Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001435370
Ethics application status
Approved
Date submitted
26/08/2017
Date registered
10/10/2017
Date last updated
11/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized controlled trial of Strengths Model Case Management with Chinese mental health service users in Hong Kong
Scientific title
Randomized controlled trial to evaluate the effect of Strengths Model Case Management on recovery with Chinese mental health service users in Hong Kong
Secondary ID [1] 292711 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 304472 0
Anxiety 304473 0
Schizophrenia 304474 0
Psychosis 304475 0
Bipolar Disorder 304476 0
Condition category
Condition code
Mental Health 303807 303807 0 0
Depression
Mental Health 303808 303808 0 0
Anxiety
Mental Health 303809 303809 0 0
Schizophrenia
Mental Health 303810 303810 0 0
Psychosis and personality disorders
Mental Health 303811 303811 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Strengths Model Case Management (SMCM, please see: Rapp CA, Goscha RJ. The strengths model: a recovery-oriented approach to mental health services. New York: Oxford University Press; 2011) has been developed to promote recovery through instilling hope and empowering the choices and autonomy of clients. Case management refers to the process of assessing needs, implementing a service plan, and monitoring progress to bring about positive outcomes The six fundamental principles of the Kansas SMCM are: (1) people with psychiatric disabilities can learn, grow, and change; (2) the focus is on individual strengths rather than deficits; (3) the community is viewed as an oasis of resources; (4) the client is the director of the helping process; (5) the worker-client relationship is essential; and (6) the primary setting is the community.

SMCM comprises two primary tools that are used during sessions between case workers and clients: (1) Strengths Assessment, which appraises the client’s strengths, niches, and other attributes, such as self-efficacy and sense of hope, as well as the resources available in the family and community; (2) Personal Recovery Plan, which uses the information obtained from the strengths assessment to derive a plan comprising recovery goals that are meaningful for the client. Co-construction of recovery goals between clients and case workers poses challenges. Weekly strengths-based supervision (i.e., group supervision and field mentoring that helps workers improve their practice skills in an actual setting with a service user) will assure the use of the SMCM tools.

Group supervision follows these specific steps: (1) The presenting staff hand out clients’ strengths assessments and specify the help needed from the group. (2) The team are to clarify the assessment and brainstorm ideas. (3) The presenting staff review the ideas and state the next steps. Field mentoring is a structured form of supervision where the supervisor and case worker meet together with a client for the specific purpose of the case worker learning, developing, and/or enhancing skills or use of tools related to the model. Field mentoring sessions most often occur in the client’s home or in the community but they can be conducted at the office in some circumstances as long as it is structured as a learning opportunity for the case worker. These implementation features will be monitored by the Fidelity Scale.

The intervention period is 12 months. The clients allocated to the Intervention Group will receive individual sessions of approximately 30 minutes once about every 2 weeks, at the centre or in the community. The case workers delivering the SMCM intervention received training provided by Kansas University previously. The Strengths Assessment and Personal Recovery Plan will be used to guide the intervention sessions. During the intervention, case workers will help the clients identify recovery goals that are meaningful to them. Case workers will attend group supervision sessions with Goscha (i.e. Dr. Rick Goscha, the founder of Strengths Model, he is the present project's one of the named investigators. Please see: Fukui S, Goscha R, Rapp CA, Mabry A, Liddy P, Marty D. Strengths model case management fidelity scores and client outcomes. Psychiatric Services. 2012;63(7):708-10) via Skype on a regular basis (i.e. once a month over the 12 month intervention period) and will engage in a weekly strengths-based supervision (led by their own agency's supervisor[s])run at ICCMWs. Strengths-based supervision includes review case notes, case discussion and seeking advise from team members and supervisors. Fidelity Scale will be used every 6-month to monitor if these high-fidelity activities take place as expected. A leadership team has been established in each ICCMW to oversee the activities.
Intervention code [1] 298953 0
Treatment: Other
Comparator / control treatment
Clients in the control group will receive generic recovery-based intervention (i.e. Standard care). Examples of intervention activities include recovery groups, medical appointments, leisure/hobby groups, general community activities, such as outings, and regular sessions with case workers (each session lasts approximately 30 minutes and will serve as the attention placebo).
Control group
Active

Outcomes
Primary outcome [1] 303172 0
Recovery Assessment Scale
Timepoint [1] 303172 0
Baseline, 6 and 12 months after intervention commencement. The endpoint is after 12 month follow-up intervention or is decided by the participant and his/her case worker according to participant's recovery progress.
Secondary outcome [1] 338115 0
Hope measured by State Hope Scale
Timepoint [1] 338115 0
Baseline, 6 and 12 months after intervention commencement
Secondary outcome [2] 338116 0
Goal achievement as measured by client's self-report
Timepoint [2] 338116 0
Baseline, 6 and 12 months after intervention commencement
Secondary outcome [3] 338118 0
Psychiatric symptoms measured by Colorado Symptoms Index
Timepoint [3] 338118 0
Baseline, 6 and 12 months after intervention commencement
Secondary outcome [4] 339241 0
Qualitative data from interviews on perceived therapeutic ingredients, perceptions of the benefits and challenges of the Strengths Model Case Management
Timepoint [4] 339241 0
After 12 months intervention period
Secondary outcome [5] 339285 0
Community Integration as measured by Community Integration Measure
Timepoint [5] 339285 0
Baseline, 6 and 12 months after intervention commencement
Secondary outcome [6] 339286 0
Working Alliance as measured by Working Alliance Inventory
Timepoint [6] 339286 0
Baseline, 6 and 12 months after intervention commencement
Secondary outcome [7] 352778 0
Mattering as measured by Mattering Scale
Timepoint [7] 352778 0
Baseline, 6 and 12 months after intervention commencement

