The Effect of Mindfulness-Based Psychoeducation

NCT ID: NCT06417619

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-12-30

Brief Summary

This study is a randomized controlled experimental study conducted to determine the effect of mindfulness-based psychoeducation on levels of mindfulness, cognitive defusion, and depression in patients with depression. The sample of the study will consist of 60 patients (30 experimental, 30 control) diagnosed with major depression, recruited from a state hospital. Mindfulness-based psychoeducation will be applied to the experimental group once a week for a total of 8 weeks in the form of group sessions. No intervention other than routine treatment will be applied to the control group.

The primary questions that the study aims to answer are as follows:

Does mindfulness-based psychoeducation increase levels of mindfulness and cognitive defusion in depression patients? Does mindfulness-based psychoeducation decrease levels of depression in depression patients?

Detailed Description

In this research, the sample size calculation was performed using the G Power program by conducting a priori power analysis. Previous studies were reviewed and using the Beck Depression Inventory, expected confidence intervals were determined. With a confidence interval of α=0.05 and a test power (1-β) of 0.95, with an effect size of d=0.9632193, a total of 60 patients were calculated, with 30 patients in the experimental group and 30 patients in the control group. Participants included in the study will be assigned to experimental or control groups using block randomization.

Inclusion Criteria for Participation in the study:

Individuals who are literate.Individuals are willing to participate in the study voluntarily.

Individuals without any communication barriers. Individuals aged between 18 and 65 years. Outpatients being followed up with a diagnosis of major depressive disorder according to DSM-5 criteria. Individuals who have not participated in a mindfulness-based psychoeducation program for their illness in the last 5 years.

Exclusion Criteria for Participation in the study:

Individuals diagnosed with comorbid psychiatric disorders. Patients with intellectual impairment (e.g., intellectual disability) or cognitive conditions that make collaboration impossible, such as dementia.

Patients with psychotic symptoms in addition to the depressive picture. Illiterate individuals. Individuals who do not consent to an interview. Individuals receiving inpatient treatment

Conditions

Depressive Disorder, Major

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Patients

Mindfulness-based psychoeducation will be implemented in the experimental group in the form of group sessions once a week for a total of 8 weeks. Post-tests will be administered immediately after the completion of psychoeducation sessions for the experimental group, and a follow-up test will be conducted 3 months after the post-test.

Group Type: EXPERIMENTAL

Mindfulness-Based Psychoeducation

Intervention Type: BEHAVIORAL

The Effect of Mindfulness-Based Psychoeducation on Depression Level of Depression Patients

Depression Patients

No intervention will be applied to the control group other than routine treatment. For the control group, no intervention will be made, and post-tests will be administered 8 weeks after the pre-test, followed by a follow-up test 3 months after the post-test.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness-Based Psychoeducation

The Effect of Mindfulness-Based Psychoeducation on Depression Level of Depression Patients

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Those who are literate.
• Those willing to participate in the study voluntarily.
• Those without any communication barriers.
• Those aged between 18 and 65 years.
• Outpatients being followed up with a diagnosis of major depressive disorder according to DSM-5 criteria.
• Those who have not participated in a mindfulness-based psychoeducation program for their illness in the last 5 years.

Exclusion Criteria

• Those diagnosed with another comorbid mental illness
• Patients with mental conditions that make cooperation impossible, such as intellectual impairment (mental retardation) or dementia
• Patients with psychotic symptoms in addition to depression illiterate people
• Patients who do not consent to the interview
• Those receiving inpatient treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Gaziantep

OTHER

Sponsor Role: lead

Responsible Party

Rabia Arpaci

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gaziantep University

Gaziantep, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Rabia ARPACI, Student

Role: CONTACT

rabiaarpaci118@gmail.com

+90542 694 52 31

Facility Contacts

Gaziantep University Gaziantep University, University

Role: primary

Other Identifiers

Depression Patients

Identifier Type: -

Identifier Source: org_study_id