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Assessing a WeChat-based Integrative Family Intervention (WIFI) for Schizophrenia

Assessing a WeChat-based Integrative Family Intervention (WIFI) for Schizophrenia: a Stepped-wedge Cluster Randomized Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04393896
Enrollment
240
Registered
2020-05-19
Start date
2021-09-01
Completion date
2022-06-30
Last updated
2021-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, Family intervention, WeChat, Stepped wedge, Psycho-education, Peer support, Professional support

Brief summary

The study aims to test both the effectiveness and implementation strategy of a WeChat-based integrative family intervention (WIFI) to support family caregiving of schizophrenia in China.

Detailed description

The investigators will conduct a type 2 hybrid effectiveness-implementation study to test both the effect of and the implementation process of a WeChat-based integrative family intervention (WIFI) program. The program will include three core components: 1) psycho-education through WeChat Official Account (WOA), 2) peer support through WeChat chat group, and 3) professional support through WeChat video chat. A rigorous stepped wedge cluster randomized trial will be used to evaluate the implementation, effectiveness, and cost of the WIFI program. The WIFI program will be implemented in 12 communities affiliated with the Changsha psychiatric hospital through the free medicine delivery process in the 686 Program. 20 families of schizophrenia will be selected from each community. The 12 communities will be randomized to one of four fixed sequences every two months during an 8-month intervention period in four clusters of 3 communities each. All clusters will receive the usual financial benefit of the Reward Policy as the control condition, and then successively and in random order, will cross over to the WIFI program at 2-month intervals until the study ends. Outcomes will be assessed for both family caregivers and the family member with schizophrenia. Family caregivers will be assessed for their knowledge and skills about caregiving, social support and coping, perceived stigma, caregiver burden, family functioning, positive feelings, and psychological distress. Schizophrenia individuals will be assessed for their symptoms and functioning, quality of life, recovery and re-hospitalization. Cost data such as costs of the intervention, health care utilization, and costs associated with lost productivity will also be collected. In addition, the investigators will collect process data including fidelity and quality of program implementation as well as users' attitudes will also be collected. Treatment effects will be estimated using generalized linear maximum likelihood mixed modeling (GLMM) with clusters as a random effect and time as a fixed effect. Cost-effectiveness analysis will be performed from the societal perspective using incremental cost effectiveness ratios (ICERs). Qualitative analysis will use the grounded theory approach and immersion-crystallization process. All statistical analyses will be conducted according to the intention-to-treat principle.

Interventions

BEHAVIORALWeChat-based integrative family intervention (WIFI)

The WIFI program will include three key components: psycho-education through WeChat Official Account publications, peer-support through a WeChat chat group, and professional support through WeChat private chat and video call

Sponsors

Xiangya Hospital of Central South University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

people living with schizophrenia, family caregivers, psychiatrists and researchers cannot be blinded for the allocated treatment. The program team conducting the intervention will not be involved in assessing any of the outcomes. The analyses of the data by the researcher will be blinded.

Intervention model description

This is a stepped-wedge cluster randomized trial. The WeChat-based integrative family intervention (WIFI) program will be implemented in 12 communities affiliated with the Changsha psychiatric hospital through the free medicine delivery process in the 686 Program. The 12 communities will be randomized to one of four fixed sequences every two months during an 8-month intervention period in four clusters of 3 communities each. All clusters will receive the usual financial benefit of the Reward Policy as the control condition, and then successively and in random order, will cross over to the WIFI intervention at 2-month intervals until the study ends.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

For people living with schizophrenia: * being registered in the 686 Program * fulfilling the Chinese Classification of Mental Disorders-3 (CCMD-3) or the International Classification of Diseases-10 (ICD-10) criteria for schizophrenia * living with at least one family member * able to use a smartphone and WeChat to read and communicate For family members: * joining the Reward Policy and receiving a subsidy for family care * living with schizophrenia individuals for at least the past two years * involved with caregiving activities of schizophrenia individuals * able to use a smartphone and WeChat to read and communicate * at least one family member having a smartphone with WeChat app installed.

Exclusion criteria

For people living with schizophrenia: * diagnosed with mental illness other than schizophrenia * living alone with no family members * not able to use smartphones or WeChat For family members: * not involved with caregiving activities for the schizophrenia individuals * not able to use smartphones or WeChat

Design outcomes

Primary

MeasureTime frameDescription
caregiver burden at month 22 monthscaregiver burden will be measured using the internationally standard caregiving burden scale---Zarit Burden Interview (ZBI) after 2 months. The total score ranges from 0 to 88, with higher composite score indicating higher caregiver burden.
caregiver burden at month 66 monthscaregiver burden will be measured using the internationally standard caregiving burden scale---Zarit Burden Interview (ZBI) after 6 months. The total score ranges from 0 to 88, with higher composite score indicating higher caregiver burden.
caregiver burden at month 88 monthscaregiver burden will be measured using the internationally standard caregiving burden scale---Zarit Burden Interview (ZBI) after 8 months. The total score ranges from 0 to 88, with higher composite score indicating higher caregiver burden.
caregiver burden at baselinebaselinecaregiver burden will be measured using the internationally standard caregiving burden scale---Zarit Burden Interview (ZBI) at baseline. The total score ranges from 0 to 88, with higher composite score indicating higher caregiver burden.
caregiver burden at month 44 monthscaregiver burden will be measured using the internationally standard caregiving burden scale---Zarit Burden Interview (ZBI) after 4 months. The total score ranges from 0 to 88, with higher composite score indicating higher caregiver burden.

Secondary

MeasureTime frameDescription
Anxiety8 monthsAnxiety will be measured using the internationally standard anxiety scale---Generalized Anxiety Disorder Scale-7 (GAD-7) at baseline, 2 months, 4 months, 6 months, 8 months. The total score ranges from 0 to 27, with higher score indicating more anxiety symptoms.
Depression8 monthsDepression will be measured using the internationally standard depression scale---Patient Health Questionnaire-9 (PHQ-9) at baseline, 2 months, 4 months, 6 months, 8 months. The total score ranges from 0 to 27, with higher score indicating more depressive symptoms.

Countries

China

Contacts

Primary ContactYu Yu, PhD
403616846@qq.com+8618774897811
Backup ContactTongxin Li, Master
tongxin@csu.edu.cn+15274984256

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026