Clinical trial NCT06101953: The Impact of Coping Strategies on Interoception and Psychological Resilience in Response to Stress
Official title: The Impact of Coping Strategies on Interoception and Psychological Resilience in Response to Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: stress
resilience
interoception
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this observational study is to explore the impact of a 12-week online knowledge-sharing program focusing on stress management, psychological resilience, and interoception in university students who face various stressors. The primary questions it aims to answer are:

* How does participating in the online program influence students' understanding and management of stress?
* Can engaging in this program enhance students' resilience in the face of academic and life challenges?
* Does the program improve students' interoception skills, helping them recognize and manage internal bodily sensations and emotions more effectively?

Participants will be asked to:

* Attend weekly sessions covering topics such as stress, its sources, stages, diseases related to stress, coping methods, psychological resilience, and interoception.
* Engage in discussions, self-reflection, and practical exercises.
* Share their experiences and insights.
* Complete assessments to measure their perceived stress level, resilience, and interoceptive awareness.

Researchers will compare the group that participates in the program with a control group to determine if the program significantly improves stress management, enhances psychological resilience, and bolsters interoception skills among university students.

Detailed description: Participants and Sampling: The study sample consisted of university students enrolled in the Department of Occupational Therapy at Hacettepe University Faculty of Health Sciences, particularly those taking the Stress Coping Methods course. The determination of the sample size was guided by a rigorous statistical approach, employing G Power for power analysis. Following this, randomization was performed to create both a control group and an intervention group. The inclusion criteria required participants to be at least 18 years old, studying at a university in Turkey, and having Turkish as their native language. The sole exclusion criterion was the presence of any psychiatric diagnosis, ensuring the homogeneity of the sample.

Study Procedure: The intervention program, stretching over 12 weeks, was based on the Stress Coping Mechanisms lecture, derived from various resources such as Pendleton and Schultz-Khron (2001), Brown et al. (2019), and Reitz et al. (2020). Delivered by a seasoned practitioner with over 20 years of expertise in stress coping education, the program consisted of three hours per week. The curriculum was thoughtfully structured to ensure a comprehensive understanding of stress, its sources, stages, diseases associated with stress, coping strategies, psychological resilience, and interoception.

The online knowledge-sharing format encouraged interactivity, with participants engaging in discussions, self-reflection, and practical exercises. As part of the learning process, students were encouraged to conduct self-inquiries and present their findings to the class. The program aimed to provide students with a profound understanding of stress, emphasizing the critical role of psychological resilience and interoception in effective stress management and overall well-being.

Statistical Analysis: The statistical analysis was carried out using SPSS v26 software. The Kolmogorov-Smirnov test was used to assess the normality of all variables. Descriptive statistics were applied, including frequency, percentage, mean, minimum, maximum, and standard deviation for categorical and numerical variables. To evaluate differences between categorical variables, the chi-square test was employed. The Wilcoxon signed-rank test was used to compare baseline and final scores, while the Mann-Whitney U test compared the results between the control and intervention groups. The significance level was set at p\<0.05. Detailed statistical analyses were guided by a predefined analytical plan that encompassed both primary and secondary objectives as outlined in the study protocol. Quality assurance, data validation, and other registry-specific procedures were followed in line with best practices, ensuring data integrity and the accuracy of the results. Site monitoring and auditing, data checks for data quality, and source data verification were integral parts of the quality assurance plan. Additionally, a data dictionary containing detailed variable descriptions, as well as Standard Operating Procedures for various registry operations, was meticulously maintained. Further components included sample size assessment, a plan for addressing missing data, and a comprehensive statistical analysis plan to address the primary and secondary objectives as specified in the study protocol.

Eligibility criteria: Inclusion Criteria:

* Participants must be over 18 years of age.
* Participants must speak and understand the Turkish language fluently.
* Participants must be enrolled in the Stress Coping Methods course at Hacettepe University.

Exclusion Criteria:

* Participants with any psychiatric diagnosis were excluded from the study.

Primary outcomes:
measure: Perceived Stress Level
timeFrame: 12 weeks
Secondary outcomes:
measure: Interoceptive Sensory Questionnaire
timeFrame: 12 weeks
measure: Brief Resilience Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Onur Altuntas
role: STUDY_DIRECTOR
References: