- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07661225
The Effect of ACT-Based Nursing Interventions on Social Cognition, Emotion Regulation and Psychological Flexibility in Patients With Schizophrenia
The Effect of Acceptance and Commitment Therapy (ACT)-Based Nursing Interventions on Social Cognition, Emotion Regulation and Psychological Flexibility in Individuals With Schizophrenia: A Randomized Controlled Trial
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Schizophrenia is a chronic psychiatric disorder associated with significant impairments in social cognition, emotion regulation, and psychological flexibility. These impairments contribute to social withdrawal, functional decline, and reduced quality of life. While pharmacological treatments address positive symptoms, psychosocial interventions targeting functional outcomes remain underdeveloped, especially those delivered within a nursing framework.
Acceptance and Commitment Therapy (ACT) is a third-wave cognitive behavioral approach centered on psychological flexibility, defined as the ability to contact the present moment fully and to persist in or change behavior in the service of chosen values. ACT's core processes - cognitive defusion, acceptance, present-moment contact, self-as-context, values clarification, and committed action - offer a theoretically coherent intervention framework for addressing the functional deficits seen in schizophrenia.
This study integrates ACT principles into nursing practice through structured group sessions. The intervention program was developed based on a review of the literature and will be evaluated for content validity by at least twelve experts in psychiatric nursing, psychology, and psychiatry prior to implementation. The program consists of 8 weekly sessions (45-60 min each), covering the following themes: 1. Introduction and ACT psychoeducation; 2. Present-moment contact and mindfulness; 3. Emotion awareness and acceptance; 4. Cognitive defusion; 5. Self-as-context and social cognition; 6. Values clarification; 7. Committed action and flexible coping; 8. Consolidation and relapse prevention.
Sample size was determined by G*Power 3.1 power analysis based on three outcome variables. The largest required sample (n = 58) was drawn from the emotion regulation variable (mean scores: 28.06 ± 11.58 vs. 19.08 ± 16.23; effect size d = 0.82; 95% CI; alpha = 0.05; power = 85%). Adding a 10% buffer for attrition yields a total sample of 64 (32 experimental + 32 control). Randomization will be performed using a computer-generated randomization sequence by an independent researcher to prevent selection bias.
Blinding: Due to the nature of psychosocial interventions, participant and investigator blinding is not possible. Outcome assessors will not be involved in the intervention to reduce performance bias. Data will be analyzed using SPSS 22.0; paired comparisons will use Dependent t-Test or Wilcoxon Signed-Rank Test; between-group comparisons will use Independent t-Test or Mann-Whitney U Test. Statistical significance is set at p < 0.05.
After data collection is complete, control group participants will receive a condensed 2-session version of the ACT-based program as an ethical courtesy.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Buse N GEDIK, PhD Candidate
- Telefonnummer: +90(544)2810589
- E-Mail: busenurgedik.1997@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Hatice DURMAZ, Associate Professor
- Telefonnummer: +90(530)9218527
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Diagnosed with schizophrenia (ICD-10/DSM-5) and followed at Erzincan Community Mental Health Center (TRSM)
- Registered at Erzincan TRSM
- Duration of schizophrenia diagnosis of at least 6 months
- No cognitive or sensory (hearing/visual) deficit that would prevent participation
- Literate
- Provides written informed consent to participate
Exclusion Criteria:
- Comorbid psychiatric diagnosis other than schizophrenia
- Active acute psychotic episode at enrollment
Discontinuation / Withdrawal Criteria
- Voluntary withdrawal from the study
- Acute psychotic relapse during the study period
- Additional psychiatric diagnosis during the study period
- Radical change in medication type or dosage during the study period
- Incomplete responses on data collection forms
- Completion of less than 80% of assigned homework
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Acceptance and Commitment Therapy (ACT)-Based Nursing Intervention
32 individuals diagnosed with schizophrenia and registered at Erzincan TRSM who meet inclusion criteria and provide written informed consent, assigned through computer-based simple randomization.
The experimental group will receive 8 structured weekly group sessions (45-60 min) based on Acceptance and Commitment Therapy (ACT) principles integrated into nursing practice.
Sessions are organized around the six core ACT processes: present-moment contact, acceptance, cognitive defusion, self-as-context, values clarification, and committed action.
Each session follows a standard flow: review of previous session and homework, mindfulness exercise, ACT-based content and experiential exercises, homework assignment, and feedback.
Participants will be divided into 3 subgroups (11/11/10 persons).
