Please be advised that due to the high volume of submissions, the ANZCTR is currently experiencing delays in processing submissions. Please allow additional time for registration or updates to registration records. As the ANZCTR is funded by Australia and New Zealand, we must prioritise submissions from these countries first, therefore international submissions will experience further delays. Apologies for any inconvenience caused.

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
ACTRN12615000887572
Ethics application status
Approved
Date submitted
13/08/2015
Date registered
25/08/2015
Date last updated
9/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial evaluating an internet-based cognitive behavioural therapy (iCBT) program for health anxiety
Scientific title
A randomised controlled trial comparing the impact of internet-based cognitive behavioural therapy (iCBT) for health anxiety to psychoeducation on health anxiety symptoms
Secondary ID [1] 287274 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Illness Anxiety Disorder 295902 0
Somatic Symptom Disorder 295903 0
Health Anxiety 295904 0
Condition category
Condition code
Mental Health 296154 296154 0 0
Anxiety
Mental Health 296155 296155 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The internet Health Anxiety Program program comprises 6 lessons completed over 12 weeks. It includes all treatment components typically seen in face­-to­-face cognitive behavioural therapy (CBT) (the first­-line treatment for severe health anxiety). One lesson will be completed every 7 to 14 days (it will become available after the preceding lesson has been completed, with a minimum of 5 days between lessons and a maximum of 14 days). Each lesson will take approximately 20-30 minutes to complete. Participants will have access to summaries of each lesson, homework exercises, extra resources, email contact from the clinician (registered clinical psychologist) after completion of the first two lessons, then as required. The participant is also able to email or phone the clinician at any point during the trial as required. The participant completes a measure of psychological distress before each lesson and if their scores increase by one or more standard deviations the clinician is automatically alerted and initiates contact with the participant by phone or email.

Strategies used to improved adherence to intervention protocols and procedures for monitoring adherence include: automated email reminders, monitoring the downloading of homework, collection of data on how long participants spent reading lessons and practicing skills.
Intervention code [1] 292582 0
Behaviour
Intervention code [2] 292583 0
Treatment: Other
Comparator / control treatment
Psychoeducation control group. These participants will complete 6 sets of brief questionnaires (once per fortnight for 12 weeks), and receive 6 fact sheets that explain key information about how to recognise and understand anxiety over the 12 week waiting period.
Once the immediate treatment group has completed their online program and post-treatment questionnaires (at week 13), the control group will be offered the same internet treatment program for Health Anxiety.
Control group
Active

Outcomes
Primary outcome [1] 295836 0
Mean score on the Short Health Anxiety Inventory
Timepoint [1] 295836 0
Baseline, before each lesson, one week post-treatment, and at 3-months post-treatment (week 26, for treatment group only).
Secondary outcome [1] 316629 0
Mean score on the Patient Health Questionnaire 9-item (PHQ-9)
Timepoint [1] 316629 0
Baseline, mid treatment (before lesson 4), one week post-treatment, and at 3-months post-treatment (week 26, for treatment group only).
Secondary outcome [2] 316630 0
Severity of psychological distress according to mean scores on the Kessler-10 (K10)
Timepoint [2] 316630 0
Baseline, before each lesson, one week post-treatment, and at 3-months post-treatment (week 26, for treatment group only).
Secondary outcome [3] 316631 0
Level of functional impairment and disability according to mean score on the World Health Organisation Disability Assessment Schedule (WHODAS-II).
Timepoint [3] 316631 0
Baseline, one week post-treatment, and at 3-months post-treatment (week 26, for treatment group only).
Secondary outcome [4] 316632 0
Proportion of participants with a change in the frequency of service use and days out of role according to the Service Use and Days out of Role Questionnaire (SUDOR), and the Service Use Inventory adapted from the Australian National Health and Wellbeing Survey.
Timepoint [4] 316632 0
Baseline, one week post-treatment, and at 3-months post-treatment (week 26, for treatment group only).
Secondary outcome [5] 316656 0
Perceived health status according to the proportion of participants who report improvements on the Self-Rated Health questionnaire.
Timepoint [5] 316656 0
Baseline, one week post-treatment, and at 3-months post-treatment (week 26).
Secondary outcome [6] 316657 0
Changes in worry behaviours (e.g., checking and reassurance-seeking) according to the mean scores on the Brief Worry Behaviours Questionnaire.
Timepoint [6] 316657 0
Baseline, prior to each lesson, one week post-treatment, and at 3-months post-treatment (week 26).
Secondary outcome [7] 316658 0
Changes in hypervigilance to bodily sensations according to the mean scores on the adapted version of the Body Vigilance Questionnaire.
Timepoint [7] 316658 0
Baseline, prior to each lesson, one week post-treatment, and at 3-months post-treatment (week 26).
Secondary outcome [8] 316659 0
Changes in intolerance of uncertainty according to the mean score on the Intolerance of Uncertainty 12-item (IUS-12).
Timepoint [8] 316659 0
Baseline, one week post-treatment, and at 3-months post-treatment (week 26).
Secondary outcome [9] 316660 0
Changes in mindful awareness and attention according to the mean scores on the Mindful Awareness and Attention Scale (MAAS).
Timepoint [9] 316660 0
Baseline, one week post-treatment, and at 3-months post-treatment (week 24).
Secondary outcome [10] 316661 0
Changes in unhelpful beliefs about body and health according to mean scores on the Cognitions about Body and Health Questionnaire (CABAH)
Timepoint [10] 316661 0
Baseline, one week post-treatment, and at 3-months post-treatment (week 24).
Secondary outcome [11] 316662 0
Changes in symptoms of 'cyberchondria' or excessive internet searching, according to mean scores on the Cyberchondria Severity Scale (CSS).
Timepoint [11] 316662 0
Baseline, one week post-treatment, and at 3-months post-treatment (week 24).
Secondary outcome [12] 316663 0
Treatment Satisfaction according to the Treatment Satisfaction Questionnaire.
Timepoint [12] 316663 0
One week post-treatment.

