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StressNCT06101953

The Impact of Coping Strategies on Interoception and Psychological Resilience in Response to Stress

A study testing Stress management in people with Stress, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stress
What is being tested?
Stress management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteTurkey (Türkiye)
Study dates
27 Feb 2023to 11 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hacettepe University

    Ankara

Other trials in Turkey (Türkiye)

About this study

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?
Read more

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.

Read the 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.

Conditions
Stress
Being tested
Stress management
Keywords
stress, resilience, interoception

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stress managementBehavioural

    It spanned 12 weeks, with three hours per week (comprising two hours of theoretical content and one hour of practical application) and employed diverse teaching methods, including lectures, interactive learning, research, fieldwork, hands-on practice, and question-answer sessions. The primary objective of this course was to enhance students' awareness of stress by helping them identify its sources, symptoms, and effects. Also interception and resilience. Furthermore, it aimed to teach students how to assess stress and apply stress-management techniques effectively in their daily lives.

Study groups in NCT06101953
Study groupRoleWhat they receive
ControlNo interventionNot described
InterventionExperimentalNot described
Receives: Behavioral: Stress management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceived Stress Level

    The Perceived Stress Scale (PSS), a self-report questionnaire, is used to measure participants' perceived stress in various life situations. It consists of 14 items that assess the extent to which specific situations in an individual's life are perceived as stressful. Participants evaluate each item on a 5-point Likert scale, ranging from "Never (0)" to "Very Often (4)."

    Measured: 12 weeks

Secondary outcomes (2)
  1. Interoceptive Sensory Questionnaire

    Interoceptive awareness was assessed using the Interoceptive Sensory Questionnaire, which is a self-report questionnaire designed to evaluate individuals' ability to perceive internal sensory information. The questionnaire consists of items inquiring about how individuals feel and interpret sensory cues from their bodies, with responses scored on a scale from 1 to 7. The scale defines individuals scoring 71 and above as "Alexithymia," and those scoring 94 and above as "High Alexithymia."

    Measured: 12 weeks

  2. Brief Resilience Scale

    Psychological resilience was assessed using the Brief Resilience Scale (BRS). The BRS is a 5-item self-report scale designed to measure individuals' psychological resilience. The scale uses a 5-point Likert format, and after reverse-coding certain items, higher scores on the BRS indicate greater psychological resilience. Adaptation of the scale to Turkish, as well as the validation and reliability study, were conducted by Doğan (2015).

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2023
  2. Study start27 Feb 2023
  3. Primary completion4 Jun 2023
  4. Study completion11 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06101953
Sponsor's protocol ID
HU23INSPIRE
Other IDs
E-68552689-000-00003048522
Status last verified
Oct 2023
First submitted
21 Oct 2023
Last updated
26 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to privacy and confidentiality concerns.

Questions about this trial

What is this clinical trial studying?

A study testing Stress management in people with Stress, run by Hacettepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived Stress Level (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.

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