NCT04677270

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
397

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

December 18, 2020

Last Update Submit

December 18, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • System Usability Scale

    Self-rated assessment of usability, higher score is better

    immediately after the intervention

  • Treatment Credibility Scale

    Self-rated assessment of treatment credibility, higher score is better

    immediately after the intervention

Secondary Outcomes (1)

  • Use of intervention

    immediately after the intervention

Other Outcomes (1)

  • Problem categories

    immediately after the intervention

Study Arms (2)

Traditional interface

EXPERIMENTAL

Digital problem solving tool with a simple textbased graphical interface

Behavioral: Digital problem solving tool

Advanced interface

EXPERIMENTAL

Digital problem solving tool with an advanced graphical interface and automatic functions

Behavioral: Digital problem solving tool

Interventions

Digital problem solving tool - adapted for practical and emotional problems during the COVID-19 pandemic

Advanced interfaceTraditional interface

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • can use the Swedish language
  • access to, and knowledge how to use, a digital internet-capable device

You may not qualify if:

  • under 16 years
  • no practical or emotional problems during pandemic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centrum för Psykiatriforskning

Stockholm, Sweden

Location

Related Publications (1)

  • 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.

Study Officials

  • Martin Kraepelien, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Licensed clinical psychologist, Principal investigator, PhD

Study Record Dates

First Submitted

December 18, 2020

First Posted

December 21, 2020

Study Start

August 31, 2020

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

December 21, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations