The Effect of Acceptance and Commitment Approach-Based Psychoeducation on Nursing Students' Psychological Distress

May 21, 2025 updated by: Neslihan Partlak Günüşen, Dokuz Eylul University

The Effect of Acceptance and Commitment Approach-Based Psychoeducation on Nursing Students' Psychological Distress, Psychological Flexibility, Mindfullness and Values: A Randomized Control Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • İzmir, Turkey, 35340
        • Dokuz Eylul University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experiment
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.
Behavioral: Acceptance and commitment approach-based psychoeducation
The psychoeducation based on acceptance and commitment approach reducing psychological distress in nursing students; It has been prepared to increase psychological flexibility, mindfullness and level valuing. A potential approach that has been shown to be effective in reducing psychological distress is one of the third generation cognitive behavioral therapies; acceptance and commitment therapy. Acceptance and commitment-based approaches encourage participants to change their relationship with their thoughts and physical sensations through acceptance, mindfullness, and value-based action mechanisms.
No Intervention: Control
The control group will not receive any intervention during the application period and will be put on waitlist.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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
Depression, Anxiety and Stress Scale Short Form (DASS-21) the DASS-21 scale will be used to evaluate the psychological distress level of students. In this scale (DASS-21), there are seven questions each to measure the dimensions of depression, anxiety and stress. The first seven questions on the scale are about anxiety, seven questions between 8-14 are about depression and seven questions between 15-21 are about stress. The scale has a four-point Likert-type rating of 0 "not at all suitable for me", 1 "somewhat suitable for me", 2 "usually suitable for me", and 3 "completely suitable for me". While the lowest score that can be obtained for all dimensions in the scale is zero, the highest score can be 21.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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
Acceptance and Action Questionnaire-II (AAQ-II) The seven-item Acceptance and Action Questionnaire-II is a reliable and valid scale for measuring psychological flexibility in both clinical and non-clinical samples. The mean Cronbach Alpha coefficient was found to be .84, and the internal consistency was high.The questionnaire consists of seven items in total. The scale items are graded from 1 (never true) to 7 (always true). The lowest score to be taken from the scale is 7 and the highest score is 49. The AAQ-II is a seven-point Likert-type scale, and as the total score increases, psychological rigidity increases and psychological flexibility decreases
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
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
Time Frame: 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
Mindfull Attention Awareness Scale The Mindful Attention Awareness Scale was developed to measure the general level of mindfullness and attention to current processes in daily life. The Cronbach Alpha internal consistency coefficient calculated for the reliability of the scale is 0.80. The scale consists of 15 items. The lowest score that can be obtained from the scale is 15 and the highest 90. The scale is a 6-point Likert type scale: almost always (1), often (2), sometimes (3), rarely (4), rarely (5), almost never (6). The Mindful Attention Awareness Scale has a single factor and a single total score is obtained from the scale. As the score obtained from the scale increases, the level of mindfullness of the individual increases.
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
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
Time Frame: 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
The Valuing Questionnaire measures the extent to which people live in accordance with the value they have determined in the last week. The questionnaire is a Likert-type questionnaire consisting of 10 items and two sub-dimensions, "progression" and "obstruction". Progress sub-dimension emphasized being able to do daily tasks in line with values, while blocking sub-dimension emphasized living a life away from values in activities carried out for a week, unlike progress. The Cronbach's alpha value for the whole scale is 0.78. The lowest total score is zero, while the highest is 60. A high score indicates that individuals live a life in line with their values.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dokuz Eylul University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tuğçe Şık, Msc, Dokuz Eylul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6596-GOA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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