Clinical trial NCT05653674: The Effect of Acceptance and Commitment Approach-Based Psychoeducation on Nursing Students' Psychological Distress
Official title: The Effect of Acceptance and Commitment Approach-Based Psychoeducation on Nursing Students' Psychological Distress, Psychological Flexibility, Mindfullness and Values: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Keywords: Psychological Distress
Mindfullness
Values
Acceptance and commitment approach
Psychological flexibility
Psychiatric Nursing
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study is planned to be conducted in a randomized controlled experimental design in accordance with CONSORT. The study is planned to be carried out at X Nursing Faculty between November 2022 and February 2024. The randomization list will be hidden from the students, and the group to which each student will be included will be revealed after they are included in the study. In order to determine which group the nursing students to be included in the study will be in, the "Layered Block Randomization" method will be used and they will be assigned to the experimental and control groups according to the stress scores they get from the DASS-21 scale. Assignment of intervention and control groups to conceal randomization information to avoid study bias; It will be done by an expert who was not involved in the research. The experimental group will consist of 40 students in total, 4 groups of 10 students each, and the students will receive face-to-face psychoeducation for 6 weeks, each session for 60 minutes. The control group will not receive any intervention during the application period and will be put on waitlist. After the psychoeducation, as a post-test, one month, six months and one year later, follow-up measurements will be applied face-to-face and by telephone to the students who have completed the psychoeducation, and the scores will be compared with the control group. Among the sampling criteria; Being a nursing student, getting at least 8 points (mild and above) from the stress sub-dimension of the DASS-21 scale; Exclusion criteria from the sample included starting psychiatric treatment in the last three months, having previously participated in an acceptance and commitment or mindfullness-based program. In the research, descriptive information form will be filled from the students. The level of psychological distress will be measured with the Depression, Anxiety and Stress Scale Short Form (DASS-21). Psychological flexibility will be measured with the Acceptance and Action Questionnaire-II , mindfullness with the Mindfull Attention Awareness Scale and the level of valuing with the Valuing Questionnaire . Validity and reliability studies of the scales were carried out. Institutional permission was obtained from the faculty where the research was conducted.

