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Trial registered on ANZCTR


Registration number
ACTRN12620000464965
Ethics application status
Approved
Date submitted
15/11/2019
Date registered
9/04/2020
Date last updated
9/04/2020
Date data sharing statement initially provided
9/04/2020
Date results information initially provided
9/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Positive Psychotherapy Group Intervention of people with psychosis: A Randomized Controlled Trial.
Scientific title
A Proposal for an Evaluation Study of a Positive Psychotherapy Group Intervention of people with psychosis: A Randomized Controlled Trial.
Secondary ID [1] 299834 0
Nil
Universal Trial Number (UTN)
U1111-1243-7408
Trial acronym
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Psychosis 315215 0
Condition category
Condition code
Mental Health 313532 313532 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Intervention Group will receive treatment as usual and in addition receive the WELLFOCUS Positive Psychotherapy (PPT), a 13-session of WELLFOCUS PPT with a group size of 8-10 in 7 consecutive weeks (2 sessions a week) by a trained therapist and co-therapist in a Group Therapy Room of our occupational therapy department. Each session lasts for about 1 hour and 45 min. Trained occupational therapists with a co-therapist should conduct the sessions according to the manual of WELLFOCUS Positive Psychotherapy for psychosis Intervention Manual (Chinese) in which the session outlines, activities, scripts and materials of each session were all well documented.
Session Outlines are:
1. Welcome to WELLFOCUS PPT
2. Positive Experiences
3. Savouring
4. Good Things
5. Identifying a Personal Strength
6. Personal Strengths Activity
7. At my best
8. One door closes, another door opens
Identify positive conclusions from negative experiences, Meaningful self-narrative
9. Forgiveness 1
10. Forgiveness 2
11. Gratitude
12. Looking back, moving forward
13. Celebration

In order to ensure fidelity to the manual, peer observation would be arranged to make sure the implementation is based on the Chinese manual.
A third party personnel who is not the member in the research team will sit in randomly in some sessions to impartially check the implementation against the session contents of the Chinese manual in order to ensure the fidelity.
Intervention code [1] 316088 0
Treatment: Other
Comparator / control treatment
Treatment as usual is defined as ordinary occupational therapy service received in our Occupational Therapy Department, such as vocational guidance and workshop-based prevocational training.
Control group
Active

Outcomes
Primary outcome [1] 321983 0
Personal Wellbeing is measured by a Short Chinese Warwick-Edinburgh Mental Well-being Scale, C-SWEMWBS , validated locally and published. The subjects are asked to rate their overall wellbeing on the scale.
Ng, S., Leung, T., Chan, F., Won, A. Lam, R., Tsang D. (2014). Translation and validation of the Chinese version of the short Warwick Edinburgh mental wee-being scale for patients with mental illness in Hong Kong, East Asian Archive of Psychiatry. 24(1), 3-9.
Timepoint [1] 321983 0
at baseline and after intervention, usually within 2 weeks after the last session of the group.
Secondary outcome [1] 376909 0
Change on depressive symptoms is measured by Cantonese version of the Calgary Depression Rating Scale, CDSS-C. by 2 psychiatry specialists
Timepoint [1] 376909 0
at baseline and after intervention, usually within 2 weeks after the last session of the group.
Secondary outcome [2] 378298 0
Hope is measured by Hope Scale.
Snyder, C.R., Harris, C., Anderson, J.R., Holleran, S.A., Irving, L.M., Sigmon, S.T., Yoshinobu, L., Gibb, J., Langelle, C., & Harney, P. (1991). The will and the ways: development and validation of an individual-differences measure of hope. Journal of personality and social psychology, 60(4), 570-585.
Timepoint [2] 378298 0
at baseline and after intervention, usually within 2 weeks after the last session of the group.
Secondary outcome [3] 378299 0
Self-efficacy is measured by a locally validated general self-efficacy scale.

