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SCHIZOPHRENIA 1 (Disorder)NCT07661225

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

A study testing Acceptance and Commitment Therapy (ACT)-Based Nursing Intervention in people with SCHIZOPHRENIA 1 (Disorder), run by Ataturk University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
SCHIZOPHRENIA 1 (Disorder)
What is being tested?
Acceptance and Commitment Therapy (ACT)-Based Nursing Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
No sites listed yet
Study dates
Oct 2026to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Buse N GEDIK, PhD Candidate contact

+90(544)2810589

busenurgedik.1997@gmail.com

Hatice DURMAZ, Associate Professor contact

+90(530)9218527

About this study

Official title: 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).

Read the 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.

Being tested
Acceptance and Commitment Therapy (ACT)-Based Nursing Intervention
Keywords
Acceptance and Commitment Therapy, ACT-based nursing intervention, Social cognition, Emotion regulation, Psychological flexibility
Medical subject headings
Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acceptance and Commitment Therapy (ACT)-Based Nursing InterventionBehavioural

    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.

Study groups in NCT07661225
Study groupRoleWhat they receive
Acceptance and Commitment Therapy (ACT)-Based Nursing InterventionExperimental32 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.
Receives: Behavioral: Acceptance and Commitment Therapy (ACT)-Based Nursing Intervention
Routine Care Control GroupNo intervention32 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (before Session 1, Week 0) and immediately following Session 8 (Week 8)

  2. 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.

    Measured: Baseline (before Session 1, Week 0) and immediately following Session 8 (Week 8)

  3. 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.

    Measured: Baseline (before Session 1, Week 0) and immediately following Session 8 (Week 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07661225
Sponsor's protocol ID
BuseNur_GEDİK_DoktoraTezi
Status last verified
Jun 2026
First submitted
4 Jun 2026
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 22035996

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Commitment Therapy (ACT)-Based Nursing Intervention in people with SCHIZOPHRENIA 1 (Disorder), run by Ataturk University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Buse N GEDIK, PhD Candidate (+90(544)2810589, busenurgedik.1997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Social Cognition (time frame: Baseline (before Session 1, Week 0) and immediately following Session 8 (Week 8)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07661225, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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