Smartphone Application, Mood and Stress

NCT ID: NCT02365220

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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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

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Smartphone Application Placebo Effect Mood Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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No expectancy (control)

No expectancy instruction with regard to the efficacy of the daily smartphone-based training

Group Type ACTIVE_COMPARATOR

No expectancy (control)

Intervention Type BEHAVIORAL

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

Group Type EXPERIMENTAL

Prospective expectancy

Intervention Type 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

Retrospective expectancy instruction ("Training already had an effect on...") with regard to the efficacy of the daily smartphone-based training

Group Type EXPERIMENTAL

Retrospective expectancy

Intervention Type 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

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

Group Type EXPERIMENTAL

Prospective and retrospective expectancy

Intervention Type 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)

Interventions

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No expectancy (control)

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

Intervention Type 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)

Intervention Type 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)

Intervention Type 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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Basel

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gunther Meinlschmidt, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Basel, Department of Psychology, Division of Clinical Psychology and Epidemiology

Locations

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University of Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 33594991 (View on PubMed)

Other Identifiers

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UNIBAS-MMH-SMA1

Identifier Type: -

Identifier Source: org_study_id