Effect of Cognitive Therapy on Immunosuppressive Treatment Compliance and Motivation

February 24, 2026 updated by: Serafettin Okutan, Bitlis Eren University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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."
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
It will take approximately 5 minutes
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.
It will take approximately 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bitlis Eren University

Investigators

  • Principal Investigator: Şerafettin OKUTAN, PhD., Bitlis Eren University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2025

Primary Completion (Actual)

May 30, 2025

Study Completion (Actual)

August 30, 2025

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 14, 2025

First Posted (Actual)

March 17, 2025

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • okutan8

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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