- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07545941
The Effects of an Online Family Psychoeducation Program on Expressed Emotion of Family Members and Medication Adherence of Patients With First-Episode Schizophrenia
April 22, 2026 updated by: Areerat Yongprasert, Mahidol University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
53
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bangkok
-
Bangkok Noi, Bangkok, Thailand, 10700
- Faculty of Nursing, Mahidol University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion criteria for patients were:
- 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
- ability to communicate in Thai and via telephone using the LINE application
Inclusion criteria for family members were:
- 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.
Exclusion criteria for both patients and caregivers were:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control
Participants in the control group received routine outpatient psychiatric care only.
No structured family psychoeducation was provided during the study period.
|
|
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Experimental: Mobile based Family Psychoeducation Program
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment (week 1) to post treatment at week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medication Adherence
Time Frame: From enrollment (week 1) to post treatment at week 8
|
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.
|
From enrollment (week 1) to post treatment at week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Yajai Sitthimongkol, PhD, Faculty of Nursing, Mahidol University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 26, 2025
Primary Completion (Actual)
September 14, 2025
Study Completion (Actual)
September 14, 2025
Study Registration Dates
First Submitted
April 16, 2026
First Submitted That Met QC Criteria
April 16, 2026
First Posted (Actual)
April 22, 2026
Study Record Updates
Last Update Posted (Actual)
April 27, 2026
Last Update Submitted That Met QC Criteria
April 22, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Faculty of Nursing (Registry Identifier: Mahidol University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Prohibited from laws
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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