Depression - Major Depressive DisorderNCT07484789
Effect of Mindfulness-based Psychoeducation in Depression
A study testing Mindfulness-based psychoeducation in people with Depression - Major Depressive Disorder and Mindfulness Based Stress Reduction, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression - Major Depressive Disorder, Mindfulness Based Stress Reduction, Psychiatric Nursing
- What is being tested?
- Mindfulness-based psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Gaziantep Üniversitesi
Gaziantep, şehitkamil, 34000
Songül n KAPLAN, +90 507 415 90 29, nndkpln@gmail.com
Songül n KAPLAN
About this study
Official title: The Effect Of Mındfulness-Based Psychoeducatıon On Symptom Severıty, Stress Tolerance, And Emotıon Regulatıon Dıffıculty İn Patıents Dıagnosed Wıth Depressıon
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.
Read the detailed description
Individuals with depression are emotionally pessimistic, unhappy, and hopeless. They experience inner turmoil and restlessness, and even activities they previously enjoyed no longer bring them pleasure. They also feel sad and lonely. Their interest in their surroundings decreases, and their negative emotions increase (Demir, 2015). Another factor associated with depression is distress tolerance, defined as the ability to withstand negative emotional states (Rette et al., 2021). It has been noted that individuals who have difficulty demonstrating distress tolerance show more depressive symptoms. Intolerance encompasses deficiencies in a person's ability to tolerate negative emotions (Çaylak, 2021). In depression, which negatively affects individuals' quality of life and functionality, and also leads to workforce and economic losses and suicide attempts, selecting the appropriate treatment and taking necessary measures to improve the individual's functionality in a short time, shorten hospital stays and reduce the number of hospitalizations are extremely important (Başoğul and Buldukoğlu, 2015; Çelik and Hocaoğlu, 2016; Lopez and Murray, 1998; Greenberg et al., 2021; Tamam et al., 2012). Pharmacological treatment alone is not sufficient to treat depression (Foroughi et al., 2020). In this context, clinical guidelines recommend the combined use of pharmacological and psychosocial interventions in the treatment of depression (Başoğul and Buldukoğlu, 2015). Psychosocial interventions include health education and interventions that focus on psychological or social factors rather than biological factors (Ruddy and House, 2005). Through psychosocial interventions, patients learn how to cope with their problems and their adherence to treatment increases (Foroughi et al., 2020). In today's world, where the search for new solutions for the treatment of depression continues, various psychosocial interventions are being applied. A review of national and international literature reveals research conducted with different study groups on the prevalence, causes, and treatment options of depression (Çalık and Altaş, 2011; Koruç and Bayar, 2004). All research indicates that difficulties in emotion regulation processes play a role in the emergence and persistence of depressive symptoms that impair cognitive, physical, and behavioral functioning in daily life. One of the situations that makes adaptation difficult by causing physical or mental distress and threats to the individual is stress (Baltaş and Baltaş, 2010). While some events can trigger a stress response, the stress response begins with a mental interpretation of the situation, leading to the decision that it is dangerous (Uçar, 2004). The ability to accept negative emotional situations, regulate emotions, and tolerate distress-which means constructing emotions to prevent or alleviate negative emotional states-is crucial for coping with difficulties and maintaining health. Individuals with low distress tolerance focus on negative emotions, stating that their emotions negatively affect their lives and that they are exhausted (Simons and Gaher, 2005). Theoretical studies examining emotion regulation mechanisms have indicated that the fundamental mechanism of mindful awareness is emotion regulation. A review of the literature reveals that the prevailing view is that there is a negative correlation between mindful awareness and difficulty in emotion regulation. Current studies indicate that as individuals' levels of mindful awareness increase, the difficulties they experience related to emotion regulation decrease (Çelik, 2020). The literature also supports the idea that mindful awareness is a fundamental mechanism (Akkuzu et al., 2023). A study conducted on university students demonstrated the effect of a mindful awareness-based cognitive therapy program on the levels of depressive symptoms in individuals. Although many descriptive, correlational, and experimental studies have been conducted on major depression, no study has been found that demonstrates the effect of mindfulness-based psychoeducation on emotion regulation difficulties, distress tolerance, and symptom severity in patients diagnosed with major depression. This study differs from previous studies in this respect. It is believed that the data obtained from this study can help provide scientific information on the effect of mindfulness-based psychoeducation on emotion regulation difficulties, distress tolerance, and symptom severity in depressed patients, provide data to healthcare professionals on managing the symptoms of patients diagnosed with major depressive disorder, and contribute to guiding future research in this area.
- Conditions
- Depression - Major Depressive Disorder, Mindfulness Based Stress Reduction, Psychiatric Nursing
- Being tested
- Mindfulness-based psychoeducation
- Keywords
- depression, mindfulness, psychiatric nursing
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based psychoeducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Mindfulness-based psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1.5 years
Secondary outcomes (3)
Distress Tolerance Scale (DTS):
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.
Measured: 1.5 years
Personal Information Form
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.
Measured: 1.5 years
Difficulties in Emotion Regulation Scale (DDRS)
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.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songül Nida Kaplan, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484789
- Sponsor's protocol ID
- MINDFULNESSNK
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be shared in order to protect patient privacy and avoid stigmatization.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Mındfulness-Based Psychoeducatıon On Symptom Severıty, Stress Tolerance, And Emotıon Regulatıon Dıffıculty İn Patıents Dıagnosed Wıth Depressıon
- ClinicalTrials.gov ID
- NCT07484789
- Acronym / sponsor ID
- MINDFULNESSNK
- Conditions
- Depression - Major Depressive Disorder, Mindfulness Based Stress Reduction, Psychiatric Nursing
- Keywords
- depression, mindfulness, psychiatric nursing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Individuals with depression are emotionally pessimistic, unhappy, and hopeless. They experience inner turmoil and restlessness, and even activities they previously enjoyed no longer bring them pleasure. They also feel sad and lonely. Their interest in their surroundings decreases, and their negative emotions increase (Demir, 2015). Another factor associated with depression is distress tolerance, defined as the ability to withstand negative emotional states (Rette et al., 2021). It has been noted that individuals who have difficulty demonstrating distress tolerance show more depressive symptoms. Intolerance encompasses deficiencies in a person's ability to tolerate negative emotions (Çaylak, 2021). In depression, which negatively affects individuals' quality of life and functionality, and also leads to workforce and economic losses and suicide attempts, selecting the appropriate treatment and taking necessary measures to improve the individual's functionality in a short time, shorten hospital stays and reduce the number of hospitalizations are extremely important (Başoğul and Buldukoğlu, 2015; Çelik and Hocaoğlu, 2016; Lopez and Murray, 1998; Greenberg et al., 2021; Tamam et al., 2012). Pharmacological treatment alone is not sufficient to treat depression (Foroughi et al., 2020). In this context, clinical guidelines recommend the combined use of pharmacological and psychosocial interventions in the treatment of depression (Başoğul and Buldukoğlu, 2015). Psychosocial interventions include health education and interventions that focus on psychological or social factors rather than biological factors (Ruddy and House, 2005). Through psychosocial interventions, patients learn how to cope with their problems and their adherence to treatment increases (Foroughi et al., 2020). In today's world, where the search for new solutions for the treatment of depression continues, various psychosocial interventions are being applied. A review of national and international literature reveals research conducted with different study groups on the prevalence, causes, and treatment options of depression (Çalık and Altaş, 2011; Koruç and Bayar, 2004). All research indicates that difficulties in emotion regulation processes play a role in the emergence and persistence of depressive symptoms that impair cognitive, physical, and behavioral functioning in daily life. One of the situations that makes adaptation difficult by causing physical or mental distress and threats to the individual is stress (Baltaş and Baltaş, 2010). While some events can trigger a stress response, the stress response begins with a mental interpretation of the situation, leading to the decision that it is dangerous (Uçar, 2004). The ability to accept negative emotional situations, regulate emotions, and tolerate distress-which means constructing emotions to prevent or alleviate negative emotional states-is crucial for coping with difficulties and maintaining health. Individuals with low distress tolerance focus on negative emotions, stating that their emotions negatively affect their lives and that they are exhausted (Simons and Gaher, 2005). Theoretical studies examining emotion regulation mechanisms have indicated that the fundamental mechanism of mindful awareness is emotion regulation. A review of the literature reveals that the prevailing view is that there is a negative correlation between mindful awareness and difficulty in emotion regulation. Current studies indicate that as individuals' levels of mindful awareness increase, the difficulties they experience related to emotion regulation decrease (Çelik, 2020). The literature also supports the idea that mindful awareness is a fundamental mechanism (Akkuzu et al., 2023). A study conducted on university students demonstrated the effect of a mindful awareness-based cognitive therapy program on the levels of depressive symptoms in individuals. Although many descriptive, correlational, and experimental studies have been conducted on major depression, no study has been found that demonstrates the effect of mindfulness-based psychoeducation on emotion regulation difficulties, distress tolerance, and symptom severity in patients diagnosed with major depression. This study differs from previous studies in this respect. It is believed that the data obtained from this study can help provide scientific information on the effect of mindfulness-based psychoeducation on emotion regulation difficulties, distress tolerance, and symptom severity in depressed patients, provide data to healthcare professionals on managing the symptoms of patients diagnosed with major depressive disorder, and contribute to guiding future research in this area.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Mindfulness-based psychoeducationPre-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based psychoeducationThe 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. | Other | experimental group |
Primary outcome
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.
3 secondary outcomes
Distress Tolerance Scale (DTS):
Time frame: 1.5 years
Personal Information Form
Time frame: 1.5 years
Difficulties in Emotion Regulation Scale (DDRS)
Time frame: 1.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No. Individual patient data will not be shared in order to protect patient privacy and avoid stigmatization.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based psychoeducation in people with Depression - Major Depressive Disorder and Mindfulness Based Stress Reduction, run by University of Gaziantep at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Songül N Kaplan (+90 507 415 90 29, nndkpln@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory (BDI) (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.