Eligibility
Key inclusion criteria
1. New user of ICCMWs mental health service;
2. aged 18 or above;
3. Chinese and are able to read Chinese and speak Cantonese;
4. with diagnosis of mental illness, including major depressive disorders, anxiety disorder, bipolar disorder, and psychotic disorders, by a psychiatrist; and
5. ability to provide written informed consent to participate in the study and willingness to be allocated to intervention or control group.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. For all participants, they will be excluded if they are likely to engage in immediate risk behavior, such as suicide and/or violence; and/or
2. Client participants will be excluded if they are identified by case workers as unsuitable to join the study (e.g., cannot sustain meaningful conversation for more than 15 mins, showing active florid psychiatric symptoms).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule, who is an "off-site" research team member based in the university.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation generated by an online randomisation software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participants will be recruited from multiple sites in Hong Kong, which are three Integrated Community Centres for Mental Wellness (ICCMWs) operated by three non-governmental organisations.

A small-scale qualitative study will be conducted to explore the therapeutic ingredients of SMCM and examine the link between fidelity features and clients’ recovery outcomes. Grounded theory methodology is chosen to guide the data collection and analyses for this qualitative study. The proposed method involves the analysis of in-depth interviews with 21 clients and nine case workers from the intervention group at the end of the 12-month assessment period using a maximum variation technique, a form of purposive sampling. We will use semi-structured interviews exploring the client and case worker participants’ perceived therapeutic ingredients, perceptions of the benefits, challenges of the intervention, and any suggestions for improvement. These interviews will be conducted at the ICCMWs for convenience.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Monte Carlo simulation for sample size calculation was conducted with Mplus v.7.1 to generate data for the intervention effect on the slope (change rate) of the primary outcome measure (a mean slope difference between the treatment and control groups), assuming a linear change trend across time. We hypothesized a medium effect size (Cohen’s d = .6) for the slope difference and assumed 15% and 30% missing data at the 6- and 12-month points, respectively, based on previous research. The results suggested that a sample size of 210 clients (n =105 per group) is required for the study to have 80% power to detect a medium effect with the amount of missing data taken into account.

We will examine the intervention effects on the outcomes as compared to the control group outcomes. Background information, including socio-demographic characteristics and all outcome variables, will be summarized using means and standard deviations for continuous variables and frequencies, percentages, and cross-tabulations for categorical variables. Univariate and multivariate outliers, histograms, probability plots, and residual plots will be examined to select the best-fitting models. Clients will be nested within case workers who are nested within agencies (implementation sites) to test whether there are any post-intervention improvements in outcomes, e.g. recovery and hope. Given the small sample size at the worker and agency levels, a fixed-effects model will be used at the agency level to control for potential agency effects. We will perform intent-to-treat analysis to reflect the real-world setting. Model fit will be evaluated using the multi-index
approach, based on the root mean square error of approximation (RMSEA values < .08
are acceptable, but values < .05 are preferred) and comparative fit index (CFI values > .90 are acceptable, but values > .95 are preferred).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
16/10/2017
Actual
16/10/2017
Date of last participant enrolment
Anticipated
31/03/2018
Actual
31/05/2018
Date of last data collection
Anticipated
31/05/2019
Actual
Sample size
Target
210
Accrual to date
Final
209
Recruitment outside Australia
Country [1] 9159 0
Hong Kong
State/province [1] 9159 0

Funding & Sponsors
Funding source category [1] 297355 0
Government body
Name [1] 297355 0
Research Grants Council
Country [1] 297355 0
Hong Kong
Primary sponsor type
University
Name
The University of Hong Kong
Address
The University of Hong Kong, Pokfulam, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 296331 0
None
Name [1] 296331 0
Address [1] 296331 0
Country [1] 296331 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298451 0
Human Research Ethics Committee, The University of Hong Kong
Ethics committee address [1] 298451 0
Ethics committee country [1] 298451 0
Hong Kong
Date submitted for ethics approval [1] 298451 0
Approval date [1] 298451 0
31/03/2017
Ethics approval number [1] 298451 0
EA1703078

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77134 0
Prof Samson Tse
Address 77134 0
Room 520, 5/F, The Jockey Club Tower, Centennial Campus,
The University of Hong Kong, Pokfulam Road, Hong Kong.
Country 77134 0
Hong Kong
Phone 77134 0
+852-39171071
Fax 77134 0
Email 77134 0
[email protected]
Contact person for public queries
Name 77135 0
Winnie Yuen
Address 77135 0
5/F, The Jockey Club Tower, Centennial Campus,
The University of Hong Kong, Pokfulam Road, Hong Kong.
Country 77135 0
Hong Kong
Phone 77135 0
+85239172980
Fax 77135 0
Email 77135 0
[email protected]
Contact person for scientific queries
Name 77136 0
Winnie Yuen
Address 77136 0
5/F, The Jockey Club Tower, Centennial Campus,
The University of Hong Kong, Pokfulam Road, Hong Kong.
Country 77136 0
Hong Kong
Phone 77136 0
+85239172980
Fax 77136 0
Email 77136 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStudy protocol for a randomised controlled trial evaluating the effectiveness of strengths model case management (SMCM) with Chinese mental health service users in Hong Kong.2019https://dx.doi.org/10.1136/bmjopen-2018-026399
EmbaseProcess research: compare and contrast the recovery-orientated strengths model of case management and usual community mental health care.2021https://dx.doi.org/10.1186/s12888-021-03523-5
N.B. These documents automatically identified may not have been verified by the study sponsor.