Mental Health Wellness 1NCT06706505
Mindfulness-Based Art Therapy for Nurses: Difficulties in Emotion Regulation, Burnout, and Psychological Flexibility
A study testing Mindfulness-based art therapy in people with Mental Health Wellness 1 and Burnout, Professional, run by Mehtap Ağaç at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effects of mindfulness-based art therapy on the difficulties in emotional regulation, burnout, and psychological resilience levels of nurses working in the earthquake-affected region. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1, Burnout, Professional
- What is being tested?
- Mindfulness-based art therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 5 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To have provided active care for individuals affected by the earthquake for at least three months
- To voluntarily agree to participate in the study.
Who cannot join
- To have received or be currently receiving training or individual/group therapy in art therapy or mindfulness.
- To have a condition that would prevent them from actively participating in the sessions, comprehending the scales, and completing them.
- To fail to attend two consecutive study sessions for any reason
- To voluntarily withdraw from the study at any time
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University
Kahramanmaraş, Onikişubat, 46000
About this study
Official title: The Effect of Mindfulness Based Art Therapy Applied to Nurses Working in a University Hospital in the Earthquake Zone on Difficulties in Emotion Regulation, Burnout and Psychological Flexibility
The aim of this study is to examine the effects of mindfulness-based art therapy on the difficulties in emotional regulation, burnout, and psychological resilience levels of nurses working in the earthquake-affected region. The main questions it aims to answer are:
Does MBAT reduce the burnout levels of nurses working in the earthquake-affected region? Does MBAT reduce the emotional regulation difficulties of nurses working in the earthquake-affected region? Does MBAT increase the psychological resilience levels of nurses working in the earthquake-affected region? Researchers plan to compare the intervention group where MBAT is applied and the control group where no intervention is applied to see the effects of MBAT on nurses.
Read more
Participants :
The intervention group will receive MBAT once a week for 5 weeks. The control group will receive MBAT again after the application is completed, if they are willing.
Follow-up tests will be administered before the intervention, after it is completed, and at the 3rd and 6th months."**
Read the detailed description
The nursing profession, by its very nature, involves direct interaction with individuals, creating a highly emotionally charged work environment. This necessitates nurses to understand and manage their emotional states. Emotion regulation is a process that determines when, how, and to what extent individuals experience and express their emotions. Disruptions in this process can lead to difficulties in emotion regulation, anxiety, and depression.
Nurses constantly encounter patients experiencing pain, loss, and difficulties. This can lead to emotional burnout and decreased job satisfaction among nurses. Studies have shown that difficulties in emotion regulation and low psychological flexibility contribute to burnout, depersonalization, and emotional exhaustion in nurses. On the other hand, emotion regulation training and the development of psychological flexibility skills can effectively reduce occupational stress for nurses.
Psychological flexibility is defined as the ability to cope with challenges, adapt to changing circumstances, and accept negative emotional experiences. Psychological flexibility enables individuals to better adapt to life's difficulties and improve their overall well-being. For individuals working under constant stress, such as nurses, psychological flexibility is crucial for job satisfaction, quality of life, and overall health.
Mindfulness-Based Art Therapy (MBAT) is a therapeutic approach aimed at developing emotional awareness, acceptance, mental focus, and emotional regulation skills. Combining art therapy and mindfulness techniques, MBAT can help nurses cope with emotional challenges, reduce stress levels, enhance psychological flexibility, and improve overall well-being.
Nurses' emotional regulation and psychological flexibility skills are crucial for both their own psychological well-being and the quality of care they provide. Difficulties in emotion regulation and low psychological flexibility can lead to burnout and other negative consequences. Therapeutic approaches such as Mindfulness-Based Art Therapy (MBAT) offer promising solutions to support nurses' emotional health and create more sustainable professional lives.
Study Design: This study is a randomized controlled trial with a pre-test, post-test, and follow-up design. It aims to determine the effects of mindfulness-based art therapy on nurses' difficulties in emotion regulation, burnout, and psychological flexibility.
