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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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10 February 2020 |
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Main ID: |
ACTRN12617000900314 |
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Date of registration:
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19/06/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Can Computerised Interpretation Training improve Health Anxiety?
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Scientific title:
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A randomised controlled trial of interpretation bias modification for health anxiety. |
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Date of first enrolment:
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17/07/2017 |
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Target sample size:
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88 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12617000900314.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Jill Newby
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Address:
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Level 13, Mathews Building,
The University of New South Wales
Sydney NSW 2052 Australia
Australia |
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Telephone:
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+61 (2) 9385 3425 |
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Email:
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j.newby@unsw.edu.au |
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Affiliation:
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Name:
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Dr Jill Newby
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Address:
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Level 13, Mathews Building,
The University of New South Wales
Sydney NSW 2052 Australia
Australia |
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Telephone:
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+61 (2) 9385 3425 |
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Email:
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j.newby@unsw.edu.au |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
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.
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Health Anxiety ;Illness anxiety disorder;Somatic Symptom Disorder;
Health Anxiety
Illness anxiety disorder
Somatic Symptom Disorder
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Mental Health - Anxiety
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Intervention(s)
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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.
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Primary Outcome(s)
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Changes in health anxiety according to scores on the Short Health Anxiety Inventory (SHAI)[Administered at Baseline (T1), Post iCBM intervention (T2, 1 week after baseline) and 2 weeks after the completion of the intervention (T3)]
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Secondary Outcome(s)
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Changes in the level of sensitivity and hypervigilance to body sensations according to scores on the Body Vigilance Scale- Short Form (BVS-SF)[Administered at Baseline (T1), Post iCBM intervention (T2, 1 week after baseline) and 2 weeks after the completion of the intervention (T3)]
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Changes in cognitions about health according to the Cognitions About Body And Health Questionnaire (CABAH)[Administered at Baseline (T1), Post iCBM intervention (T2, 1 week after baseline) and 2 weeks after the completion of the intervention (T3)]
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Changes in the frequency of behaviours related to worry according to scores on the Worry Behaviours Inventory - Short Form (WBI-SF)[Administered at Baseline (T1), Post iCBM intervention (T2, 1 week after baseline) and 2 weeks after the completion of the intervention (T3)]
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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)[Administered at Baseline (T1) and at Post iCBM intervention (T2, 1 week after baseline).]
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Acceptability, as measured by the credibility and expectancy scale.[Post-intervention (T2, 1 week after baseline)]
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Changes in depression, anxiety and stress according to scores on the Depression Anxiety Stress Scales (DASS-21)[Administered at Baseline (T1), Post iCBM intervention (T2, 1 week after baseline) and 2 weeks after the completion of the intervention (T3)]
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Changes in the severity of bodily sensations according to scores on the Patient Health Questionnaire - 15 item (PHQ)[Administered at Baseline (T1), Post iCBM intervention (T2, 1 week after baseline) and 2 weeks after the completion of the intervention (T3)]
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Changes in anxiety sensitivity according to scores on the Anxiety Sensitivity Index (ASI) [Administered at Baseline (T1), Post iCBM intervention (T2, 1 week after baseline) and 2 weeks after the completion of the intervention (T3)]
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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University of New South Wales
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National Health and Medical Research Council
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Ethics review
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Status: Approved
Approval date: 17/05/2017
Contact:
University of New South Wales Human Research Ethics Committee
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Results
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Results available:
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Yes |
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Date Posted:
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05/02/2020 |
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Date Completed:
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16/02/2018 |
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URL:
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