Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001371785
Ethics application status
Approved
Date submitted
5/12/2013
Date registered
13/12/2013
Date last updated
13/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Helping Health Anxiety: Evaluation of a pure self-help treatment program for Health Anxiety
Scientific title
In adults with Health Anxiety, is the self-help program of Helping Health Anxiety effective in improving health anxiety, anxiety sensitivity and general stress, depression and anxiety.
Secondary ID [1] 283642 0
None
Universal Trial Number (UTN)
U1111-1150-6830
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health Anxiety 290600 0
Condition category
Condition code
Mental Health 290986 290986 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve a Cognitive Behavioural Therapy (CBT) based self-help program called “Helping Health Anxiety” developed by the Centre for Clinical Interventions (CCI). There are nine modules providing the following intervention components: psychoeducation; attention training; worry postponement; thought diaries; reducing unhelpful checking and reassurance seeking; challenging avoidance and safety behaviours (exposure); adjusting health rules and assumptions; healthy living; and self- management planning (Anderson, Saulsman, & Nathan, 2011). Each week, over nine weeks, one module will be sent to the participants via email. Each module takes approximately 1 hour to complete, plus any time the participant spends on doing the associated practice tasks throughout the week. Each week the participants are required to complete a questionnaire via email, before they are sent the module, in order to tracks their Health Anxiety.
Their experience of the modules will also be explored during the follow-up interview (a month after the intervention is completed).
Intervention code [1] 288352 0
Behaviour
Comparator / control treatment
An A-B (pre-post) single case experimental design series will be implemented. The study aims to evaluate if there are positive reliable changes as well as clinically significant changes between pre-test and post-test in terms of health anxiety, anxiety sensitivity and general anxiety, depression and stress. Post-test (post-intervention) scores will be compared to each individual's Pre-test (pre-intervention) scores.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290992 0
Health Anxiety Score as assessed by the Short Health Anxiety Inventory (Salkovskis, Rimes, Warwick, & Clarke, 2002)
Timepoint [1] 290992 0
Week before the commencement of treatment, each week of the treatment and one month after treatment completion
Primary outcome [2] 290993 0
Anxiety Sensitivity as measured by the Anxiety Sensitivity Index (Peterson, Gursky, & McNally, 1986)
Timepoint [2] 290993 0
One week before treatment commences, the first week of treatment, the final week of treatment and one month after the final week of treatment
Primary outcome [3] 290994 0
General levels of depression, anxiety and stress as measured by the Depression, Anxiety, and Stress Scale Short Form (Lovibond & Lovibond, 1995)
Timepoint [3] 290994 0
A week before the commencement of treatment, the first week of treatment, the final week of treatment and one month after treatment completion
Secondary outcome [1] 305762 0
Feedback on the self-help program and it's effects using a semi-structures interview
Timepoint [1] 305762 0
One month after the completion of the program

Eligibility
Key inclusion criteria
Have health anxiety as the primary problem as assessed using diagnostic and questionnaire measures of: a semi-structured intake interview, the Short Health Anxiety Inventory and the Mini-International Neuropsychiatric Interview
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants excluded if they meet criteria for psychosis, substance misuse, bipolar disorder, or are at high risk for self-harm or suicide.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
16/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 288354 0
University
Name [1] 288354 0
Curtin University of Technology
Country [1] 288354 0
Australia
Primary sponsor type
Individual
Name
Dr Rebecca Anderson
Address
Curtin University
Kent Street, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 287062 0
Individual
Name [1] 287062 0
Timea Zalanyi
Address [1] 287062 0
Curtin University
Kent Street, Bentley WA 6102
Country [1] 287062 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290263 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 290263 0
Office of Research and Development
Curtin University
GPO Box U1987
Perth, W.A. 6845
Ethics committee country [1] 290263 0
Australia
Date submitted for ethics approval [1] 290263 0
20/05/2013
Approval date [1] 290263 0
03/07/2013
Ethics approval number [1] 290263 0
HR 100/2013

Summary
Brief summary
The project is a case series looking at the effectiveness of a series of self help modules for the treatment of health anxiety. The self-help modules are based on evidence-supported intervention and were developed by expert clinical psychologists. The project will entail the recruitment of four participants whose primary condition is health anxiety and their assessment. The selected participants who meet the selection criteria and consent to the participation will be emailed these modules weekly. The project aims to investigate if pure self-help is an effective treatment for health anxiety by assessing if the participants demonstrate reliable and clinically significant change. If so, this will improve treatment accessibility and affordability for individuals who suffer from this problem.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44498 0
Dr Rebecca Anderson
Address 44498 0
Curtin University
Kent St
Bentley, WA 6102
Country 44498 0
Australia
Phone 44498 0
+61 8 9266 3012
Fax 44498 0
Email 44498 0
[email protected]
Contact person for public queries
Name 44499 0
Miss Timea Zalanyi
Address 44499 0
Curtin University
Kent St
Bentley, WA 6102
Country 44499 0
Australia
Phone 44499 0
+61411116260
Fax 44499 0
Email 44499 0
[email protected]
Contact person for scientific queries
Name 44500 0
Dr Rebecca Anderson
Address 44500 0
Curtin University
Kent St
Bentley, WA 6102
Country 44500 0
Australia
Phone 44500 0
+61 8 9266 3012
Fax 44500 0
Email 44500 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
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Documents added automatically
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