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Smartphone Application, Mood and Stress

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ClinicalTrials.gov Identifier: NCT02365220
Recruitment Status : Completed
First Posted : February 18, 2015
Last Update Posted : March 31, 2016
Sponsor:
Collaborator:
University of Basel
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment Phase
Smartphone Application Placebo Effect Mood Stress Behavioral: No expectancy (control) Behavioral: Prospective expectancy Behavioral: Retrospective expectancy Behavioral: Prospective and retrospective expectancy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Smartphone Application, Mood and Stress
Study Start Date : February 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

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)




Primary Outcome Measures :
  1. Change in mood (Assessed via Multidimensional Mood State Questionnaire) [ Time Frame: Pre- and post-training, during 20 days of training ]
    Assessed via Multidimensional Mood State Questionnaire

  2. Change in perceived stress [ Time Frame: Pre- and post-training, during 20 days of training ]
    Assessed via State-Trait-Anxiety Inventory; Visual Analog Scale


Secondary Outcome Measures :
  1. Emotional state (Assessed via Self-Assessment-Manikin scales) [ Time Frame: Post-training, during 20 days of training ]
    Assessed via Self-Assessment-Manikin scales after exposition to affective pictures taken from International Affective Picture System


Other Outcome Measures:
  1. Efficacy expectancy (Assessed via Credibility Expectancy Questionnaire) [ Time Frame: Post-training, training day 1, 7, 14, 20 ]
    Assessed via Credibility Expectancy Questionnaire

  2. Feedback on adverse events during the daily training session (Number of subjects reporting an adverse event) [ Time Frame: Post-training, last training day (day 20) ]
    Number of subjects reporting an adverse event



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02365220


Locations
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Switzerland
University of Basel
Basel, Switzerland, 4055
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University of Basel
Investigators
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Principal Investigator: Gunther Meinlschmidt, Prof. Dr. University of Basel, Department of Psychology, Division of Clinical Psychology and Epidemiology

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02365220     History of Changes
Other Study ID Numbers: UNIBAS-MMH-SMA1
First Posted: February 18, 2015    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016