Study Setting and Characteristics: The study will be conducted at Kahramanmaraş Sütçü İmam University Health Practices and Research Hospital, located in Kahramanmaraş, Turkey. This center provides services in various departments, including internal medicine, surgery, oncology, and psychiatry, with separate units for children and adults. Nurses at this center primarily work in inpatient units, intensive care units, operating rooms, and emergency departments. Their work schedules include both day shifts and rotating shifts.
Population and Sample: The study population consists of all nurses working at Kahramanmaraş Sütçü İmam University Health Practices and Research Hospital. Based on information obtained from the institution, the total number of nurses is 500. The sample will include nurses who meet the inclusion criteria. To determine the sample size, the G*Power program was used. The effect size was calculated based on a similar study in the literature. With an alpha level of 0.05, a power of 0.95, and an effect size of 1.109189, the total sample size was calculated to be 38 (19 in the intervention group and 19 in the control group). Considering a potential dropout rate of 10-20% as reported in previous studies, the sample size was increased by 20%, resulting in a final sample size of 23 nurses in each group.
Pilot Study: Prior to the main study, a pilot study was conducted to evaluate the feasibility of a structured mindfulness-based art therapy intervention. A group of eight volunteer nurses from the outpatient clinics and polyclinics of Kahramanmaraş Sütçü İmam University Health Practices and Research Hospital participated in this pilot intervention.
Study Implementation: The main study will be conducted at Kahramanmaraş Sütçü İmam University Health Practices and Research Hospital following the pilot study. Before the intervention, both the intervention and control groups will be administered the Participant Information Form once, and the Difficulty in Emotion Regulation Scale (Short Form), the Maslach Burnout Inventory, and the Psychological Flexibility Scale three times (pre-test: one week before the MBAT, post-test: one week after the MBAT, follow-up: 3 and 6 months after the MBAT). Following the pre-test, a 5-session MBAT will be initiated for the intervention group. Considering the effectiveness of the intervention and the characteristics of psychological counseling groups, the intervention group will be divided into subgroups. Each subgroup will receive the intervention on different days or times within the same week. After the intervention period and post-test, the MBAT will be applied to the control group.
Data Analysis: Data collected from the study will be analyzed using International Business Machines (IBM) Statistical Package for the Social Sciences (SPSS) V23. To assess normality, the Shapiro-Wilk test will be used. For normally distributed data, independent samples t-test and paired samples t-test will be employed. For non-normally distributed data, the Mann-Whitney U test and the Wilcoxon signed-rank test will be used. The relationship between variables will be examined using Spearman correlation analysis. Data will be presented as mean and standard deviation for normally distributed data and median and range for non-normally distributed data. Categorical data will be analyzed using the chi-square test and presented as frequencies and percentages.
Ethical Considerations: Ethical approval has been obtained from the Ethics Committee of Gazi University (dated 16.04.2024, number 07) and the relevant departments of Kahramanmaraş Sütçü İmam University Health Practices and Research Hospital. Permission to use the data collection tools was obtained via email from the authors who conducted the validity and reliability studies. Before the study began, participants were provided with detailed information about the study's purpose, procedures, and expected outcomes. Written informed consent was obtained from each participant in the pre-test, intervention, and control groups. The researcher conducting the study possesses the necessary qualifications and certifications to implement the intervention.
- Conditions
- Mental Health Wellness 1, Burnout, Professional
- Being tested
- Mindfulness-based art therapy
- Keywords
- art therapy, mindfulness, emotional regulation, burnout, psychological flexibility, nurses
- Medical subject headings
- Burnout, Professional, Emotional Regulation, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based art therapyBehavioural
MBAT combines art therapy and mindfulness to promote self-awareness and emotional well-being. It uses art to express thoughts and feelings, while cultivating mindfulness skills. MBAT addresses stress, anxiety, and emotional regulation. Grounded in research, it's an effective therapeutic approach.
