NCT06764199

Brief Summary

The concept of mental disorders is defined as health conditions characterized by various changes in individuals' emotions, thoughts, behaviors, and cognitive processes. The most significant feature of mental disorders is the frequent recurrence and persistence of psychiatric symptoms. Due to their widespread prevalence in society and their substantial contribution to disability, mental disorders are among the groups of diseases requiring early intervention, particularly due to their chronic nature. Chronic mental disorders are associated with hallucinations, delusions, self-stigmatization, and reduced quality of life. Chronic conditions such as schizophrenia, bipolar disorder, and schizoaffective disorder are reported in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) to be linked with impairments in occupational and social functionality. In the literature, these chronic mental disorders are often referred to as "severe," "persistent," or "serious" mental illnesses due to their destructive effects on cognitive, executive, and social skills. Chronic mental disorders, which cause significant disability, are considered a public health issue. Even when the symptoms of diseases such as schizophrenia, bipolar disorder, and schizoaffective disorder are treated, the resulting functional impairments often persist for an extended period, posing a significant burden on both individuals and society. Studies conducted in hospital and community mental health centers have indicated that individuals diagnosed with schizophrenia and bipolar disorder experience impairments in social functioning and significant disabilities. Research highlights various challenges faced by individuals with chronic mental disorders, such as deterioration in social relationships, stigmatization, lack of motivation, insufficient self-care, and challenges in daily living skills like financial management, communication, and shopping. Another critical issue in individuals with chronic mental disorders is self-stigmatization, which is closely related to social disadvantage and functionality. Studies examining the self-stigmatization levels of these individuals have reported an increase in such behaviors, identifying self-stigma as a significant global concern in the literature. Consequently, it is evident that psychosocial interventions addressing functionality, insight, and self-stigmatization levels, which are thought to be interrelated, should be prioritized for individuals with chronic mental disorders. Addressing these issues underscores the importance of psychiatric rehabilitation activities designed for this population. While pharmacotherapy is the first choice in the treatment of chronic mental disorders, research indicates that medications alone do not achieve clinically significant improvements in negative and cognitive symptoms, nor do they produce the desired outcomes in functionality. Current guidelines emphasize that the inclusion of psychosocial interventions alongside pharmacotherapy can yield more favorable outcomes in the prognosis of psychotic disorders. Treatment of chronic mental disorders should not only focus on mitigating psychotic symptoms but also aim to improve quality of life, social, and occupational functioning. Acceptance and Commitment Therapy (ACT), a relatively new psychotherapy, incorporates psychopathological hypotheses and interventions grounded in contextual behavioral sciences and Relational Frame Theory. Limited studies have shown that ACT applied to patients with psychosis reduces levels of depression and anxiety, enhances psychological resilience, facilitates independent daily living, and thereby improves functionality. In light of these findings, psychosocial interventions for individuals with chronic mental disorders are deemed highly valuable. It is anticipated that ACT applied to these individuals may positively alter the course of the illness, reduce self-stigmatization and internalized shame, contribute to improved functionality, and ultimately enhance quality of life. Conducting research to explore the significance and effectiveness of these interventions is of utmost importance.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

January 8, 2025

Status Verified

December 1, 2024

Enrollment Period

12 months

First QC Date

December 19, 2024

Last Update Submit

January 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-Stigma Scale

    It was developed to accurately assess self-stigma in individuals with mental illnesses by ensuring that patients understand the questions and that the items reflect the stigma they experience within their cultural context. The scale consists of 17 items, with no reverse-scored items. Responses to each item are rated on a 5-point Likert scale: 1 = strongly disagree, 2 = somewhat disagree, 3 = moderately agree, 4 = generally agree, and 5 = completely agree. Higher scores indicate higher levels of self-stigma. The scale's Cronbach's alpha correlation coefficient is 0.93, indicating high reliability.

    1 year

Secondary Outcomes (2)

  • Social Functioning Assessment Scale

    1 year

  • Quality of Life Scale for Patients with Schizophrenia

    1 year

Study Arms (3)

Intervention Group

EXPERIMENTAL

Acceptance and Commitment Therapy will be applied.

Behavioral: Acceptance and Commitment Therapy

Participant Group

NO INTERVENTION

Only data collection was carried out. No attempt was made by the researcher during the study.

Control Group

NO INTERVENTION

Only data collection was carried out. No attempt was made by the researcher during the study.

Interventions

Acceptance and Commitment Therapy (ACT), a relatively new psychotherapy, incorporates psychopathological hypotheses and interventions based on contextual behavioral sciences and Relational Frame Theory.

Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being registered with a Community Mental Health Center (CMHC).
  • Providing consent to participate in the study, either personally or through a legal guardian.
  • Being between the ages of 18 and 65. Being literate.
  • According to the treatment team and records, having been in a stable condition for at least six months.

You may not qualify if:

  • Being under 18 years of age.
  • Presence of an organic psychotic disorder.
  • Experiencing an episode during the intervention process.
  • Refusing to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ERZURUM

Erzurum, Ağrı, 04100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Acceptance and Commitment Therapy

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Ceylan AKSOY lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2024

First Posted

January 8, 2025

Study Start

January 1, 2025

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

January 8, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations