ClinicalTrials.gg
Not yet recruitingNCT07781748Updated Aug 25, 2026

Improving Quality of Informal Care for People With Schizophrenia

An interventional study of Dyadic Multicomponent Intervention (DMI) and Dyadic Benefit-Finding Intervention (DBFI) in Schizophrenia, sponsored by Chinese University of Hong Kong. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
228
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 247 studies in Schizophrenia with a site in China — 61 open to participants now, 65 under way, 4 of them phase 3. Schizophrenia · China.

Planned enrollment
55th of 212
228 · median 100
Started
2027
with 1 other
No phase
106 of 247
34 open now
Primary completion
2028-11
later than 58 of 64 live
Registered
241st of 247
by date

Among the 247 studies in Schizophrenia with a site in China, this one is the 55th largest by planned enrollment of the 212 interventional ones that give a count, is one of 2 that started in 2027, is one of 106 with no phase, reaches primary completion later than 58 of the 64 other live ones, and was the 241st registered.

Schizophrenia

3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.

Browse Schizophrenia studies →

Open to participants now

61 of the 247 studies in Schizophrenia with a site in China are open now. Recruiting first, the newest first:

56 more — sign in →

All 61 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 331 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 257 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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. 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
03

Conditions studied

  • Schizophrenia

Keywords

  • Schizophrenia
  • Quality of Informal care
  • Caregiver-patient dyad
  • Dyadic intervention
  • Psychoeducation
  • Benefit-finding
  • Randomized controlled trial
  • Rural China
  • Mental health
  • Caregiver burden
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • 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

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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
228 participants (estimated)

Study 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.

    Behavioral: Dyadic Multicomponent Intervention (DMI)

  • 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.

    Behavioral: Dyadic Benefit-Finding Intervention (DBFI)

  • 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.

Interventions

  • BehavioralDyadic 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.

  • BehavioralDyadic 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.

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

07

Study locations

1 site
  • Xinjin Second Peope's Hospital
    Chengdu, Sichuan 611432, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2027; primary completion for Nov 2028, 16 months later.

Of 753 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 16 months is below that.

Counting every sponsor, half of 766 studies reached it within 32 months; a quarter within 16 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2026
First posted
Aug 24, 2026
StartEst.
Jul 1, 2027
Primary completionEst.
Nov 30, 2028
CompletionEst.
May 31, 2029
Last update
Aug 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07781748
Responsible party
Manman Peng (Principal Investigator, Chinese University of Hong Kong) — Principal investigator
First posted
Aug 24, 2026
Start date
Jul 1, 2027 (estimated)
Primary completion
Nov 30, 2028 (estimated)
Completion
May 31, 2029 (estimated)
Last update
Aug 25, 2026

Study contacts

Manman Peng, Ph.D.
Contact
mmpeng@cuhk.edu.hk
852-3943-9372

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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