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NCT Number: NCT07781748

Improving Quality of Informal Care for People With Schizophrenia

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

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Key information

Conditions

Schizophrenia Behavior Behavioral Symptoms Caregiver Burden Mental Disorders Personal Satisfaction Psychological Well-Being Schizophrenia Spectrum and Other Psychotic Disorders Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Primary outcomes

  1. Positive Aspects of Caregiving

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

    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.

  2. Exemplary Care

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

    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.

  3. Commitment to Care

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

    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.

  4. Adequacy of Care (Activities of Daily Living)

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

    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.

  5. Satisfaction with Care

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

    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.

Secondary outcomes

  1. Caregiver Burnout / Strain

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

    Caregiver strain reported by informal caregivers, measured with the 13-item Modified Caregiver Strain Index (M-CSI) on a 3-point scale. Higher scores indicate greater caregiver strain.

  2. Caregiver Psychological Health

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

    Psychological health reported by informal caregivers, measured with the 21-item Depression, Anxiety and Stress Scale (DASS-21) on a 4-point scale. Higher scores indicate greater depression, anxiety, and stress.

  3. Treatment Adherence (Care Recipient)

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

    Treatment adherence of persons with schizophrenia, rated by health professionals using the observer-rated Kemp Compliance Scale (KCS) on a 7-point Likert scale. Higher scores indicate better treatment adherence.

  4. Social Functioning (Care Recipient)

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

    Social functioning of persons with schizophrenia, assessed by health professionals using the 10-item Social Disability Screening Schedule (SDSS). Higher scores indicate greater social disability.

Study contacts

Contact information is provided by the study sponsor or research team.

Manman Peng, Ph.D.

CONTACT

[email protected]

852-3943-9372

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Improving Quality of Informal Care for Persons With Schizophrenia: A Randomized Controlled Trial of Multicomponent Dyadic Intervention

Important dates

Study start
2027
Primary completion
2028
Study completion
2029
First posted
Aug 24, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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