Screening and Support for Health and General Anxiety at the Prince of Wales Hospital - An Exploratory Study

Not Applicable

Active, not recruiting

• Conditions: Illness Anxiety Disorder; Somatic Symptom Disorder; Generalised Anxiety Disorder; Mental Health - Anxiety; Mental Health - Other mental health disorders

• Registration Number: ACTRN12621001023842
• Lead Sponsor: Mindgardens Neuroscience Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-05
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 8113

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.

Exclusion Criteria

Step-1 (Screening):
-Has participated in the trial within the past 3 months (to avoid duplication).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rates of self-reported health anxiety in hospital outpatients via Whitely Index-6 score.[Step-1 screening survey<br>];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).[Step-1 screening survey <br>Step-2 0 weeks (pre-intervention) <br>Step-2 6 weeks (mid-intervention) <br>Step-2 12 weeks (post-intervention) <br>Step-2 24 weeks (follow-up)<br>];Healthcare utilisation rates, assessed by data linkage to medical records.[Measured for the period of 2 years before intervention and 2 years after intervention. <br><br><br>]