Eligibility
Key inclusion criteria
* Self-identified as suffering from excessive health anxiety.
* Meet criteria for either Illness Anxiety Disorder (IAD) or Somatic Symptom Disorder (SSD) according to the Anxiety Disorders Interview Schedule for DSM-5 (ADIS-5).
* Australian resident status
* At least 18 years of age
* Access to a computer, printer, and the internet
* If taking medication, must have been taking the same dose for at least 1 month and not intend to change that dose during the course of the program.
* Prepared to provide name, phone number, and address, and to provide the name and phone number of a local general practitioner.
* Willing to provide informed consent.
* Willing to provide consent for study team to notify their GP of their participation in this project.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Does not meet IAD or SSD diagnostic criteria
- Currently experiencing severe depression symptoms (score of 24 or above on the PHQ-9).
- Regularly using illicit drugs or regularly consuming more than three standard drinks per day
- Current regular use of benzodiazepines
- Current use of atypical anti-psychotics
- Currently experiencing a psychotic mental illness or bipolar disorder
- severe symptoms of suicidal ideation (defined as responding 3 to the PHQ-9 question 9 item that assesses the frequency of suicidal ideation over the past fortnight).
-Those scoring 1 or 2 on the Patient Health Questionnaire-9 Item (PHQ-9) item 9 will require risk assessment with the responsible clinician before being admitted into the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants apply online, followed by a telephone interview to confirm diagnosis via the Anxiety Disorders Interview Schedule for DSM-5 (ADIS-5), a structured clinical interview.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized using a list generated prior to the study. Allocation concealment will occur in the following way: A staff member not involved in the clinical trial will generate the sequence using computer software and place each choice in a sequentially numbered, opaque sealed and stapled envelope.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A pre-to-post-treatment improvement of effect size (ES) 1.0 is expected for the active treatment group on the primary health anxiety measure (the SHAI). This group is also expected to improve more than the waitlist control group by an ES of 0.8. Sample size is powered to have an 80% chance of detecting differences at p<.05. This will require n=25 per group, but we will recruit up to 30 participants per group to account for possible participant drop-out.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 291835 0
Hospital
Name [1] 291835 0
St Vincent's Hospital, Sydney
Address [1] 291835 0
390 Victoria Street Darlinghurst, NSW 2010
Country [1] 291835 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney
Address
390 Victoria Street
Darlinghurst, NSW, 2010
Country
Australia
Secondary sponsor category [1] 290503 0
None
Name [1] 290503 0
Address [1] 290503 0
Country [1] 290503 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293352 0
St Vincent's Hospital HREC
Ethics committee address [1] 293352 0
390 Victoria Street Darlinghurst, NSW 2010
Ethics committee country [1] 293352 0
Australia
Date submitted for ethics approval [1] 293352 0
Approval date [1] 293352 0
06/11/2014
Ethics approval number [1] 293352 0
HREC/14/SVH/294

Summary
Brief summary
The project aims to evaluate the acceptability and clinical efficacy of the online Health Anxiety Program; and to examine the moderators and mediators of change during the Health Anxiety Program.


Up to 60 people with Health Anxiety will be randomly assigned to either the active treatment group or a
control group which receives psychoeducation about anxiety in the form of 6 brief fact sheets. The treatment group will commence the Health Anxiety program immediately, whereas the control group will commence once the treatment group has completed.

The efficacy of the Health Anxiety program will be determined by comparing the health anxiety severity levels of the two groups at the time the treatment group completes treatment. Mediation analyses will be used to explore the role of variables that may influence positive change (such as changes in behaviours, catastrophic thinking, hypervigilance and intolerance of uncertainty)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59522 0
Prof Gavin Andrews
Address 59522 0
Clinical Research Unit for Anxiety and Depression 390 Victoria St Darlinghurst NSW 2010
Country 59522 0
Australia
Phone 59522 0
+61 2 8382 1405
Fax 59522 0
Email 59522 0
gavina@unsw.edu.au
Contact person for public queries
Name 59523 0
Dr Jill Newby
Address 59523 0
Clinical Research Unit for Anxiety and Depression 390 Victoria St Darlinghurst NSW 2010
Country 59523 0
Australia
Phone 59523 0
+83821433
Fax 59523 0
Email 59523 0
j.newby@unsw.edu.au
Contact person for scientific queries
Name 59524 0
Dr Jill Newby
Address 59524 0
Clinical Research Unit for Anxiety and Depression 390 Victoria St Darlinghurst NSW 2010
Country 59524 0
Australia
Phone 59524 0
+83821433
Fax 59524 0
Email 59524 0
j.newby@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary