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| Name | Class |
|---|---|
| University of Basel | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No expectancy (control) | Active Comparator | No expectancy instruction with regard to the efficacy of the daily smartphone-based training |
|
| Prospective expectancy | Experimental | Prospective expectancy instruction ("Training will have an effect on...") with regard to the efficacy of the daily smartphone-based training |
|
| Retrospective expectancy | Experimental | Retrospective expectancy instruction ("Training already had an effect on...") with regard to the efficacy of the daily smartphone-based training |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No expectancy (control) | Behavioral | No expectancy instruction with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mood (Assessed via Multidimensional Mood State Questionnaire) | Assessed via Multidimensional Mood State Questionnaire | Pre- and post-training, during 20 days of training |
| Change in perceived stress | Assessed via State-Trait-Anxiety Inventory; Visual Analog Scale | Pre- and post-training, during 20 days of training |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Post-training, during 20 days of training |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy expectancy (Assessed via Credibility Expectancy Questionnaire) | Assessed via Credibility Expectancy Questionnaire | Post-training, training day 1, 7, 14, 20 |
| Feedback on adverse events during the daily training session (Number of subjects reporting an adverse event) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunther Meinlschmidt, Prof. Dr. | University of Basel, Department of Psychology, Division of Clinical Psychology and Epidemiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Basel | Basel | 4055 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33594991 | Derived | 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. |
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| ID | Term |
|---|---|
| D008137 | Longitudinal Studies |
| ID | Term |
|---|---|
| D015331 | Cohort Studies |
| D016021 | Epidemiologic Studies |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
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| Prospective expectancy | Behavioral | 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 expectancy | Behavioral | 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 expectancy | Behavioral | 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) |
|
Number of subjects reporting an adverse event |
| Post-training, last training day (day 20) |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |