Clinical trial NCT06417619: The Effect of Mindfulness-Based Psychoeducation
Official title: The Effect of Mindfulness-Based Psychoeducation on the Mindfulness, Cognitive Defusion and Depression Level of Depression Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Disorder, Major
Keywords: Depression
Mindfulness
Cognitive Defusion
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized controlled experimental study (Interventional Study Model)
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: The Personal Information Data Form baseline and 2 months
timeFrame: 2 months
measure: Beck Depression Inventory baseline and 2 months
timeFrame: 2 months
measure: Mindfulness Scale baseline and 2 months
timeFrame: 2 months
measure: Drexel Cognitive Defusion Scale baseline and 2 months
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep University
Study officials:
References: