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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Thailand
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: control
Participants in the control group received routine outpatient psychiatric care only. No structured family psychoeducation was provided during the study period.
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.
Behavioral: Mobile based family psychoeducation program
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mahidol University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 14, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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