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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
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Problem Solving

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
December 18, 2020
Last Updated
December 18, 2020
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
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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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