Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001023842
Ethics application status
Approved
Date submitted
9/06/2021
Date registered
5/08/2021
Date last updated
11/07/2022
Date data sharing statement initially provided
5/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Screening and Support for Health and General Anxiety at the Prince of Wales Hospital - An Exploratory Study
Scientific title
Screening and Support for Health and General Anxiety in adult patients at the Prince of Wales Hospital - An Exploratory Study
Secondary ID [1] 304443 0
None
Universal Trial Number (UTN)
Trial acronym
SHAPE
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Illness Anxiety Disorder 322214 0
Somatic Symptom Disorder 322215 0
Generalised Anxiety Disorder 322216 0
Condition category
Condition code
Mental Health 319910 319910 0 0
Anxiety
Mental Health 319911 319911 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During Step-1, participants at selected outpatient clinics will be asked to complete an online survey via an SMS link. This survey will include self-report measures of health anxiety and general anxiety, and will take approximately 5 minutes.
Those who score high on the health anxiety measure (Whitely Index-6 score =>18) will be offered follow-up contact to discuss treatment options. Those who accept will be offered access to treatment (Step-2), and will be able to choose either an internet cognitive-behavioural therapy (iCBT) course or access to a new face-to-face clinic. As this is a pilot study, with an aim to determine the acceptability of treatment options, participants will not be randomised, but will rather be able to engage in their preferred treatment.
Those who participate in iCBT will be given access to This Way Up's Health Anxiety course (https://thiswayup.org.au/courses/the-health-anxiety-course/), developed by St Vincent's Hospital. This is a validated iCBT course that has been shown to be effective in managing health anxiety. This Way Up features 6 online sessions (presented as story-based slide shows), lasting approximately 1-hour, over a 12-week period, and will require some work from participants between sessions. The sessions will in turn cover information about health anxiety, reducing focus on worries, awareness of anxious thoughts, putting thoughts/fears to the test, tackling avoidance/safety behaviours, and staying well. “Homework” is provided as downloadable documents, and typically involves the applying skills and techniques learned in the sessions in the individual’s life. Throughout the program, they will have access to a clinician via email and phone. No limit is placed on how often they may contact the clinician. Adherence will be monitored using data such as number of sessions completed.
Those who participate in our face-to-face program will meet with a member of the SHAPE psychiatry team to determine a treatment plan. This plan will be personalised to the participant, with the participant and clinician working together to discuss all options, as well as the pros and cons for each treatment in their specific case. This plan could feature treatments such as psychotherapy, medication, exercise physiology and social worker support. Note that this program is not testing new medications; any medications prescribed will be chosen based on clinical best-practice and used only where appropriate. Participants will engage in a minimum of one 1-hour session, with three sessions as the expected number. Number of sessions with other treatments will be determined as part of clinical review, as per best practice. Adherence will be monitored by tracking whether people return to planned follow-up appointments.
Participants in Step-2 will be asked to complete online assessments (Whitely Index-6, General Anxiety Disorder-7, Patient Health Questionnaire-9, Patient Health Questionnaire-15; EuroQoL-5 Dimensions, Social Functioning Questionnaire, Credibility/Expectancy Questionnaire, Treatment Satisfaction Questionnaire, Standardised Assessment of Personality - Abbreviated Scale at 0-weeks, 6-weeks, 12-weeks and 24-weeks (follow-up). The cumulative time to complete these assessments is expected to be up to 20 minutes per time-period. Additional assessments will be administered for those attending the face-to-face clinic, including The Montreal Cognitive Assessment, Anxiety and related disorders interview schedule for DSM-5, an intrusive thoughts assessment and a semi-structured qualitative assessment of the clinic. These assessments will form part of the initial session, which may take up to 90 minutes in total.
Intervention code [1] 320770 0
Early detection / Screening
Intervention code [2] 320771 0
Treatment: Other
Intervention code [3] 321024 0
Behaviour
Comparator / control treatment
The project compares two groups; a face-to-face clinic and an iCBT group. The iCBT group can be considered the comparator.
Control group
Active

