Effect of Mindfulness-based Psychoeducation in Depression

NCT07484789 | Not Yet Recruiting

• 1 other identifier: MINDFULNESSNK
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Major depression is a mental illness that seriously threatens public health, leading to disability, reduced quality of life, economic burden, and premature death. It is estimated that 18.4% of the world's population lived with depression between 2005 and 2015, and it is projected to be a leading cause of global disease burden by 2030. Major depressive disorder manifests with symptoms such as decreased interest and desire, a depressed mood, increased or decreased sleep and appetite, feelings of worthlessness and guilt, decreased energy, suicidal thoughts and attempts, leading to significant impairment in functioning. Choosing the appropriate treatment for depression and taking measures to improve the individual's functionality quickly, shorten hospital stays, and reduce the number of hospitalizations are crucial. In addition to pharmacological treatment, clinical guidelines recommend the combined use of pharmacological and psychosocial interventions in the treatment of depression. The mindfulness-based cognitive therapy, which forms the basis of the psychoeducation planned for this study, was developed as an 8-week group approach. Theoretical studies examining emotion regulation mechanisms have indicated that mindful awareness is a fundamental mechanism for emotion regulation. The literature suggests a negative correlation between mindful awareness and the severity of depressive symptoms and difficulty in emotion regulation. Furthermore, despite numerous descriptive, correlational, and experimental studies on major depression, no studies have been found demonstrating the effect of mindful awareness-based psychoeducation on emotion regulation difficulties, distress tolerance, and symptom severity in patients diagnosed with major depression. This study, therefore, differs from existing research and will make a significant contribution to the literature.

Conditions

Depression - Major Depressive Disorder; Mindfulness Based Stress Reduction; Psychiatric Nursing

Keywords

depression; mindfulness; psychiatric nursing

Outcome Measures

Primary Outcomes (1)

• Beck Depression Inventory (BDI)

  Beck Depression Inventory (BDI): Developed by Beck in 1961, the Beck Depression Inventory is designed to measure the risk of depression, the level of depressive symptoms, and variations in severity in adults. Consisting of 21 items, each item in the BDI has four options. Each item is scored between 0 and 3. The sum of these scores yields a depression score. The highest possible score is 63, and a higher total score indicates a higher severity of depression. In the Turkish adaptation of the BDI by Hisli (1988, 1989), the Cronbach α reliability coefficient was determined as α=0.80 in the validity and reliability study.

  1.5 years

Secondary Outcomes (3)

• Distress Tolerance Scale (DTS):

  1.5 years

• Personal Information Form

  1.5 years

• Difficulties in Emotion Regulation Scale (DDRS)

  1.5 years

Study Arms (2)

control group

NO INTERVENTION

The control group will be administered the pre-test scales. Participants will not receive any intervention. Then, the same scales will be administered as a post-test, and a follow-up test using the same scales will be conducted two months later.

experimental group

ACTIVE COMPARATOR

Pre-test scales will be administered to participants in the experimental group. Participants will receive mindfulness-based psychoeducation. Then, post-test scales consisting of the same scales will be administered, and a follow-up test consisting of the same scales will be conducted 2 months later.

Other: Mindfulness-based psychoeducation

Interventions

Mindfulness-based psychoeducation OTHER

The experimental group will receive an 8-session mindfulness-based psychoeducation program, administered twice a week for four weeks. Each session of the eight-week program will be 45-60 minutes long. Sessions will be conducted in groups. Following an initial face-to-face meeting to inform the experimental group about the program and schedule meetings, the sessions will continue in person. Each group will consist of 7 people, with a total of 5 groups. Patients will be contacted by phone before each session to remind them of the program time. Immediately after the program sessions are completed, the experimental group will take a post-test. Additionally, follow-up tests will be administered two months after the program is completed. The control group will receive a pre-test followed by no intervention; a post-test will be administered two months later, and follow-up tests two months after the post-test.

experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteering to participate in the study
• Residing in Gaziantep city center
• Not having any communication impediments
• Being between 18 and 65 years of age
• Being followed up as an outpatient with a diagnosis of depression according to DSM-V criteria
• Having been receiving treatment for depression for at least 6 months
• Being literate
• Not having been enrolled in such an educational program related to their illness within the last 5 years

You may not qualify if:

• Those diagnosed with another comorbid mental illness
• Patients with mental conditions that make cooperation impossible, such as intellectual disability or dementia
• Those who are illiterate
• Patients who do not consent to the interview
• Those receiving inpatient treatment

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

Gaziantep Üniversitesi

Gaziantep, şehitkamil, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Songül N Kaplan

CONTACT

+90 507 415 90 29; nndkpln@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants in the experimental group will receive mindfulness-based psychoeducation, and the results will be evaluated by the researcher.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist nurse

Model Details: Two groups of patients diagnosed with depressive disorder: an experimental group where mindfulness-based psychoeducation will be applied, and a control group where no intervention will be performed.

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)