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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Поведенческое Acceptance and Commitment Therapy (ACT)-Based Nursing Intervention
  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 va

Первичные конечные точки

• Social Cognition [Срок оценки: Baseline (before Session 1, Week 0) and immediately following Session 8 (Week 8)]
• Emotion Regulation [Срок оценки: Baseline (before Session 1, Week 0) and immediately following Session 8 (Week 8)]
• Psychological Flexibility [Срок оценки: Baseline (before Session 1, Week 0) and immediately following Session 8 (Week 8)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 34647290
• 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. PMID 27239096
• 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. PMID 25675960
• 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. PMID 22035996

Идентификаторы

NCT: NCT07661225 · BuseNur_GEDİK_DoktoraTezi

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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