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Trial registered on ANZCTR


Registration number
ACTRN12617000900314
Ethics application status
Approved
Date submitted
15/06/2017
Date registered
19/06/2017
Date last updated
5/02/2020
Date data sharing statement initially provided
5/02/2020
Date results provided
5/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Can Computerised Interpretation Training improve Health Anxiety?
Scientific title
A randomised controlled trial of interpretation bias modification for health anxiety.
Secondary ID [1] 291953 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health Anxiety 303301 0
Illness anxiety disorder 303363 0
Somatic Symptom Disorder 303364 0
Condition category
Condition code
Mental Health 302734 302734 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Computerised Cognitive bias modification of Interpretations (iCBM) intervention with 2 sessions completed online over 7 days at home (each session approx 30 minutes).

During iCBM, participants will be presented with a series of written ambiguous health-related scenarios on the computer screen and asked to complete word fragments at the end of the ambiguous scenarios to resolve the scenario in a positive manner.

Adherence will be monitored by completion of iCBM sessions, as well as the time taken to complete the session.
Intervention code [1] 298081 0
Behaviour
Intervention code [2] 298390 0
Treatment: Other
Comparator / control treatment
Neutral interpretation training group: computer training will involve being presented with the same series of ambiguous health-related scenarios as the positive training (as explained above). In contrast to positive interpretation training, where participants will be repeatedly asked to resolve all of the sentences in a positive manner, in the neutral group, participants will be asked to resolve half of the scenarios in a negative manner, and half in a positive manner.

Control group
Active

Outcomes
Primary outcome [1] 302128 0
Changes in health anxiety according to scores on the Short Health Anxiety Inventory (SHAI)
Timepoint [1] 302128 0
Administered at Baseline (T1), Post iCBM intervention (T2, 1 week after baseline) and 2 weeks after the completion of the intervention (T3)
Secondary outcome [1] 334897 0
Changes in depression, anxiety and stress according to scores on the Depression Anxiety Stress Scales (DASS-21)
Timepoint [1] 334897 0
Administered at Baseline (T1), Post iCBM intervention (T2, 1 week after baseline) and 2 weeks after the completion of the intervention (T3)
Secondary outcome [2] 334898 0
Changes in the severity of bodily sensations according to scores on the Patient Health Questionnaire - 15 item (PHQ)
Timepoint [2] 334898 0
Administered at Baseline (T1), Post iCBM intervention (T2, 1 week after baseline) and 2 weeks after the completion of the intervention (T3)
Secondary outcome [3] 334899 0
Changes in the frequency of behaviours related to worry according to scores on the Worry Behaviours Inventory - Short Form (WBI-SF)
Timepoint [3] 334899 0
Administered at Baseline (T1), Post iCBM intervention (T2, 1 week after baseline) and 2 weeks after the completion of the intervention (T3)
Secondary outcome [4] 334900 0
Changes in cognitions about health according to the Cognitions About Body And Health Questionnaire (CABAH)
Timepoint [4] 334900 0
Administered at Baseline (T1), Post iCBM intervention (T2, 1 week after baseline) and 2 weeks after the completion of the intervention (T3)
Secondary outcome [5] 334901 0
Changes in the level of sensitivity and hypervigilance to body sensations according to scores on the Body Vigilance Scale- Short Form (BVS-SF)
Timepoint [5] 334901 0
Administered at Baseline (T1), Post iCBM intervention (T2, 1 week after baseline) and 2 weeks after the completion of the intervention (T3)
Secondary outcome [6] 334902 0
Changes in anxiety sensitivity according to scores on the Anxiety Sensitivity Index (ASI)
Timepoint [6] 334902 0
Administered at Baseline (T1), Post iCBM intervention (T2, 1 week after baseline) and 2 weeks after the completion of the intervention (T3)
Secondary outcome [7] 334903 0
Changes in the interpretation of bodily sensations according to scores on the Attribution Task (a task that requires participants to generate reasons for the occurrence of a set list of symptoms)
Timepoint [7] 334903 0
Administered at Baseline (T1) and at Post iCBM intervention (T2, 1 week after baseline).
Secondary outcome [8] 336065 0
Acceptability, as measured by the credibility and expectancy scale.
Timepoint [8] 336065 0
Post-intervention (T2, 1 week after baseline)

