Stress (Psychology)CBT-SMPNCT07852117
CBT-Based Stress Management Program for Healthcare Students
A study testing Cognitive-Behavioral-Based Stress Management Skills Program and Group Interaction and Guidance Activities in people with Stress (Psychology) and Stress Management, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress (Psychology), Stress Management
- What is being tested?
- Cognitive-Behavioral-Based Stress Management Skills Program and Group Interaction and Guidance Activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2026to 30 Apr 2027
- Phase
- Interventional
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University Faculty of Health Sciences, Department of Nursing
Afyonkarahisar
Kevser Pamuk, PhD, 05052643087, kevser.pamuk@afsu.edu.tr
kevser.pamuk@afsu.edu.tr
About this study
Official title: Effectiveness of a Cognitive-Behavioral-Based Stress Management Skills Program in Healthcare Students: A Mixed-Methods Study
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.
Read the detailed description
This study is designed as a nested mixed-methods study to evaluate the effectiveness of a cognitive-behavioral-based stress management skills program developed for healthcare students. The study consists of three phases. In the first phase, semi-structured individual interviews will be conducted to explore healthcare students' sources and experiences of stress and their coping strategies. Findings from this qualitative phase will contribute to the development and refinement of the intervention program.
In the second phase, an experimental study will be conducted using intervention, placebo, and control groups. Participants will be assigned to the three groups using computer-supported full randomization. The intervention group will participate in a 9-session cognitive-behavioral-based group program designed to develop stress management and coping skills. The placebo group will participate in a program distinct from the cognitive-behavioral-based intervention, while the control group will not receive an intervention during the study period. Quantitative and qualitative data will be collected during this phase. The quantitative assessment will be conducted at three time points: before the intervention, immediately after completion of the intervention, and 12 weeks after the intervention. To reduce potential researcher effects and measurement bias, quantitative data collection will be conducted by a researcher who is independent of the intervention facilitators.
In addition to quantitative assessments, participants in the intervention group will complete a session evaluation form after each session to provide information about the content, implementation process, participant interaction, and perceived benefits of the sessions. In the third phase, a focus group interview will be conducted with students who complete the intervention program to explore their views regarding the content, feasibility, and perceived effectiveness of the program. The qualitative findings obtained throughout the study will be integrated with the quantitative findings to provide a comprehensive evaluation of the intervention.
Qualitative data obtained from the semi-structured interviews, session evaluation forms, and focus group interview will be analyzed using content analysis. Quantitative data will be analyzed using two-way repeated-measures analysis of variance to examine the effects of group and time on perceived stress and coping skills. Appropriate assumption tests and corrections will be applied where necessary. Intention-to-treat and per-protocol analyses will be used to address potential participant loss or missing data.
- Conditions
- Stress (Psychology), Stress Management
- Being tested
- Cognitive-Behavioral-Based Stress Management Skills Program, Group Interaction and Guidance Activities
- Keywords
- stress management, coping, cognitive-behavioral skills, health students, mixed methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral-Based Stress Management Skills ProgramBehavioural
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.
Group Interaction and Guidance ActivitiesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-intervention), immediately after the intervention, and 12 weeks after the intervention
Secondary outcomes (1)
Stress Coping Skills
Coping Inventory for Stressful Situations-Short Form: Coping strategies for dealing with stress will be assessed using the 21-item Coping Inventory for Stressful Situations-Short Form developed by Endler and Parker (1999) and adapted into Turkish by Boysan (2012). Each item is rated on a 5-point Likert scale ranging from 1 (not at all like me) to 5 (entirely like me). The total score ranges from 21 to 105. The scale consists of three subdimensions: problem-focused coping, emotion-focused coping, and avoidant coping. Higher scores on each subscale indicate a higher level of the corresponding coping strategy.
Measured: Baseline (pre-intervention), immediately after the intervention, and 12 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress (Psychology)Studies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevser Pamuk, Afyonkarahisar Health Sciences University
- Investigators
- Kevser Pamuk, PhD, Principal investigator, Afyonkarahisar Health Sciences University Faculty of Health Sciences, Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852117
- Sponsor's protocol ID
- AfyonkarahisarHSU-KPAMUK-2
- Other IDs
- 26.GENEL.022
- Acronym
- CBT-SMP
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because no plan for sharing individual participant data was established in the study protocol.