HypochondriasisNCT03024593
An Examination of the Effects of Health-related Internet Use in Individuals With Pathological Health Anxiety
A study testing Health- and illness-related internet use in people with Hypochondriasis, run by Johannes Gutenberg University Mainz.
Trial summary
The purpose of the current study is to examine the effects of health-related internet use on affect, health anxiety and symptom severity in individuals with pathological levels of health anxiety. The present randomized controlled study compares an online medical searching condition with a waiting (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypochondriasis
- What is being tested?
- Health- and illness-related internet use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Sep 2018
- Phase
- Interventional
- 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
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 smartphone 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
Official title: An Examination of the Effects of Health-related Internet Use in Individuals With Pathological Health Anxiety in a Randomized Controlled Trial
The purpose of the current study is to examine the effects of health-related internet use on affect, health anxiety and symptom severity in individuals with pathological levels of health anxiety. The present randomized controlled study compares an online medical searching condition with a waiting (i.e. non-searching) condition to manipulate the attentional focus. After an induction of health anxiety using the Autobiographical Emotional Memory Task the participants in the searching condition go online and search for subjectively relevant health information (external focus of attention). Individuals in the waiting (i.e. non-searching) condition are requested to do nothing and not to distract themselves (internal focus of attention).
Read the detailed description
The internet is a popular method for obtaining information. Increasingly, it is also used to answer medical and health related 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 randomized controlled experimental study investigates the effects of health-related internet use on affect, symptom severity and health anxiety in individuals with pathological health anxiety. Participants will first undergo a baseline assessment. After that health anxiety is induced using the Autobiographical Emotional Memory Task and participants complete another assessment. Then participants are randomly assigned to either an online medical searching condition (experimental group, EG) or a non-searching condition (control group, CG) to manipulate attentional focus. The EG is requested to search online for health information (external focus of attention), the CG is requested to do nothing and not to distract themselves (internal focus of attention). Then another assessment is completed and the treatment groups are compared regarding the effects on affect, symptom severity and health anxiety. Besides examining these effects a further aim of this study is to identify the underlying mechanism. Two possibilities are supposed: a) An increase of the variables of interest due to health-related information or b) a decrease due to externalization.
- Conditions
- Hypochondriasis
- Being tested
- Health- and illness-related internet use
- Keywords
- Cyberchondria, health-related internet use, pathological health anxiety
- Medical subject headings
- Hypochondriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health- and illness-related internet useBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Searching condition | Experimental | To simulate participants' natural behavior they are requested to search online for personally relevant health or illness information in their usual manner. By doing so their attentional focus lies on the searching process and the information they obtain. Receives: Behavioral: Health- and illness-related internet use |
| Waiting condition (i.e. non- searching, no distraction) | No intervention | Participants are requested to do nothing and not to distract themselves by reading or using their smartphone for instance. By doing so, it is expected that their attentional focus lies on their induced worries and symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of health anxiety before and after 8 minutes of health-related internet searching or waiting
self-created item
Measured: right before and after 8 minutes of health-related internet searching or waiting
Change of positive and negative affect before and after 8 minutes of health-related internet searching or waiting
Positive Affect Negative Affect Schedule - State (PANAS-State)
Measured: right before and after 8 minutes of health-related internet searching or waiting
Change of symptom severity before and after 8 minutes of health-related internet searching or waiting
Checklist for symptoms in daily life (CSD)
Measured: right before and after 8 minutes of health-related internet searching or waiting
Secondary outcomes (3)
Change of health anxiety before and after 10 minutes of anxiety induction
self-created item
Measured: right before and after 10 minutes of anxiety induction
Change of positive and negative affect before and after 10 minutes of anxiety induction
Positive Affect Negative Affect Schedule - State (PANAS-State)
Measured: right before and after 10 minutes of anxiety induction
Change of symptom severity before and after 10 minutes of anxiety induction
Checklist for symptoms in daily life (CSD)
Measured: right before and after 10 minutes of anxiety induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 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 HypochondriasisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 80 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
- NCT03024593
- Sponsor's protocol ID
- C1-L
- Status last verified
- Jan 2017
- First submitted
- 5 Jan 2017
- Last updated
- 19 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 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 in a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03024593
- Acronym / sponsor ID
- C1-L
- Conditions
- Hypochondriasis
- Keywords
- Cyberchondria, health-related internet use, pathological health anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- University of Cologne
- Primary completion
- Sep 2018 (estimated)
- First posted
- 19 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 study is to examine the effects of health-related internet use on affect, health anxiety and symptom severity in individuals with pathological levels of health anxiety. The present randomized controlled study compares an online medical searching condition with a waiting (i.e. non-searching) condition to manipulate the attentional focus. After an induction of health anxiety using the Autobiographical Emotional Memory Task the participants in the searching condition go online and search for subjectively relevant health information (external focus of attention). Individuals in the waiting (i.e. non-searching) condition are requested to do nothing and not to distract themselves (internal focus of attention).
Detailed description
The internet is a popular method for obtaining information. Increasingly, it is also used to answer medical and health related 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 randomized controlled experimental study investigates the effects of health-related internet use on affect, symptom severity and health anxiety in individuals with pathological health anxiety. Participants will first undergo a baseline assessment. After that health anxiety is induced using the Autobiographical Emotional Memory Task and participants complete another assessment. Then participants are randomly assigned to either an online medical searching condition (experimental group, EG) or a non-searching condition (control group, CG) to manipulate attentional focus. The EG is requested to search online for health information (external focus of attention), the CG is requested to do nothing and not to distract themselves (internal focus of attention). Then another assessment is completed and the treatment groups are compared regarding the effects on affect, symptom severity and health anxiety. Besides examining these effects a further aim of this study is to identify the underlying mechanism. Two possibilities are supposed: a) An increase of the variables of interest due to health-related information or b) a decrease due to externalization.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Searching condition | Experimental | Behavioral: Health- and illness-related internet useTo simulate participants' natural behavior they are requested to search online for personally relevant health or illness information in their usual manner. By doing so their attentional focus lies on the searching process and the information they obtain. |
| Waiting condition (i.e. non- searching, no distraction) | No intervention | –Participants are requested to do nothing and not to distract themselves by reading or using their smartphone for instance. By doing so, it is expected that their attentional focus lies on their induced worries and symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 smartphone 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 |
|---|---|---|
| Health- and illness-related internet use | Behavioural | Searching condition |
Primary outcome
Change of health anxiety before and after 8 minutes of health-related internet searching or waiting
Time frame: right before and after 8 minutes of health-related internet searching or waiting
self-created item
Change of positive and negative affect before and after 8 minutes of health-related internet searching or waiting
Time frame: right before and after 8 minutes of health-related internet searching or waiting
Positive Affect Negative Affect Schedule - State (PANAS-State)
Change of symptom severity before and after 8 minutes of health-related internet searching or waiting
Time frame: right before and after 8 minutes of health-related internet searching or waiting
Checklist for symptoms in daily life (CSD)
3 secondary outcomes
Change of health anxiety before and after 10 minutes of anxiety induction
Time frame: right before and after 10 minutes of anxiety induction
Change of positive and negative affect before and after 10 minutes of anxiety induction
Time frame: right before and after 10 minutes of anxiety induction
Change of symptom severity before and after 10 minutes of anxiety induction
Time frame: right before and after 10 minutes of anxiety induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 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?
A study testing Health- and illness-related internet use in people with Hypochondriasis, 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 19 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 8 minutes of health-related internet searching or waiting (time frame: right before and after 8 minutes of health-related internet searching or waiting). The study lists 3 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 19 Jan 2017.