NCT03019705

Brief 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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

First QC Date

January 5, 2017

Last Update Submit

January 10, 2017

Conditions

Health Anxiety

Keywords

Cyberchondriahealth-related internet usepathological health anxietyambulatory assessment

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • frequency of occurence of health-related internet use

    during seven days

Study Arms (1)

Participants

Individuals with pathological health anxiety

Other: Observation

Interventions

ObservationOTHER
Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

individuals with pathological health anxiety

You may qualify if:

  • 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

You may not qualify if:

  • Suicidal tendency
  • Clinical diagnosis of alcohol or drug abuse, acute schizophrenia
  • Organic brain disorders
  • Impairment of intelligence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Michael Witthoeft, Professor

    Department of Clinical Psychology, Psychotherapy and Experimental Psychopathology, Johannes Gutenberg University Mainz

    STUDY CHAIR

Central Study Contacts

Sandra K Hamann, Dipl.-Psych.

CONTACT

(+49) 6131 - 3939 214sahamann@uni-mainz.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 13, 2017

Primary Completion

September 1, 2018

Last Updated

January 13, 2017

Record last verified: 2017-01