Smartphone Application, Mood and Stress

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.

Study Overview

• Status: Completed
• Conditions: Stress; Mood; Placebo Effect; Smartphone Application
• Intervention / Treatment: Behavioral: No expectancy (control); Behavioral: Prospective expectancy; Behavioral: Retrospective expectancy; Behavioral: Prospective and retrospective expectancy

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 Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4055
    • University of Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No expectancy (control); No expectancy instruction with regard to the efficacy of the daily smartphone-based training	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)
Experimental: Prospective expectancy; Prospective expectancy instruction ("Training will have an effect on...") with regard to the efficacy of the daily smartphone-based training	Behavioral: 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)
Experimental: Retrospective expectancy; Retrospective expectancy instruction ("Training already had an effect on...") with regard to the efficacy of the daily smartphone-based training	Behavioral: 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)
Experimental: 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	Behavioral: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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)	Number of subjects reporting an adverse event	Post-training, last training day (day 20)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: University of Basel
• Investigators: Principal Investigator: Gunther Meinlschmidt, Prof. Dr., University of Basel, Department of Psychology, Division of Clinical Psychology and Epidemiology

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: February 10, 2015
• First Posted (Estimate): February 18, 2015

Study Record Updates

• Last Update Posted (Estimate): March 31, 2016
• Last Update Submitted That Met QC Criteria: March 30, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: UNIBAS-MMH-SMA1