Smartphone Application, Mood and Stress

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Completed
• CT.gov ID: NCT02365220
• Collaborator: University of Basel (Other)
• Enrollment: 132
• Location: 1
• Arms: 4
• Duration (Months): 8
• Patients Per Site Per Month: 16.6

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Feb 1, 2015
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

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

   Assessed via Multidimensional Mood State Questionnaire

2. Change in perceived stress [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) [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) [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) [Post-training, last training day (day 20)]

   Number of subjects reporting an adverse event

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Basel	Basel		Switzerland	4055

Sponsors and Collaborators

• University Hospital, Basel, Switzerland
• University of Basel

Investigators

• Principal Investigator: Gunther Meinlschmidt, Prof. Dr., University of Basel, Department of Psychology, Division of Clinical Psychology and Epidemiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT02365220
• Other Study ID Numbers: UNIBAS-MMH-SMA1
• First Posted: Feb 18, 2015
• Last Update Posted: Mar 31, 2016
• Last Verified: Mar 1, 2016

Study Results

No Results Posted as of Mar 31, 2016