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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03019705
Other study ID # C2-aA
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 5, 2017
Last updated January 10, 2017

Study information

Verified date January 2017
Source Johannes Gutenberg University Mainz
Contact Sandra K Hamann, Dipl.-Psych.
Phone (+49) 6131 - 3939 214
Email sahamann@uni-mainz.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

The purpose of the current explorative study is to examine the effects of health-related internet use in individuals with pathological health anxiety using ambulatory assessment. In a naturalistic setting participants answer over a seven-day period questionnaires about their health-related internet use and its effects on affect, health anxiety and symptom severity in their usual daily lives.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Observation


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Johannes Gutenberg University Mainz University of Cologne

Outcome

Type Measure Description Time frame Safety issue
Primary Change of health anxiety before and after health-related internet use 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
Primary Change of positive and negative affect before and after health-related internet use 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
Primary Change of symptom severity before and after health-related internet 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
Primary Change of health anxiety before and after health-related internet use 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
Primary Change of positive and negative affect before and after health-related internet use 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
Primary Change of symptom severity before and after health-related internet 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 frequency of occurence of health-related internet use start of health-related internet use is recorded by the push of a special button on the mobile phone during seven days
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