CBT-Based Stress Management Program for Healthcare Students (CBT-SMP)
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Kevser Pamuk, PhD
- Telefonnummer: 05052643087
- E-post: kevser.pamuk@afsu.edu.tr
Studieorter
-
-
-
Afyonkarahisar, Turkiet (Türkiye)
- Afyonkarahisar Health Sciences University Faculty of Health Sciences, Department of Nursing
-
Kontakt:
- Kevser Pamuk, PhD
- Telefonnummer: 05052643087
- E-post: kevser.pamuk@afsu.edu.tr
-
Kontakt:
- E-post: kevser.pamuk@afsu.edu.tr
-
Huvudutredare:
- Kevser Pamuk, PhD
-
Underutredare:
- Ömer Faruk Akbulut, PhD
-
Underutredare:
- Beyza Yavuz, PhD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Cognitive-Behavioral-Based Stress Management Skills Program
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. |
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. |
|
Placebo-jämförare: Group Interaction and Guidance Activities
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. |
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. |
|
Inget ingripande: No Intervention Control Group
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Perceived Stress Level
Tidsram: Baseline (pre-intervention), immediately after the intervention, and 12 weeks after the intervention
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Stress Coping Skills
Tidsram: Baseline (pre-intervention), immediately after the intervention, and 12 weeks after the intervention
|
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. |
Baseline (pre-intervention), immediately after the intervention, and 12 weeks after the intervention
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Kevser Pamuk, PhD, Afyonkarahisar Health Sciences University Faculty of Health Sciences, Department of Nursing
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- AfyonkarahisarHSU-KPAMUK-2
- 26.GENEL.022 (Annat bidrag/finansieringsnummer: Afyonkarahisar Health Sciences University Scientific Research Projects Coordination Unit)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Individual participant data will not be shared with other researchers because no plan for sharing individual participant data was established in the study protocol.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .