Kidney Failure, ChronicPhase 4NCT07899281
Bisoprolol Versus Cognitive Behavioral Therapy for Stress in Patients on Peritoneal Dialysis
A Phase 4 study testing Cognitive behavioral therapy and Bisoprolol in people with Kidney Failure, Chronic and Peritoneal Dialysis, Continuous Ambulatory, run by Universitas Sebelas Maret at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Peritoneal Dialysis, Continuous Ambulatory, Psychological Stress
- What is being tested?
- Cognitive behavioral therapy and Bisoprolol
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Nov 2022to 9 Mar 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Stage 5 chronic kidney disease treated with continuous ambulatory peritoneal dialysis
- Willing to take part and able to give written informed consent
Who cannot join
- Use of drugs other than routine medicines prescribed by the internal medicine clinic
- Previous psychotherapy
- Known allergy to bisoprolol
- Bradycardia
- Severe illness
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Moewardi General Hospital
Surakarta, Central Java, 57126
About this study
Official title: Bisoprolol Versus Cognitive Behavioral Therapy on Cortisol, Blood Pressure, and Anxiety in Patients on Continuous Ambulatory Peritoneal Dialysis: A Pilot Quasi-Experimental Study
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.
Read the detailed description
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.
- Conditions
- Kidney Failure, Chronic, Peritoneal Dialysis, Continuous Ambulatory, Psychological Stress, Anxiety
- Being tested
- Cognitive behavioral therapy, Bisoprolol
- Keywords
- bisoprolol, cognitive behavioral therapy, cortisol, CAPD, blood pressure
- Medical subject headings
- Kidney Failure, Chronic, Stress, Psychological, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
Also called CBT
Individual cognitive behavioral therapy based on psychological principles, given during routine clinic visits over 30 days, in addition to usual care.
BisoprololDrug
Bisoprolol 5 mg tablet taken orally once daily for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy | Experimental | Individual cognitive behavioral therapy for 30 days, given during routine clinic visits, in addition to usual care. Receives: Behavioral: Cognitive behavioral therapy |
| Bisoprolol | Experimental | Oral bisoprolol 5 mg once daily for 30 days, in addition to usual care. Receives: Drug: Bisoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in morning blood cortisol
Blood cortisol (microgram/dL) measured from a morning venous blood sample. Change = day-30 value minus baseline value.
Measured: Baseline and day 30
Secondary outcomes (5)
Change in systolic blood pressure
Office systolic blood pressure (mmHg) after at least 5 minutes of rest. Change = day-30 value minus baseline value.
Measured: 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.
Measured: Baseline and day 30
Change in pulse rate
Pulse rate (beats per minute) measured at rest. Change = day-30 value minus baseline value.
Measured: 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.
Measured: 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.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start10 Nov 2022
- Primary completion9 Mar 2023
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups. Eligible patients were enrolled in sequence and divided into a CBT group and a bisoprolol group. Outcomes were measured before and after 30 days of treatment.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sebelas Maret
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurhasan Agung Prabowo, MD, Universitas Sebelas Maret
- Investigators
- Bayu Perkasa Roos Trisaputra, MD, Principal investigator, Universitas Sebelas Maret / Dr. Moewardi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899281
- Sponsor's protocol ID
- KEPK-RSDM-1230-IX-HREC-2022
- Other IDs
- 1.230/IX/HREC/2022
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be posted publicly. De-identified data are available from the study team on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bisoprolol Versus Cognitive Behavioral Therapy on Cortisol, Blood Pressure, and Anxiety in Patients on Continuous Ambulatory Peritoneal Dialysis: A Pilot Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07899281
- Acronym / sponsor ID
- KEPK-RSDM-1230-IX-HREC-2022
- Conditions
- Kidney Failure, Chronic, Peritoneal Dialysis, Continuous Ambulatory, Psychological Stress, Anxiety
- Keywords
- bisoprolol, cognitive behavioral therapy, cortisol, CAPD, blood pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitas Sebelas MaretUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel groups. Eligible patients were enrolled in sequence and divided into a CBT group and a bisoprolol group. Outcomes were measured before and after 30 days of treatment.
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy | Experimental | Behavioral: Cognitive behavioral therapyIndividual cognitive behavioral therapy for 30 days, given during routine clinic visits, in addition to usual care. |
| Bisoprolol | Experimental | Drug: BisoprololOral bisoprolol 5 mg once daily for 30 days, in addition to usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years or older
- Stage 5 chronic kidney disease treated with continuous ambulatory peritoneal dialysis
- Willing to take part and able to give written informed consent
Key exclusion criteria (5 listed)
- Use of drugs other than routine medicines prescribed by the internal medicine clinic
- Previous psychotherapy
- Known allergy to bisoprolol
- Bradycardia
- Severe illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapyAlso: CBTIndividual cognitive behavioral therapy based on psychological principles, given during routine clinic visits over 30 days, in addition to usual care. | Behavioural | Cognitive behavioral therapy |
| BisoprololBisoprolol 5 mg tablet taken orally once daily for 30 days. | Drug | Bisoprolol |
Primary outcome
Change in morning blood cortisol
Time frame: Baseline and day 30
Blood cortisol (microgram/dL) measured from a morning venous blood sample. Change = day-30 value minus baseline value.
5 secondary outcomes
Change in systolic blood pressure
Time frame: Baseline and day 30
Change in diastolic blood pressure
Time frame: Baseline and day 30
Change in pulse rate
Time frame: Baseline and day 30
Change in anxiety score
Time frame: Baseline and day 30
Pittsburgh Sleep Quality Index (PSQI) global score
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be posted publicly. De-identified data are available from the study team on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayu Perkasa Roos Trisaputra, MD principal investigator
Universitas Sebelas Maret / Dr. Moewardi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cognitive behavioral therapy and Bisoprolol in people with Kidney Failure, Chronic and Peritoneal Dialysis, Continuous Ambulatory, run by Universitas Sebelas Maret at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in morning blood cortisol (time frame: Baseline and day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.