Effect of Mindfulness-based Psychoeducation in Depression
The Effect Of Mındfulness-Based Psychoeducatıon On Symptom Severıty, Stress Tolerance, And Emotıon Regulatıon Dıffıculty İn Patıents Dıagnosed Wıth Depressıon
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Songül n KAPLAN
- Phone Number: +90 507 415 90 29
- Email: nndkpln@gmail.com
Study Locations
-
-
şehitkamil
-
Gaziantep, şehitkamil, Turkey (Türkiye), 34000
- Gaziantep Üniversitesi
-
Contact:
- Songül n KAPLAN
- Phone Number: +90 507 415 90 29
- Email: nndkpln@gmail.com
-
Principal Investigator:
- Songül n KAPLAN
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
No Intervention: control group
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.
|
|
|
Active Comparator: experimental group
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Depression Inventory (BDI)
Time Frame: 1.5 years
|
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 Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Distress Tolerance Scale (DTS):
Time Frame: 1.5 years
|
Distress Tolerance Scale (DTS): The Distress Tolerance Scale (DTS) is a self-report scale developed by Gather and Simons in 2005 to measure individuals' capacity to tolerate distress.
It consists of 15 questions providing a five-point Likert-type measurement.
Higher scores indicate a high capacity for tolerating distress.
The scale has three sub-dimensions: tolerance, regulation, and self-efficacy.
The Turkish adaptation of the scale was carried out by Sargın et al. in 2012.
The Cronbach's alpha reliability coefficient of the scale was found to be 0.89, and between 0.64-0.90
for the sub-dimensions.
|
1.5 years
|
|
Personal Information Form
Time Frame: 1.5 years
|
Prepared by the researcher, this personal information form consists of 12 questions aimed at determining gender, age, education level, marital status, living conditions, time to diagnosis, hospitalization history, suicidal thoughts or attempts, and medication use.
|
1.5 years
|
|
Difficulties in Emotion Regulation Scale (DDRS)
Time Frame: 1.5 years
|
Difficulties in Emotion Regulation Scale (DDRS): Developed by Gratz and Roemer (2004), this self-assessment scale aims to identify difficulties in emotion regulation.
Consisting of 36 items, this scale has six sub-dimensions: awareness, clarity, acceptance, strategy, drive, and goals.
It provides a five-point Likert-type measurement.
Higher scores indicate which dimension experiences more difficulty.
The Turkish adaptation and validity-reliability study were conducted by Rugancı and Gençöz in 2010.
The Cronbach's alpha reliability coefficient of the scale was calculated as 0.85, and for the sub-dimensions it ranged from 0.75 to 0.90.
Test-retest reliability was calculated as 0.83, and for the subscales it ranged from 0.60 to 0.85.
|
1.5 years
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- MINDFULNESSNK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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