NCT07781748

Brief Summary

The goal of this clinical trial is to learn if a new support program can improve the quality of informal care for people with schizophrenia in rural China. Informal care means the unpaid care given by family members. Quality of care involves both the care that family members give and the care that people with schizophrenia receive. The study also looks at whether the program improves the health and well-being of both groups. The main questions it aims to answer are:

  1. 1.Does the support program improve the quality of care that family caregivers provide and that people with schizophrenia receive?
  2. 2.Does the program improve the health and well-being of people with schizophrenia and their caregivers?
  3. 3.A full support program with health education, physical activities, and spiritual activities
  4. 4.A program with health education only
  5. 5.A control group that receives only routine care
  6. 6.Take part in an 8-week program in their community
  7. 7.Answer survey questions three times: before the program, right after it ends, and 6 months later
  8. 8.Some participants will also join interviews to share their experiences

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
228

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
23mo left

Started Jul 2027

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
10 months until next milestone

Study Start

First participant enrolled

July 1, 2027

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2029

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

1.4 years

First QC Date

August 20, 2026

Last Update Submit

August 21, 2026

Conditions

Schizophrenia

Keywords

SchizophreniaQuality of Informal careCaregiver-patient dyadDyadic interventionPsychoeducationBenefit-findingRandomized controlled trialRural ChinaMental healthCaregiver burden

Outcome Measures

Primary Outcomes (5)

  • Positive Aspects of Caregiving

    Positive aspects of caregiving reported by informal caregivers, measured with the 11-item Positive Aspects of Caregiving Scale (C-PAC) on a 5-point Likert scale. Higher scores indicate more positive appraisal of caregiving.

    Baseline (T0), immediately after the intervention (T1), and 6 months post-intervention (T2)

  • Exemplary Care

    Quality of caregiving reported by informal caregivers, measured with the 11-item Exemplary Care Scale on a 4-point scale. Higher scores indicate higher-quality caregiving.

    Baseline (T0), immediately after the intervention (T1), and 6 months post-intervention (T2)

  • Commitment to Care

    Commitment to caregiving reported by informal caregivers, measured with the 12-item Valued Living Questionnaire Adapted to Caregiving (VLQAC) on a 10-point Likert scale. Higher scores indicate stronger commitment to valued caregiving.

    Baseline (T0), immediately after the intervention (T1), and 6 months post-intervention (T2)

  • Adequacy of Care (Activities of Daily Living)

    Adequacy of care received, reported by persons with schizophrenia, measured with an 18-item activities of daily living (ADL) scale on a 4-point scale. Higher scores indicate greater adequacy of care received.

    Baseline (T0), immediately after the intervention (T1), and 6 months post-intervention (T2)

  • Satisfaction with Care

    Satisfaction with care received, reported by persons with schizophrenia, measured with the Client Assessment of Treatment Scale (CAT) on a 10-point scale. Higher scores indicate greater satisfaction with care.

    Baseline (T0), immediately after the intervention (T1), and 6 months post-intervention (T2)

Secondary Outcomes (4)

  • Caregiver Burnout / Strain

    Baseline (T0), immediately after the intervention (T1), and 6 months post-intervention (T2)

  • Caregiver Psychological Health

    Baseline (T0), immediately after the intervention (T1), and 6 months post-intervention (T2)

  • Treatment Adherence (Care Recipient)

    Baseline (T0), immediately after the intervention (T1), and 6 months post-intervention (T2)

  • Social Functioning (Care Recipient)

    Baseline (T0), immediately after the intervention (T1), and 6 months post-intervention (T2)

Study Arms (3)

Intervention Group 1: Dyadic Multicomponent Intervention (DMI)

EXPERIMENTAL

This arm includes 38 dyads (38 persons with schizophrenia and 38 informal caregivers, 76 participants). Participants receive the full Dyadic Multicomponent Intervention (DMI), which combines psychoeducation, physical exercise, and spiritual training, over 8 weeks.

Behavioral: Dyadic Multicomponent Intervention (DMI)

Intervention Group 2: Dyadic Benefit-Finding Intervention (DBFI)

ACTIVE COMPARATOR

This arm includes 38 dyads (38 persons with schizophrenia and 38 informal caregivers, 76 participants). Participants receive only the Dyadic Benefit-Finding Intervention (DBFI) over 8 weeks, without the exercise or spiritual training components.

Behavioral: Dyadic Benefit-Finding Intervention (DBFI)

Control Group: Routine Care

NO INTERVENTION

This arm includes 38 dyads (38 persons with schizophrenia and 38 informal caregivers, 76 participants). Participants receive only routine care over the 8-week period, with no additional study intervention.

Interventions

Dyadic Multicomponent Intervention (DMI)BEHAVIORAL

An 8-week program delivered face-to-face to each person-with-schizophrenia and informal-caregiver dyad together, one 120-minute session per week. Each session combines three components: Dyadic Benefit-Finding Intervention (psychoeducation and positive reappraisal, 60 minutes), Dyadic Exercise Intervention (guided mind-body exercise such as Qigong, Tai Chi, or Baduanjin, 30 minutes), and Dyadic Spiritual Training (mindfulness and life review, 30 minutes). Content is tailored to each dyad and delivered by a trained team of psychiatrists, exercise physiologists, and social workers.

Intervention Group 1: Dyadic Multicomponent Intervention (DMI)
Dyadic Benefit-Finding Intervention (DBFI)BEHAVIORAL

An 8-week program delivered face-to-face to each person-with-schizophrenia and informal-caregiver dyad together, one 60-minute session per week. It provides psychoeducation about schizophrenia and caregiving, benefit-finding diaries, and guided practice in positive reappraisal, helping dyads recognize positive experiences and coping resources. This arm does not include the exercise or spiritual training components. It is delivered by a trained team of psychiatrists and social workers.

Intervention Group 2: Dyadic Benefit-Finding Intervention (DBFI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persons with schizophrenia (PwS): Aged 18 years or older; Diagnosed with schizophrenia by a psychiatrist, with the diagnosis validated using SCID-5; Have not previously participated in any intervention studies; Functional and able to communicate and take part in group activities; Able to provide written informed consent
  • Informal caregivers (ICGs): Aged 18 years or older; Provide unpaid care to a person with schizophrenia; Have not previously participated in any intervention studies; Able to provide written informed consent

You may not qualify if:

  • Persons with schizophrenia (PwS): Likely to engage in risky behaviors (e.g., suicide or violence), or a history of alcohol or substance abuse; Identified by professionals as unsuitable to participate (e.g., unable to sustain meaningful conversation); Having other schizophrenia spectrum disorders or co-existing neurodevelopmental disorders
  • Informal caregivers (ICGs): Likely to engage in risky behaviors (e.g., suicide or violence); Identified by professionals as unsuitable to participate (e.g., having a mental illness or unable to understand instructions)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinjin Second Peope's Hospital

Chengdu, Sichuan, 611432, China

Location

MeSH Terms

Conditions

SchizophreniaPsychological Well-BeingCaregiver Burden

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPersonal SatisfactionBehaviorStress, PsychologicalBehavioral Symptoms

Central Study Contacts

Manman Peng, Ph.D.

CONTACT

852-3943-9372mmpeng@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 20, 2026

First Posted

August 24, 2026

Study Start (Estimated)

July 1, 2027

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

May 31, 2029

Last Updated

August 25, 2026

Record last verified: 2026-08

Locations

CN(1)