Effect of Cognitive Therapy on Immunosuppressive Treatment Compliance and Motivation

NCT ID: NCT06879106

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-15

Study Completion Date

2025-08-30

Brief Summary

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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

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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.

Conditions

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Liver Transplant; Complications Immunosuppression Compliance, Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

It will be conducted as a randomized controlled experimental study in a pretestpost- test control group experimental model.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention 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 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.

Group Type EXPERIMENTAL

Intervention group

Intervention Type OTHER

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."

control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intervention group

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."

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Having any hearing or mental problems
* Wanting to leave the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bitlis Eren University

OTHER

Sponsor Role lead

Responsible Party

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Serafettin Okutan

Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Şerafettin OKUTAN, PhD.

Role: PRINCIPAL_INVESTIGATOR

Bitlis Eren University

Locations

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Bitlis Eren University

Bitlis, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Şerafettin OKUTAN, PhD.

Role: CONTACT

+90 (434) 222 01 01 ext. 8325

Facility Contacts

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Şerafettin OKUTAN, Dr.

Role: primary

+90 (434) 222 01 01 ext. 8325

Other Identifiers

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okutan8

Identifier Type: -

Identifier Source: org_study_id

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