Problem SolvingCOVIDPROBLEMNCT04677270
Evaluation of Two Versions of a Digital Problem Solving Tool for the General Public Specific for the COVID-19 Pandemic
A study testing Digital problem solving tool in people with Problem Solving, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Problem Solving
- What is being tested?
- Digital problem solving tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 397 participants
- Where
- 1 siteSweden
- Study dates
- 31 Aug 2020to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- can use the Swedish language
- access to, and knowledge how to use, a digital internet-capable device
Who cannot join
- under 16 years
- no practical or emotional problems during pandemic
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Problem Solving
- Being tested
- Digital problem solving tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital problem solving toolBehavioural
Digital problem solving tool - adapted for practical and emotional problems during the COVID-19 pandemic
| Study group | Role | What they receive |
|---|---|---|
| Traditional interface | Experimental | Digital problem solving tool with a simple textbased graphical interface Receives: Behavioral: Digital problem solving tool |
| Advanced interface | Experimental | Digital problem solving tool with an advanced graphical interface and automatic functions Receives: Behavioral: Digital problem solving tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale
Self-rated assessment of usability, higher score is better
Measured: immediately after the intervention
Treatment Credibility Scale
Self-rated assessment of treatment credibility, higher score is better
Measured: immediately after the intervention
Secondary outcomes (1)
Use of intervention
How much has the participant interacted with the problem solving tool.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start31 Aug 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Problem SolvingStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Martin Kraepelien, Karolinska Institutet
- Investigators
- Martin Kraepelien, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677270
- Sponsor's protocol ID
- COVIDPROBLEM
- Acronym
- COVIDPROBLEM
- Status last verified
- Dec 2020
- First submitted
- 18 Dec 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34559670
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Versions of a Digital Problem Solving Tool for the General Public Specific for the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04677270
- Acronym / sponsor ID
- COVIDPROBLEM / COVIDPROBLEM
- Conditions
- Problem Solving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional interface | Experimental | Behavioral: Digital problem solving toolDigital problem solving tool with a simple textbased graphical interface |
| Advanced interface | Experimental | Behavioral: Digital problem solving toolDigital problem solving tool with an advanced graphical interface and automatic functions |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- can use the Swedish language
- access to, and knowledge how to use, a digital internet-capable device
Key exclusion criteria (2 listed)
- under 16 years
- no practical or emotional problems during pandemic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital problem solving toolDigital problem solving tool - adapted for practical and emotional problems during the COVID-19 pandemic | Behavioural | Advanced interface, Traditional interface |
Primary outcome
System Usability Scale
Time frame: immediately after the intervention
Self-rated assessment of usability, higher score is better
Treatment Credibility Scale
Time frame: immediately after the intervention
Self-rated assessment of treatment credibility, higher score is better
1 secondary outcome
Use of intervention
Time frame: immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Derived from this study: PubMed 34559670Hentati 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Kraepelien, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital problem solving tool in people with Problem Solving, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04677270, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.