SCHIZOPHRENIA 1 (Disorder)NCT07656558
ACT-Based Psychoeducation for Caregivers of Patients With Schizophrenia
A study testing Acceptance and Commitment Therapy (ACT)-Based Psychoeducation Program in people with SCHIZOPHRENIA 1 (Disorder), run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to examine the effects of an Acceptance and Commitment Therapy (ACT)-based psychoeducation program on expressed emotion, perceived family burden, and psychological flexibility among caregivers of patients with schizophrenia attending a Community Mental Health Center. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- SCHIZOPHRENIA 1 (Disorder)
- What is being tested?
- Acceptance and Commitment Therapy (ACT)-Based Psychoeducation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 15 Jan 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Living with an individual diagnosed with schizophrenia who has been followed and actively receiving services from a Community Mental Health Center for at least one year.
- Being the primary caregiver responsible for the care of the individual diagnosed with schizophrenia.
- Having been involved in the care and treatment of the individual diagnosed with schizophrenia for at least 12 months prior to the study.
- Being between 18 and 65 years of age.
- Being literate.
- Being able to speak and understand Turkish.
- Willing to participate in the study and providing informed consent.
Who cannot join
- Having a medically diagnosed psychiatric disorder.
- Having a diagnosis of an organic mental disorder or intellectual disability.
- Having a physical impairment that may interfere with participation in the study or data collection process (e.g., hearing or speech impairment).
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
Nevşehir State Hospital Community Mental Health Center
Nevşehir, Merkez, 50040
Sinem Sönmez, MSc, -90+539-816-4391
About this study
Official title: The Effect of Acceptance and Commitment Therapy-Based Psychoeducation Applied to Caregivers of Schizophrenia Patients Attending the Community Mental Health Center on Emotional Expression, Perceived Family Burden, and Psychological Flexibility: A Randomized Controlled Trial
This randomized controlled trial aims to examine the effects of an Acceptance and Commitment Therapy (ACT)-based psychoeducation program on expressed emotion, perceived family burden, and psychological flexibility among caregivers of patients with schizophrenia attending a Community Mental Health Center.
The main questions this study aims to answer are:
Read more
- Does ACT-based psychoeducation reduce expressed emotion among caregivers of patients with schizophrenia?
- Does ACT-based psychoeducation reduce perceived family burden among caregivers of patients with schizophrenia?
- Does ACT-based psychoeducation improve psychological flexibility among caregivers of patients with schizophrenia?
Researchers will randomly assign eligible caregivers to either an intervention group receiving an 8-session ACT-based psychoeducation program or a control group receiving routine care.
Participants will:
- Complete assessment measures before the intervention (pre-test).
- Participate in 8 ACT-based psychoeducation sessions if assigned to the intervention group.
- Continue receiving routine care if assigned to the control group.
- Complete assessment measures immediately after the intervention (post-test).
- Complete follow-up assessments at 1 month and 3 months after the intervention.
Read the detailed description
Schizophrenia is a severe mental disorder that affects millions of people worldwide. It has devastating consequences that impact not only the health of affected individuals but also their social, occupational, and economic functioning. The effects of schizophrenia extend beyond patients and significantly influence family members who assume caregiving responsibilities. The behavioral and emotional difficulties experienced by individuals with schizophrenia may expose caregivers to various physical and psychological challenges.
Family caregivers frequently experience emotions such as anger, helplessness, anxiety, and uncertainty, and they may have difficulty managing these emotional reactions. With the increasing adoption of community-based mental health care services, families have assumed greater responsibility for the care of individuals with schizophrenia. As a result, caregivers often face substantial caregiving demands, contributing to increased family burden and emotional distress.
Psychological flexibility refers to the ability to maintain or change behavior in accordance with personal values and long-term goals despite the presence of distressing thoughts, emotions, or experiences. Caregivers of individuals with schizophrenia are frequently exposed to stressful situations and negative emotional experiences that may adversely affect their psychological flexibility.
Acceptance and Commitment Therapy (ACT) is a behavioral intervention that aims to enhance psychological flexibility through acceptance, mindfulness, values clarification, and committed action. Previous studies have suggested that ACT-based interventions may help family members develop more adaptive beliefs and attitudes, reduce psychological distress, and improve coping with caregiving challenges. Through the acceptance process, caregivers may learn to engage more effectively with difficult thoughts and emotions associated with long-term caregiving responsibilities.
The aim of this randomized controlled trial is to determine the effects of an ACT-based psychoeducation program on expressed emotion, perceived family burden, and psychological flexibility among caregivers of patients with schizophrenia attending a Community Mental Health Center. Eligible caregivers will be randomly assigned to either an intervention group receiving an eight-session ACT-based psychoeducation program or a control group receiving routine care. Outcome measures will be assessed at baseline (pre-test), immediately after the intervention (post-test), at 1-month follow-up, and at 3-month follow-up.
- Conditions
- SCHIZOPHRENIA 1 (Disorder)
- Being tested
- Acceptance and Commitment Therapy (ACT)-Based Psychoeducation Program
- Keywords
- Acceptance and Commitment Therapy, Psychoeducation, Community Mental Health Center, Family Caregiver, Expressed Emotion, Family Burden, Psychological Flexibility, Randomized Controlled Trial, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)-Based Psychoeducation ProgramBehavioural
The intervention consists of an Acceptance and Commitment Therapy (ACT)-based psychoeducation program developed in accordance with expert opinions. The program is delivered in a group format and includes eight structured sessions lasting approximately 60-90 minutes each. Session topics include introduction to the program and ACT principles, contact with the present moment, acceptance, cognitive defusion, self-as-context (observing self), values, values-based actions, and review and evaluation of the psychoeducation process. The intervention is designed to reduce expressed emotion and perceived family burden and to improve psychological flexibility among caregivers of patients with schizophrenia attending a Community Mental Health Center.
| Study group | Role | What they receive |
|---|---|---|
| ACT-Based Psychoeducation Group | Experimental | Caregivers of patients with schizophrenia attending a Community Mental Health Center will receive an Acceptance and Commitment Therapy (ACT)-based psychoeducation program developed in accordance with expert opinions. The intervention consists of eight structured group sessions lasting approximately 60-90 minutes each. Session topics include introduction to the program and ACT principles, contact with the present moment, acceptance, cognitive defusion, self-as-context (observing self), values, values-based actions, and review of the psychoeducation process. Outcome measures will be assessed at baseline (pre-test), immediately after the intervention (post-test), at 1-month follow-up, and at 3-month follow-up. Receives: Behavioral: Acceptance and Commitment Therapy (ACT)-Based Psychoeducation Program |
| Routine Care Group | No intervention | Caregivers of patients with schizophrenia attending a Community Mental Health Center will continue to receive routine care and services provided by the center. Outcome measures will be assessed at baseline (pre-test), immediately after the intervention period (post-test), at 1-month follow-up, and at 3-month follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Family Burden
Change in scores obtained from the Family Burden Scale.
Measured: Time Frame: Baseline (pre-test), immediately post-intervention (post-test), 1-month follow-up, and 3-month follow-up.
Psychological Flexibility
Change in scores obtained from the Psychological Flexibility Scale.
Measured: Time Frame: Baseline (pre-test), immediately post-intervention (post-test), 1-month follow-up, and 3-month follow-up.
Expressed Emotion
Change in scores obtained from the Expressed Emotion Scale.
Measured: Time Frame: Baseline (pre-test), immediately post-intervention (post-test), 1-month follow-up, and 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SCHIZOPHRENIA 1 (Disorder)Studies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Participants will be randomly assigned to either an intervention group or a control group in a parallel-group design. The intervention group will receive an eight-session Acceptance and Commitment Therapy (ACT)-based psychoeducation program, while the control group will receive routine care. Outcome measures will be assessed at baseline (pre-test), immediately after the intervention (post-test), at 1-month follow-up, and at 3-month follow-up.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hülya Arslantaş, Aydin Adnan Menderes University
- Investigators
- Hülya Arslantaş, Principal investigator, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656558
- Sponsor's protocol ID
- E-50107718-050.04-782534
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The decision to share the study results will be made during the study period or when it is concluded.
Publications
Berksun OE (1992) Şizofrenide aile faktörü: expressed emotion (EE): ölçek geliştirme ve uyarlama denemesi. Doktora Tezi, Ankara Üniversitesi Sağlık Bilimleri Enstitüsü, Ankara.
Arslantas, H., Adana, F., Dereboy, F., Altinyazar, V., İnal, S., Ildirli, G. S., Kirci, Ç. (2011). Algılanan Aile Yükü Ölçeği'nin Türkçe Sürümünün Geçerlilik ve Güvenilirlik Çalışması. Archives of Neuropsychiatry/Nöropsikiyatri Arşivi, 48(1): 53-8.
Karakuş, S. ve Akbay, S. E. (2020). Psikolojik esneklik ölçeği: Uyarlama, geçerlik ve güvenirlik çalışması. Mersin Üniversitesi Eğitim Fakültesi Dergisi, 16(1), 32-43.
Tunc E, Orak OS, Avci IA. Acceptance and Commitment Therapy-Based Counseling Among Family Members of Individuals With Schizophrenia: A Randomized Controlled Trial. J Psychosoc Nurs Ment Health Serv. 2025 Aug;63(8):24-32. doi: 10.3928/02793695-20250314-02. Epub 2025 Mar 27.
PubMed 40145690Wright, S. R., Graham, C. D., Houghton, R., Ghiglieri, C. and Berry, E. (2023). Acceptance and commitment therapy (ACT) for caregivers of children with chronic conditions: A mixed methods systematic review (MMSR) of efficacy, process, and acceptance. Journal of Contextual Behavioral Science, 27, 72-97.
Koujalgi, S. R., & Nayak, R. B. (2021). Family burden among caregivers of patients with chronic mental disorders. BLDE University Journal of Health Sciences, 6(2), 164-167.
James, R., & Tungol, J. (2022). Wellness Enhancement Therapy (WET) to Reduce Expressed Emotion and Subjective Burden among the Family Caregivers of Schizophrenia Patients: A Pilot Study. Indian Journal of Positive Psychology, 13(1), 1-5.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acceptance and Commitment Therapy-Based Psychoeducation Applied to Caregivers of Schizophrenia Patients Attending the Community Mental Health Center on Emotional Expression, Perceived Family Burden, and Psychological Flexibility: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07656558
- Acronym / sponsor ID
- E-50107718-050.04-782534
- Conditions
- SCHIZOPHRENIA 1 (Disorder)
- Keywords
- Acceptance and Commitment Therapy, Psychoeducation, Community Mental Health Center, Family Caregiver, Expressed Emotion, Family Burden, Psychological Flexibility, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 18 Jun 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.
This randomized controlled trial aims to examine the effects of an Acceptance and Commitment Therapy (ACT)-based psychoeducation program on expressed emotion, perceived family burden, and psychological flexibility among caregivers of patients with schizophrenia attending a Community Mental Health Center.
The main questions this study aims to answer are:
- Does ACT-based psychoeducation reduce expressed emotion among caregivers of patients with schizophrenia?
- Does ACT-based psychoeducation reduce perceived family burden among caregivers of patients with schizophrenia?
- Does ACT-based psychoeducation improve psychological flexibility among caregivers of patients with schizophrenia?
Researchers will randomly assign eligible caregivers to either an intervention group receiving an 8-session ACT-based psychoeducation program or a control group receiving routine care.
Participants will:
- Complete assessment measures before the intervention (pre-test).
- Participate in 8 ACT-based psychoeducation sessions if assigned to the intervention group.
- Continue receiving routine care if assigned to the control group.
- Complete assessment measures immediately after the intervention (post-test).
- Complete follow-up assessments at 1 month and 3 months after the intervention.
