CommunicationNCT03221985
ESM Pilot: Mobile Phones and Psychology
A study testing questionnaires in people with Communication and Addiction, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The research team will investigate whether there is a relation between smartphone usage and psychological parameters using the smartphone application. Read more about this study
- Who is it for?
- Ages 20 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Communication, Addiction, Affect
- What is being tested?
- questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2016to 15 May 2017
- 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 20 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- good understanding of dutch language
- smartphone user
Who cannot join
- psychiatric diagnosis
- pregnancy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Mondriaan, locatie Vijverdal, Maastricht University
Maastricht, Limburg, 6226 NB
About this study
Official title: Investigating the Relationship Between Mobile Phone Usage and Emotions. A Pilot Study Using the Experienced Sampling Method
The research team will investigate whether there is a relation between smartphone usage and psychological parameters using the smartphone application.
Read the 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.
- Conditions
- Communication, Addiction, Affect
- Being tested
- questionnaires
- Keywords
- experience sampling method
- Medical subject headings
- Communication, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
questionnaire with application on smartphone
| Study group | Role | What they receive |
|---|---|---|
| Questionnaires | Other | Not described Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire using the experience sampling method, administered by the mobile phone application.
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'.
Measured: after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study startSep 2016
- Primary completionMay 2017
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jim van Os, prof. dr., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221985
- Sponsor's protocol ID
- NL55632.068.15
- Status last verified
- Jul 2017
- First submitted
- 14 May 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: digitally obtained data will be uploaded
Publications
Roggeveen S, van Os J, Bemelmans K, van Poll M, Lousberg R. Investigating Associations Between Changes in Mobile Phone Use and Emotions Using the Experience Sampling Method: Pilot Study. JMIR Form Res. 2018 Jun 18;2(1):e12. doi: 10.2196/formative.8499.
PubMed 30684428
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Relationship Between Mobile Phone Usage and Emotions. A Pilot Study Using the Experienced Sampling Method
- ClinicalTrials.gov ID
- NCT03221985
- Acronym / sponsor ID
- NL55632.068.15
- Conditions
- Communication, Addiction, Affect
- Keywords
- experience sampling method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- May 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 19 Jul 2017 (actual)
- 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 research team will investigate whether there is a relation between smartphone usage and psychological parameters using the smartphone application.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaires | Other | Other: questionnaires |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy
- good understanding of dutch language
- smartphone user
Key exclusion criteria (2 listed)
- psychiatric diagnosis
- pregnancy
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 |
|---|---|---|
| questionnairesquestionnaire with application on smartphone | Other | Questionnaires |
Primary outcome
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'.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Derived from this study: PubMed 30684428Roggeveen S, van Os J, Bemelmans K, van Poll M, Lousberg R. Investigating Associations Between Changes in Mobile Phone Use and Emotions Using the Experience Sampling Method: Pilot Study. JMIR Form Res. 2018 Jun 18;2(1):e12. doi: 10.2196/formative.8499.
- Individual participant dataSharing planned: Yes. digitally obtained data will be uploaded
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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.
Jim van Os, prof. dr. principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaires in people with Communication and Addiction, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire using the experience sampling method, administered by the mobile phone application. (time frame: after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03221985, which also lists 1 linked publication.
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 21 Jul 2017; AzTrials last refreshed its copy on 1 Nov 2026.