Schizophrenia CaregiverNCT07877207
AI-Supported CBT-Based Psychoeducation for Caregivers of Individuals With Schizophrenia
A study testing Interactive AI-Supported Learning Activities and AI-Supported Cognitive Behavioral Approach-Based Psychoeducation Program in people with Schizophrenia Caregiver and Caregiver Burden, run by Kastamonu University.
Trial summary
Schizophrenia is a chronic mental disorder that affects the diagnosed individual and the family members involved in the care process from a biopsychosocial perspective. The course of the illness, the recurrence of symptoms, and the high level of care required can increase the burden on caregivers and make it difficult… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia Caregiver, Caregiver Burden, Emotional Expressivity
- What is being tested?
- Interactive AI-Supported Learning Activities and AI-Supported Cognitive Behavioral Approach-Based Psychoeducation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to 20 Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older. Able to read and write, communicate in Turkish, and possess sufficient cognitive ability to understand and complete the study questionnaires.
- A family member and primary caregiver of an individual who is being followed at a healthcare institution with a diagnosis of schizophrenia.
- Providing care to the individual diagnosed with schizophrenia for at least six months.
- The schizophrenia diagnosis of the care recipient is documented in the healthcare institution's medical records.
- Having access to an internet-connected digital device, such as a smartphone, tablet, or computer.
- Willing to participate in the artificial intelligence-supported psychoeducation program if assigned to the intervention group.
- Voluntarily agreeing to participate and providing written informed consent.
Who cannot join
- Presence of a psychotic disorder, severe depression, an active episode of bipolar disorder, or cognitive impairment that would prevent participation in the study.
- Experiencing an acute psychiatric crisis, intense grief, or severe emotional distress that would interfere with study participation.
- Inability to read and write, communicate in Turkish, understand the study questionnaires, or provide valid responses.
- The schizophrenia diagnosis of the care recipient has not been confirmed, is still under evaluation, or is not documented in the healthcare institution's medical records.
- Lack of access to an internet-connected digital device.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development of an Artificial Intelligence-Supported, Cognitive Behavioral Approach-Based Psychoeducation Program for Caregivers of Individuals Diagnosed With Schizophrenia and Evaluation of Its Effects on Caregiver Burden and Emotional Expressivity
Schizophrenia is a chronic mental disorder that affects the diagnosed individual and the family members involved in the care process from a biopsychosocial perspective. The course of the illness, the recurrence of symptoms, and the high level of care required can increase the burden on caregivers and make it difficult for them to express their emotions. Structured psychoeducation and cognitive-behavioral interventions have been reported to be beneficial for caregivers in managing these challenges.
The aim of this study is to develop an AI-supported psychoeducation program based on a cognitive-behavioral approach for caregivers of individuals diagnosed with schizophrenia and to evaluate the program's impact on caregiving burden and the level of emotional expression. The six-week program will cover topics such as the caregiver role and burden, schizophrenia, the thought-emotion-behavior cycle, recognizing and expressing emotions, effective communication, setting boundaries, seeking support, signs of relapse, and crisis planning. Content based on scientific literature will be evaluated by experts. Artificial intelligence will facilitate interaction with the content, participation in activities, the application of skills, and structured feedback. The system will not provide clinical assessments, diagnoses, or personalized treatment recommendations; participants will be referred to appropriate healthcare services in situations requiring professional evaluation.
Read more
The study will be conducted using a quasi-experimental design with pre-test and post-test control groups. A total of 88 caregivers will be recruited, with 44 assigned to the experimental group and 44 to the control group. The program will be administered to the experimental group, while the control group will receive routine care. Data will be collected using the Caregiver Descriptive Information Form, the Zarit Caregiver Burden Scale, and the Emotional Expression Scale. A Program Evaluation Form will also be used for the experimental group.
The program to be developed is expected to reduce the caregiving burden on caregivers and improve their ability to express emotions. It is anticipated that the findings will contribute to psychiatric nursing practice, the development of AI-supported psychoeducation programs, and the strengthening of psychosocial support provided to caregivers.
Read the detailed description
Schizophrenia is a severe mental disorder that affects an individual's thoughts, perceptions, emotions, behaviors, and cognitive processes and may cause substantial difficulties in social and occupational functioning. Although the nature and severity of symptoms vary among individuals, schizophrenia generally requires long-term treatment, follow-up, rehabilitation, and psychosocial support. Because of its chronic course, risk of relapse, and adverse effects on daily living skills, individuals with schizophrenia often require extensive care and support from family members. Family caregivers assume important responsibilities, including meeting daily living needs, monitoring medication use and symptoms, maintaining healthcare appointments, supporting treatment adherence, managing crises, and promoting independent living skills and social functioning
Long-term caregiving responsibilities may negatively affect caregivers' physical and psychological health, social relationships, employment, and financial circumstances. Previous studies have shown that family caregivers of individuals with schizophrenia experience substantial caregiver burden, burnout, financial difficulties, health problems, social stigma, and concerns about the patient's future . These findings indicate that caregiver burden is a multidimensional problem involving physical, psychological, social, and economic factors.
Caregivers may also experience intense emotions such as fear, sadness, anger, guilt, helplessness, and hopelessness . Suppressing these emotions or being unable to express them appropriately may further increase caregiver burden. Therefore, interventions for caregivers should not be limited to providing information about schizophrenia and caregiving. They should also help caregivers recognize their thoughts and emotions, express their feelings appropriately, and cope more effectively with caregiving-related challenges.
Psychoeducation is a structured psychosocial intervention designed to improve patients' and family members' knowledge of illness, treatment, and caregiving while developing skills related to stress management, effective communication, problem-solving, recognition of relapse warning signs, and crisis management . Family members are regarded as active partners in the treatment and caregiving process rather than passive recipients of information . Evidence suggests that family-based psychoeducational interventions may reduce caregiver burden, improve caregivers' knowledge and psychological outcomes, and contribute to reducing the risk of relapse among individuals with schizophrenia .
Incorporating a cognitive behavioral approach into psychoeducation may help caregivers identify dysfunctional automatic thoughts, understand the relationships among their thoughts, emotions, and behaviors, and develop more realistic and adaptive responses . A previous experimental study conducted with caregivers of individuals with schizophrenia demonstrated that a cognitive behavioral therapy-based stress management program reduced caregivers' stress symptoms and caregiving burden and improved their problem-focused and emotion-focused coping skills .
Artificial intelligence may enhance this process by facilitating caregivers' interaction with psychoeducational content and supporting the application and reinforcement of acquired knowledge and skills. Generative artificial intelligence can create new text, explanations, examples, and feedback based on user-provided input and previously learned data patterns . In mental healthcare, generative artificial intelligence has the potential to strengthen text-based support programs and provide personalized and interactive support . It may also facilitate the interactive delivery of structured psychoeducational content and improve user engagement .
Research on artificial intelligence-supported education and mental health interventions has increased in recent years. Studies involving artificial intelligence-based conversational agents have indicated that users can interact with these systems, complete the programs, and acquire the intended skills. However, inconsistent findings regarding psychosocial outcomes indicate that these interventions should be evaluated not only in terms of engagement and completion rates but also according to their effects on targeted clinical and psychosocial outcomes .
Digital interventions developed for family caregivers of individuals experiencing psychosis have generally been perceived as acceptable, accessible, flexible, and useful, with psychoeducation identified as one of their central components. Nevertheless, some randomized controlled studies have found no significant superiority of digital psychoeducation, peer-support, or telehealth programs over comparison conditions in caregiver well-being or caregiver burden . These findings suggest that merely providing digital content may be insufficient and that active user engagement and professional support may influence intervention effectiveness.
Existing research has generally examined psychoeducation, cognitive behavioral interventions, digital health applications, and artificial intelligence-supported education separately or in populations other than caregivers of individuals with schizophrenia. Furthermore, expressed emotion examined in some digital interventions for caregivers of individuals with psychosis differs conceptually from caregivers' ability to recognize and appropriately express their own emotions . Based on the reviewed literature, no study has simultaneously evaluated the effects of a professionally supervised, artificial intelligence-supported psychoeducation program based on a cognitive behavioral approach on caregiver burden and emotional expressivity among caregivers of individuals with schizophrenia.
In this study, a six-week artificial intelligence-supported psychoeducation program based on a cognitive behavioral approach will be developed for caregivers of individuals with schizophrenia. The standardized core content will be developed based on current scientific evidence and evaluated according to the opinions of relevant experts. The program will consist of the following six modules.
- Being tested
- Control, Interactive AI-Supported Learning Activities, AI-Supported Cognitive Behavioral Approach-Based Psychoeducation Program
- Keywords
- Schizophrenic, caregiver, artificial intelligence.
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Also called standard
Participants in the control group will receive routine care and standard information provided by the healthcare institution throughout the six-week study period. They will not receive the AI-supported, cognitive-behavioral approach-based psychoeducation program. Outcome assessments will be conducted at baseline and immediately after the six-week study period, using the same measurement tools administered to the intervention group.
Interactive AI-Supported Learning ActivitiesBehavioural
As part of the six-week program, participants will complete professionally supervised, AI-supported psychoeducational activities. These activities will include flashcards, case studies, thought-emotion-behavior logs, reflective questions, emotion recognition exercises, communication practice, and structured psychoeducational feedback. The AI system will support learning and engagement but will not make independent clinical decisions or alter the program's standardized scientific content.
AI-Supported Cognitive Behavioral Approach-Based Psychoeducation ProgramBehavioural
Also called psychoeducation
Participants in the intervention group will undergo a six-week, AI-supported psychoeducation program based on the cognitive-behavioral approach. The program consists of six structured modules: (1) recognizing the caregiving role and burden, (2) understanding schizophrenia through reliable information, (3) balancing the thought-emotion-behavior cycle, (4) recognizing and expressing emotions, (5) communicating, setting boundaries, and seeking support, and (6) developing a safety plan for relapse and crisis situations.
Artificial intelligence will be used as a supportive educational tool under professional supervision; it will not alter the program's standardized scientific content nor make independent clinical decisions. It will facilitate interaction with the program through brief explanations, information cards, case examples, thought-emotion-behavior logs, reflective questions, emotion recognition exercises, communication examples, short skill-based activities, and structured psychoe
| Study group | Role | What they receive |
|---|---|---|
| AI-Supported Psychoeducation Group | Experimental | Participants in this arm will receive a six-week, artificial intelligence-supported psychoeducation program based on a cognitive behavioral approach. The program will include six structured modules addressing the caregiving role and burden, reliable information about schizophrenia, the thought-emotion-behavior cycle, recognition and expression of emotions, communication and boundary-setting skills, and relapse and crisis planning. Artificial intelligence will be used as a supportive educational tool under professional supervision and will not make independent clinical decisions. Receives: Behavioral: Interactive AI-Supported Learning Activities; Behavioral: AI-Supported Cognitive Behavioral Approach-Based Psychoeducation Program |
| Control Group | Experimental | Participants in this arm will receive routine care and standard information provided by the healthcare institution during the study period. They will not receive the artificial intelligence-supported, cognitive behavioral approach-based psychoeducation program. Outcome measurements will be administered to both groups at baseline and after the six-week study period. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Emotional Expressivity Assessed by the Emotional Expressivity Scale
Emotional expressivity will be assessed using the Turkish version of the Emotional Expressivity Scale (EES). The scale consists of 15 items rated on a 7-point scale and includes three subscales: expression of intimacy, expression of positive emotions, and expression of negative emotions. Items 6 and 14 are reverse-scored. The total score ranges from 15 to 105, with higher scores indicating a greater tendency to express emotions. The outcome will be the change in the total and subscale scores from baseline to immediately after the six-week intervention. Changes over time will be compared between the intervention and control groups.
Measured: Baseline (T0) and immediately after the six-week intervention (T1)
Change in Caregiver Burden Assessed by the Zarit Burden Interview
Caregiver burden will be assessed using the Zarit Burden Interview (ZBI), developed by Zarit, Reever, and Bach-Peterson (1980) and adapted into Turkish by İnci and Erdem (2008). The scale consists of 22 items rated from 0 (never) to 4 (nearly always). The total score ranges from 0 to 88, with higher scores indicating greater caregiver burden. The change in total score from baseline to post-intervention will be compared between the intervention and control groups.
Measured: Baseline (T0) and immediately after the six-week intervention (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia CaregiverStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will use a randomized controlled, pretest-posttest, parallel-group design. Eligible caregivers of individuals diagnosed with schizophrenia will be randomly assigned to either the intervention group or the control group. The intervention group will receive a six-week, artificial intelligence-supported psychoeducation program based on a cognitive behavioral approach, while the control group will receive routine care. Outcomes will be assessed at baseline and immediately after the intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Havva Kaçan, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877207
- Sponsor's protocol ID
- KAEK-372026
- Status last verified
- Oct 2026
- First submitted
- 28 Aug 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be shared, as the study involves sensitive information regarding mental health and caregiving. To protect participant confidentiality and privacy, data will be used solely for the purposes specified in the research protocol and the informed consent form. Study findings may only be reported or published in an aggregated and anonymized format.
Publications
1. Akgün, N., Kongur, A., & Emen, T. (2024). Bilişsel Davranişçi Terapide Yapay Zekanin Kullanimi: Sistematik Derleme. X. Uluslararasi Turkcess Eğitim Ve Sosyal Bilimler Kongresi Tam Metin Kitabi, 142-149. https://turkcess.net/wp-content/uploads/2024/07/TURKCESS-2024-Tam-Metin-Kitabi.pdf 2. Ata, E. E., & Doğan, S. (2018). The effect of a brief cognitive behavioural stress management programme on mental status, coping with stress attitude and caregiver burden while caring for schizophrenic patients. Archives of Psychiatric Nursing, 32(1), 112-119. https://doi.org/10.1016/j.apnu.2017.10.004 3. Atalay, Z., Tamkoç, B., & Yıldız, H. (2024). Şizofrenide Bakım Yükü: "Onu Benden Sonraya Bırakma". Firat University Journal of Social Sciences, 34(2), 1021-1034. https://doi.org/10.18069/firatsbed.1341209 4. Batchelor, R., Gulshan, S., Shritharan, H., Williams, E., Henderson, C., Gillard, S., Woodham, L. A., Cornelius, V., Elkes, J., & Sin, J. (2022). Perceived acceptability and experiences of a digital psychoeducation and peer support intervention (COPe-support): Interview study with carers supporting individuals with psychosis. Journal of Medical Internet Research, 24(2), e27781. https://doi.org/10.2196/27781 5. Baysan Arabacı, L., Büyükbayram, A., Aktaş, Y., & Taşkın, N. (2018). Kronik ruhsal bozukluk tanısı alan hastaların bakım verenlerine verilen psikoeğitimin yaşadıkları güçlük ve psikososyal uyumlarına etkisi. Psikiyatri Hemşireliği Dergisi, 9(3), 175-185. https://doi.org/10.14744/phd.2018.88700 6. Bulut, M., Arslantaş, H., ve Dereboy, İ. F. (2016). Effects of psychoeducation given to caregivers of people with a diagnosis of schizophrenia. Issues in Mental Health Nursing, 37(11), 800-810. https://doi.org/10.1080/01612840.2016.1222039 7. Bulut, M., Arslantaş, H., ve Dereboy, İ. F. (2019). The effect of psychoeducation applied to the caregivers of schizophrenic patients on the emotion expressions of the caregivers and the positive and negative syndrome scale scores of the
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Artificial Intelligence-Supported, Cognitive Behavioral Approach-Based Psychoeducation Program for Caregivers of Individuals Diagnosed With Schizophrenia and Evaluation of Its Effects on Caregiver Burden and Emotional Expressivity
- ClinicalTrials.gov ID
- NCT07877207
- Acronym / sponsor ID
- KAEK-372026
- Keywords
- Schizophrenic, caregiver, artificial intelligence.
