Liver Transplant; ComplicationsNCT06879106
Effect of Cognitive Therapy on Immunosuppressive Treatment Compliance and Motivation
A study testing Intervention group in people with Liver Transplant; Complications and Immunosuppression, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial summary
The study aims to analyze the effects of Mindfulness-Based Cognitive Therapy (MBCT) on the motivation levels and compliance with immunosuppressive therapy of post-liver transplant recipients. H1-0: MBCT has no effect on the compliance of recipients to immunosuppressive therapy after liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant; Complications, Immunosuppression, Compliance, Treatment
- What is being tested?
- Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2025to 30 Aug 2025
- Phase
- Interventional
- 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
- Applying to the outpatient clinic for routine follow-up after liver transplantation,
- Receiving immunosuppressive treatment for at least one month after liver transplantation,
- Being 18 years old or older,
- Not having a communication barrier,
- Agreeing to participate in the study.
Who cannot join
- Having any hearing or mental problems
- Wanting to leave the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University
The study aims to analyze the effects of Mindfulness-Based Cognitive Therapy (MBCT) on the motivation levels and compliance with immunosuppressive therapy of post-liver transplant recipients.
H1-0: MBCT has no effect on the compliance of recipients to immunosuppressive therapy after liver transplantation.
H1-1: MBCT has an effect on the compliance of recipients to immunosuppressive therapy after liver transplantation.
H2-0: MBCT has no effect on increasing the motivation of recipients after liver transplantation.
H2-1: MBCT has an effect on increasing the motivation of recipients after liver transplantation.
Read the detailed description
Experimental group Data collection tools will be applied to the patients in the experimental group before the MBCT intervention. The 60 patients in the experimental group will be divided into six subgroups, each consisting of 10 patients. MBCT will be applied by Expert Clinical Psychologist Aybüke İğdir, who has received special training in the field. There will be a group facilitator among the MBCT trainers. The group facilitator is a psychologist with postgraduate education and experience in MBCT. The MBCT intervention will be applied to each subgroup of the experimental group on different days. During the MBCT intervention, eight consecutive sessions will be held with the themes of "Mindfulness and Autopilot", "Living in Our Mind", "Focusing on the Distracted Mind", "Recognizing Hate", "Allowing", "Thoughts Are Not Real", "How Can I Best Take Care of Myself?" and "Maintaining and Expanding New Learning". The theme of Maintaining and Expanding New Learning includes special techniques that patients can apply for medication compliance. There will be one MBCT session per week and therefore the MBCT program will continue for eight weeks. After the eight-week MBCT program ends, no intervention will be applied to the patients in the experimental group for the next month based on similar studies in the literature and at the end of this one month, in the posttest phase, these patients will be applied the scales once again.
Control group Data collection tools will be applied to patients in the control group as part of the pre-test. Patients with questions will be allowed to direct their questions to the researchers. After these questions are answered, no intervention will be made to the control group and patients in the control group will not be contacted at any time for the next three months. After three months, patients in the control group will be invited to the outpatient clinic and the scales will be applied to these patients once more during these outpatient clinic visits to collect post-test data.
- Being tested
- Intervention group
- Keywords
- Mindfulness-Based Cognitive Therapy (MBCT), liver transplantation, immunosuppressive therapy, compliance, motivation level
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupOther
The Mindfulness-Based Cognitive Therapy (MBCT) intervention is an educational program consisting of the themes "Mindfulness and Autopilot," "Living in Our Mind," "Focusing the Distracted Mind," "Recognizing Hate," "Allowing," "Thoughts Are Not Real," "How Can I Best Take Care of Myself," and "Sustaining and Expanding New Learning."