Content validity of the program will be established by expert review (≥5 experts in psychiatric nursing, psychology, and psychiatry) prior to implementation.
|
This intervention consists of an 8-session, structured, Acceptance and Commitment Therapy (ACT)-based psychosocial nursing program.
The sessions will be conducted by a trained researcher in a group format.
Each session will last approximately 60 to 90 minutes and will be held on a weekly basis.
The program is specifically tailored for individuals diagnosed with schizophrenia and focuses on the core processes of the ACT hexaflex model, including mindfulness, cognitive defusion, acceptance, and values-based actions to improve social cognition, emotion regulation, and psychological flexibility.
|
|
Kein Eingriff: Routine Care Control Group
32 individuals diagnosed with schizophrenia and registered at Erzincan TRSM who meet inclusion criteria and provide written informed consent, assigned through computer-based simple randomization.
The control group will receive routine care only during the study period.
After post-test data collection is completed, participants in the control group will receive a condensed 2-session ACT-based nursing intervention as an ethical courtesy to ensure equitable benefit.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Social Cognition
Zeitfenster: Baseline (before Session 1, Week 0) and immediately following Session 8 (Week 8)
|
Change in social cognition as measured by the Observable Social Cognition-A Rating Scale (OSCARS).
OSCARS is an 8-item interviewer-rated scale assessing social cognitive impairments in schizophrenia on a 7-point Likert scale (1 = None, 7 = Extreme).
Higher scores indicate greater impairment.
Total scores range from 8 to 56.
|
Baseline (before Session 1, Week 0) and immediately following Session 8 (Week 8)
|
|
Emotion Regulation
Zeitfenster: Baseline (before Session 1, Week 0) and immediately following Session 8 (Week 8)
|
Change in emotion regulation difficulties as measured by the Difficulties in Emotion Regulation Scale-Brief Form (DERS-16).
DERS-16 is a 16-item self-report scale scored on a 5-point Likert scale (1 = Almost never, 5 = Almost always).
Total scores range from 16 to 80; higher scores indicate greater difficulty in emotion regulation.
There is no established cut-off score.
|
Baseline (before Session 1, Week 0) and immediately following Session 8 (Week 8)
|
|
Psychological Flexibility
Zeitfenster: Baseline (before Session 1, Week 0) and immediately following Session 8 (Week 8)
|
Change in psychological flexibility/experiential avoidance as measured by the Acceptance and Action Questionnaire-II (AAQ-II).
AAQ-II is a 7-item self-report scale scored on a 7-point Likert scale (1 = Never true, 7 = Always true).
Total scores range from 7 to 49; higher scores indicate greater experiential avoidance and psychological inflexibility.
|
Baseline (before Session 1, Week 0) and immediately following Session 8 (Week 8)
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Hatice DURMAZ, Associate Professor, Ataturk University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.
- Bjureberg J, Ljotsson B, Tull MT, Hedman E, Sahlin H, Lundh LG, Bjarehed J, DiLillo D, Messman-Moore T, Gumpert CH, Gratz KL. Development and Validation of a Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16. J Psychopathol Behav Assess. 2016 Jun;38(2):284-296. doi: 10.1007/s10862-015-9514-x. Epub 2015 Sep 14.
- Yavuz, F., Ulusoy, S., Iskin, M., Esen, F. B., Burhan, H. S., Karadere, M. E., & Yavuz, N. (2016). Turkish version of Acceptance and Action Questionnaire-II (AAQ-II): A reliability and validity analysis in clinical and non-clinical samples. Klinik Psikofarmakoloji Bülteni-Bulletin of Clinical Psychopharmacology, 26(4), 397-408.
- Yiğit, İ., & Guzey Yiğit, M. (2019). Psychometric properties of Turkish version of difficulties in emotion regulation scale-brief form (DERS-16). Current Psychology, 38(6), 1503-1511.
- Ozaslan Z, Yildiz M. The Turkish Validity and Reliability Study of the Observable Social Cognition -A Rating Scale for Patients with Schizophrenia. Turk Psikiyatri Derg. 2021 Fall;32(3):192-200. doi: 10.5080/u25058. English, Turkish.
- Healey KM, Combs DR, Gibson CM, Keefe RS, Roberts DL, Penn DL. Observable Social Cognition--A Rating Scale: an interview-based assessment for schizophrenia. Cogn Neuropsychiatry. 2015;20(3):198-221. doi: 10.1080/13546805.2014.999915. Epub 2015 Feb 13.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- BuseNur_GEDİK_DoktoraTezi
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .