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The Effect of ACT-Based Nursing Interventions on Social Cognition, Emotion Regulation and Psychological Flexibility in Patients With Schizophrenia

18 giugno 2026 aggiornato da: Buse Nur Gedik, Ataturk University

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

This randomized controlled trial aims to evaluate the effect of Acceptance and Commitment Therapy (ACT)-based nursing interventions on social cognition, emotion regulation, and psychological flexibility in individuals diagnosed with schizophrenia. The study will be conducted at Erzincan Community Mental Health Center (TRSM) between October 2026 and January 2027. A total of 64 participants (32 experimental, 32 control) will be recruited from schizophrenia patients registered at the center. The experimental group will receive 8 structured group sessions based on ACT principles integrated into nursing practice (45-60 minutes per session, once weekly), while the control group will receive routine care only. Pre-test and post-test measurements will be obtained using the Observable Social Cognition Rating Scale (OSCARS), the Difficulties in Emotion Regulation Scale-Brief Form (DERS-16), and the Acceptance and Action Questionnaire-II (AAQ-II).

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

64

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Hatice DURMAZ, Associate Professor
  • Numero di telefono: +90(530)9218527

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Social Cognition
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Cattedra di studio: Hatice DURMAZ, Associate Professor, Ataturk University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 gennaio 2027

Date di iscrizione allo studio

Primo inviato

4 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 giugno 2026

Primo Inserito (Effettivo)

22 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared outside of the research team to ensure participant confidentiality and data privacy in accordance with institutional ethics committee approval and local data protection regulations.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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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