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

18 de junio de 2026 actualizado por: 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).

Descripción general del estudio

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Estimado)

64

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Hatice DURMAZ, Associate Professor
  • Número de teléfono: +90(530)9218527

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Social Cognition
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Silla de estudio: Hatice DURMAZ, Associate Professor, Ataturk University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

1 de diciembre de 2026

Finalización del estudio (Estimado)

1 de enero de 2027

Fechas de registro del estudio

Enviado por primera vez

4 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

18 de junio de 2026

Publicado por primera vez (Actual)

22 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

18 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • BuseNur_GEDİK_DoktoraTezi

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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