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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04393896
• Other study ID #: 71804197
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2020
• Source: Xiangya Hospital of Central South University
• Contact: Yu Yu, PhD
• Phone: +8618774897811
• Email: 403616846[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• WeChat-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

Locations

Country	Name	City	State
China	Xiangya Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (5)

Yu Y, Liu ZW, Tang BW, Zhao M, Liu XG, Xiao SY. Reported family burden of schizophrenia patients in rural China. PLoS One. 2017 Jun 19;12(6):e0179425. doi: 10.1371/journal.pone.0179425. eCollection 2017. — View Citation

Yu Y, Liu ZW, Zhou W, Chen XC, Zhang XY, Hu M, Xiao SY. Assessment of Burden Among Family Caregivers of Schizophrenia: Psychometric Testing for Short-Form Zarit Burden Interviews. Front Psychol. 2018 Dec 19;9:2539. doi: 10.3389/fpsyg.2018.02539. eCollection 2018. — View Citation

Yu Y, Tang BW, Liu ZW, Chen YM, Zhang XY, Xiao S. Who cares for the schizophrenia individuals in rural China - A profile of primary family caregivers. Compr Psychiatry. 2018 Jul;84:47-53. doi: 10.1016/j.comppsych.2018.04.002. Epub 2018 Apr 11. — View Citation

Yu Y, Zhou W, Liu ZW, Hu M, Tan ZH, Xiao SY. Gender differences in caregiving among a schizophrenia population. Psychol Res Behav Manag. 2018 Dec 20;12:7-13. doi: 10.2147/PRBM.S187975. eCollection 2019. — View Citation

Yu Y, Zhou W, Xiao S. China's Reward Policy for Family Care of Persons With Serious Mental Illness. Psychiatr Serv. 2018 Dec 1;69(12):1210-1211. doi: 10.1176/appi.ps.201800114. Epub 2018 Oct 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	caregiver burden at baseline	caregiver 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.	baseline
Primary	caregiver burden at month 2	caregiver 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.	2 months
Primary	caregiver burden at month 4	caregiver 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.	4 months
Primary	caregiver burden at month 6	caregiver 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.	6 months
Primary	caregiver burden at month 8	caregiver 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.	8 months
Secondary	Depression	Depression 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.	8 months
Secondary	Anxiety	Anxiety 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.	8 months