First- Episode SchizophreniaNCT07545941
The Effects of an Online Family Psychoeducation Program on Expressed Emotion of Family Members and Medication Adherence of Patients With First-Episode Schizophrenia
A study testing Mobile based family psychoeducation program in people with First- Episode Schizophrenia, run by Mahidol University at 1 site in Thailand.
Trial summary
This study examined the effects of family psychoeducation program via line application on expressed emotion of family members and medication adherence in patients with first-episode schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- First- Episode Schizophrenia
- What is being tested?
- Mobile based family psychoeducation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteThailand
- Study dates
- 26 May 2025to 14 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- a diagnosis of schizophrenia according to the International Classification of Diseases, 10th Revision ICD-10 (F20.00 to F20.09), with a duration of illness not exceeding five years from the date of initial diagnosis
- received oral antipsychotic treatment for at least 6 months but no longer than five years
- aged between 18 to 35 years.
- mild psychotic symptoms severity, defined as a total score of 18 to 36 on the Brief Psychiatric Rating Scale (BPRS)
- documented history of medication non-adherence, as recorded in medical records
- availability of a primary caregiver and
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- ability to communicate in Thai and via telephone using the LINE application
- being a family member living in the same household as the patients and serving as the primary caregiver for at least six months without financial compensation
- Aged 20 to 60 years
- ownership of a mobile phone capable of using the LINE application
- no prior participation in family psychoeducation programs
- ability to speak, read, and write Thai
- no history of psychiatric disorders, including schizophrenia, bipolar disorder, or major depressive disorder.
Who cannot join
- acute exacerbation of psychotic symptoms requiring hospitalization during the study period
- missing one or more scheduled intervention sessions
- inability of the researcher to contact the family caregiver within one week despite repeated attempts.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Nursing, Mahidol University
Bangkok Noi, Bangkok, 10700
About this study
This study examined the effects of family psychoeducation program via line application on expressed emotion of family members and medication adherence in patients with first-episode schizophrenia.
Read the detailed description
The investigators examined if LINE family Psychoeducation Program plus routine treatment is effective for reducing Expressed Emotion and improving Medication Adherence in real practice. Family members and patients with first-episode schizophrenia received a 7-week online family psychoeducation program via the LINE application, while the control group received routine care. Family caregivers completed the Thai Expressed Emotion Scale (TEES) and the Medication Adherence Report Scale (MARS). Baseline assessments were conducted prior to group allocation. Post-intervention assessments were conducted at week 8. Intervention fidelity was monitored through weekly quizzes and researcher oversight.
- Conditions
- First- Episode Schizophrenia
- Being tested
- Mobile based family psychoeducation program
- Keywords
- Mobile -based family psychoeducation, Expressed emotion, Medication adherence, First-episode schizophrenia, Randomized controlled trial
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile based family psychoeducation programBehavioural
A structured 7week Online Psychoeducation Program delivered via the LINE application. The program was developed based on the Vulnerability Stress Model and aimed to reduce expressed emotion among family caregivers and improve medication adherence in patients with first-episode schizophrenia. The intervention consisted of seven video-based sessions, each lasting no more than 10 minutes, delivered weekly over seven consecutive weeks through a private LINE chat. Content covered program orientation, knowledge about schizophrenia, medication management and adherence, stigma and coping strategies, expressed emotion and family communication, stress management, and early warning signs of relapse.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Participants in the control group received routine outpatient psychiatric care only. No structured family psychoeducation was provided during the study period. |
| Mobile based Family Psychoeducation Program | Experimental | Mobile based Family Psychoeducation Program, In addition to routine treatment, a structured 7week Online Psychoeducation Program delivered via the LINE application. The program was developed based on the Vulnerability Stress Model and aimed to reduce expressed emotion among family caregivers and improve medication adherence in patients with first-episode schizophrenia. The intervention consisted of seven video-based sessions, each lasting no more than 10 minutes, delivered weekly over seven consecutive weeks through a private LINE chat. Content covered program orientation, knowledge about schizophrenia, medication management and adherence, stigma and coping strategies, expressed emotion and family communication, stress management, and early warning signs of relapse. Receives: Behavioral: Mobile based family psychoeducation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expressed Emotion
Expressed Emotion was measured using the Thai Expressed Emotion Scale (TEES), developed by Sunpaveerawong. The instrument consists of 49 items encompassing seven components of expressed emotion. Negative expressed emotion includes Critical Comments (items 1-7), Hostility (items 8-15), Emotional Overinvolvement (items 16-20), and Emotional Under involvement (items 42-49), totaling 28 items. Positive expressed emotion includes Warmth (items 21-27), Positive Remarks (items 28-34), and Emotion Regulation (items 35-41), totaling 21 items.