The mindfulness-based art therapy sessions were designed based on the literature, drawing on the researches. By integrating art therapy techniques and mindfulness practices, the sessions were developed. Expert opinions were sought from specialists in the field to ensure the content validity of the sessions, and necessary adjustments were made accordingly. The MBAT application consists of five sessions in total. Each session has a specific theme and is designed to last 90-120 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness based art therapy | Experimental | Prior to the MBAT intervention, data collection forms were administered and randomization was performed. Following the pre-test, participants in this group will attend weekly MBAT sessions for five weeks. Post-intervention, data collection forms will be administered again. Subsequent follow-up assessments will be conducted at 3 and 6 months. Receives: Behavioral: Mindfulness-based art therapy |
| Therapy waiting list | No intervention | Following the pre-test and randomization, the control group will receive follow-up assessments concurrently with the intervention group at predetermined intervals (post-intervention, 3 months, and 6 months). Upon completion of the research, the participants assigned to the control group will undergo the MBAT intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)
The Difficulties in Emotion Regulation Scale (DERS) was developed by Gratz and Roemer (2004) to assess emotional regulation difficulties. A shorter version was created by Bjureberg et al. (2016) and adapted into Turkish by Yiğit and Güzey Yiğit (2019). The DERS-Short Form consists of 16 items and measures five factors: acceptance, clarity, goals, strategies, and impulsivity. The acceptance subscale measures rejection of emotional responses; clarity assesses understanding emotions; goals evaluates focus on goal-directed behavior during emotional experiences; strategies measures access to emotion regulation strategies; and impulsivity evaluates control over impulses when experiencing negative emotions. Higher scores indicate greater difficulties. The scale's internal consistency (Cronbach's alpha) is 0.92, with subscale consistency ranging from 0.78 to 0.87.
Measured: 7 months
Maslach Burnout Inventory (MBI)
The Maslach Burnout Inventory (MBI), developed by Maslach and Jackson in 1981 to measure burnout, was adapted into Turkish by Ergin in 1992. The scale consists of 22 items and utilizes a 5-point Likert scale (0: Never, 1: Very rarely, 2: Sometimes, 3: Often, 4: Always). The MBI assesses three dimensions of burnout: emotional exhaustion (items 1, 2, 3, 6, 8, 13, 14, 16, 20), depersonalization (items 5, 10, 11, 15, 22), and personal accomplishment (items 4, 7, 9, 12, 17, 18, 19, and 21). Items in the personal accomplishment subscale are reverse-coded. Higher scores on emotional exhaustion and depersonalization, and lower scores on personal accomplishment, reflect greater burnout. The Turkish version's Cronbach's alpha coefficients were 0.83 for emotional exhaustion, 0.65 for depersonalization, 0.72 for personal accomplishment, and 0.93 overall (Ergin, 1992).
Measured: 7 months
The Psychological Flexibility Scale
The original Psychological Flexibility Scale was developed by Francis, Dawson, and Golijani Moghaddam (2016). A Turkish adaptation, consisting of 37 items, was created by Karakuş and Akbay (2020) to assess psychological flexibility in adults. The original scale contained 23 items, while the Turkish version includes 28 items across five subscales: "values and behaviors aligned with values" (items 1, 7, 9, 13, 16, 19, 21, 26, 27, 28), "being in the present moment" (8, 14, 18, 20, 22, 23, 25), "acceptance" (2, 3, 5, 6, 24), "contextual self" (4, 10, 12), and "defusion" (11, 15, 17). Items 2, 3, 5, 6, 8, 18, 20, 22, 23, 24, and 25 are reverse-scored. The scale's total score ranges from 28 to 196, with higher scores indicating greater psychological flexibility. The internal consistency reliability coefficient was 0.79.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Dec 2024
- Primary completion5 Dec 2024
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies 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
- pre-test post-test follow-up and control group experimental study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehtap Ağaç
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehtap Ağaç, Kahramanmaras Sutcu Imam University
- Investigators
- Mehtap Ağaç, PhD, Principal investigator, Kahramanmaras Sutcu Imam UniversitySultan Ayaz Alkaya, Professor, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706505
- Sponsor's protocol ID
- GAZI-HEM-MA-01
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2024
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing is not desired
Publications
Bjureberg J, Ljotsson B, Tull MT, Hedman E, Sahlin H, Lundh LG, Bjarehed J, DiLillo D, Messman-Moore T, Gumpert CH, Gratz KL. Development and Validation of a Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16. J Psychopathol Behav Assess. 2016 Jun;38(2):284-296. doi: 10.1007/s10862-015-9514-x. Epub 2015 Sep 14.
PubMed 27239096Ergin C. Doktor ve hemsirelerde tukenmislik ve Maslach tukenmislik olceginin uyarlanmasi. VII. Ulusal Psikoloji Kongresi, 22th September 1992. Ankara (Turkey).
Maslach C, Jackson SE. Maslach Burnout Inventory--ES Form (MBI). 1981. https://doi.org/10.1037/t05190-000
Francis AW, Dawson DL, & Golijani-Moghaddam N. The development and validation of the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT). Journal of Contextual Behavioral Science. 2016: 5(3): 134-145. https://doi.org/10.1016/j.jcbs.2016.05.003
Karakuş S, Akbay SE. Psychological Flexibility Scale: Adaptation, Validity and Reliability Study. Mersin University Journal of the Faculty of Education. 2020: 16(1): 32-43. https://doi.org/10.17860/mersinefd.665406
Yiğit İ, Guzey Yiğit, M. Psychometric Properties of Turkish Version of Difficulties in Emotion Regulation Scale-Brief Form (DERS-16). Current Psychology. 2019: 38: 1503-1511. https://doi.org/10.1007/s12144-017-9712-7.
Gratz, KL, Roemer, L. Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology and Behavioral Assessment. 2004: 26: 41-54. https://doi.org/10.1023/B:JOBA.0000007455.08539.94
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Based Art Therapy Applied to Nurses Working in a University Hospital in the Earthquake Zone on Difficulties in Emotion Regulation, Burnout and Psychological Flexibility
- ClinicalTrials.gov ID
- NCT06706505
- Acronym / sponsor ID
- GAZI-HEM-MA-01
- Conditions
- Mental Health Wellness 1, Burnout, Professional
- Keywords
- art therapy, mindfulness, emotional regulation, burnout, psychological flexibility, nurses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Mehtap AğaçUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 26 Nov 2024 (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.
The aim of this study is to examine the effects of mindfulness-based art therapy on the difficulties in emotional regulation, burnout, and psychological resilience levels of nurses working in the earthquake-affected region. The main questions it aims to answer are:
Does MBAT reduce the burnout levels of nurses working in the earthquake-affected region? Does MBAT reduce the emotional regulation difficulties of nurses working in the earthquake-affected region? Does MBAT increase the psychological resilience levels of nurses working in the earthquake-affected region? Researchers plan to compare the intervention group where MBAT is applied and the control group where no intervention is applied to see the effects of MBAT on nurses.
Participants :
The intervention group will receive MBAT once a week for 5 weeks. The control group will receive MBAT again after the application is completed, if they are willing.
Follow-up tests will be administered before the intervention, after it is completed, and at the 3rd and 6th months."**
Detailed description
The nursing profession, by its very nature, involves direct interaction with individuals, creating a highly emotionally charged work environment. This necessitates nurses to understand and manage their emotional states. Emotion regulation is a process that determines when, how, and to what extent individuals experience and express their emotions. Disruptions in this process can lead to difficulties in emotion regulation, anxiety, and depression.
Nurses constantly encounter patients experiencing pain, loss, and difficulties. This can lead to emotional burnout and decreased job satisfaction among nurses. Studies have shown that difficulties in emotion regulation and low psychological flexibility contribute to burnout, depersonalization, and emotional exhaustion in nurses. On the other hand, emotion regulation training and the development of psychological flexibility skills can effectively reduce occupational stress for nurses.
Psychological flexibility is defined as the ability to cope with challenges, adapt to changing circumstances, and accept negative emotional experiences. Psychological flexibility enables individuals to better adapt to life's difficulties and improve their overall well-being. For individuals working under constant stress, such as nurses, psychological flexibility is crucial for job satisfaction, quality of life, and overall health.
Mindfulness-Based Art Therapy (MBAT) is a therapeutic approach aimed at developing emotional awareness, acceptance, mental focus, and emotional regulation skills. Combining art therapy and mindfulness techniques, MBAT can help nurses cope with emotional challenges, reduce stress levels, enhance psychological flexibility, and improve overall well-being.
Nurses' emotional regulation and psychological flexibility skills are crucial for both their own psychological well-being and the quality of care they provide. Difficulties in emotion regulation and low psychological flexibility can lead to burnout and other negative consequences. Therapeutic approaches such as Mindfulness-Based Art Therapy (MBAT) offer promising solutions to support nurses' emotional health and create more sustainable professional lives.
Study Design: This study is a randomized controlled trial with a pre-test, post-test, and follow-up design. It aims to determine the effects of mindfulness-based art therapy on nurses' difficulties in emotion regulation, burnout, and psychological flexibility.
Study Setting and Characteristics: The study will be conducted at Kahramanmaraş Sütçü İmam University Health Practices and Research Hospital, located in Kahramanmaraş, Turkey. This center provides services in various departments, including internal medicine, surgery, oncology, and psychiatry, with separate units for children and adults. Nurses at this center primarily work in inpatient units, intensive care units, operating rooms, and emergency departments. Their work schedules include both day shifts and rotating shifts.
Population and Sample: The study population consists of all nurses working at Kahramanmaraş Sütçü İmam University Health Practices and Research Hospital. Based on information obtained from the institution, the total number of nurses is 500. The sample will include nurses who meet the inclusion criteria. To determine the sample size, the G*Power program was used. The effect size was calculated based on a similar study in the literature. With an alpha level of 0.05, a power of 0.95, and an effect size of 1.109189, the total sample size was calculated to be 38 (19 in the intervention group and 19 in the control group). Considering a potential dropout rate of 10-20% as reported in previous studies, the sample size was increased by 20%, resulting in a final sample size of 23 nurses in each group.
Pilot Study: Prior to the main study, a pilot study was conducted to evaluate the feasibility of a structured mindfulness-based art therapy intervention. A group of eight volunteer nurses from the outpatient clinics and polyclinics of Kahramanmaraş Sütçü İmam University Health Practices and Research Hospital participated in this pilot intervention.
Study Implementation: The main study will be conducted at Kahramanmaraş Sütçü İmam University Health Practices and Research Hospital following the pilot study. Before the intervention, both the intervention and control groups will be administered the Participant Information Form once, and the Difficulty in Emotion Regulation Scale (Short Form), the Maslach Burnout Inventory, and the Psychological Flexibility Scale three times (pre-test: one week before the MBAT, post-test: one week after the MBAT, follow-up: 3 and 6 months after the MBAT). Following the pre-test, a 5-session MBAT will be initiated for the intervention group. Considering the effectiveness of the intervention and the characteristics of psychological counseling groups, the intervention group will be divided into subgroups. Each subgroup will receive the intervention on different days or times within the same week. After the intervention period and post-test, the MBAT will be applied to the control group.
Data Analysis: Data collected from the study will be analyzed using International Business Machines (IBM) Statistical Package for the Social Sciences (SPSS) V23. To assess normality, the Shapiro-Wilk test will be used. For normally distributed data, independent samples t-test and paired samples t-test will be employed. For non-normally distributed data, the Mann-Whitney U test and the Wilcoxon signed-rank test will be used. The relationship between variables will be examined using Spearman correlation analysis. Data will be presented as mean and standard deviation for normally distributed data and median and range for non-normally distributed data. Categorical data will be analyzed using the chi-square test and presented as frequencies and percentages.
Ethical Considerations: Ethical approval has been obtained from the Ethics Committee of Gazi University (dated 16.04.2024, number 07) and the relevant departments of Kahramanmaraş Sütçü İmam University Health Practices and Research Hospital. Permission to use the data collection tools was obtained via email from the authors who conducted the validity and reliability studies. Before the study began, participants were provided with detailed information about the study's purpose, procedures, and expected outcomes. Written informed consent was obtained from each participant in the pre-test, intervention, and control groups. The researcher conducting the study possesses the necessary qualifications and certifications to implement the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- pre-test post-test follow-up and control group experimental study
| Arm | Type | Receives |
|---|---|---|
| Mindfulness based art therapy | Experimental | Behavioral: Mindfulness-based art therapyPrior to the MBAT intervention, data collection forms were administered and randomization was performed. Following the pre-test, participants in this group will attend weekly MBAT sessions for five weeks. Post-intervention, data collection forms will be administered again. Subsequent follow-up assessments will be conducted at 3 and 6 months. |
| Therapy waiting list | No intervention | –Following the pre-test and randomization, the control group will receive follow-up assessments concurrently with the intervention group at predetermined intervals (post-intervention, 3 months, and 6 months). Upon completion of the research, the participants assigned to the control group will undergo the MBAT intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To have provided active care for individuals affected by the earthquake for at least three months
- To voluntarily agree to participate in the study.
Key exclusion criteria (4 listed)
- To have received or be currently receiving training or individual/group therapy in art therapy or mindfulness.
- To have a condition that would prevent them from actively participating in the sessions, comprehending the scales, and completing them.
- To fail to attend two consecutive study sessions for any reason
- To voluntarily withdraw from the study at any time
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 art therapyMBAT combines art therapy and mindfulness to promote self-awareness and emotional well-being. It uses art to express thoughts and feelings, while cultivating mindfulness skills. MBAT addresses stress, anxiety, and emotional regulation. Grounded in research, it's an effective therapeutic approach. The mindfulness-based art therapy sessions were designed based on the literature, drawing on the researches. By integrating art therapy techniques and mindfulness practices, the sessions were developed. Expert opinions were sought from specialists in the field to ensure the content validity of the sessions, and necessary adjustments were made accordingly. The MBAT application consists of five sessions in total. Each session has a specific theme and is designed to last 90-120 minutes. | Behavioural | Mindfulness based art therapy |
Primary outcome
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)
Time frame: 7 months
The Difficulties in Emotion Regulation Scale (DERS) was developed by Gratz and Roemer (2004) to assess emotional regulation difficulties. A shorter version was created by Bjureberg et al. (2016) and adapted into Turkish by Yiğit and Güzey Yiğit (2019). The DERS-Short Form consists of 16 items and measures five factors: acceptance, clarity, goals, strategies, and impulsivity. The acceptance subscale measures rejection of emotional responses; clarity assesses understanding emotions; goals evaluates focus on goal-directed behavior during emotional experiences; strategies measures access to emotion regulation strategies; and impulsivity evaluates control over impulses when experiencing negative emotions. Higher scores indicate greater difficulties. The scale's internal consistency (Cronbach's alpha) is 0.92, with subscale consistency ranging from 0.78 to 0.87.
Maslach Burnout Inventory (MBI)
Time frame: 7 months
The Maslach Burnout Inventory (MBI), developed by Maslach and Jackson in 1981 to measure burnout, was adapted into Turkish by Ergin in 1992. The scale consists of 22 items and utilizes a 5-point Likert scale (0: Never, 1: Very rarely, 2: Sometimes, 3: Often, 4: Always). The MBI assesses three dimensions of burnout: emotional exhaustion (items 1, 2, 3, 6, 8, 13, 14, 16, 20), depersonalization (items 5, 10, 11, 15, 22), and personal accomplishment (items 4, 7, 9, 12, 17, 18, 19, and 21). Items in the personal accomplishment subscale are reverse-coded. Higher scores on emotional exhaustion and depersonalization, and lower scores on personal accomplishment, reflect greater burnout. The Turkish version's Cronbach's alpha coefficients were 0.83 for emotional exhaustion, 0.65 for depersonalization, 0.72 for personal accomplishment, and 0.93 overall (Ergin, 1992).
The Psychological Flexibility Scale
Time frame: 7 months
The original Psychological Flexibility Scale was developed by Francis, Dawson, and Golijani Moghaddam (2016). A Turkish adaptation, consisting of 37 items, was created by Karakuş and Akbay (2020) to assess psychological flexibility in adults. The original scale contained 23 items, while the Turkish version includes 28 items across five subscales: "values and behaviors aligned with values" (items 1, 7, 9, 13, 16, 19, 21, 26, 27, 28), "being in the present moment" (8, 14, 18, 20, 22, 23, 25), "acceptance" (2, 3, 5, 6, 24), "contextual self" (4, 10, 12), and "defusion" (11, 15, 17). Items 2, 3, 5, 6, 8, 18, 20, 22, 23, 24, and 25 are reverse-scored. The scale's total score ranges from 28 to 196, with higher scores indicating greater psychological flexibility. The internal consistency reliability coefficient was 0.79.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Results publication: PubMed 27239096Bjureberg J, Ljotsson B, Tull MT, Hedman E, Sahlin H, Lundh LG, Bjarehed J, DiLillo D, Messman-Moore T, Gumpert CH, Gratz KL. Development and Validation of a Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16. J Psychopathol Behav Assess. 2016 Jun;38(2):284-296. doi: 10.1007/s10862-015-9514-x. Epub 2015 Sep 14.
- Results publicationErgin C. Doktor ve hemsirelerde tukenmislik ve Maslach tukenmislik olceginin uyarlanmasi. VII. Ulusal Psikoloji Kongresi, 22th September 1992. Ankara (Turkey).
- Results publicationMaslach C, Jackson SE. Maslach Burnout Inventory--ES Form (MBI). 1981. https://doi.org/10.1037/t05190-000
- Results publicationFrancis AW, Dawson DL, & Golijani-Moghaddam N. The development and validation of the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT). Journal of Contextual Behavioral Science. 2016: 5(3): 134-145. https://doi.org/10.1016/j.jcbs.2016.05.003
- Results publicationKarakuş S, Akbay SE. Psychological Flexibility Scale: Adaptation, Validity and Reliability Study. Mersin University Journal of the Faculty of Education. 2020: 16(1): 32-43. https://doi.org/10.17860/mersinefd.665406
- Results publicationYiğit İ, Guzey Yiğit, M. Psychometric Properties of Turkish Version of Difficulties in Emotion Regulation Scale-Brief Form (DERS-16). Current Psychology. 2019: 38: 1503-1511. https://doi.org/10.1007/s12144-017-9712-7.
- Results publicationGratz, KL, Roemer, L. Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology and Behavioral Assessment. 2004: 26: 41-54. https://doi.org/10.1023/B:JOBA.0000007455.08539.94
- Individual participant dataSharing planned: No. Data sharing is not desired
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Friends/Family of Individuals at Risk of Suicide Training Program
Caregiver, Caregiver Mental Health
Recruiting
GUT-FEELINGS: Using Citizen Science for Large-Scale Prebiotic Clinical Trials for Mental Wellness in Adults
Sleep Disturbance, Stress
Not yet recruitingPhase 1
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
Schizophrenia
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. This study is not recruiting at the moment.
Mehtap Ağaç, PhD principal investigator
Kahramanmaras Sutcu Imam University
Sultan Ayaz Alkaya, Professor study chair
Gazi University
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 art therapy in people with Mental Health Wellness 1 and Burnout, Professional, run by Mehtap Ağaç 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 31 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16) (time frame: 7 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06706505, which also lists 7 linked publications.
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 31 Dec 2025.