Detailed description
Schizophrenia is a severe mental disorder that affects millions of people worldwide. It has devastating consequences that impact not only the health of affected individuals but also their social, occupational, and economic functioning. The effects of schizophrenia extend beyond patients and significantly influence family members who assume caregiving responsibilities. The behavioral and emotional difficulties experienced by individuals with schizophrenia may expose caregivers to various physical and psychological challenges.
Family caregivers frequently experience emotions such as anger, helplessness, anxiety, and uncertainty, and they may have difficulty managing these emotional reactions. With the increasing adoption of community-based mental health care services, families have assumed greater responsibility for the care of individuals with schizophrenia. As a result, caregivers often face substantial caregiving demands, contributing to increased family burden and emotional distress.
Psychological flexibility refers to the ability to maintain or change behavior in accordance with personal values and long-term goals despite the presence of distressing thoughts, emotions, or experiences. Caregivers of individuals with schizophrenia are frequently exposed to stressful situations and negative emotional experiences that may adversely affect their psychological flexibility.
Acceptance and Commitment Therapy (ACT) is a behavioral intervention that aims to enhance psychological flexibility through acceptance, mindfulness, values clarification, and committed action. Previous studies have suggested that ACT-based interventions may help family members develop more adaptive beliefs and attitudes, reduce psychological distress, and improve coping with caregiving challenges. Through the acceptance process, caregivers may learn to engage more effectively with difficult thoughts and emotions associated with long-term caregiving responsibilities.
The aim of this randomized controlled trial is to determine the effects of an ACT-based psychoeducation program on expressed emotion, perceived family burden, and psychological flexibility among caregivers of patients with schizophrenia attending a Community Mental Health Center. Eligible caregivers will be randomly assigned to either an intervention group receiving an eight-session ACT-based psychoeducation program or a control group receiving routine care. Outcome measures will be assessed at baseline (pre-test), immediately after the intervention (post-test), at 1-month follow-up, and at 3-month follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either an intervention group or a control group in a parallel-group design. The intervention group will receive an eight-session Acceptance and Commitment Therapy (ACT)-based psychoeducation program, while the control group will receive routine care. Outcome measures will be assessed at baseline (pre-test), immediately after the intervention (post-test), at 1-month follow-up, and at 3-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| ACT-Based Psychoeducation Group | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT)-Based Psychoeducation ProgramCaregivers of patients with schizophrenia attending a Community Mental Health Center will receive an Acceptance and Commitment Therapy (ACT)-based psychoeducation program developed in accordance with expert opinions. The intervention consists of eight structured group sessions lasting approximately 60-90 minutes each. Session topics include introduction to the program and ACT principles, contact with the present moment, acceptance, cognitive defusion, self-as-context (observing self), values, values-based actions, and review of the psychoeducation process. Outcome measures will be assessed at baseline (pre-test), immediately after the intervention (post-test), at 1-month follow-up, and at 3-month follow-up. |
| Routine Care Group | No intervention | –Caregivers of patients with schizophrenia attending a Community Mental Health Center will continue to receive routine care and services provided by the center. Outcome measures will be assessed at baseline (pre-test), immediately after the intervention period (post-test), at 1-month follow-up, and at 3-month follow-up. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Living with an individual diagnosed with schizophrenia who has been followed and actively receiving services from a Community Mental Health Center for at least one year.
- Being the primary caregiver responsible for the care of the individual diagnosed with schizophrenia.
- Having been involved in the care and treatment of the individual diagnosed with schizophrenia for at least 12 months prior to the study.
- Being between 18 and 65 years of age.
- Being literate.
Key exclusion criteria (3 listed)
- Having a medically diagnosed psychiatric disorder.
- Having a diagnosis of an organic mental disorder or intellectual disability.
- Having a physical impairment that may interfere with participation in the study or data collection process (e.g., hearing or speech impairment).
