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).
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
Turkey (Türkiye)1 site
ERZURUM
Erzurum, Ağrı, 04100
ceylan ATATÜRK ÜNİVERSİTESİ, +905360595757, ceylangulmez.11@gmail.com
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.
- Conditions
- Chronic Mental Disorders
- 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 group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Acceptance and Commitment Therapy will be applied. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted8 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Mental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceylan Aksoy, Ataturk University
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06764199
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/618
- Conditions
- Chronic Mental Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Acceptance and Commitment TherapyAcceptance and Commitment Therapy will be applied. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyAcceptance and Commitment Therapy (ACT), a relatively new psychotherapy, incorporates psychopathological hypotheses and interventions based on contextual behavioral sciences and Relational Frame Theory. | Behavioural | Intervention Group |
Primary outcome
Self-Stigma Scale
Time frame: 1 year
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.
2 secondary outcomes
Social Functioning Assessment Scale
Time frame: 1 year
Quality of Life Scale for Patients with Schizophrenia
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.