NCT07852117

Brief Summary

This study aims to evaluate the effectiveness of a cognitive-behavioral-based stress management skills program for healthcare students. The study will use a mixed-methods design and will include intervention, placebo, and control groups. Approximately 90 healthcare students will participate in the experimental phase. The intervention group will receive a 9-session cognitive-behavioral-based stress management program designed to help students recognize and manage stress, identify dysfunctional thoughts, and develop effective stress management and coping skills. The study will assess changes in perceived stress and coping skills before and after the program and at follow-up. Qualitative interviews and group discussions will also be conducted to explore students' experiences and perceptions of stress management and the program. It is hypothesized that students who participate in the stress management program will show improvements in perceived stress and coping skills compared with students in the placebo and control groups.

Trial Health

63
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Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

September 23, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

October 20, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

1 month

First QC Date

September 23, 2026

Last Update Submit

September 29, 2026

Conditions

Keywords

stress managementcopingcognitive-behavioral skillshealth studentsmixed methods

Outcome Measures

Primary Outcomes (1)

  • Perceived Stress Level

    Perceived Stress Scale (PSS): Perceived stress levels will be assessed using the 14-item Perceived Stress Scale developed by Cohen et al. (1983) and adapted into Turkish by Eskin et al. (2013). Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score ranges from 0 to 56, with higher scores indicating higher levels of perceived stress and therefore a worse outcome. The scale consists of two subdimensions: inadequate self-efficacy perception and perception of stress/distress. Items 4, 5, 6, 7, 9, 10, and 13 are reverse scored.

    Baseline (pre-intervention), immediately after the intervention, and 12 weeks after the intervention

Secondary Outcomes (1)

  • Stress Coping Skills

    Baseline (pre-intervention), immediately after the intervention, and 12 weeks after the intervention

Study Arms (3)

Cognitive-Behavioral-Based Stress Management Skills Program

EXPERIMENTAL

Participants in this arm will receive a 9-session cognitive-behavioral-based stress management skills program designed to improve stress management and coping skills. The sessions will be conducted as a structured group intervention in accordance with the study protocol.

Behavioral: Cognitive-Behavioral-Based Stress Management Skills Program

Group Interaction and Guidance Activities

PLACEBO COMPARATOR

Participants in this arm will participate in group guidance activities that are not directly related to stress management but are designed to increase awareness of general social and life skills. The sessions will involve structured group activities and group interaction and will be conducted in accordance with the study protocol.

Other: Group Interaction and Guidance Activities

No Intervention Control Group

NO INTERVENTION

Participants in this arm will not receive any intervention during the intervention period and will only participate in the scheduled outcome assessments. After completion of the data collection process, participants in the control group will be offered the cognitive-behavioral-based stress management skills program in accordance with the ethical principles of the study.

Interventions

A 9-session cognitive-behavioral-based stress management skills program designed for health sciences students. The program is delivered as a structured group intervention and aims to improve participants' stress management and coping skills. Each session is conducted in accordance with the study protocol.

Cognitive-Behavioral-Based Stress Management Skills Program

Participants in this arm will participate in group guidance activities that are not directly related to stress management but are designed to increase awareness of general social and life skills. The sessions will involve structured group activities and group interaction and will be conducted in accordance with the study protocol.

Group Interaction and Guidance Activities

Eligibility Criteria

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

You may qualify if:

  • Be an active student in an associate or undergraduate program at the university.
  • Be willing to participate in the study.
  • Be 18 years of age or older.
  • Have sufficient time to attend all sessions of the program.
  • Agree to complete the pre-test, post-test, and follow-up assessments.
  • Be able to read and write in Turkish.

You may not qualify if:

  • Have a history of a psychiatric diagnosis (e.g., major depressive disorder, bipolar disorder, or psychotic disorder).
  • Be currently receiving psychotherapy or psychiatric treatment.
  • Regularly use psychiatric medication (e.g., antidepressants, antipsychotics, or anxiolytics).
  • Have participated in a similar stress management, mindfulness, or cognitive-behavioral-based training/program within the previous 6 months.
  • Be unable to attend the sessions regularly (e.g., due to prolonged absence or being away from the city).
  • Have a condition that interferes with communication (e.g., hearing, visual, or speech impairment).
  • Decline participation after randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar Health Sciences University Faculty of Health Sciences, Department of Nursing

Afyonkarahisar, Turkey (Türkiye)

Location

Study Officials

  • Kevser Pamuk, PhD

    Afyonkarahisar Health Sciences University Faculty of Health Sciences, Department of Nursing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevser Pamuk, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
No additional parties are masked.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This study uses a randomized, parallel-group design with three groups: an intervention group, a placebo group, and a control group. Participants will be randomly assigned to one of the three groups using computer-generated randomization. The intervention group will receive a 9-session cognitive-behavioral-based stress management program, the placebo group will receive an alternative program, and the control group will not receive an intervention during the study period. Outcomes will be assessed at baseline, immediately after the intervention, and at a 12-week follow-up.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

September 23, 2026

First Posted

October 1, 2026

Study Start (Estimated)

October 20, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

April 30, 2027

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with other researchers because no plan for sharing individual participant data was established in the study protocol.

Locations