Effect of Cognitive Therapy on Immunosuppressive Treatment Compliance and Motivation

NCT06879106 | Completed DMC

• 1 other identifier: okutan8
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunosuppression; Compliance, Treatment; Liver Transplant; Complications

Keywords

Mindfulness-Based Cognitive Therapy (MBCT); liver transplantation; immunosuppressive therapy; compliance; motivation level

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  It will take approximately 15 minutes

Study Arms (2)

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.

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.

Interventions

Intervention group 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."

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Having any hearing or mental problems
• Wanting to leave the study

Sponsors & Collaborators

• Bitlis Eren University: lead

Study Sites (1)

Bitlis Eren University

Bitlis, 13100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Şerafettin OKUTAN, PhD.

  Bitlis Eren University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University

Model Details: It will be conducted as a randomized controlled experimental study in a pretestpost- test control group experimental model.

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: February 15, 2025
• Primary Completion: May 30, 2025
• Study Completion: August 30, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

TU (1)