- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03221985
ESM Pilot: Mobile Phones and Psychology
Investigating the Relationship Between Mobile Phone Usage and Emotions. A Pilot Study Using the Experienced Sampling Method
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There are indications for mobile phone effects on psychological and psychological functioning. Most publications on this subject report effects on 'mobile phone addiction'. A methodological problem in these studies is the collection of data in retrospect. With the mobile phone application it is possible to prevent this type of bias. By collecting real-life data in a longitudinal design with a 2 x N=1 pilot study, it is possible to obtain an impression of the relationship between mobile phone usage and emotion/behavior efficiently.
The objective of this study is to investigate whether there is a relation between smartphone usage and psychological parameters in young adults. Taking into accordance the type of research (observational) and the present state of literature (the relationship between mobile phones and psychological effects has not been studied before using the experience sampling method (E.S.M.)) the following hypothesis are formulated. It is expected that the undesired absence of one's phone will lead to an enlarged stress level. Furthermore, it is expected that an increase of phone usage will lead to more depressive symptoms, to less concentration and to sleep disturbance. Finally, it is expected that loneliness will lead to increased phone usage.
A longitudinal pilot study, in which the participant will be asked to fill out the mobile phone application questionnaire 10 times a day at random moments on a smartphone, during a 3 months period.
The mobile phone application questionnaire contains a series of multiple choice questions about the present affect (three positive, five negative), the present context and activities (physical activity, occupation, presence of other people), physical discomfort (fatigue, concentration level, pain) and mobile phone usage (frequency, frustration when unable to use phone) since the last beep. Positive affect: cheerful, mentally fit and relaxed. Negative affect: irritated, bored, lonely, stressed and worrying. The answers will be registered using a 7-point Likert scale, ranging from 'not' to 'very'.
Participants will be invited to the research location twice for a briefing (30 minutes) and a debriefing session (30 minutes). Furthermore the participants will be asked to fill out the mobile phone application questionnaire on a daily base after every beep. It is expected this will cost a time investment of approximately 15 minutes per day. The questionnaires are generally experienced as a small burden (in previous research performed by this department). Participation is not associated with health risks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6226 NB
- Mondriaan, locatie Vijverdal, Maastricht University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy
- good understanding of dutch language
- smartphone user
Exclusion Criteria:
- psychiatric diagnosis
- pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Questionnaires
|
questionnaire with application on smartphone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Questionnaire using the experience sampling method, administered by the mobile phone application.
Time Frame: after 3 months
|
The mobile phone application questionnaire will be offered 10 times a day at random moments on the smartphone of the participants, during a 3 months period. The mobile phone application questionnaire contains a series of multiple choice questions about the present affect (three positive, five negative), the present context and activities (physical activity, occupation, presence of other people), physical discomfort (fatigue, concentration level, pain) and mobile phone usage (frequency, frustration when unable to use phone) since the last beep. Positive affect: cheerful, mentally fit and relaxed. Negative affect: irritated, bored, lonely, stressed and worrying. The answers will be registered using a 7-point scale, ranging from 'not' to 'very'. |
after 3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jim van Os, prof. dr., Maastricht University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
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
- NL55632.068.15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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