kidney Failure, Chronic, Peritoneal Dialysis, Continuous Ambulatory and Psychological Stress, sponsored by Universitas Sebelas Maret. Completed at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Universitas Sebelas Maret · Phase 4, Interventional, and Supportive care
Patients on continuous ambulatory peritoneal dialysis (CAPD) often have chronic stress and anxiety. This pilot study compared two ways to reduce stress in adults on CAPD: cognitive behavioral therapy (CBT) and the beta-blocker bisoprolol. Each patient received one treatment for 30 days. The main question was whether either treatment lowers morning blood cortisol, a stress hormone. The study also compared changes in blood pressure, pulse rate, anxiety score, and sleep quality.
Design: single-center, open-label, non-randomized, two-arm parallel pilot study with a pre-test and post-test design.
Setting: Internal Medicine Outpatient Clinic (Division of Nephrology and Hypertension), Dr. Moewardi General Hospital, Surakarta, Central Java, Indonesia.
Participants: adults with stage 5 chronic kidney disease on CAPD attending routine follow-up.
Interventions: (1) individual cognitive behavioral therapy based on psychological principles, given during routine clinic visits over 30 days; (2) oral bisoprolol 5 mg once daily for 30 days. Both groups continued usual treatment.
Measurements: morning blood cortisol, blood pressure, pulse rate, and anxiety score (standard anxiety rating scale) at baseline and after 30 days. Sleep quality was assessed with the Pittsburgh Sleep Quality Index at day 30.
Analysis: changes from baseline were compared between groups with the independent t-test or the Mann-Whitney U test.
Sample size: 36 participants were planned; 20 were enrolled (10 per arm).
Registration note: this study was registered retrospectively after completion.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 20 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Universitas Sebelas Maret is the lead sponsor of 30 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individual cognitive behavioral therapy for 30 days, given during routine clinic visits, in addition to usual care.
Behavioral: Cognitive behavioral therapy
Oral bisoprolol 5 mg once daily for 30 days, in addition to usual care.
Drug: Bisoprolol
Individual cognitive behavioral therapy based on psychological principles, given during routine clinic visits over 30 days, in addition to usual care.
Also known as: CBT
Bisoprolol 5 mg tablet taken orally once daily for 30 days.
Change in morning blood cortisol
Blood cortisol (microgram/dL) measured from a morning venous blood sample. Change = day-30 value minus baseline value.
Time frame: Baseline and day 30
Change in systolic blood pressure
Office systolic blood pressure (mmHg) after at least 5 minutes of rest. Change = day-30 value minus baseline value.
Time frame: Baseline and day 30
Change in diastolic blood pressure
Office diastolic blood pressure (mmHg) after at least 5 minutes of rest. Change = day-30 value minus baseline value.
Time frame: Baseline and day 30
Change in pulse rate
Pulse rate (beats per minute) measured at rest. Change = day-30 value minus baseline value.
Time frame: Baseline and day 30
Change in anxiety score
Anxiety measured with a standard anxiety rating scale. Higher scores mean more severe anxiety. Change = day-30 value minus baseline value.
Time frame: Baseline and day 30
Pittsburgh Sleep Quality Index (PSQI) global score
Global PSQI score (range 0-21). Higher scores mean poorer sleep quality; a score above 5 indicates poor sleep.
Time frame: Day 30
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data will not be posted publicly. De-identified data are available from the study team on reasonable request.
Ran from Nov 2022 to primary completion in Mar 2023, 3 months.
Of 52 non-industry phase 4 interventional studies under Kidney Failure, Chronic, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 80. This study's 3 months is below that.
Counting every sponsor, half of 63 studies reached it within 31 months; a quarter within 16 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bisoprolol
Universitas Sebelas Maret