Improving Quality of Informal Care for People With Schizophrenia

Sponsor
Chinese University of Hong Kong
Study ID
NCT07781748
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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. Does the support program improve the quality of care that family caregivers provide and that people with schizophrenia receive? 2. Does the program improve the health and well-being of people with schizophrenia and their caregivers? Researchers will compare three groups to see which works best: 1. A full support program with health education, physical activities, and spiritual activities 2. A program with health education only 3. A control group that receives only routine care Each person with schizophrenia takes part together with their family caregiver as a pair. Participants will: 1. Take part in an 8-week program in their community 2. Answer survey questions three times: before the program, right after it ends, and 6 months later 3. Some participants will also join interviews to share their experiences

Key Dates

First listed
Aug 24, 2026
Start date
Jul 1, 2027
Status verified
Aug 2026
Primary completion
Nov 30, 2028
Completion
May 31, 2029

Study Design

Enrollment
228 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention Group 1: Dyadic Multicomponent Intervention (DMI)
    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.
  • Active Comparator: Intervention Group 2: Dyadic Benefit-Finding Intervention (DBFI)
    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.
  • No Intervention: Control Group: Routine Care
    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.

Primary Outcome Measure

Positive Aspects of Caregiving [ Time Frame: Baseline (T0), immediately after the intervention (T1), and 6 months post-intervention (T2) ]

Central Contacts

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