Clinical trial NCT02453217: The Potential Efficacy of the Chinese Health Improvement Profile- A Pilot Clustered Randomised Controlled Trial
Official title: The Potential Efficacy and Acceptability of the Chinese Health Improvement Profile (CHIP) in Improving the Physical Health of People With Severe Mental Illness - A Pilot Clustered Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Mental Illness
Schizophrenia
Schizoaffective Disorder
Bipolar Affective Disorder
Cardiovascular Health
Keywords: severe mental illness
physical health screening
randomised controlled trial
health behaviour change
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Castle Peak Hospital
First posted: 2015-05-25
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators programme of research will evaluate an existing physical health care screening intervention with the aim of helping Community Psychiatric Nurses (CPN) to improve the physical health wellbeing of people with a SMI.

This pilot clustered randomised controlled trial aims to establish the potential efficacy and acceptability of the Chinese Health Improvement Profile (CHIP) in improving the physical health of people with severe mental illness.

Detailed description: This pilot study will use a non-blinded parallel group clustered randomised controlled trial design.

The study will be carried out by CPNs with community-dwelling people aged 18-65 who have a psychiatric diagnosis of SMI (i.e. schizophrenia, schizoaffective disorder, other psychotic disorder or bipolar affective disorder) and at the point of recruitment are being treated in the community. It will investigate the potential clinical impact of the use of the CHIP tool when used by CPNs with this patient group. Because the CHIP is designed to be used as both an enhanced physical health risk screening tool and as an instrument to direct appropriate clinical interventions the investigators will ask the patients' allocated CPNs to recruit consenting patients , collect outcome measure data and where appropriate use the CHIP tool with patients that they work with within their routine clinical practice.

Primary objective:

To test the potential efficacy and acceptability of the CHIP intervention compared to treatment as usual on patients' physical well- being over a 12 month period.

Secondary objectives:

To measure and compare changes in perceived mental well-being between the groups as measured at baseline, and at 6 months and 12 months after the start of the intervention.

To establish differences in the objective physical health state of patients between the groups at 12 months as indicated by data routinely recorded in medical/outpatient/nursing notes during the duration of study.

To establish changes in health behaviours and physical indicators of cardiovascular risk within the intervention group between baseline and 12 months after the start of the intervention.

Eligibility criteria: Inclusion Criteria:

Those psychiatric outpatients under the care of the community psychiatric nursing service who are:

* Aged 18-65 years;
* Having a case-note diagnosis (as confirmed by a registered clinician) within the illness group entitled "severe mental illness" (SMI) containing schizophrenia, schizoaffective disorder, other psychotic disorders, depressive or bipolar affective disorder (type 1 or 2); and
* Able to speak Chinese/English
* Able to provide written informed consent and considered safe and competent to participate in the study (as suggested by attending psychiatrist).

Exclusion Criteria:

* Co-morbidity of learning disability or organic brain diseases.

Primary outcomes:
measure: Self-reported physical well being
timeFrame: 6 months after intervention
measure: Self-reported physical well being
timeFrame: 12 months after intervention
Secondary outcomes:
measure: Self-reported mental health
timeFrame: 6 months after intervention
measure: Satisfaction with services
timeFrame: 12 months after intervention
measure: Self-reported mental health
timeFrame: 12 months after intervention
Other outcomes:
measure: The Chinese CHIP data (treatment group only)
timeFrame: 12 months after intervention
measure: Physical state
timeFrame: 12 months after intervention
Locations:
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Daniel T Bressington, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese University of Hong Kong
name: Wai Tong Chien, PhD
role: STUDY_DIRECTOR
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citation: Bressington D, Mui J, Yu C, Leung SF, Cheung K, Wu CST, Bollard M, Chien WT. Feasibility of a group-based laughter yoga intervention as an adjunctive treatment for residual symptoms of depression, anxiety and stress in people with depression. J Affect Disord. 2019 Apr 1;248:42-51. doi: 10.1016/j.jad.2019.01.030. Epub 2019 Jan 28.
citation: Bressington D, Yu C, Wong W, Ng TC, Chien WT. The effects of group-based Laughter Yoga interventions on mental health in adults: A systematic review. J Psychiatr Ment Health Nurs. 2018 Oct;25(8):517-527. doi: 10.1111/jpm.12491.
citation: Bressington D, Mui J, Tse ML, Gray R, Cheung EF, Chien WT. Cardiometabolic health, prescribed antipsychotics and health-related quality of life in people with schizophrenia-spectrum disorders: a cross-sectional study. BMC Psychiatry. 2016 Nov 18;16(1):411. doi: 10.1186/s12888-016-1121-1.