SCHIZOPHRENIA 1 (Disorder)
Conditions
Keywords
Acceptance and Commitment Therapy, ACT-based nursing intervention, Social cognition, Emotion regulation, Psychological flexibility
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALAcceptance 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 values-based actions to improve social cognition, emotion regulation, and psychological flexibility.
Sponsors
Ataturk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized controlled pre-test post-test experimental design. Participants registered at Erzincan TRSM who meet inclusion criteria will be randomly assigned to experimental or control groups using the Research Randomizer program (https://www.randomizer.org/). The experimental group will consist of 32 participants divided into 3 subgroups (11/11/10) to facilitate group interaction.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Social Cognition | 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. |
| Emotion Regulation | 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. |
| Psychological Flexibility | 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. |
Contacts
CONTACTBuse N GEDIK, PhD Candidate
CONTACTHatice DURMAZ, Associate Professor
STUDY_CHAIRHatice DURMAZ, Associate Professor
Ataturk University
Outcome results
None listed