Detailed description: It is emphasized that nursing students experience high levels of stress (Köse et al., 2021; Ching et al., 2020). Since nursing students are exposed to different stressors during their education and their stress levels are high, it is important to examine their psychological distress (Reverté Villarloya et al., 2021; Serçe et al., 2021). In the literature, it is emphasized that there is a need for interventions including methods such as psychological flexibility and mindfullness in order to reduce psychological distress in nursing students and strengthen them against difficult experiences (Ching et al.,2020; Ten Hoeve et al.,2017;Günüşen 2017). A potential approach that has been shown to be effective in reducing psychological distress and gaining psychological flexibility is one of the third generation cognitive behavioral therapies; acceptance and commitment approach. The aim of the study is to examine the effect of psychoeducation based on acceptance and commitment approach applied to nursing students on psychological distress, psychological flexibility, mindfullness and values. The study is planned to be conducted in a randomized controlled experimental design in accordance with CONSORT. The study is planned to be carried out at X Nursing Faculty between November 2022 and February 2024. Firstly, the Depression, Anxiety and Stress Scale Short Form (DASS-21) will be applied to the students studying at the X Nursing Faculty, and students who get at least 8 points from the stress sub-dimension of the form will be invited to work by e-mail and telephone. G power statistical analysis program was used in the sample calculation required for the study, Type I error was 0.05, Type II error was 0.20 (power 0.80). In the analysis, it was determined that 25 students should be taken for each group. Considering that there may be losses, it is planned to include 80 students in total, 40 students in each group. The experimental group will consist of 40 students in total, 4 groups of 10 students each, and the students will receive face-to-face psychoeducation for 6 weeks, each session for 60 minutes. The control group will not receive any intervention during the application period and will be put on waitlist. After the completion of the research, if the initiative is determined to be effective, the program is planned to be applied to the volunteer students in the control group. After the psychoeducation, as a post-test, one month and six months late and one year, follow-up measurements will be applied face-to-face and by telephone to the students who have completed the psychoeducation, and the scores will be compared with the control group. The randomization list will be hidden from the students, and the group to which each student will be included will be revealed after they are included in the study. In order to determine which group the nursing students to be included in the study will be in, the "Layered Block Randomization" method will be used and they will be assigned to the experimental and control groups according to the stress scores they get from the DASS-21 scale. Assignment of intervention and control groups to conceal randomization information to avoid study bias; It will be done by an expert who was not involved in the research. Among the sampling criteria; Being a nursing student, getting at least 8 points (mild and above) from the stress sub-dimension of the DASS-21 scale; Exclusion criteria from the sample included starting psychiatric treatment in the last three months, having previously participated in an acceptance and commitment or mindfullness-based program. In the research, descriptive information form will be filled from the students. The level of psychological distress will be measured with the Depression, Anxiety and Stress Scale Short Form (DASS-21). Psychological flexibility will be measured with the Acceptance and Action Questionnaire-II , mindfullness with the Mindfull Attention Awareness Scale and the level of valuing with the Valuing Questionnaire . Validity and reliability studies of the scales were carried out. Institutional permission was obtained from the faculty where the research was conducted. The study was approved by the ethics committee of the relevant university (2021/26-08). The verbal and written consent will be obtained from the nursing students who will participate in the research; individuals will be informed that information about themselves will not be disclosed to others, and the "principle of confidentiality" will be followed. Nursing students will be informed about the purpose of the research and how to apply it. The primary researcher, who is not responsible for the education of the students, will lead the initiatives to protect the vulnerability of the students.There is no anticipated limitation of the study. The expenses of the study will be covered by the researcher. With this study, it is hoped that nursing students who participate in acceptance and commitment-based psychoeducation will participate in the health system in a more psychologically flexibility and strenghten way.

Eligibility criteria: Inclusion Criteria:

* Being a nursing student
* Getting at least 8 points (mild and above) from the stress sub-dimension of the DASS-21 scale

Exclusion Criteria:

-The sample included starting psychiatric treatment in the last three months Having previously participated in an acceptance and commitment or mindfullness-based program.

Primary outcomes:
measure: Change from baseline psychological distress levels to the end point of the intervention and one month (4 weeks), six months (24 weeks), 12 months (48 weeks) after the intervention
timeFrame: Change from to the end point of the intervention and one month (4 weeks), six months (24 weeks), 12 months (48 weeks) after the intervention
Secondary outcomes:
measure: Change from baseline psychological flexibility levels to the end point of the intervention and one month (4 weeks), six months (24 weeks), 12 months (48 weeks) after the intervention
timeFrame: Change from to the end point of the intervention and one month (4 weeks), six months (24 weeks), 12 months (48 weeks) after the intervention
measure: Change from baseline mindfullness levels to the end point of the intervention and one month (4 weeks), six months (24 weeks), 12 months (48 weeks) after the intervention
timeFrame: Change from to the end point of the intervention and one month (4 weeks), six months (24 weeks), 12 months (48 weeks) after the intervention
measure: Change from baseline valuing levels to the end point of the intervention and one month (4 weeks), six months (24 weeks), 12 months (48 weeks) after the intervention
timeFrame: Change from to the end point of the intervention and one month (4 weeks), six months (24 weeks), 12 months (48 weeks) after the intervention
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
affiliation: Dokuz Eylul University
name: Tuğçe Şık, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hayes SC. Acceptance and Commitment Therapy, Relational Frame Theory, and the Third Wave of Behavioral and Cognitive Therapies - Republished Article. Behav Ther. 2016 Nov;47(6):869-885. doi: 10.1016/j.beth.2016.11.006. Epub 2016 Nov 10.