None listed
Conditions
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)
Interventions
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
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.
Sponsors
St Vincent's Hospital Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed