NCT02453217

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

March 31, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

2.7 years

First QC Date

May 19, 2015

Last Update Submit

February 20, 2019

Conditions

Severe Mental IllnessSchizophreniaSchizoaffective DisorderBipolar Affective DisorderCardiovascular Health

Keywords

severe mental illnessphysical health screeningrandomised controlled trialhealth behaviour change

Outcome Measures

Primary Outcomes (2)

  • Self-reported physical well being

    The primary outcome will be measured using the widely used and well-established Chinese version of the physical and mental health measure (SF12v2-PCS-12 subscale).

    6 months after intervention

  • Self-reported physical well being

    The primary outcome will be measured using the widely used and well-established Chinese version of the physical and mental health measure (SF12v2-PCS-12 subscale).

    12 months after intervention

Secondary Outcomes (3)

  • Self-reported mental health

    6 months after intervention

  • Satisfaction with services

    12 months after intervention

  • Self-reported mental health

    12 months after intervention

Other Outcomes (2)

  • The Chinese CHIP data (treatment group only)

    12 months after intervention

  • Physical state

    12 months after intervention

Study Arms (2)

Chinese CHIP

EXPERIMENTAL

Chinese Health Improvement Profile (CHIP) screening and intervention

Behavioral: Chinese CHIPOther: Treatment as usual

Treatment as usual

NO INTERVENTION

Routine community mental health care and medical outpatient appointments

Interventions

Chinese CHIPBEHAVIORAL

The CHIP physical health screening tool will be used by community psychiatric nurses in the treatment group to assess patients' physical health risk and identify problematic lifestyle behaviours. The findings from the assessment will be used to devise an individualized care plan with patients. This treatment plan may involve community psychiatric nurses collaborated with psychiatrists, drawing patients attention to indicators of physical health risk by using a traffic light system The community nurses will use motivational interviewing approaches to make patients be aware of their physical health risks and enhance their motivation to adopt healthier behaviours.

Also known as: CHIP
Chinese CHIP
Treatment as usualOTHER

The routine community mental health care provided by the community psychiatric nursing service and outpatient clinic.

Also known as: TAU
Chinese CHIP

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Ware, J.E., Jr., Kosinski, M., Dewey, J.E. How to Score Version 2 of the SF-36® Health Survey (Standard & Acute Forms). Lincoln, RI: QualityMetric Incorporated, 2000.

    BACKGROUND

  • Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.

    PMID: 10259963BACKGROUND

  • White J, Gray R, Jones M. The development of the serious mental illness physical Health Improvement Profile. J Psychiatr Ment Health Nurs. 2009 Jun;16(5):493-8. doi: 10.1111/j.1365-2850.2009.01375.x. Epub 2008 Mar 9.

    PMID: 19538607BACKGROUND

  • 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.

    PMID: 30711868RESULT

  • 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.

    PMID: 30030938RESULT

  • 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.

    PMID: 27863522DERIVED

MeSH Terms

Conditions

Mental DisordersSchizophreniaPsychotic DisordersBipolar Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersBipolar and Related DisordersMood Disorders

Study Officials

  • Daniel T Bressington, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

  • Wai Tong Chien, PhD

    Chinese University of Hong Kong

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Associate Head (Research)

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 25, 2015

Study Start

March 31, 2016

Primary Completion

November 30, 2018

Study Completion

January 31, 2019

Last Updated

February 22, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share