NCT05653674

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

December 5, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2024

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

1.2 years

First QC Date

November 22, 2022

Last Update Submit

May 21, 2025

Conditions

Keywords

Psychological DistressMindfullnessValuesAcceptance and commitment approachPsychological flexibilityPsychiatric Nursing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

    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

    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

    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

Study Arms (2)

Experiment

EXPERIMENTAL

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

Control

NO INTERVENTION

The control group will not receive any intervention during the application period and will be put on waitlist.

Interventions

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.

Experiment

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Study Officials

  • Tuğçe Şık, Msc

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 22, 2022

First Posted

December 16, 2022

Study Start

December 5, 2022

Primary Completion

February 25, 2024

Study Completion

February 25, 2024

Last Updated

May 23, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations