Evaluation of Two Versions of a Digital Problem Solving Tool for the General Public Specific for the COVID-19 Pandemic (COVIDPROBLEM)
Primary Purpose
Problem Solving
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Digital problem solving tool
Sponsored by
About this trial
This is an interventional other trial for Problem Solving
Eligibility Criteria
Inclusion Criteria:
- can use the Swedish language
- access to, and knowledge how to use, a digital internet-capable device
Exclusion Criteria:
- under 16 years
- no practical or emotional problems during pandemic
Sites / Locations
- Centrum för Psykiatriforskning
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Traditional interface
Advanced interface
Arm Description
Digital problem solving tool with a simple textbased graphical interface
Digital problem solving tool with an advanced graphical interface and automatic functions
Outcomes
Primary Outcome Measures
System Usability Scale
Self-rated assessment of usability, higher score is better
Treatment Credibility Scale
Self-rated assessment of treatment credibility, higher score is better
Secondary Outcome Measures
Use of intervention
How much has the participant interacted with the problem solving tool.
Full Information
NCT ID
NCT04677270
First Posted
December 18, 2020
Last Updated
December 18, 2020
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
1. Study Identification
Unique Protocol Identification Number
NCT04677270
Brief Title
Evaluation of Two Versions of a Digital Problem Solving Tool for the General Public Specific for the COVID-19 Pandemic
Acronym
COVIDPROBLEM
Official Title
Evaluation of Two Versions of a Digital Problem Solving Tool for the General Public Specific for the COVID-19 Pandemic
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A digital problem solving tool was tailored to people in the general public with practical or emotional problems during COVID-19. Content analysis were used to account for the types of problems participants used the tool to solve. Participants were randomized to one of two versions of the problem solving tool, a simple and a more advanced graphical interface. These versions were compared on participant-rated usability, credibility and the level of actual interaction with the tool.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Problem Solving
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
397 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional interface
Arm Type
Experimental
Arm Description
Digital problem solving tool with a simple textbased graphical interface
Arm Title
Advanced interface
Arm Type
Experimental
Arm Description
Digital problem solving tool with an advanced graphical interface and automatic functions
Intervention Type
Behavioral
Intervention Name(s)
Digital problem solving tool
Intervention Description
Digital problem solving tool - adapted for practical and emotional problems during the COVID-19 pandemic
Primary Outcome Measure Information:
Title
System Usability Scale
Description
Self-rated assessment of usability, higher score is better
Time Frame
immediately after the intervention
Title
Treatment Credibility Scale
Description
Self-rated assessment of treatment credibility, higher score is better
Time Frame
immediately after the intervention
Secondary Outcome Measure Information:
Title
Use of intervention
Description
How much has the participant interacted with the problem solving tool.
Time Frame
immediately after the intervention
Other Pre-specified Outcome Measures:
Title
Problem categories
Description
What categories of problems do participants solve with the problem solving tool.
Time Frame
immediately after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
can use the Swedish language
access to, and knowledge how to use, a digital internet-capable device
Exclusion Criteria:
under 16 years
no practical or emotional problems during pandemic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Kraepelien, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centrum för Psykiatriforskning
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34559670
Citation
Hentati A, Forsell E, Ljotsson B, Kraepelien M. Practical and Emotional Problems Reported by Users of a Self-guided Digital Problem-solving Intervention During the COVID-19 Pandemic: Content Analysis. JMIR Form Res. 2021 Oct 4;5(10):e31722. doi: 10.2196/31722.
Results Reference
derived
Learn more about this trial
Evaluation of Two Versions of a Digital Problem Solving Tool for the General Public Specific for the COVID-19 Pandemic
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