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).
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Experimental | Not described Receives: Behavioral: Stress management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted26 Oct 2023
- Study start27 Feb 2023
- Primary completion4 Jun 2023
- Study completion11 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Rana Aydemir, Hacettepe University
- Investigators
- Onur Altuntas, Study director, Hacettepe University
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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Coping Strategies on Interoception and Psychological Resilience in Response to Stress
- ClinicalTrials.gov ID
- NCT06101953
- Acronym / sponsor ID
- HU23INSPIRE
- Conditions
- Stress
- Keywords
- stress, resilience, interoception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 4 Jun 2023 (actual)
- Study completion
- 11 Jun 2023 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Experimental | Behavioral: Stress management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants with any psychiatric diagnosis were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress managementIt 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. | Behavioural | Intervention |
Primary outcome
Perceived Stress Level
Time frame: 12 weeks
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)."
2 secondary outcomes
Interoceptive Sensory Questionnaire
Time frame: 12 weeks
Brief Resilience Scale
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy and confidentiality concerns.
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Onur Altuntas study director
Hacettepe University
1 site in 1 country: see every site and its status.
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.