An interventional study of Mindfulness-Based Psychoeducation in Depressive Disorder, Major, sponsored by University of Gaziantep. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by University of Gaziantep · Not applicable, Interventional, and Treatment
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?
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
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →University of Gaziantep is the lead sponsor of 100 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Mindfulness-Based Psychoeducation
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.
The Effect of Mindfulness-Based Psychoeducation on Depression Level of Depression Patients
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).
Time frame: 2 months
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
Time frame: 2 months
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 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.
Time frame: 2 months
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.
Time frame: 2 months
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Gaziantep