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 Therapy (ACT)-Based Psychoeducation ProgramThe intervention consists of an Acceptance and Commitment Therapy (ACT)-based psychoeducation program developed in accordance with expert opinions. The program is delivered in a group format and includes eight structured sessions lasting approximately 60-90 minutes each. Session topics include introduction to the program and ACT principles, contact with the present moment, acceptance, cognitive defusion, self-as-context (observing self), values, values-based actions, and review and evaluation of the psychoeducation process. The intervention is designed to reduce expressed emotion and perceived family burden and to improve psychological flexibility among caregivers of patients with schizophrenia attending a Community Mental Health Center. | Behavioural | ACT-Based Psychoeducation Group |
Primary outcome
Perceived Family Burden
Time frame: Time Frame: Baseline (pre-test), immediately post-intervention (post-test), 1-month follow-up, and 3-month follow-up.
Change in scores obtained from the Family Burden Scale.
Psychological Flexibility
Time frame: Time Frame: Baseline (pre-test), immediately post-intervention (post-test), 1-month follow-up, and 3-month follow-up.
Change in scores obtained from the Psychological Flexibility Scale.
Expressed Emotion
Time frame: Time Frame: Baseline (pre-test), immediately post-intervention (post-test), 1-month follow-up, and 3-month follow-up.
Change in scores obtained from the Expressed Emotion Scale.
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 18 Jun 2026.
- BackgroundBerksun OE (1992) Şizofrenide aile faktörü: expressed emotion (EE): ölçek geliştirme ve uyarlama denemesi. Doktora Tezi, Ankara Üniversitesi Sağlık Bilimleri Enstitüsü, Ankara.
- BackgroundArslantas, H., Adana, F., Dereboy, F., Altinyazar, V., İnal, S., Ildirli, G. S., Kirci, Ç. (2011). Algılanan Aile Yükü Ölçeği'nin Türkçe Sürümünün Geçerlilik ve Güvenilirlik Çalışması. Archives of Neuropsychiatry/Nöropsikiyatri Arşivi, 48(1): 53-8.
- BackgroundKarakuş, S. ve Akbay, S. E. (2020). Psikolojik esneklik ölçeği: Uyarlama, geçerlik ve güvenirlik çalışması. Mersin Üniversitesi Eğitim Fakültesi Dergisi, 16(1), 32-43.
- Background: PubMed 40145690Tunc E, Orak OS, Avci IA. Acceptance and Commitment Therapy-Based Counseling Among Family Members of Individuals With Schizophrenia: A Randomized Controlled Trial. J Psychosoc Nurs Ment Health Serv. 2025 Aug;63(8):24-32. doi: 10.3928/02793695-20250314-02. Epub 2025 Mar 27.
- BackgroundWright, S. R., Graham, C. D., Houghton, R., Ghiglieri, C. and Berry, E. (2023). Acceptance and commitment therapy (ACT) for caregivers of children with chronic conditions: A mixed methods systematic review (MMSR) of efficacy, process, and acceptance. Journal of Contextual Behavioral Science, 27, 72-97.
- BackgroundKoujalgi, S. R., & Nayak, R. B. (2021). Family burden among caregivers of patients with chronic mental disorders. BLDE University Journal of Health Sciences, 6(2), 164-167.
- BackgroundJames, R., & Tungol, J. (2022). Wellness Enhancement Therapy (WET) to Reduce Expressed Emotion and Subjective Burden among the Family Caregivers of Schizophrenia Patients: A Pilot Study. Indian Journal of Positive Psychology, 13(1), 1-5.
- Individual participant dataSharing planned: No. The decision to share the study results will be made during the study period or when it is concluded.
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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.
Hülya Arslantaş principal investigator
Aydin Adnan Menderes University
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 (ACT)-Based Psychoeducation Program in people with SCHIZOPHRENIA 1 (Disorder), run by Aydin Adnan Menderes 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 7 inclusion and 3 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 18 Jun 2026. 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 Sinem Sönmez, Msc (09+539-816-4391, snmz.sinem@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Family Burden (time frame: Time Frame: Baseline (pre-test), immediately post-intervention (post-test), 1-month follow-up, and 3-month follow-up.). The study lists 3 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 NCT07656558, which also lists 7 linked publications.
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 18 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.