Smartphone Application, Mood and Stress

Stress Clinical Trial

Official title:

Smartphone Application, Mood and Stress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02365220
• Other study ID #: UNIBAS-MMH-SMA1
• Status: Completed
• Phase: N/A
• First received: February 3, 2015
• Last updated: March 30, 2016
• Start date: February 2015
• Est. completion date: October 2015

Study information

• Verified date: March 2016
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Access to smartphone during study period

Exclusion Criteria:

• Severe visual impairment

• Dyschromatopsia

• Severe defective hearing

• Regular intake of medication (excl. contraceptives)

• Severe mental disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Mood
• Placebo Effect
• Smartphone Application
• Stress

Intervention

Behavioral:
• No expectancy (control)
No expectancy instruction with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color)
• Prospective expectancy
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
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
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)

Locations

Country	Name	City	State
Switzerland	University of Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Efficacy expectancy (Assessed via Credibility Expectancy Questionnaire)	Assessed via Credibility Expectancy Questionnaire	Post-training, training day 1, 7, 14, 20	No
Other	Feedback on adverse events during the daily training session (Number of subjects reporting an adverse event)	Number of subjects reporting an adverse event	Post-training, last training day (day 20)	Yes
Primary	Change in mood (Assessed via Multidimensional Mood State Questionnaire)	Assessed via Multidimensional Mood State Questionnaire	Pre- and post-training, during 20 days of training	No
Primary	Change in perceived stress	Assessed via State-Trait-Anxiety Inventory; Visual Analog Scale	Pre- and post-training, during 20 days of training	No
Secondary	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	No