Outcomes
Primary outcome [1] 327791 0
Rates of self-reported health anxiety in hospital outpatients via Whitely Index-6 score.
Timepoint [1] 327791 0
Step-1 screening survey
Primary outcome [2] 327792 0
Efficacy of the iCBT and face-to-face interventions will be assessed by determining any change in anxiety, using a composite of the Whitely-Index 6 (health anxiety) and the General Anxiety Disorder-7 (general anxiety).
Timepoint [2] 327792 0
Step-1 screening survey
Step-2 0 weeks (pre-intervention)
Step-2 6 weeks (mid-intervention)
Step-2 12 weeks (post-intervention)
Step-2 24 weeks (follow-up)
Primary outcome [3] 327793 0
Healthcare utilisation rates, assessed by data linkage to medical records.
Timepoint [3] 327793 0
Measured for the period of 2 years before intervention and 2 years after intervention.


Secondary outcome [1] 396614 0
Rate of uptake of survey by hospital outpatients, assessed by audit of completed surveys relative to the number of patients contacted.
Timepoint [1] 396614 0
Step-1 screening survey
Secondary outcome [2] 396616 0
Whitely Index-6 accuracy, assessed by comparison with clinical interview (using Anxiety and related disorders interview schedule for DSM-5) in the clinic treatment group.
Timepoint [2] 396616 0
Step-1 screening survey, Step-2 0 weeks (pre-intervention) (during initial consultation).
Secondary outcome [3] 396626 0
Completion rate of screening, measured as a rate of completions versus survey accesses, using survey analytics.
Timepoint [3] 396626 0
Step-1 screening survey
Secondary outcome [4] 396627 0
Completion rates of each intervention, assessed as a rate of intervention completions versus intervention commencements, measured using drop-out rates by the overseeing clinician.
Timepoint [4] 396627 0
Assessed from 0 weeks (pre-intervention) until 12 weeks (post-intervention)'.
Secondary outcome [5] 397661 0
Rate of uptake of clinician contact by those with Whitely Index-6 equal to or greater than 18. Determined by the percentage of those who meet this score threshold who agree to clinician contact in the Step-1 survey.
Timepoint [5] 397661 0
Step-1 screening survey
Secondary outcome [6] 397666 0
Rate of uptake of treatment by those who agree to clinician contact. Determined by the rate at which participants who agree to clinician contact agree to participate in a treatment, recorded by clinician notes.
Timepoint [6] 397666 0
Measured based on contacts to participants made immediately following Step-1.
Secondary outcome [7] 397667 0
Rate of uptake of each of the two treatment options (iCBT vs clinic) by those who agree to treatment. Determined by the number of people who choose each option, recorded by clinician notes.
Timepoint [7] 397667 0
Step-2 (pre-intervention) (asked during questionnaires).
Secondary outcome [8] 397668 0
Accuracy Ritter-4 self-report of healthcare utilisation assessed by comparison with data linkage results.
Timepoint [8] 397668 0
Ritter-4 measured at Step-2 0 weeks (pre-intervention) and Step-2 24 weeks (follow-up).
Utilisation measured for the period of 2 years before intervention and 2 years after intervention.



Secondary outcome [9] 397669 0
Primary outcome- Self-reported general anxiety (via General Anxiety Disorder-7) in hospital outpatients via Whitely Index-6 score.
Timepoint [9] 397669 0
Step-1 screening survey
Secondary outcome [10] 397670 0
Primary outcome- Efficacy of the iCBT and face-to-face interventions will be assessed by examining patient satisfaction, assessed as a composite of the Treatment Satisfaction Questionnaire and a newly developed qualitative interview. The qualitative interview will use a semi-structured questionnaire featuring 12 brief questions, conducted one-on-one and audio-recorded.
Timepoint [10] 397670 0
Step-2 12 weeks (post-intervention)
Secondary outcome [11] 398507 0
Change in patient experiences of depression after iCBT/face-to-face interventions, via Patient Health Questionnaire-9.
Timepoint [11] 398507 0
Step-2 0 weeks (pre-intervention)
Step-2 6 weeks (mid-intervention)
Step-2 12 weeks (post-intervention)
Step-2 24 weeks (follow-up)
Secondary outcome [12] 398508 0
Change in patient experiences of somatic symptoms after iCBT/face-to-face interventions, via Patient Health Questionnaire-15.
Timepoint [12] 398508 0
Step-2 0 weeks (pre-intervention)
Step-2 12 weeks (post-intervention)
Step-2 24 weeks (follow-up)
Secondary outcome [13] 398509 0
Change in patient quality of life after iCBT/face-to-face interventions, via EuroQoL-5 Dimensions.
Timepoint [13] 398509 0
Step-2 0 weeks (pre-intervention)
Step-2 12 weeks (post-intervention)
Step-2 24 weeks (follow-up)
Secondary outcome [14] 398510 0
Change in patient social functioning after iCBT/face-to-face interventions, via Social Functioning Questionnaire.
Timepoint [14] 398510 0
Step-2 0 weeks (pre-intervention)
Step-2 12 weeks (post-intervention)
Step-2 24 weeks (follow-up)

Eligibility
Key inclusion criteria
Step-1 (Screening):
The study will be made available to:
- All adult (equal to or greater than 18 years old) attendees at four specified clinics (dermatology, rheumatology, endocrinology, and Upper GI surgery).
- Physical health: attendees to the assigned outpatient clinics.
- Willing to give electronic informed consent.
- Understand spoken and written English.
There is no specific laboratory, radiological or other investigation parameters.

Step-2 (SHAPE Pilot):
- Meet criteria for Part 1.
- Completion of full screening.
- WI-6 score of 18+.
- Agree (opt in) to having further contact, or later contacts us to request involvement.
- Willing to participate with study schedule.
- Provides verbal ongoing consent when contacted.
- Provides home address.
- Is eligible for Medicare.

Part 3 (Data (record) linkage):
- Meet inclusion criteria for Part 1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Step-1 (Screening):
- Has participated in the trial within the past 3 months (to avoid duplication).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a non-randomised, exploratory study. There is very little background data on the rates of health anxiety in Australian hospital clinic outpatients, acceptability of mental health screening in hospital clinic outpatients, uptake of treatment for health anxiety in hospital clinic outpatients, or outcomes of treatment interventions in real world clinics.
Furthermore, survey invitation text messages will be distributed to all patients who attend selected outpatient clinics during the designated timeframe. In that context, statistical analysis does not include a sample size or power estimate. It is estimated that the survey will be distributed to approximately 10,000 patients.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
5/07/2021
Date of last participant enrolment
Anticipated
31/01/2022
Actual
8/07/2022
Date of last data collection
Anticipated
30/07/2022
Actual
Sample size
Target
5000
Accrual to date
Final
8113
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19649 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 34281 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 308781 0
Other Collaborative groups
Name [1] 308781 0
Mindgardens Neuroscience Network
Country [1] 308781 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Mindgardens Neuroscience Network
Address
Mindgardens Neuroscience Network, Prince of Wales Hospital, 320-346 Barker St, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 309719 0
None
Name [1] 309719 0
Address [1] 309719 0
Country [1] 309719 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308693 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 308693 0
Ethics committee country [1] 308693 0
Australia
Date submitted for ethics approval [1] 308693 0
01/03/2021
Approval date [1] 308693 0
02/06/2021
Ethics approval number [1] 308693 0
2021/ETH00357

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

Contacts
Principal investigator
Name 111582 0
Dr Michael Murphy
Address 111582 0
Black Dog Institute, Hospital Rd, Randwick, NSW, 2031
Country 111582 0
Australia
Phone 111582 0
+61290659066
Fax 111582 0
Email 111582 0
[email protected]
Contact person for public queries
Name 111583 0
Michael Murphy
Address 111583 0
Black Dog Institute, Hospital Rd, Randwick, NSW, 2031
Country 111583 0
Australia
Phone 111583 0
+61290659066
Fax 111583 0
Email 111583 0
[email protected]
Contact person for scientific queries
Name 111584 0
Michael Murphy
Address 111584 0
Black Dog Institute, Hospital Rd, Randwick, NSW, 2031
Country 111584 0
Australia
Phone 111584 0
+61290659066
Fax 111584 0
Email 111584 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
To ensure participant privacy and confidentiality, individual participant data will not be made available. Any dissemination of results will use grouped, de-identified data only.


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.