Clinical trial NCT06879106: Effect of Cognitive Therapy on Immunosuppressive Treatment Compliance and Motivation
Official title: Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Transplant; Complications
Immunosuppression
Compliance, Treatment
Keywords: Mindfulness-Based Cognitive Therapy (MBCT)
liver transplantation
immunosuppressive therapy
compliance
motivation level
Lead sponsor: Bitlis Eren University
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: It will be conducted as a randomized controlled experimental study in a pretestpost- test control group experimental model.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to Immunosuppressive Therapy
timeFrame: It will take approximately 5 minutes
measure: Mindful Attention
timeFrame: It will take approximately 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bitlis
country: Turkey
facility: Bitlis Eren University
Study officials:
affiliation: Bitlis Eren University
name: Şerafettin OKUTAN, PhD.
role: PRINCIPAL_INVESTIGATOR
References: