NCT06101953

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

October 21, 2023

Last Update Submit

October 25, 2023

Conditions

Keywords

stressresilienceinteroception

Outcome Measures

Primary Outcomes (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)."

    12 weeks

Secondary Outcomes (2)

  • Interoceptive Sensory Questionnaire

    12 weeks

  • Brief Resilience Scale

    12 weeks

Study Arms (2)

Control

NO INTERVENTION

Intervention

EXPERIMENTAL
Behavioral: Stress management

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Study Officials

  • Onur Altuntas

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Occupational therapist

Study Record Dates

First Submitted

October 21, 2023

First Posted

October 26, 2023

Study Start

February 27, 2023

Primary Completion

June 4, 2023

Study Completion

June 11, 2023

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to privacy and confidentiality concerns.

Locations