The Effect of Mindfulness-Based Psychoeducation

Depressive Disorder, Major Clinical Trial

— Mindfulness  

Official title:

The Effect of Mindfulness-Based Psychoeducation on the Mindfulness, Cognitive Defusion and Depression Level of Depression Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06417619
• Other study ID #: Depression Patients
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: University of Gaziantep
• Contact: Rabia ARPACI, Student
• Phone: +90542 694 52 31
• Email: rabiaarpaci118[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major

Intervention

Behavioral:
• Mindfulness-Based Psychoeducation
The Effect of Mindfulness-Based Psychoeducation on Depression Level of Depression Patients

Locations

Country	Name	City	State
Turkey	Gaziantep University	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
University of Gaziantep

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Personal Information Data Form baseline and 2 months	The Personal Information Data Form prepared by the researcher will consist of a total of 10 questions (gender, age, education level, marital status, employment status, income level, cohabitation status, history of hospitalization, history of suicide attempt, medication use, and adherence to treatment).	2 months
Primary	Beck Depression Inventory baseline and 2 months	The Beck Depression Inventory, developed by Beck et al. (1961), is designed to measure the risk of depression, level of depressive symptoms, and changes in severity in adults (Beck et al., 1961). The Turkish adaptation of the Beck Depression Inventory was conducted by Hisli (1988). The Beck Depression Scale consists of 21 items, each with four options. Each item scores from 0 to 3. Depression score is obtained by summing these scores. The highest possible score is 63, and a higher total score indicates greater severity of depression. A depression score of 17 or higher indicates depression above normal levels	2 months
Primary	Mindfulness Scale baseline and 2 months	The Mindfulness Scale was developed by Brown and Ryan (2003) (Brown & Ryan, 2003). The Turkish validity and reliability of the scale were conducted by Özyesil et al. (2011). The scale was designed to measure the overall level of awareness of skills in daily life and attentiveness to them. The scale consists of 15 items, rated on a six-point Likert scale.The scale is also unifactorial, yielding a single score. The lowest possible score on the scale is 15, and the highest is 90. An increase in the score indicates a higher level of mindfulness awareness in individuals.	2 months
Primary	Drexel Cognitive Defusion Scale baseline and 2 months	Drexel Cognitive Defusion Scale: The Drexel Cognitive Defusion Scale was developed by Forman et al. (2012) to measure the ability to distance oneself from emotions and thoughts (Forman et al., 2012). The scale consists of 10 items rated on a 6-point Likert scale (0: None; 1: A little, 2: To some extent, 3: Moderate level, 4: Quite a lot, 5: A lot). It is possible to calculate a total score from the scale, where higher scores indicate a higher ability to distance oneself from internal emotions and thoughts.	2 months