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

NCT07661225 | Not Yet Recruiting

• 1 other identifier: BuseNur_GEDİK_DoktoraTezi
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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).

Conditions

SCHIZOPHRENIA 1 (Disorder)

Keywords

Acceptance and Commitment Therapy; ACT-based nursing intervention; Social cognition; Emotion regulation; Psychological flexibility

Outcome Measures

Primary Outcomes (3)

• Social Cognition

  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

  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

  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)

Study Arms (2)

Acceptance and Commitment Therapy (ACT)-Based Nursing Intervention

EXPERIMENTAL

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.

Behavioral: Acceptance and Commitment Therapy (ACT)-Based Nursing Intervention

Routine Care Control Group

NO 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 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.

Interventions

Acceptance and Commitment Therapy (ACT)-Based Nursing Intervention BEHAVIORAL

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.

Acceptance and Commitment Therapy (ACT)-Based Nursing Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Related Publications (6)

• 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.

  RESULT

• 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.

  RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Hatice DURMAZ, Associate Professor

  Ataturk University

  STUDY CHAIR

Central Study Contacts

Buse N GEDIK, PhD Candidate

CONTACT

+90(544)2810589; busenurgedik.1997@gmail.com

Hatice DURMAZ, Associate Professor

CONTACT

+90(530)9218527

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate, Psychiatric Nursing, Graduate School of Health Sciences

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share