- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06417619
The Effect of Mindfulness-Based Psychoeducation (Mindfulness)
The Effect of Mindfulness-Based Psychoeducation on the Mindfulness, Cognitive Defusion and Depression Level of Depression Patients
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?
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rabia ARPACI, Student
- Phone Number: +90542 694 52 31
- Email: rabiaarpaci118@gmail.com
Study Locations
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Gaziantep, Turkey
- Recruiting
- Gaziantep University
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Contact:
- Gaziantep University Gaziantep University, University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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The Effect of Mindfulness-Based Psychoeducation on Depression Level of Depression Patients
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No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Personal Information Data Form baseline and 2 months
Time Frame: 2 months
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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).
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2 months
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Beck Depression Inventory baseline and 2 months
Time Frame: 2 months
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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
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2 months
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Mindfulness Scale baseline and 2 months
Time Frame: 2 months
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The Mindfulness Scale was developed by Brown and Ryan (2003) (Brown & Ryan, 2003).
The Turkish validity and reliability of the scale were conducted by Özyeşil 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.
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2 months
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Drexel Cognitive Defusion Scale baseline and 2 months
Time Frame: 2 months
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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.
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2 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Depression Patients
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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