NCT07545941

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 16, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

Mobile -based family psychoeducationExpressed emotionMedication adherenceFirst-episode schizophreniaRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment (week 1) to post treatment at week 8

Secondary Outcomes (1)

  • Medication Adherence

    From enrollment (week 1) to post treatment at week 8

Study Arms (2)

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.

Behavioral: Mobile based family psychoeducation program

Interventions

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.

Mobile based Family Psychoeducation Program

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 34299972BACKGROUND

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Yajai Sitthimongkol, PhD

    Faculty of Nursing, Mahidol University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 22, 2026

Study Start

May 26, 2025

Primary Completion

September 14, 2025

Study Completion

September 14, 2025

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Prohibited from laws

Locations