- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07579767
Positive Psychology Based Psychoeducation for Psychological Flexibility and Perceived Stress in University Students
The Effect of a Multi-Component Positive Psychology-Based Psychoeducation Program on Psychological Flexibility and Perceived Stress in University Students: A Controlled Pretest-Posttest Study
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This study is designed as a two-arm, parallel-group, waitlist-controlled randomized trial with a pretest-posttest design. The study will be conducted among first-year undergraduate nursing students at Harran University.
After eligibility screening and informed consent, participants will complete baseline assessments and will then be randomly assigned in a 1:1 ratio to either the intervention group or the waitlist control group. Randomization will be performed by an independent person who is not involved in the study design, intervention delivery, or data analysis. Allocation will be concealed until eligibility and baseline assessment procedures are completed.
The intervention group will receive an 8-week multi-component positive psychology-based psychoeducation program. Sessions will be conducted once weekly and will last approximately 60-75 minutes. The program includes positive psychology components such as gratitude, savoring, signature strengths, hope and goal-setting, meaning and values-based action, self-compassion, and maintenance of personal wellbeing practices. Each session will include brief psychoeducation, an experiential exercise, group reflection, and a home practice assignment.
The waitlist control group will continue their usual routine during the 8-week study period and will not receive the intervention before post-test assessment. After post-test data collection is completed, the waitlist control group will be offered the psychoeducation program content as a booklet.
Assessments will be conducted at baseline and immediately after the 8-week intervention. The main analysis will evaluate between-group differences in post-intervention outcomes while controlling for baseline scores.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Rabia Kaya, PhD
- Numero di telefono: +90 414 318 30 00
- Email: r.kurumluoglugil@harran.edu.tr
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Being a first-year undergraduate student in the Department of Nursing at Harran University.
- Volunteering to participate in the study and providing informed consent.
- Having no reading, comprehension, or communication difficulty that would prevent completion of the data collection tools.
- Being 18 years of age or older.
Exclusion Criteria:
- Receiving regular psychotherapy or psychoeducation during the same academic period.
- Having participated in a structured positive psychology-based psychoeducation or intervention program within the last 6 months.
- Having a history of psychiatric hospitalization within the last 3 months or having an acute psychiatric crisis or instability that would make participation in the sessions inappropriate.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Positive Psychology Based Psychoeducation Program
Participants in this arm will receive an 8-week multi-component positive psychology based psychoeducation program.
Sessions will be delivered once weekly and will last approximately 60-75 minutes.
Each session will include brief psychoeducation, experiential exercises, shared reflection, and home practice assignments.
|
The intervention is an 8-week multi-component positive psychology based psychoeducation program delivered once weekly in 60-75 minute sessions.
The program includes psychoeducation and experiential practices related to gratitude, savoring, signature strengths, hope and goal-setting, meaning and values-based action, self-compassion, and maintenance of wellbeing practices.
Each session includes brief psychoeducation, practice exercises, shared reflection, and a home practice assignment.
|
|
Nessun intervento: Waitlist Control
Participants in this arm will continue their usual routine during the 8-week study period and will not receive the psychoeducation program before post-test assessment.
After post-test data collection is completed, they will be offered the psychoeducation program content as a booklet.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Perceived Stress Scale-14 Total Score From Baseline to Post-intervention
Lasso di tempo: Baseline and immediately after the 8-week intervention
|
Perceived stress will be assessed using the Perceived Stress Scale-14.
The scale consists of 14 self-report items scored on a 5-point Likert scale from 0 to 4. Total scores range from 0 to 56, with higher scores indicating higher perceived stress.
Change will be evaluated from baseline to immediately after the 8-week intervention.
|
Baseline and immediately after the 8-week intervention
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Acceptance and Action Questionnaire-II Total Score From Baseline to Post-intervention
Lasso di tempo: Baseline and immediately after the 8-week intervention
|
Psychological inflexibility and experiential avoidance will be assessed using the Acceptance and Action Questionnaire-II.
The scale consists of 7 self-report items scored on a 7-point Likert scale.
Total scores range from 7 to 49, with higher scores indicating greater psychological inflexibility and experiential avoidance.
Change will be evaluated from baseline to immediately after the 8-week intervention.
|
Baseline and immediately after the 8-week intervention
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Rabia Kaya, PhD, Harran University
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HU-SOBEK-2026-00108
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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