Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000907246
Ethics application status
Approved
Date submitted
25/05/2018
Date registered
30/05/2018
Date last updated
16/09/2019
Date data sharing statement initially provided
16/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The mind-body relationship of common physical symptoms in the community.
Scientific title
Epidemiology of Multiple Somatic Symptoms in the community, and its association with illness related cognitions`
Secondary ID [1] 295004 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Somatic Symptoms 308024 0
Somatic Symptom Disorder 308025 0
Somatisation 308055 0
Health Anxiety 308056 0
Condition category
Condition code
Mental Health 307059 307059 0 0
Other mental health disorders
Public Health 307060 307060 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a longitudinal study based on questionnaire data. Multiple somatic symptoms are determined via the Patient Health Questionnaire - 15 (PHQ-15). Those who score high on the PHQ-15 experience a collection of symptoms such as back pain, stomach ache, dizziness and headache. Over a 1 year period, these symptoms will be correlated with co-morbid diseases and psychological health, in order to a) determine the stability of these symptoms and b) its temporal relationship with co-morbid diseases and psychological health.
Intervention code [1] 301341 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306032 0
Multiple Somatic symptom (Patient Health Questionnaire - 15). Symptom severity cut-offs;
0 - 9 = mild, 9 - 14 = moderate, 15 - 30 = severe. Determine the numbers of participants with multiple somatic symptoms
Timepoint [1] 306032 0
Baseline and 1 year follow-up
Secondary outcome [1] 347387 0
Whitely Scale for hypochondriasis - 7. Higher scores reflect increased health anxiety. Change in hypochondriasis and identify temporal relationships with multiple somatic symptoms.
Timepoint [1] 347387 0
Baseline and 1 year follow up
Secondary outcome [2] 347388 0
Patient Health Questionnaire - 4. Higher scores reflect increased anxiety and depressive symptoms. Change in anxiety and depression. Change in anxiety and depression, and identify temporal relationships with multiple somatic symptoms.
Timepoint [2] 347388 0
Baseline and 1 year follow up
Secondary outcome [3] 347389 0
Cognitive Emotion Regulation Questionnaire - (Catastrophising sub scale ). Higher scores reflect symptom catastrophising. Change in catastrophising, and identify temporal relationships with multiple somatic symptoms.
Timepoint [3] 347389 0
Baseline and 1 year follow up
Secondary outcome [4] 347390 0
Co-morbid chronic diseases. Total score represents increased medical co-morbidity. This was designed specifically for the study. A checklist of common chronic disorders is presented, in addition to a space for participants to indicate any other chronic diseases they have been diagnosed with.
Timepoint [4] 347390 0
Baseline and 1 year follow up
Secondary outcome [5] 348297 0
Short Form 12 V2 - Quality of Life Scale
Timepoint [5] 348297 0
Baseline and 1-year follow up

Eligibility
Key inclusion criteria
Random selection of community individuals from NSW electorates (Bradfield, Bennelong, North Sydney, Sydney, Grayndler, Reid, Parramatta and Mitchell)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-response to survey

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
1. Descriptive analyses: all measures will be reported descriptively. Numeric measures
will be reported as mean and standard deviation while qualitative measures will be
reported as count and percentage. The prevalence of individual with clinical rates of
low, moderate or high MSS will be reported along with 95% confidence intervals.
2. Cross-sectional analyses: Common connections between MSS with respect to
psychosocial factors will be understood through multivariate modelling.
3. Longitudinal analyses will be undertaken for two purposes. The first is to understand
the stability of individual MSS and also whether there is substitution between MSS which is possible given their reported comorbidity. The second is to understand whether psychological state at baseline predicts MSS state at follow-up. In doing so we will study mind-body and body-mind axes to determine whether a reciprocal relationship exists for MSS.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/03/2020
Actual
Date of last participant enrolment
Anticipated
6/04/2020
Actual
Date of last data collection
Anticipated
2/09/2020
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299587 0
University
Name [1] 299587 0
Macquarie University
Country [1] 299587 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Road, Macquarie University, North Ryde, 2109 NSW
Country
Australia
Secondary sponsor category [1] 298905 0
None
Name [1] 298905 0
Address [1] 298905 0
Country [1] 298905 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300488 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 300488 0
Balaclava Road, Macquarie University, North Ryde 2019 NSW
Ethics committee country [1] 300488 0
Australia
Date submitted for ethics approval [1] 300488 0
10/04/2018
Approval date [1] 300488 0
01/06/2018
Ethics approval number [1] 300488 0
5201800286

Summary
Brief summary
Multiple somatic symptoms (MSS) can be defined as a range of non-specific symptoms such as musculoskeletal pain, fatigue and abdominal pain, and are expressed in the absence of any clear pathology.

MSS is measured on scale. Those who score highly on that scale are associated with a reduced quality of life and substantial increase in healthcare utilisation.

By way of example, disorders such as Somatization Disorder (Diagnostic and Statistical Manual of Mental Disorders-V), fibromyalgia, chronic fatigue syndrome, functional Gastrointestinal disorders and multiple chemical sensitivity have all been associated with MSS.

This study focuses on MSS, rather than specific diseases or only a few symptoms. It is important to do so, as MSS is considered to be a predictor of negative health consequences, independent of other chronic diseases or psychopathology. For the present study, MSS are identified using the Patient Health Questionnaire-15.

At present a large proportion of Australians seek help for MSS, which places a burden on generalist and specialist services. In addition, the natural course of MSS is unfortunately unfavourable (meaning that symptoms suffered by people with MSS are less likely to resolve with time). By way of comparison, MSS stability rates are as high as depressive disorders and higher than anxiety disorders.

However, to date, limited research of MSS has been conducted in an Australian community setting. Identifying, the prevalence of MSS in the community and related psychological predictors of its development and maintenance remains an important health priority.

The present study seeks to address the following aims:
1. To determine the incidence and prevalence of MSS in an Australian community setting and its relationship with co-morbid chronic diseases, specific illness related cognitions and psychological distress.
2. To determine the stability of MSS over the course of 1 year.
3. To suggest potential psychosocial aetiologies for MSS by studying mind-body and body-mind interactions in these conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83818 0
Prof Michael Jones
Address 83818 0
Balaclava Road, Macquarie University, North Ryde 2109 NSW
Department of Psychology
Country 83818 0
Australia
Phone 83818 0
+61 2 9850 8601
Fax 83818 0
Email 83818 0
[email protected]
Contact person for public queries
Name 83819 0
Mr David McNaughton
Address 83819 0
Balaclava Road, Macquarie University, North Ryde 2109 NSW
Department of Psychology
Country 83819 0
Australia
Phone 83819 0
+61 2 9850 8601
Fax 83819 0
Email 83819 0
[email protected]
Contact person for scientific queries
Name 83820 0
Mr David McNaughton
Address 83820 0
Balaclava Road, Macquarie University, North Ryde 2109 NSW
Department of Psychology
Country 83820 0
Australia
Phone 83820 0
+61 2 9850 8601
Fax 83820 0
Email 83820 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Results from the study will be made available through peer reviewed publications and conference presentations.


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
No additional documents have been identified.