- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03019705
An Examination of the Effects of Health-related Internet Use in Individuals With Pathological Health Anxiety Using Ambulatory Assessment
Study Overview
Detailed Description
The internet is a popular method for obtaining information. Increasingly, it is also used to answer medical and health questions, because compared to other methods (e.g. going to the library or visiting a doctor) it has a number of advantages to offer like low costs, availability, easy accessibility, anonymity, and great diversity of information types and sources. 60 to 80 percent of internet users search online for medical information. In this context the term "cyberchondria" was coined in the media to describe the potentially detrimental effects of this behavior. The first studies in this field using self-report retrospective data showed that individuals with elevated levels of health anxiety seem to make increased use of the internet for this purpose and it seems to maintain health anxiety in the long-term. However, up until today little is known about the consequences of this behavior and the maintaining mechanism.
This observational study aims to investigate the effects of health-related internet use in individuals with pathological health anxiety in a naturalistic setting using ambulatory assessment. The variables of interest are monitored using time- and event-based sampling methods. Therefore, over a seven-day period participants answer seven times a day questionnaires on a mobile phone in their usual daily lives and additionally track the variables of interest in the moment the target behavior (health-related internet use) occurs. To our knowledge, this is the first study to investigate these relations using ambulatory assessment and therefore additionally aims to investigate the feasibility of this study design in this specific field of research.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pathological health anxiety according to the criteria of Fink et al., 2004
- Informed consent
- Sufficient German language skills
- Sufficient skills using a computer, a mobile phone and the internet
Exclusion Criteria:
- Suicidal tendency
- Clinical diagnosis of alcohol or drug abuse, acute schizophrenia
- Organic brain disorders
- Impairment of intelligence
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Participants
Individuals with pathological health anxiety
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of health anxiety before and after health-related internet use
Time Frame: Time-based sampling: every day at 9am, 11am, 1pm, 3pm, 5pm, 7pm and 9pm during seven days
|
Self-created item.
The occurence of health-related internet use is indicated by answering a question (yes/no) for a specific time period (e.g. between 9am and 11am), then the difference score for levels of health anxiety between these two time points is calculated.
|
Time-based sampling: every day at 9am, 11am, 1pm, 3pm, 5pm, 7pm and 9pm during seven days
|
|
Change of positive and negative affect before and after health-related internet use
Time Frame: Time-based sampling: every day at 9am, 11am, 1pm, 3pm, 5pm, 7pm and 9pm during seven days
|
Short-form of the Positive Affect Negative Affect Schedule -State (PANAS-State) by Thompson (2007), translated into German. The occurence of health-related internet use is indicated by answering a question (yes/no) for a specific time period (e.g. between 9am and 11am), then the difference score for levels of health anxiety between these two time points is calculated. |
Time-based sampling: every day at 9am, 11am, 1pm, 3pm, 5pm, 7pm and 9pm during seven days
|
|
Change of symptom severity before and after health-related internet
Time Frame: Time-based sampling: every day at 9am, 11am, 1pm, 3pm, 5pm, 7pm and 9pm during seven days
|
Self-created item.
The occurence of health-related internet use is indicated by answering a question (yes/no) for a specific time period (e.g. between 9am and 11am), then the difference score for levels of health anxiety between these two time points is calculated.
|
Time-based sampling: every day at 9am, 11am, 1pm, 3pm, 5pm, 7pm and 9pm during seven days
|
|
Change of health anxiety before and after health-related internet use
Time Frame: Event-based sampling: before and after every health-related internet use that is conducted during a seven-day-period
|
Self-created item.
Start and end of health-related internet use is indicated by the push of a special button on the mobile phone and triggers the presentation of this item.
|
Event-based sampling: before and after every health-related internet use that is conducted during a seven-day-period
|
|
Change of positive and negative affect before and after health-related internet use
Time Frame: Event-based sampling: before and after every health-related internet use that is conducted during a seven-day-period
|
Short-form of the Positive Affect Negative Affect Schedule -State (PANAS-State) by Thompson (2007), translated into German. Start and end of health-related internet use is indicated by the push of a special button on the mobile phone and triggers the presentation of this questionnaire. |
Event-based sampling: before and after every health-related internet use that is conducted during a seven-day-period
|
|
Change of symptom severity before and after health-related internet
Time Frame: Event-based sampling: before and after every health-related internet use that is conducted during a seven-day-period
|
Self-created item.
Start and end of health-related internet use is indicated by the push of a special button on the mobile phone and triggers the presentation of this item.
|
Event-based sampling: before and after every health-related internet use that is conducted during a seven-day-period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
frequency of occurence of health-related internet use
Time Frame: during seven days
|
start of health-related internet use is recorded by the push of a special button on the mobile phone
|
during seven days
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Michael Witthoeft, Professor, Department of Clinical Psychology, Psychotherapy and Experimental Psychopathology, Johannes Gutenberg University Mainz
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C2-aA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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