NCT06706505

Brief 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. 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."\*\*

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2025

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

4 days

First QC Date

November 25, 2024

Last Update Submit

December 25, 2025

Conditions

Keywords

art therapymindfulnessemotional regulationburnoutpsychological flexibilitynurses

Outcome Measures

Primary Outcomes (3)

  • 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.

    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).

    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.

    7 months

Study Arms (2)

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.

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.

Interventions

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.

Mindfulness based art therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To have provided active care for individuals affected by the earthquake for at least three months
  • To voluntarily agree to participate in the study.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, Onikişubat, 46000, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

  • Ergin C. Doktor ve hemsirelerde tukenmislik ve Maslach tukenmislik olceginin uyarlanmasi. VII. Ulusal Psikoloji Kongresi, 22th September 1992. Ankara (Turkey).

    RESULT
  • Maslach C, Jackson SE. Maslach Burnout Inventory--ES Form (MBI). 1981. https://doi.org/10.1037/t05190-000

    RESULT
  • 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

    RESULT
  • 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

    RESULT
  • 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.

    RESULT
  • 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

    RESULT

MeSH Terms

Conditions

Burnout, ProfessionalEmotional RegulationBurnout, Psychological

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorSelf-ControlSocial Behavior

Study Officials

  • Mehtap Ağaç, PhD

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR
  • Sultan Ayaz Alkaya, Professor

    Gazi University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
In randomized controlled trials, it is crucial for groups to be equal and balanced in terms of baseline characteristics. To achieve this, simple stratified randomization based on gender was used to assign nurses to the intervention and control groups. To prevent bias, both researchers and participants were blinded to group assignments until after randomization. Due to the study's nature, blinding the researcher administering the intervention and participants was not feasible. However, a pre-test was administered before randomization. A blind technique was applied with the help of an independent statistician. Participants were randomly assigned using a number generator, and a third party conducted a coin flip to determine group assignments. The data will be coded by a nursing expert to ensure the statistician remains unaware during analysis. Group codes will be revealed after data analysis to minimize bias.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: pre-test post-test follow-up and control group experimental study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 25, 2024

First Posted

November 26, 2024

Study Start

December 1, 2024

Primary Completion

December 5, 2024

Study Completion

June 5, 2025

Last Updated

December 31, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Data sharing is not desired

Locations