Smartphone ApplicationNCT02365220
Smartphone Application, Mood and Stress
A study testing Prospective expectancy, Retrospective expectancy and Prospective and retrospective expectancy in people with Smartphone Application and Placebo Effect, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The purpose of this study is to investigate the placebo effect in a smartphone-based training, ostensibly designed to improve mood and perceived stress by daily exposition to either mock sound or color. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smartphone Application, Placebo Effect, Mood
- What is being tested?
- Prospective expectancy, Retrospective expectancy and Prospective and retrospective expectancy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2015to Oct 2015
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Access to smartphone during study period
Who cannot join
- Severe visual impairment
- Dyschromatopsia
- Severe defective hearing
- Regular intake of medication (excl. contraceptives)
- Severe mental disorders
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the placebo effect in a smartphone-based training, ostensibly designed to improve mood and perceived stress by daily exposition to either mock sound or color.
Read the detailed description
The overall goal of the outlined study is to investigate the placebo effect in a smartphone-based training, ostensibly designed to improve mood and perceived stress by daily exposition to either mock sound or color. During 14 days, subjects will participate in regular daily training sessions. During another 6 days, subjects will transfer the smartphone-based training to daily life.
- Conditions
- Smartphone Application, Placebo Effect, Mood, Stress
- Being tested
- No expectancy (control), Prospective expectancy, Retrospective expectancy, Prospective and retrospective expectancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No expectancy (control)Behavioural
No expectancy instruction with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color)
Prospective expectancyBehavioural
Prospective expectancy instruction ("Training will have an effect on...") with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color)
Retrospective expectancyBehavioural
Retrospective expectancy instruction ("Training already had an effect on...") with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color)
Prospective and retrospective expectancyBehavioural
Prospective ("Training will have an effect on...") and retrospective ("Training already had an effect on...") expectancy instruction with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color)
| Study group | Role | What they receive |
|---|---|---|
| No expectancy (control) | Active comparator | No expectancy instruction with regard to the efficacy of the daily smartphone-based training Receives: Behavioral: No expectancy (control) |
| Prospective expectancy | Experimental | Prospective expectancy instruction ("Training will have an effect on...") with regard to the efficacy of the daily smartphone-based training Receives: Behavioral: Prospective expectancy |
| Retrospective expectancy | Experimental | Retrospective expectancy instruction ("Training already had an effect on...") with regard to the efficacy of the daily smartphone-based training Receives: Behavioral: Retrospective expectancy |
| Prospective and retrospective expectancy | Experimental | Prospective ("Training will have an effect on...") and retrospective ("Training already had an effect on...") expectancy instruction with regard to the efficacy of the daily smartphone-based training Receives: Behavioral: Prospective and retrospective expectancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mood (Assessed via Multidimensional Mood State Questionnaire)
Assessed via Multidimensional Mood State Questionnaire
Measured: Pre- and post-training, during 20 days of training
Change in perceived stress
Assessed via State-Trait-Anxiety Inventory; Visual Analog Scale
Measured: Pre- and post-training, during 20 days of training
Secondary outcomes (1)
Emotional state (Assessed via Self-Assessment-Manikin scales)
Assessed via Self-Assessment-Manikin scales after exposition to affective pictures taken from International Affective Picture System
Measured: Post-training, during 20 days of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2015
- Study completionOct 2015
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 Smartphone ApplicationStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel
- Responsible party
- Sponsor
- Investigators
- Gunther Meinlschmidt, Prof. Dr., Principal investigator, University of Basel, Department of Psychology, Division of Clinical Psychology and Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365220
- Sponsor's protocol ID
- UNIBAS-MMH-SMA1
- Status last verified
- Mar 2016
- First submitted
- 3 Feb 2015
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Stalujanis E, Neufeld J, Glaus Stalder M, Belardi A, Tegethoff M, Meinlschmidt G. Induction of Efficacy Expectancies in an Ambulatory Smartphone-Based Digital Placebo Mental Health Intervention: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Feb 17;9(2):e20329. doi: 10.2196/20329.
