Smartphone Application, Mood and Stress
1 other identifier
interventional
132
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 3, 2015
CompletedFirst Posted
Study publicly available on registry
February 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedMarch 31, 2016
March 1, 2016
8 months
February 3, 2015
March 30, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (1)
Emotional state (Assessed via Self-Assessment-Manikin scales)
Post-training, during 20 days of training
Other Outcomes (2)
Efficacy expectancy (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)
Post-training, last training day (day 20)
Study Arms (4)
No expectancy (control)
ACTIVE COMPARATORNo expectancy instruction with regard to the efficacy of the daily smartphone-based training
Prospective expectancy
EXPERIMENTALProspective expectancy instruction ("Training will have an effect on...") with regard to the efficacy of the daily smartphone-based training
Retrospective expectancy
EXPERIMENTALRetrospective expectancy instruction ("Training already had an effect on...") with regard to the efficacy of the daily smartphone-based training
Prospective and retrospective expectancy
EXPERIMENTALProspective ("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
Interventions
No expectancy instruction with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color)
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 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 ("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)
Eligibility Criteria
You may qualify if:
- Access to smartphone during study period
You may not qualify if:
- Severe visual impairment
- Dyschromatopsia
- Severe defective hearing
- Regular intake of medication (excl. contraceptives)
- Severe mental disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Basel, Switzerlandlead
- University of Baselcollaborator
Study Sites (1)
University of Basel
Basel, 4055, Switzerland
Related Publications (1)
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.
PMID: 33594991DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gunther Meinlschmidt, Prof. Dr.
University of Basel, Department of Psychology, Division of Clinical Psychology and Epidemiology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2015
First Posted
February 18, 2015
Study Start
February 1, 2015
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
March 31, 2016
Record last verified: 2016-03