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 16 Oct 2026 (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.
Schizophrenia is a chronic mental disorder that affects the diagnosed individual and the family members involved in the care process from a biopsychosocial perspective. The course of the illness, the recurrence of symptoms, and the high level of care required can increase the burden on caregivers and make it difficult for them to express their emotions. Structured psychoeducation and cognitive-behavioral interventions have been reported to be beneficial for caregivers in managing these challenges.
The aim of this study is to develop an AI-supported psychoeducation program based on a cognitive-behavioral approach for caregivers of individuals diagnosed with schizophrenia and to evaluate the program's impact on caregiving burden and the level of emotional expression. The six-week program will cover topics such as the caregiver role and burden, schizophrenia, the thought-emotion-behavior cycle, recognizing and expressing emotions, effective communication, setting boundaries, seeking support, signs of relapse, and crisis planning. Content based on scientific literature will be evaluated by experts. Artificial intelligence will facilitate interaction with the content, participation in activities, the application of skills, and structured feedback. The system will not provide clinical assessments, diagnoses, or personalized treatment recommendations; participants will be referred to appropriate healthcare services in situations requiring professional evaluation.
The study will be conducted using a quasi-experimental design with pre-test and post-test control groups. A total of 88 caregivers will be recruited, with 44 assigned to the experimental group and 44 to the control group. The program will be administered to the experimental group, while the control group will receive routine care. Data will be collected using the Caregiver Descriptive Information Form, the Zarit Caregiver Burden Scale, and the Emotional Expression Scale. A Program Evaluation Form will also be used for the experimental group.
The program to be developed is expected to reduce the caregiving burden on caregivers and improve their ability to express emotions. It is anticipated that the findings will contribute to psychiatric nursing practice, the development of AI-supported psychoeducation programs, and the strengthening of psychosocial support provided to caregivers.
Detailed description
Schizophrenia is a severe mental disorder that affects an individual's thoughts, perceptions, emotions, behaviors, and cognitive processes and may cause substantial difficulties in social and occupational functioning. Although the nature and severity of symptoms vary among individuals, schizophrenia generally requires long-term treatment, follow-up, rehabilitation, and psychosocial support. Because of its chronic course, risk of relapse, and adverse effects on daily living skills, individuals with schizophrenia often require extensive care and support from family members. Family caregivers assume important responsibilities, including meeting daily living needs, monitoring medication use and symptoms, maintaining healthcare appointments, supporting treatment adherence, managing crises, and promoting independent living skills and social functioning
Long-term caregiving responsibilities may negatively affect caregivers' physical and psychological health, social relationships, employment, and financial circumstances. Previous studies have shown that family caregivers of individuals with schizophrenia experience substantial caregiver burden, burnout, financial difficulties, health problems, social stigma, and concerns about the patient's future . These findings indicate that caregiver burden is a multidimensional problem involving physical, psychological, social, and economic factors.
Caregivers may also experience intense emotions such as fear, sadness, anger, guilt, helplessness, and hopelessness . Suppressing these emotions or being unable to express them appropriately may further increase caregiver burden. Therefore, interventions for caregivers should not be limited to providing information about schizophrenia and caregiving. They should also help caregivers recognize their thoughts and emotions, express their feelings appropriately, and cope more effectively with caregiving-related challenges.
Psychoeducation is a structured psychosocial intervention designed to improve patients' and family members' knowledge of illness, treatment, and caregiving while developing skills related to stress management, effective communication, problem-solving, recognition of relapse warning signs, and crisis management . Family members are regarded as active partners in the treatment and caregiving process rather than passive recipients of information . Evidence suggests that family-based psychoeducational interventions may reduce caregiver burden, improve caregivers' knowledge and psychological outcomes, and contribute to reducing the risk of relapse among individuals with schizophrenia .
Incorporating a cognitive behavioral approach into psychoeducation may help caregivers identify dysfunctional automatic thoughts, understand the relationships among their thoughts, emotions, and behaviors, and develop more realistic and adaptive responses . A previous experimental study conducted with caregivers of individuals with schizophrenia demonstrated that a cognitive behavioral therapy-based stress management program reduced caregivers' stress symptoms and caregiving burden and improved their problem-focused and emotion-focused coping skills .
Artificial intelligence may enhance this process by facilitating caregivers' interaction with psychoeducational content and supporting the application and reinforcement of acquired knowledge and skills. Generative artificial intelligence can create new text, explanations, examples, and feedback based on user-provided input and previously learned data patterns . In mental healthcare, generative artificial intelligence has the potential to strengthen text-based support programs and provide personalized and interactive support . It may also facilitate the interactive delivery of structured psychoeducational content and improve user engagement .
Research on artificial intelligence-supported education and mental health interventions has increased in recent years. Studies involving artificial intelligence-based conversational agents have indicated that users can interact with these systems, complete the programs, and acquire the intended skills. However, inconsistent findings regarding psychosocial outcomes indicate that these interventions should be evaluated not only in terms of engagement and completion rates but also according to their effects on targeted clinical and psychosocial outcomes .
Digital interventions developed for family caregivers of individuals experiencing psychosis have generally been perceived as acceptable, accessible, flexible, and useful, with psychoeducation identified as one of their central components. Nevertheless, some randomized controlled studies have found no significant superiority of digital psychoeducation, peer-support, or telehealth programs over comparison conditions in caregiver well-being or caregiver burden . These findings suggest that merely providing digital content may be insufficient and that active user engagement and professional support may influence intervention effectiveness.
Existing research has generally examined psychoeducation, cognitive behavioral interventions, digital health applications, and artificial intelligence-supported education separately or in populations other than caregivers of individuals with schizophrenia. Furthermore, expressed emotion examined in some digital interventions for caregivers of individuals with psychosis differs conceptually from caregivers' ability to recognize and appropriately express their own emotions . Based on the reviewed literature, no study has simultaneously evaluated the effects of a professionally supervised, artificial intelligence-supported psychoeducation program based on a cognitive behavioral approach on caregiver burden and emotional expressivity among caregivers of individuals with schizophrenia.
In this study, a six-week artificial intelligence-supported psychoeducation program based on a cognitive behavioral approach will be developed for caregivers of individuals with schizophrenia. The standardized core content will be developed based on current scientific evidence and evaluated according to the opinions of relevant experts. The program will consist of the following six modules.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study will use a randomized controlled, pretest-posttest, parallel-group design. Eligible caregivers of individuals diagnosed with schizophrenia will be randomly assigned to either the intervention group or the control group. The intervention group will receive a six-week, artificial intelligence-supported psychoeducation program based on a cognitive behavioral approach, while the control group will receive routine care. Outcomes will be assessed at baseline and immediately after the intervention.
| Arm | Type | Receives |
|---|---|---|
| AI-Supported Psychoeducation Group | Experimental | Behavioral: Interactive AI-Supported Learning Activities, Behavioral: AI-Supported Cognitive Behavioral Approach-Based Psychoeducation ProgramParticipants in this arm will receive a six-week, artificial intelligence-supported psychoeducation program based on a cognitive behavioral approach. The program will include six structured modules addressing the caregiving role and burden, reliable information about schizophrenia, the thought-emotion-behavior cycle, recognition and expression of emotions, communication and boundary-setting skills, and relapse and crisis planning. Artificial intelligence will be used as a supportive educational tool under professional supervision and will not make independent clinical decisions. |
| Control Group | Experimental | Other: ControlParticipants in this arm will receive routine care and standard information provided by the healthcare institution during the study period. They will not receive the artificial intelligence-supported, cognitive behavioral approach-based psychoeducation program. Outcome measurements will be administered to both groups at baseline and after the six-week study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 years or older. Able to read and write, communicate in Turkish, and possess sufficient cognitive ability to understand and complete the study questionnaires.
- A family member and primary caregiver of an individual who is being followed at a healthcare institution with a diagnosis of schizophrenia.
- Providing care to the individual diagnosed with schizophrenia for at least six months.
- The schizophrenia diagnosis of the care recipient is documented in the healthcare institution's medical records.
- Having access to an internet-connected digital device, such as a smartphone, tablet, or computer.
Key exclusion criteria (6 listed)
- Presence of a psychotic disorder, severe depression, an active episode of bipolar disorder, or cognitive impairment that would prevent participation in the study.
- Experiencing an acute psychiatric crisis, intense grief, or severe emotional distress that would interfere with study participation.
- Inability to read and write, communicate in Turkish, understand the study questionnaires, or provide valid responses.
- The schizophrenia diagnosis of the care recipient has not been confirmed, is still under evaluation, or is not documented in the healthcare institution's medical records.
- Lack of access to an internet-connected digital device.
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 |
|---|---|---|
| ControlAlso: standardParticipants in the control group will receive routine care and standard information provided by the healthcare institution throughout the six-week study period. They will not receive the AI-supported, cognitive-behavioral approach-based psychoeducation program. Outcome assessments will be conducted at baseline and immediately after the six-week study period, using the same measurement tools administered to the intervention group. | Other | Control Group |
| Interactive AI-Supported Learning ActivitiesAs part of the six-week program, participants will complete professionally supervised, AI-supported psychoeducational activities. These activities will include flashcards, case studies, thought-emotion-behavior logs, reflective questions, emotion recognition exercises, communication practice, and structured psychoeducational feedback. The AI system will support learning and engagement but will not make independent clinical decisions or alter the program's standardized scientific content. | Behavioural | AI-Supported Psychoeducation Group |
| AI-Supported Cognitive Behavioral Approach-Based Psychoeducation ProgramAlso: psychoeducationParticipants in the intervention group will undergo a six-week, AI-supported psychoeducation program based on the cognitive-behavioral approach. The program consists of six structured modules: (1) recognizing the caregiving role and burden, (2) understanding schizophrenia through reliable information, (3) balancing the thought-emotion-behavior cycle, (4) recognizing and expressing emotions, (5) communicating, setting boundaries, and seeking support, and (6) developing a safety plan for relapse and crisis situations. Artificial intelligence will be used as a supportive educational tool under professional supervision; it will not alter the program's standardized scientific content nor make independent clinical decisions. It will facilitate interaction with the program through brief explanations, information cards, case examples, thought-emotion-behavior logs, reflective questions, emotion recognition exercises, communication examples, short skill-based activities, and structured psychoe | Behavioural | AI-Supported Psychoeducation Group |
Primary outcome
Change in Emotional Expressivity Assessed by the Emotional Expressivity Scale
Time frame: Baseline (T0) and immediately after the six-week intervention (T1)
Emotional expressivity will be assessed using the Turkish version of the Emotional Expressivity Scale (EES). The scale consists of 15 items rated on a 7-point scale and includes three subscales: expression of intimacy, expression of positive emotions, and expression of negative emotions. Items 6 and 14 are reverse-scored. The total score ranges from 15 to 105, with higher scores indicating a greater tendency to express emotions. The outcome will be the change in the total and subscale scores from baseline to immediately after the six-week intervention. Changes over time will be compared between the intervention and control groups.