Measured: From enrollment (week 1) to post treatment at week 8
Secondary outcomes (1)
Medication Adherence
was assessed using the Medication Adherence Report Scale (MARS), The instrument consists of 5 items evaluating non-adherent behaviors: forgetting to take medication, altering dosage, temporarily stopping medication, intentionally skipping doses, and taking less medication than prescribed. Each item is rated on a 5-point Likert scale (1-5). A total score of 25 indicates full adherence, whereas scores <25 indicate some degree of non-adherence.
Measured: From enrollment (week 1) to post treatment at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start26 May 2025
- Primary completion14 Sep 2025
- Study completion14 Sep 2025
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 First- Episode SchizophreniaStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A structured 7week Online Psychoeducation Program delivered via the LINE application. The program was developed based on the Vulnerability Stress Model and aimed to reduce expressed emotion among family caregivers and improve medication adherence in patients with first-episode schizophrenia. The intervention consisted of seven video-based sessions, each lasting no more than 10 minutes, delivered weekly over seven consecutive weeks through a private LINE chat. Content covered program orientation, knowledge about schizophrenia, medication management and adherence, stigma and coping strategies, expressed emotion and family communication, stress management, and early warning signs of relapse.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Areerat Yongprasert, Mahidol University
- Investigators
- Yajai Sitthimongkol, PhD, Study chair, Faculty of Nursing, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545941
- Sponsor's protocol ID
- Faculty of Nursing
- Other IDs
- Faculty of Nursing
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Prohibited from laws
Publications
Budiono W, Kantono K, Kristianto FC, Avanti C, Herawati F. Psychoeducation Improved Illness Perception and Expressed Emotion of Family Caregivers of Patients with Schizophrenia. Int J Environ Res Public Health. 2021 Jul 15;18(14):7522. doi: 10.3390/ijerph18147522.
PubMed 34299972
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Online Family Psychoeducation Program on Expressed Emotion of Family Members and Medication Adherence of Patients With First-Episode Schizophrenia
- ClinicalTrials.gov ID
- NCT07545941
- Acronym / sponsor ID
- Faculty of Nursing
- Conditions
- First- Episode Schizophrenia
- Keywords
- Mobile -based family psychoeducation, Expressed emotion, Medication adherence, First-episode schizophrenia, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 26 May 2025 (actual)
- Primary completion
- 14 Sep 2025 (actual)
- Study completion
- 14 Sep 2025 (actual)
- First posted
- 22 Apr 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 study examined the effects of family psychoeducation program via line application on expressed emotion of family members and medication adherence in patients with first-episode schizophrenia.
Detailed description
The investigators examined if LINE family Psychoeducation Program plus routine treatment is effective for reducing Expressed Emotion and improving Medication Adherence in real practice. Family members and patients with first-episode schizophrenia received a 7-week online family psychoeducation program via the LINE application, while the control group received routine care. Family caregivers completed the Thai Expressed Emotion Scale (TEES) and the Medication Adherence Report Scale (MARS). Baseline assessments were conducted prior to group allocation. Post-intervention assessments were conducted at week 8. Intervention fidelity was monitored through weekly quizzes and researcher oversight.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A structured 7week Online Psychoeducation Program delivered via the LINE application. The program was developed based on the Vulnerability Stress Model and aimed to reduce expressed emotion among family caregivers and improve medication adherence in patients with first-episode schizophrenia. The intervention consisted of seven video-based sessions, each lasting no more than 10 minutes, delivered weekly over seven consecutive weeks through a private LINE chat. Content covered program orientation, knowledge about schizophrenia, medication management and adherence, stigma and coping strategies, expressed emotion and family communication, stress management, and early warning signs of relapse.