Chiu, F.P.F. & Tsang, H.W.H. (2004). Validation of the Chinese general self-efficacy scale among individuals with schizophrenia in Hong Kong. International journal of rehabilitation research, 27(2),159-161.
Timepoint [3] 378299 0
at baseline and after intervention, usually within 2 weeks after the last session of the group.
Secondary outcome [4] 378300 0
Quality of Life is measured by SF-12 Health Survey.
Lam, C.L.K., Tse, E.Y.Y., & Candek B. (2005). Is the standard SF-12 health survey valid and equivalent for a Chinese population? Quality of Life Research, 14, 539-547.
Timepoint [4] 378300 0
at baseline and after intervention, usually within 2 weeks after the last session of the group.
Secondary outcome [5] 378301 0
Social Disability is measured by HoNOS. Health of the Nation Outcome.

Timepoint [5] 378301 0
at baseline and after intervention, usually within 2 weeks after the last session of the group.
Secondary outcome [6] 379735 0
General mental condition is measured by Brief Psychiatric Rating Scale, BPRS by 2 psychiatry specialists.
Timepoint [6] 379735 0
at baseline and after intervention, usually within 2 weeks after the last session of the group.

Eligibility
Key inclusion criteria
- Aged 18-65 years old
- Primary diagnosis of psychosis (F20-29)
- Able to read written Chinese and speak Cantonese
- Willing to give written consent
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Cognitive impairment
- Active Substance abuse
- Unable to give consent

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)
randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization by computer to generate no. of 1 or 2.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
SPSS will be used to conduct the quantitative analysis in the trial. To ensure the homogeneity between the intervention group and control group prior to the intervention and to avoid possible confounders such as gender, age, no. of years of receiving mental health service, the baseline demographic data will be compared between two groups, i.e. gender by chi-square and t test for other continuous data. The baseline assessment on those outcome measures will be compared also by t test.
The outcome measures after the intervention will be compared with the baseline assessment. Paired t-test on each parameter will be run to see if there is any improvement within group. At follow-up, separate t test will be conducted to see if there is any significant difference between groups on each outcome parameter.

Intention-to-treat Analysis
Intention-to- treat, ITT analysis has become the “gold standard” for analyzing the results of clinical trials. (Armijo-Olivo et al, 2009) It is a strategy used to analyze the results of an RCT that considers the subjects in the way they were randomized at the beginning of the trial regardless of “lost to follow up”, i.e. whether they completed the intervention given to their group or whether they withdrew from the treatment; or “Cross-over” i.e. what treatment they actually received. There are a number of approaches to handle the missing data when lost to follow up. The approach of dealing with the missing data in this RCT will be an endpoint analysis, i.e. “last observation carried forward, LOCF” which will include data for the last known state of the subjects in the analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22119 0
Hong Kong
State/province [1] 22119 0
Kowloon

Funding & Sponsors
Funding source category [1] 304294 0
Hospital
Name [1] 304294 0
Kwai Chung Hospital
Address [1] 304294 0
Occupational Therapy Department,
Kwai Chung Hosptial,
3-15 Kwai Chung Hospital Road, Lai King, NT, Hong Kong
Country [1] 304294 0
Hong Kong
Primary sponsor type
Hospital
Name
Kwai Chung Hospital
Address
Occupational Therapy Department,
Kwai Chung Hosptial,
3-15 Kwai Chung Hospital Road, Lai King, NT, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 304537 0
None
Name [1] 304537 0
Address [1] 304537 0
Country [1] 304537 0
Other collaborator category [1] 281035 0
Individual
Name [1] 281035 0
Professor Mike Slade
Address [1] 281035 0
School of Health Sciences
Institute of Mental Health
University of Nottingham
Triumph Road
Nottingham
NG7 2TU
United Kingdom
Country [1] 281035 0
United Kingdom
Other collaborator category [2] 281036 0
Individual
Name [2] 281036 0
Dr. Beate Schrank
Address [2] 281036 0
Karl Landsteiner University of Health Sciences, Department of Psychiatry, Vienna, Austria
Dr.-Karl-Dorrek-Straße 30, 3500 Krems an der Donau
Country [2] 281036 0
Austria

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304750 0
Research Ethics Committee, Kowloon West Cluster, Hospital Authority
Ethics committee address [1] 304750 0
Research Ethics Committee,
Kowloon West Cluster, Hospital Authority
Room 533, Block J, Prince Margaret Hospital
Ethics committee country [1] 304750 0
Hong Kong
Date submitted for ethics approval [1] 304750 0
24/03/2016
Approval date [1] 304750 0
22/06/2016
Ethics approval number [1] 304750 0
KW/FR-16-092999-10)