Change in Caregiver Burden Assessed by the Zarit Burden Interview
Time frame: Baseline (T0) and immediately after the six-week intervention (T1)
Caregiver burden will be assessed using the Zarit Burden Interview (ZBI), developed by Zarit, Reever, and Bach-Peterson (1980) and adapted into Turkish by İnci and Erdem (2008). The scale consists of 22 items rated from 0 (never) to 4 (nearly always). The total score ranges from 0 to 88, with higher scores indicating greater caregiver burden. The change in total score from baseline to post-intervention will be compared between the intervention and control groups.
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 16 Oct 2026.
- Results publication1. Akgün, N., Kongur, A., & Emen, T. (2024). Bilişsel Davranişçi Terapide Yapay Zekanin Kullanimi: Sistematik Derleme. X. Uluslararasi Turkcess Eğitim Ve Sosyal Bilimler Kongresi Tam Metin Kitabi, 142-149. https://turkcess.net/wp-content/uploads/2024/07/TURKCESS-2024-Tam-Metin-Kitabi.pdf 2. Ata, E. E., & Doğan, S. (2018). The effect of a brief cognitive behavioural stress management programme on mental status, coping with stress attitude and caregiver burden while caring for schizophrenic patients. Archives of Psychiatric Nursing, 32(1), 112-119. https://doi.org/10.1016/j.apnu.2017.10.004 3. Atalay, Z., Tamkoç, B., & Yıldız, H. (2024). Şizofrenide Bakım Yükü: "Onu Benden Sonraya Bırakma". Firat University Journal of Social Sciences, 34(2), 1021-1034. https://doi.org/10.18069/firatsbed.1341209 4. Batchelor, R., Gulshan, S., Shritharan, H., Williams, E., Henderson, C., Gillard, S., Woodham, L. A., Cornelius, V., Elkes, J., & Sin, J. (2022). Perceived acceptability and experiences of a digital psychoeducation and peer support intervention (COPe-support): Interview study with carers supporting individuals with psychosis. Journal of Medical Internet Research, 24(2), e27781. https://doi.org/10.2196/27781 5. Baysan Arabacı, L., Büyükbayram, A., Aktaş, Y., & Taşkın, N. (2018). Kronik ruhsal bozukluk tanısı alan hastaların bakım verenlerine verilen psikoeğitimin yaşadıkları güçlük ve psikososyal uyumlarına etkisi. Psikiyatri Hemşireliği Dergisi, 9(3), 175-185. https://doi.org/10.14744/phd.2018.88700 6. Bulut, M., Arslantaş, H., ve Dereboy, İ. F. (2016). Effects of psychoeducation given to caregivers of people with a diagnosis of schizophrenia. Issues in Mental Health Nursing, 37(11), 800-810. https://doi.org/10.1080/01612840.2016.1222039 7. Bulut, M., Arslantaş, H., ve Dereboy, İ. F. (2019). The effect of psychoeducation applied to the caregivers of schizophrenic patients on the emotion expressions of the caregivers and the positive and negative syndrome scale scores of the
- Individual participant dataSharing planned: Undecided. Individual participant data will not be shared, as the study involves sensitive information regarding mental health and caregiving. To protect participant confidentiality and privacy, data will be used solely for the purposes specified in the research protocol and the informed consent form. Study findings may only be reported or published in an aggregated and anonymized format.
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SCHIZOPHRENIA 1 (Disorder)
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.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive AI-Supported Learning Activities and AI-Supported Cognitive Behavioral Approach-Based Psychoeducation Program in people with Schizophrenia Caregiver and Caregiver Burden, run by Kastamonu 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 7 inclusion and 6 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 16 Oct 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 Havva KAÇAN, Assos. Prof (0366 280 4133 ext. 09, hkacan@kastamonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Emotional Expressivity Assessed by the Emotional Expressivity Scale (time frame: Baseline (T0) and immediately after the six-week intervention (T1)). The study lists 2 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 NCT07877207, which also lists 1 linked publication.
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 16 Oct 2026.