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

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: WeChat-based integrative family intervention (WIFI)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; Participants in the intervention group will receive the usual financial benefits of the Reward Policy as well as the WIFI program which will include three key components: psycho-education through WOA publications, peer-support through a WeChat chat group, and professional support through WeChat private chat and video call.	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
No Intervention: control group; Participants in the control group will receive the usual financial benefits of the Reward Policy and receive payment from the Changsha psychiatric hospital. However, they will not have access to the WIFI program since they cannot scan the WeChat barcode for the research.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University
• Investigators: Principal Investigator: Yu Yu, PhD, Xiangya Hospital of Central South University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Yu Y, Li T, Xi S, Li Y, Xiao X, Yang M, Ge X, Xiao S, Tebes J. Assessing a WeChat-Based Integrative Family Intervention (WIFI) for Schizophrenia: Protocol for a Stepped-Wedge Cluster Randomized Trial. JMIR Res Protoc. 2020 Aug 25;9(8):e18538. doi: 10.2196/18538.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: May 17, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Schizophrenia; Psycho-education; Peer support; WeChat; Family intervention; Stepped wedge; Professional support
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 71804197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Since the official start of the trial to the end of the trial
• IPD Sharing Access Criteria: Describe clearly about the reason of review
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No