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Data collection tools will be applied to the patients in the experimental group before the MBCT intervention. The 60 patients in the experimental group will be divided into six subgroups of 10 patients each. During the MBCT intervention, eight consecutive sessions will be held with the themes of "Mindfulness and Autopilot", "Living in Our Mind", "Focusing on the Distracted Mind", "Recognizing Hate", "Allowing", "Thoughts Are Not Real", "How Can I Best Take Care of Myself?" and "Maintaining and Expanding New Learning". One MBCT session will be held per week and therefore the MBCT program will continue for eight weeks. After the eight-week MBCT program ends, no intervention will be applied to the patients in the experimental group for the next month based on similar studies in the literature and at the end of this one month, in the posttest phase, these patients will be applied the scales once more. Receives: Other: Intervention group |
| control group | No intervention | Control group Data collection tools will be applied to patients in the control group as part of the pre-test. Patients with questions will be allowed to direct their questions to the researchers. After these questions are answered, no intervention will be made to the control group and patients in the control group will not be contacted at any time for the next three months. After three months, patients in the control group will be invited to the outpatient clinic and the scales will be applied to these patients once more during these outpatient clinic visits to collect post-test data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Immunosuppressive Therapy
Immunosuppressant Therapy Adherence Scale (ITAS) This scale was first developed in 1986 by Morisky and colleagues to assess the adherence of hypertensive patients to anti-hypertensive drugs. It consists of four items, each of which assesses how many times and why the recipient forgot to take immunosuppressive drugs to prevent transplant rejection in the last three months. In scoring, participants who fully adhered to immunosuppressive drug treatment in the last three months were given 3 points, those with a non-adherence rate of 1-20% were given 2 points, those with a non-adherence rate of 21-50% were given 1 point, and those with a non-adherence rate of more than 50% were given 0 points. A participant can score between 0 and 12 on the ITAS. A high ITAS score indicates a high level of adherence to treatment.
Measured: It will take approximately 5 minutes
Mindful Attention
Mindful Attention Scale (MAAS) MAAS was created by Brown and Ryan and is used to measure the awareness levels of individuals. It is a six-point Likert-type scale consisting of 15 items and is evaluated based on a single total score. A high MAAS score indicates that the participant has a high level of awareness.
Measured: It will take approximately 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start15 Feb 2025
- Primary completion30 May 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- It will be conducted as a randomized controlled experimental study in a pretestpost- test control group experimental model.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serafettin Okutan, Bitlis Eren University
- Investigators
- Şerafettin OKUTAN, PhD., Principal investigator, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879106
- Sponsor's protocol ID
- okutan8
- Status last verified
- Feb 2026
- First submitted
- 11 Mar 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University
- ClinicalTrials.gov ID
- NCT06879106
- Acronym / sponsor ID
- okutan8
- Keywords
- Mindfulness-Based Cognitive Therapy (MBCT), liver transplantation, immunosuppressive therapy, compliance, motivation level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 17 Mar 2025 (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.
The study aims to analyze the effects of Mindfulness-Based Cognitive Therapy (MBCT) on the motivation levels and compliance with immunosuppressive therapy of post-liver transplant recipients.
H1-0: MBCT has no effect on the compliance of recipients to immunosuppressive therapy after liver transplantation.
H1-1: MBCT has an effect on the compliance of recipients to immunosuppressive therapy after liver transplantation.
H2-0: MBCT has no effect on increasing the motivation of recipients after liver transplantation.
H2-1: MBCT has an effect on increasing the motivation of recipients after liver transplantation.
Detailed description
Experimental group Data collection tools will be applied to the patients in the experimental group before the MBCT intervention. The 60 patients in the experimental group will be divided into six subgroups, each consisting of 10 patients. MBCT will be applied by Expert Clinical Psychologist Aybüke İğdir, who has received special training in the field. There will be a group facilitator among the MBCT trainers. The group facilitator is a psychologist with postgraduate education and experience in MBCT. The MBCT intervention will be applied to each subgroup of the experimental group on different days. During the MBCT intervention, eight consecutive sessions will be held with the themes of "Mindfulness and Autopilot", "Living in Our Mind", "Focusing on the Distracted Mind", "Recognizing Hate", "Allowing", "Thoughts Are Not Real", "How Can I Best Take Care of Myself?" and "Maintaining and Expanding New Learning". The theme of Maintaining and Expanding New Learning includes special techniques that patients can apply for medication compliance. There will be one MBCT session per week and therefore the MBCT program will continue for eight weeks. After the eight-week MBCT program ends, no intervention will be applied to the patients in the experimental group for the next month based on similar studies in the literature and at the end of this one month, in the posttest phase, these patients will be applied the scales once again.