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Participants in the control group received routine outpatient psychiatric care only. No structured family psychoeducation was provided during the study period. |
| Mobile based Family Psychoeducation Program | Experimental | Behavioral: Mobile based family psychoeducation programMobile based Family Psychoeducation Program, In addition to routine treatment, a structured 7week Online Psychoeducation Program delivered via the LINE application. The program was developed based on the Vulnerability Stress Model and aimed to reduce expressed emotion among family caregivers and improve medication adherence in patients with first-episode schizophrenia. The intervention consisted of seven video-based sessions, each lasting no more than 10 minutes, delivered weekly over seven consecutive weeks through a private LINE chat. Content covered program orientation, knowledge about schizophrenia, medication management and adherence, stigma and coping strategies, expressed emotion and family communication, stress management, and early warning signs of relapse. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- a diagnosis of schizophrenia according to the International Classification of Diseases, 10th Revision ICD-10 (F20.00 to F20.09), with a duration of illness not exceeding five years from the date of initial diagnosis
- received oral antipsychotic treatment for at least 6 months but no longer than five years
- aged between 18 to 35 years.
- mild psychotic symptoms severity, defined as a total score of 18 to 36 on the Brief Psychiatric Rating Scale (BPRS)
- documented history of medication non-adherence, as recorded in medical records
Key exclusion criteria (3 listed)
- acute exacerbation of psychotic symptoms requiring hospitalization during the study period
- missing one or more scheduled intervention sessions
- inability of the researcher to contact the family caregiver within one week despite repeated attempts.
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 |
|---|---|---|
| Mobile based family psychoeducation programA structured 7week Online Psychoeducation Program delivered via the LINE application. The program was developed based on the Vulnerability Stress Model and aimed to reduce expressed emotion among family caregivers and improve medication adherence in patients with first-episode schizophrenia. The intervention consisted of seven video-based sessions, each lasting no more than 10 minutes, delivered weekly over seven consecutive weeks through a private LINE chat. Content covered program orientation, knowledge about schizophrenia, medication management and adherence, stigma and coping strategies, expressed emotion and family communication, stress management, and early warning signs of relapse. | Behavioural | Mobile based Family Psychoeducation Program |
Primary outcome
Expressed Emotion
Time frame: From enrollment (week 1) to post treatment at week 8
Expressed Emotion was measured using the Thai Expressed Emotion Scale (TEES), developed by Sunpaveerawong. The instrument consists of 49 items encompassing seven components of expressed emotion. Negative expressed emotion includes Critical Comments (items 1-7), Hostility (items 8-15), Emotional Overinvolvement (items 16-20), and Emotional Under involvement (items 42-49), totaling 28 items. Positive expressed emotion includes Warmth (items 21-27), Positive Remarks (items 28-34), and Emotion Regulation (items 35-41), totaling 21 items.
1 secondary outcome
Medication Adherence
Time frame: From enrollment (week 1) to post treatment at week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Background: PubMed 34299972Budiono W, Kantono K, Kristianto FC, Avanti C, Herawati F. Psychoeducation Improved Illness Perception and Expressed Emotion of Family Caregivers of Patients with Schizophrenia. Int J Environ Res Public Health. 2021 Jul 15;18(14):7522. doi: 10.3390/ijerph18147522.
- Individual participant dataSharing planned: No. Prohibited from laws
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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. This study is not recruiting at the moment.
Yajai Sitthimongkol, PhD study chair
Faculty of Nursing, Mahidol 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 Mobile based family psychoeducation program in people with First- Episode Schizophrenia, run by Mahidol University at 1 site in Thailand.
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 13 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: finished, as of the sponsor's last update on 27 Apr 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expressed Emotion (time frame: From enrollment (week 1) to post treatment at week 8). 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 NCT07545941, 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 27 Apr 2026.