An interventional study of Control and Interactive AI-Supported Learning Activities in Schizophrenia Caregiver, Caregiver Burden and Emotional Expressivity, sponsored by Kastamonu University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Kastamonu University · Not applicable, Interventional, and Supportive care
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.
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.
439 studies on the registry are indexed under Caregiver Burden; 154 are open to participants now.
This study's planned enrollment of 88 is above the median of 75 across 346 interventional studies indexed under Caregiver Burden.
Browse Caregiver Burden studies →Kastamonu University is the lead sponsor of 48 studies on the registry; 11 are open to participants now.
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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.
Exclusion Criteria:
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.
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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.
Behavioral: Interactive AI-Supported Learning Activities · Behavioral: AI-Supported Cognitive Behavioral Approach-Based Psychoeducation Program
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.
Other: Control
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.
Also known as: standard
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.
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
Also known as: psychoeducation
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.
Time frame: 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.
Time frame: Baseline (T0) and immediately after the six-week intervention (T1)
No study locations are listed for this record.
Plan to share: 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.
Start is estimated for Oct 2026; primary completion for Dec 2026, 1 month later.
Of 253 non-industry interventional studies with no phase under Caregiver Burden, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 32. This study's planned 1 month is below that.
Counting every sponsor, half of 261 studies reached it within 16 months; a quarter within 7 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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