Control group Data collection tools will be applied to patients in the control group as part of the pre-test. Patients with questions will be allowed to direct their questions to the researchers. After these questions are answered, no intervention will be made to the control group and patients in the control group will not be contacted at any time for the next three months. After three months, patients in the control group will be invited to the outpatient clinic and the scales will be applied to these patients once more during these outpatient clinic visits to collect post-test data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It will be conducted as a randomized controlled experimental study in a pretestpost- test control group experimental model.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Intervention groupData collection tools will be applied to the patients in the experimental group before the MBCT intervention. The 60 patients in the experimental group will be divided into six subgroups of 10 patients each. During the MBCT intervention, eight consecutive sessions will be held with the themes of "Mindfulness and Autopilot", "Living in Our Mind", "Focusing on the Distracted Mind", "Recognizing Hate", "Allowing", "Thoughts Are Not Real", "How Can I Best Take Care of Myself?" and "Maintaining and Expanding New Learning". One MBCT session will be held per week and therefore the MBCT program will continue for eight weeks. After the eight-week MBCT program ends, no intervention will be applied to the patients in the experimental group for the next month based on similar studies in the literature and at the end of this one month, in the posttest phase, these patients will be applied the scales once more. |
| control group | No intervention | –Control group Data collection tools will be applied to patients in the control group as part of the pre-test. Patients with questions will be allowed to direct their questions to the researchers. After these questions are answered, no intervention will be made to the control group and patients in the control group will not be contacted at any time for the next three months. After three months, patients in the control group will be invited to the outpatient clinic and the scales will be applied to these patients once more during these outpatient clinic visits to collect post-test data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Applying to the outpatient clinic for routine follow-up after liver transplantation,
- Receiving immunosuppressive treatment for at least one month after liver transplantation,
- Being 18 years old or older,
- Not having a communication barrier,
- Agreeing to participate in the study.
Key exclusion criteria (2 listed)
- Having any hearing or mental problems
- Wanting to leave the study
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 |
|---|---|---|
| Intervention groupThe Mindfulness-Based Cognitive Therapy (MBCT) intervention is an educational program consisting of the themes "Mindfulness and Autopilot," "Living in Our Mind," "Focusing the Distracted Mind," "Recognizing Hate," "Allowing," "Thoughts Are Not Real," "How Can I Best Take Care of Myself," and "Sustaining and Expanding New Learning." | Other | Intervention group |
Primary outcome
Adherence to Immunosuppressive Therapy
Time frame: It will take approximately 5 minutes
Immunosuppressant Therapy Adherence Scale (ITAS) This scale was first developed in 1986 by Morisky and colleagues to assess the adherence of hypertensive patients to anti-hypertensive drugs. It consists of four items, each of which assesses how many times and why the recipient forgot to take immunosuppressive drugs to prevent transplant rejection in the last three months. In scoring, participants who fully adhered to immunosuppressive drug treatment in the last three months were given 3 points, those with a non-adherence rate of 1-20% were given 2 points, those with a non-adherence rate of 21-50% were given 1 point, and those with a non-adherence rate of more than 50% were given 0 points. A participant can score between 0 and 12 on the ITAS. A high ITAS score indicates a high level of adherence to treatment.
Mindful Attention
Time frame: It will take approximately 15 minutes
Mindful Attention Scale (MAAS) MAAS was created by Brown and Ryan and is used to measure the awareness levels of individuals. It is a six-point Likert-type scale consisting of 15 items and is evaluated based on a single total score. A high MAAS score indicates that the participant has a high level of awareness.
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 25 Feb 2026.
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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.
Şerafettin OKUTAN, PhD. principal investigator
Bitlis Eren University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Liver Transplant; Complications and Immunosuppression, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
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 5 inclusion and 2 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 25 Feb 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 Turkey (Türkiye). 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.
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?
Adherence to Immunosuppressive Therapy (time frame: It will take approximately 5 minutes). The study lists 2 primary outcomes in all. 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 25 Feb 2026.