Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417619
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-09
Brief Title:
The Effect of Mindfulness-Based Psychoeducation
Sponsor:
University of Gaziantep
Organization:
University of Gaziantep
Study Overview
Official Title:
The Effect of Mindfulness-Based Psychoeducation on the Mindfulness Cognitive Defusion and Depression Level of Depression Patients
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mindfulness
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
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 α005 and a test power 1-β of 095 with an effect size of d09632193 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 literateIndividuals 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 eg 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
Inclusion Criteria for Participation in the study
Individuals who are literateIndividuals 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None