Psychological Distress Clinical Trial
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
Verified date | February 2024 |
Source | Dokuz Eylul University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | February 29, 2024 |
Est. primary completion date | February 29, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Dokuz Eylul University | Izmir |
Lead Sponsor | Collaborator |
---|---|
Dokuz Eylul University |
Turkey,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 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 | 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 | |
Secondary | 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 | 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 | |
Secondary | 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 | 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 |
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