Eligibility
Key inclusion criteria
• Participants who are 18 years or older.
• Participants must have access to a computer and the internet.
• Participants must report elevated symptoms of health anxiety on the Short Health Anxiety Inventory (SHAI), corresponding to a score of 20 or above.
• Willingness to give electronic informed consent and willingness to participate and comply with the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Participants who are severely depressed, who are currently at risk of harm or who have current suicidality that warrants immediate clinical attention will be excluded from the study.
• Participants who have organic brain damage or current substance dependence will not be admitted into the study.
• Participants who do not have proficiency in English that will enable them to complete the requirements of 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)
Group allocation will be concealed from the interviewer until an offer of treatment made. Group allocation will be concealed from the participant throughout the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation numbers will be generated using random.org using simple randomisation by a research assistant independent from the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention to treat linear mixed models will be used to analyse whether the positive computerised iCBM training is superior to the neutral computerised iCBM training in reducing health anxiety. If there is no missing data, independent samples t tests will be used to compare the groups at post-treatment and follow-up. Effect sizes (Cohen's d and their 95% confidence intervals) will be calculated to explore and compare the size of the within-group and between-group effects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/06/2017
Actual
17/07/2017
Date of last participant enrolment
Anticipated
Actual
31/01/2018
Date of last data collection
Anticipated
Actual
16/02/2018
Sample size
Target
88
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 296468 0
University
Name [1] 296468 0
University of New South Wales
Country [1] 296468 0
Australia
Funding source category [2] 296775 0
Other
Name [2] 296775 0
National Health and Medical Research Council
Country [2] 296775 0
Australia
Primary sponsor type
University
Name
The University of New South Wales
Address
School of Psychology
Mathews Building
UNSW Sydney
Randwick, NSW, Australia, 2052
Country
Australia
Secondary sponsor category [1] 295423 0
None
Name [1] 295423 0
Address [1] 295423 0
Country [1] 295423 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297690 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 297690 0
Ethics committee country [1] 297690 0
Australia
Date submitted for ethics approval [1] 297690 0
13/03/2017
Approval date [1] 297690 0
17/05/2017
Ethics approval number [1] 297690 0
HC17137

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

Contacts
Principal investigator
Name 74838 0
Dr Jill Newby
Address 74838 0
Level 13, Mathews Building, The University of New South Wales Sydney NSW 2052 Australia
Country 74838 0
Australia
Phone 74838 0
+61 (2) 9385 3425
Fax 74838 0
Email 74838 0
[email protected]
Contact person for public queries
Name 74839 0
Jill Newby
Address 74839 0
Level 13, Mathews Building, The University of New South Wales Sydney NSW 2052 Australia
Country 74839 0
Australia
Phone 74839 0
+61 (2) 9385 3425
Fax 74839 0
Email 74839 0
[email protected]
Contact person for scientific queries
Name 74840 0
Jill Newby
Address 74840 0
Level 13, Mathews Building, The University of New South Wales Sydney NSW 2052 Australia
Country 74840 0
Australia
Phone 74840 0
+61 (2) 9385 3425
Fax 74840 0
Email 74840 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers with ethics approval for a study for individual patient meta-analyses.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Self-reported health anxiety and secondary outcomes at each time point, by group. No identifiable information will be shared.

What types of analyses could be done with individual participant data?
• IPD meta-analyses.

When can requests for individual participant data be made (start and end dates)?
From:
De-identified data may be made available on request, depending on the request, and resources. No end date determined.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Email the chief investigator ([email protected]) to request data to be made available.

Are there extra considerations when requesting access to individual participant data?
No


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
SourceTitleYear of PublicationDOI
EmbaseA randomised controlled trial of computerised interpretation bias modification for health anxiety.2020https://dx.doi.org/10.1016/j.jbtep.2019.101518
N.B. These documents automatically identified may not have been verified by the study sponsor.