Summary
Brief summary
Recovery-oriented practice has been advocated in local clinical settings of mental health service in Hong Kong since 2009. Wellbeing has become an important area of focus in mental health service. The WELLFOCUS Positive Psychotherapy, based on the hypothesis that it could improve people’s wellbeing, was developed at the Institute of Psychology, Psychiatry and Neuroscience, King’s College London, United Kingdom. This study aimed at evaluating the effectiveness of the WELLFOCUS Positive Psychotherapy Programme (Chinese version) used for people with psychosis in terms of their primary outcome in improving participants’ wellbeing and other mental health outcomes. Hence, it would help to test the feasibility and applicability of the intervention adapted to improve the wellbeing of people with psychosis in local context of Hong Kong.
The study was a randomized controlled trial with two-arm parallel groups, i.e. intervention group and control group. The intervention group received a 13-session of WELLFOCUS PPT whilst the control group received treatment as usual.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98078 0
Mr Menza Hon Wai Chu
Address 98078 0
1/F, Day Recovery Centre,
Kwai Chung Hospital
Hong Kong
Country 98078 0
Hong Kong
Phone 98078 0
+85298232783
Fax 98078 0
+85229593565
Email 98078 0
chuhw@ha.org.hk
Contact person for public queries
Name 98079 0
Mr Menza Hon Wai Chu
Address 98079 0
1/F, Day Recovery Centre,
Kwai Chung Hospital
Hong Kong
Country 98079 0
Hong Kong
Phone 98079 0
+85298232783
Fax 98079 0
+85229593565
Email 98079 0
chuhw@ha.org.hk
Contact person for scientific queries
Name 98080 0
Mr Menza Hon Wai Chu
Address 98080 0
1/F, Day Recovery Centre,
Kwai Chung Hospital
Hong Kong
Country 98080 0
Hong Kong
Phone 98080 0
+85298232783
Fax 98080 0
+85229593565
Email 98080 0
chuhw@ha.org.hk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
outcome data after de-identification can be shared
When will data be available (start and end dates)?
Data will be available 3 months after publication and within 5 years following main results.
Available to whom?
researcher who can show high-quality research proposal or whom are interested in the research area with good projects with case-by-case consideration
Available for what types of analyses?
only for approved research or meta-analysis
How or where can data be obtained?
access subject to approvals by Principal Investigator (email: chuhw@ha.org.hk); all requests should be submitted in writing.
What supporting documents are/will be available?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5717 0
Ethical approval
Citation [1] 5717 0
Link [1] 5717 0
Email [1] 5717 0
Other [1] 5717 0
Type [2] 5719 0
Study protocol
Citation [2] 5719 0
Link [2] 5719 0
Email [2] 5719 0
Other [2] 5719 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
A total of 154 participants have been recruited. They were randomized to either intervention or control group. The Consort Diagram of the study was illustrated. Homogeneity was proven between intervention group and control group at the baseline on possible confounding factors, i.e. their demographic factors. Attrition rate in the intervention group was 11.5% whilst that in control group was 18.4%. Intention-to-treat analysis was adopted. Within-group analysis showed that after intervention, there was significant improvement on outcomes measured as compared to the baseline, i.e. Wellbeing (p<.0001), Hopes (p<.0001), Self-efficacy (p<.0001), Health outcomes (p<.0001), and Symptoms (p<.0001) with Cohen’s d effect size (ES) ranging from .18 to .40. When compared to control, intervention group showed better outcomes in Wellbeing (p<.0001; ES=.61), Agency Subscale of Hope (p= .03, ES=.36) and Self-efficacy (p<.0001, ES=.58).When compared to control, intervention group showed better outcomes in Wellbeing (p<.0001; ES=.61), Agency Subscale of Hope (p= .03, ES=.36) and Self-efficacy (p<.0001, ES=.58).

WELLFOCUS Positive Psychotherapy was proven to be an effective treatment in improving the wellbeing and other mental health outcomes for people with psychosis. It could be implemented as one of the intervention in local mental health service to promote recovery.