## Protocol Section
### Identification Module
**NCT ID:** NCT06417619

**Acronym:** Mindfulness

**Brief Title:** 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

#### Organization Study ID Info
**ID:** Depression Patients
#### Organization
**Class:** OTHER
**Full Name:** University of Gaziantep
### Status Module
#### Completion Date
**Date:** 2024-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-10-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-09
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Gaziantep

#### Responsible Party

**Investigator Affiliation:** University of Gaziantep

**Investigator Full Name:** Rabia Arpaci

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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

### Conditions Module

**Conditions:**

- Depressive Disorder, Major

**Keywords:**

- Depression

- Mindfulness

- Cognitive Defusion

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** This study is a randomized controlled experimental study (Interventional Study Model)

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Participant (Major depression patients)

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: Mindfulness-Based Psychoeducation

**Label:** Patients

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Label:** Depression Patients

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients

**Description:** The Effect of Mindfulness-Based Psychoeducation on Depression Level of Depression Patients

**Name:** Mindfulness-Based Psychoeducation

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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).

**Measure:** The Personal Information Data Form baseline and 2 months

**Time Frame:** 2 months

**Description:** 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

**Measure:** Beck Depression Inventory baseline and 2 months

**Time Frame:** 2 months

**Description:** 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.

**Measure:** Mindfulness Scale baseline and 2 months

**Time Frame:** 2 months

**Description:** 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.

**Measure:** Drexel Cognitive Defusion Scale baseline and 2 months

**Time Frame:** 2 months

### Eligibility Module

**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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** rabiaarpaci118@gmail.com

**Name:** Rabia ARPACI, Student

**Phone:** +90542 694 52 31

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Gaziantep

**Contacts:**

***Contact 1:***

- **Name:** Gaziantep University Gaziantep University, University

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Gaziantep University

**Status:** RECRUITING

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depressive Disorder

- ID: M7060

- Name: Depressive Disorder, Major

- Relevance: HIGH

- As Found: Depressive Disorder, Major

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003866

- Term: Depressive Disorder

- ID: D000003865

- Term: Depressive Disorder, Major

### Misc Info Module

- Version Holder: 2024-05-31
