SchizophreniaNCT07781748
Improving Quality of Informal Care for People With Schizophrenia
A study testing Dyadic Multicomponent Intervention (DMI) and Dyadic Benefit-Finding Intervention (DBFI) in people with Schizophrenia, run by Chinese University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Dyadic Multicomponent Intervention (DMI) and Dyadic Benefit-Finding Intervention (DBFI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2027to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xinjin Second Peope's Hospital
Chengdu, Sichuan, 611432
Huailin Yin, 86-28-8241-0372, 870458156@qq.com
About this study
Official title: Improving Quality of Informal Care for Persons With Schizophrenia: A Randomized Controlled Trial of Multicomponent Dyadic Intervention
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:
Read more
- Does the support program improve the quality of care that family caregivers provide and that people with schizophrenia receive?
- 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:
- A full support program with health education, physical activities, and spiritual activities
- A program with health education only
- A control group that receives only routine care
Each person with schizophrenia takes part together with their family caregiver as a pair. Participants will:
- Take part in an 8-week program in their community
- Answer survey questions three times: before the program, right after it ends, and 6 months later
- Some participants will also join interviews to share their experiences
- Conditions
- Schizophrenia
- Being tested
- Dyadic Multicomponent Intervention (DMI), Dyadic Benefit-Finding Intervention (DBFI)
- Keywords
- Schizophrenia, Quality of Informal care, Caregiver-patient dyad, Dyadic intervention, Psychoeducation, Benefit-finding, Randomized controlled trial, Rural China, Mental health, Caregiver burden
- Medical subject headings
- Schizophrenia, Psychological Well-Being, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic Multicomponent Intervention (DMI)Behavioural
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)Behavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (T0), immediately after the intervention (T1), and 6 months post-intervention (T2)
Secondary outcomes (4)
Caregiver Burnout / Strain
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.
Measured: Baseline (T0), immediately after the intervention (T1), and 6 months post-intervention (T2)
Caregiver Psychological Health
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.
Measured: Baseline (T0), immediately after the intervention (T1), and 6 months post-intervention (T2)
Treatment Adherence (Care Recipient)
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.
Measured: Baseline (T0), immediately after the intervention (T1), and 6 months post-intervention (T2)
Social Functioning (Care Recipient)
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.
Measured: Baseline (T0), immediately after the intervention (T1), and 6 months post-intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Jul 2027 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manman Peng, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781748
- Sponsor's protocol ID
- SBRE-24-0025B
- Other IDs
- 14604926
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Informal Care for Persons With Schizophrenia: A Randomized Controlled Trial of Multicomponent Dyadic Intervention
- ClinicalTrials.gov ID
- NCT07781748
- Acronym / sponsor ID
- SBRE-24-0025B
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Quality of Informal care, Caregiver-patient dyad, Dyadic intervention, Psychoeducation, Benefit-finding, Randomized controlled trial, Rural China
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the support program improve the quality of care that family caregivers provide and that people with schizophrenia receive?
- 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:
- A full support program with health education, physical activities, and spiritual activities
- A program with health education only
- A control group that receives only routine care
Each person with schizophrenia takes part together with their family caregiver as a pair. Participants will:
- Take part in an 8-week program in their community
- Answer survey questions three times: before the program, right after it ends, and 6 months later
- Some participants will also join interviews to share their experiences
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group 1: Dyadic Multicomponent Intervention (DMI) | Experimental | Behavioral: 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. |
| Intervention Group 2: Dyadic Benefit-Finding Intervention (DBFI) | Active comparator | Behavioral: 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyadic Multicomponent Intervention (DMI)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. | Behavioural | Intervention Group 1: Dyadic Multicomponent Intervention (DMI) |
| Dyadic Benefit-Finding Intervention (DBFI)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. | Behavioural | Intervention Group 2: Dyadic Benefit-Finding Intervention (DBFI) |
Primary outcome
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.
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.
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.
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.
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.
4 secondary outcomes
Caregiver Burnout / Strain
Time frame: Baseline (T0), immediately after the intervention (T1), and 6 months post-intervention (T2)
Caregiver Psychological Health
Time frame: Baseline (T0), immediately after the intervention (T1), and 6 months post-intervention (T2)
Treatment Adherence (Care Recipient)
Time frame: Baseline (T0), immediately after the intervention (T1), and 6 months post-intervention (T2)
Social Functioning (Care Recipient)
Time frame: Baseline (T0), immediately after the intervention (T1), and 6 months post-intervention (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic Multicomponent Intervention (DMI) and Dyadic Benefit-Finding Intervention (DBFI) in people with Schizophrenia, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manman Peng, Ph.D. (852-3943-9372, mmpeng@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Aspects of Caregiving (time frame: Baseline (T0), immediately after the intervention (T1), and 6 months post-intervention (T2)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.