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Trial registered on ANZCTR


Registration number
ACTRN12615000338561
Ethics application status
Approved
Date submitted
7/04/2015
Date registered
14/04/2015
Date last updated
18/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Health Anxiety Program: a pilot trial of an online program for people who worry excessively about their health
Scientific title
A Pilot Trial evaluating the impact of internet-delivered cognitive behavioural therapy (iCBT) on symptoms of health anxiety.
Secondary ID [1] 286482 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Illness Anxiety Disorder 294673 0
Somatic Symptom Disorder 294674 0
Hypochondriasis 294675 0
Severe Health Anxiety 294676 0
Condition category
Condition code
Mental Health 294978 294978 0 0
Anxiety
Mental Health 294979 294979 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The internet-delivered Health Anxiety program comprises 6 lessons completed over 10 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 30-40 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] 291572 0
Behaviour
Intervention code [2] 291573 0
Treatment: Other
Comparator / control treatment
N/A This is an uncontrolled pre-post study design.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294730 0
Mean score on the Short Health Anxiety Inventory
Timepoint [1] 294730 0
Baseline, before each lesson, one week post-treatment, and at 3-months post-treatment (week 24).
Secondary outcome [1] 313942 0
Mean score on the Patient Health Questionnaire 9-item (PHQ-9)
Timepoint [1] 313942 0
Baseline, mid-treatment (before lesson 4), one week post-treatment, and at 3-months post-treatment (week 24).
Secondary outcome [2] 313943 0
Severity of psychological distress according to mean scores on the Kessler-10 (K10)
Timepoint [2] 313943 0
Baseline, prior to each lesson, one week post-treatment, and at 3-months post-treatment (week 24).
Secondary outcome [3] 313944 0
Mean score on the Patient Health Questionnaire 15-item index of somatic symptom severity (PHQ-15)
Timepoint [3] 313944 0
Baseline, mid-treatment (before lesson 4), one week post-treatment, and at 3-months post-treatment (week 24).
Secondary outcome [4] 313945 0
Severity of generalised anxiety according to mean score on the Generalised Anxiety Disorder 7-item scale (GAD-7)
Timepoint [4] 313945 0
Baseline, one week post-treatment, and at 3-months post-treatment (week 24).
Secondary outcome [5] 313946 0
Level of functional impairment and disability according to mean score on the World Health Organisation Disability Assessment Schedule (WHODAS-II).
Timepoint [5] 313946 0
Baseline, one week post-treatment, and at 3-months post-treatment (week 24).
Secondary outcome [6] 313947 0
Proportion of participants with a reduction 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 [6] 313947 0
Baseline, one week post-treatment (SUDOR), and at 3-months post-treatment (week 24).
Secondary outcome [7] 313948 0
Perceived health status according to the proportion of participants who report improvements on the Self-Rated Health questionnaire.
Timepoint [7] 313948 0
Baseline, one week post-treatment, and at 3-months post-treatment (week 24).
Secondary outcome [8] 313949 0
Changes in worry behaviours (e.g., checking and reassurance-seeking) according to the mean scores on the Brief Worry Behaviours Questionnaire.
Timepoint [8] 313949 0
Baseline, prior to each lesson, one week post-treatment, and at 3-months post-treatment (week 24).
Secondary outcome [9] 313950 0
Changes in hypervigilance to bodily sensations according to the mean scores on the adapted version of the Body Vigilance Questionnaire.
Timepoint [9] 313950 0
Baseline, prior to each lesson, one week post-treatment, and at 3-months post-treatment (week 24).
Secondary outcome [10] 313951 0
Changes in intolerance of uncertainty according to the mean score on the Intolerance of Uncertainty 12-item (IUS-12).
Timepoint [10] 313951 0
Baseline, one week post-treatment, and at 3-months post-treatment (week 24).
Secondary outcome [11] 313952 0
Changes in mindful awareness and attention according to the mean scores on the Mindful Awareness and Attention Scale (MAAS).
Timepoint [11] 313952 0
Baseline, one week post-treatment, and at 3-months post-treatment (week 24).
Secondary outcome [12] 313953 0
Changes in unhelpful beliefs about body and health according to mean scores on the Cognitions about Body and Health Questionnaire (CABAH).
Timepoint [12] 313953 0
Baseline, one week post-treatment, and at 3-months post-treatment (week 24).
Secondary outcome [13] 313955 0
Changes in symptoms of 'cyberchondria' or excessive internet searching, according to mean scores on the Cyberchondria Severity Scale (CSS).
Timepoint [13] 313955 0
Baseline, one week post-treatment, and at 3-months post-treatment (week 24).
Secondary outcome [14] 313956 0
Treatment Satisfaction according to the Treatment Satisfaction Questionnaire.
Timepoint [14] 313956 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.
Minimum age
18 Years
Maximum age
No limit
Sex
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
Non-randomised 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)
This is a non-randomised study. All participants that meet criteria for entry into the study who also provide informed consent will be allocated to the intervention (iCBT) group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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 treatment group on the primary health anxiety measure (the SHAI).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/03/2015
Actual
23/03/2015
Date of last participant enrolment
Anticipated
5/06/2015
Actual
10/04/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 3671 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Funding & Sponsors
Funding source category [1] 291049 0
Charities/Societies/Foundations
Name [1] 291049 0
St Vincent's Clinic Foundation
Country [1] 291049 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] 289732 0
None
Name [1] 289732 0
Address [1] 289732 0
Country [1] 289732 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292632 0
St Vincent's Hospital HREC
Ethics committee address [1] 292632 0
St Vincent's Hospital
390 Victoria St
Darlinghurst NSW 2010
Ethics committee country [1] 292632 0
Australia
Date submitted for ethics approval [1] 292632 0
Approval date [1] 292632 0
06/11/2014
Ethics approval number [1] 292632 0
HREC/14/SVH/294

Summary
Brief summary
The project aims to evaluate the acceptability and clinical efficacy of the online Health Anxiety Program.

Up to 25 people with elevated health anxiety (either IAD or SSD) will be assigned to the active treatment group. The treatment group will commence the Health Anxiety Program immediately.

The efficacy of the Health Anxiety Program will be determined by comparing the health anxiety symptom levels before and after treatment, and at 3 month follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56326 0
Prof Gavin Andrews
Address 56326 0
Clinical Research Unit for Anxiety and Depression, Level 4 O'Brien Centre, St Vincent's Hospital, 390 Victoria St Darlinghurst NSW 2010
Country 56326 0
Australia
Phone 56326 0
+61 2 8382 1405
Fax 56326 0
Email 56326 0
[email protected]
Contact person for public queries
Name 56327 0
Jill Newby
Address 56327 0
Clinical Research Unit for Anxiety and Depression, Level 4 O'Brien Centre, St Vincent's Hospital, 390 Victoria St Darlinghurst NSW 2010
Country 56327 0
Australia
Phone 56327 0
+61283821433
Fax 56327 0
Email 56327 0
[email protected]
Contact person for scientific queries
Name 56328 0
Jill Newby
Address 56328 0
Clinical Research Unit for Anxiety and Depression, Level 4 O'Brien Centre, St Vincent's Hospital, 390 Victoria St Darlinghurst NSW 2010
Country 56328 0
Australia
Phone 56328 0
+61283821433
Fax 56328 0
Email 56328 0
[email protected]

No information has been provided regarding IPD availability


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.