Health AnxietyNCT03019705
An Examination of the Effects of Health-related Internet Use in Individuals With Pathological Health Anxiety Using Ambulatory Assessment
An observational study of Health Anxiety, run by Johannes Gutenberg University Mainz.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Anxiety
- What is being tested?
- Observation
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: individuals with pathological health anxiety
Who may be able to join
- 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
Who cannot join
- Suicidal tendency
- Clinical diagnosis of alcohol or drug abuse, acute schizophrenia
- Organic brain disorders
- Impairment of intelligence
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Health Anxiety
- Being tested
- Observation
- Keywords
- Cyberchondria, health-related internet use, pathological health anxiety, ambulatory assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
| Study group | Role | What they receive |
|---|---|---|
| Participants | Individuals with pathological health anxiety Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Event-based sampling: before and after every health-related internet use that is conducted during a seven-day-period
Secondary outcomes (1)
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
Measured: during seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Primary completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cologne
- Responsible party
- Principal investigator, Sandra K. Hamann, Johannes Gutenberg University Mainz
- Investigators
- Michael Witthoeft, Professor, Study chair, Department of Clinical Psychology, Psychotherapy and Experimental Psychopathology, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019705
- Sponsor's protocol ID
- C2-aA
- Status last verified
- Jan 2017
- First submitted
- 5 Jan 2017
- Last updated
- 13 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Examination of the Effects of Health-related Internet Use in Individuals With Pathological Health Anxiety Using Ambulatory Assessment
- ClinicalTrials.gov ID
- NCT03019705
- Acronym / sponsor ID
- C2-aA
- Conditions
- Health Anxiety
- Keywords
- Cyberchondria, health-related internet use, pathological health anxiety, ambulatory assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- University of Cologne
- Primary completion
- Sep 2018 (estimated)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: ObservationIndividuals with pathological health anxiety |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- individuals with pathological health anxiety
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Suicidal tendency
- Clinical diagnosis of alcohol or drug abuse, acute schizophrenia
- Organic brain disorders
- Impairment of intelligence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation | Other | Participants |
Primary outcome
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.
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.
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.
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.
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.
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.
1 secondary outcome
frequency of occurence of health-related internet use
Time frame: during seven days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Witthoeft, Professor study chair
Department of Clinical Psychology, Psychotherapy and Experimental Psychopathology, Johannes Gutenberg University Mainz
Questions about this trial
What is this clinical trial studying?
An observational study of Health Anxiety, run by Johannes Gutenberg University Mainz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra K Hamann, Dipl.-Psych. ((+49) 6131 - 3939 214, sahamann@uni-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.