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Chronic Mental DisordersNCT06764199

The Effect of an Acceptance and Commitment Therapy-Based Psychoeducation Program

A study testing Acceptance and Commitment Therapy in people with Chronic Mental Disorders, run by Ataturk University at 1 site in Turkey (Türkiye).

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

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Mental Disorders
What is being tested?
Acceptance and Commitment Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2025to 30 Dec 2025
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ceylan AKSOY lecturer contact

+905360595757

ceylangulmez.11@gmail.com

Turkey (Türkiye)1 site
  • ERZURUM

    Erzurum, Ağrı, 04100

    ceylan ATATÜRK ÜNİVERSİTESİ, +905360595757, ceylangulmez.11@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of an Acceptance and Commitment Therapy-Based Psychoeducation Program Applied to Individuals with Chronic Mental Disorders on Patients' Perceptions of Stigmatization, Functionality, and Quality of Life Levels

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.

Read more

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.

Being tested
Acceptance and Commitment Therapy

What participants receive

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

  • Acceptance and Commitment TherapyBehavioural

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

Study groups in NCT06764199
Study groupRoleWhat they receive
Intervention GroupExperimentalAcceptance and Commitment Therapy will be applied.
Receives: Behavioral: Acceptance and Commitment Therapy
Participant GroupNo interventionOnly data collection was carried out. No attempt was made by the researcher during the study.
Control GroupNo interventionOnly data collection was carried out. No attempt was made by the researcher during the study.

What is being measured

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

  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.

    Measured: 1 year

Secondary outcomes (2)
  1. Social Functioning Assessment Scale

    It is a 19-item Likert-type scale developed for schizophrenia patients. Each item is in the range of 1-3 points. It is seen that the scale consists of four factors as interpersonal relations and entertainment, self-care, independent living skills and working life. The score that can be obtained from the scale is in the range of 19-57, and a high score from the scale means that the individual has a high level of social functionality.

    Measured: 1 year

  2. Quality of Life Scale for Patients with Schizophrenia

    The Quality of Life Scale for Patients with Schizophrenia is an interviewer-administered tool assessed through a semi-structured interview. It consists of 4 subscales-interpersonal relationships, occupational role, psychological symptoms, and use of daily objects and activities-and includes a total of 21 items. Higher scores indicate better functioning. The scale's Cronbach's alpha reliability coefficient is reported as 0.80.

    Measured: 1 year

Timeline

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

  1. First posted8 Jan 2025
  2. Study start1 Jan 2025 (estimated)
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2025 (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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06764199
Sponsor's protocol ID
B.30.2.ATA.0.01.00/618
Status last verified
Dec 2024
First submitted
19 Dec 2024
Last updated
8 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Commitment Therapy in people with Chronic Mental Disorders, run by Ataturk University at 1 site in Turkey (Türkiye).

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 4 inclusion and 4 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 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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 Ceylan AKSOY lecturer (+905360595757, ceylangulmez.11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-Stigma Scale (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 8 Jan 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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