PubMed 33594991
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Application, Mood and Stress
- ClinicalTrials.gov ID
- NCT02365220
- Acronym / sponsor ID
- UNIBAS-MMH-SMA1
- Conditions
- Smartphone Application, Placebo Effect, Mood, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Basel
- Study start
- Feb 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 18 Feb 2015 (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 this study is to investigate the placebo effect in a smartphone-based training, ostensibly designed to improve mood and perceived stress by daily exposition to either mock sound or color.
Detailed description
The overall goal of the outlined study is to investigate the placebo effect in a smartphone-based training, ostensibly designed to improve mood and perceived stress by daily exposition to either mock sound or color. During 14 days, subjects will participate in regular daily training sessions. During another 6 days, subjects will transfer the smartphone-based training to daily life.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No expectancy (control) | Active comparator | Behavioral: No expectancy (control)No expectancy instruction with regard to the efficacy of the daily smartphone-based training |
| Prospective expectancy | Experimental | Behavioral: Prospective expectancyProspective expectancy instruction ("Training will have an effect on...") with regard to the efficacy of the daily smartphone-based training |
| Retrospective expectancy | Experimental | Behavioral: Retrospective expectancyRetrospective expectancy instruction ("Training already had an effect on...") with regard to the efficacy of the daily smartphone-based training |
| Prospective and retrospective expectancy | Experimental | Behavioral: Prospective and retrospective expectancyProspective ("Training will have an effect on...") and retrospective ("Training already had an effect on...") expectancy instruction with regard to the efficacy of the daily smartphone-based training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Access to smartphone during study period
Key exclusion criteria (5 listed)
- Severe visual impairment
- Dyschromatopsia
- Severe defective hearing
- Regular intake of medication (excl. contraceptives)
- Severe mental disorders
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 |
|---|---|---|
| No expectancy (control)No expectancy instruction with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color) | Behavioural | No expectancy (control) |
| Prospective expectancyProspective expectancy instruction ("Training will have an effect on...") with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color) | Behavioural | Prospective expectancy |
| Retrospective expectancyRetrospective expectancy instruction ("Training already had an effect on...") with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color) | Behavioural | Retrospective expectancy |
| Prospective and retrospective expectancyProspective ("Training will have an effect on...") and retrospective ("Training already had an effect on...") expectancy instruction with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color) | Behavioural | Prospective and retrospective expectancy |
Primary outcome
Change in mood (Assessed via Multidimensional Mood State Questionnaire)
Time frame: Pre- and post-training, during 20 days of training
Assessed via Multidimensional Mood State Questionnaire
Change in perceived stress
Time frame: Pre- and post-training, during 20 days of training
Assessed via State-Trait-Anxiety Inventory; Visual Analog Scale
1 secondary outcome
Emotional state (Assessed via Self-Assessment-Manikin scales)
Time frame: Post-training, during 20 days of training
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 31 Mar 2016.
- Derived from this study: PubMed 33594991Stalujanis E, Neufeld J, Glaus Stalder M, Belardi A, Tegethoff M, Meinlschmidt G. Induction of Efficacy Expectancies in an Ambulatory Smartphone-Based Digital Placebo Mental Health Intervention: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Feb 17;9(2):e20329. doi: 10.2196/20329.
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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.
Gunther Meinlschmidt, Prof. Dr. principal investigator
University of Basel, Department of Psychology, Division of Clinical Psychology and Epidemiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prospective expectancy, Retrospective expectancy and Prospective and retrospective expectancy in people with Smartphone Application and Placebo Effect, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 inclusion and 5 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 31 Mar 2016. 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 Switzerland. 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?
Change in mood (Assessed via Multidimensional Mood State Questionnaire) (time frame: Pre- and post-training, during 20 days of training). The study lists 2 primary outcomes in all. 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 NCT02365220, 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 31 Mar 2016.