Difficulties in Emotion-regulation and Interpersonal Problems During and After the COVID-19 Pandemic
1 other identifier
observational
5,041
0 countries
N/A
Brief Summary
Central indicators of psychological functioning such as difficulties in emotion regulation and habitual problems in one's relating to others are likely to have been substantially impacted by the COVID-19 amelioration measures of societal lock-down and physical (ne social) distancing. In turn, as these amelioration measures have been relaxed, that impact will presumably be reduced, gradually returning these factors to pre-crisis levels. Also, these factors are likely to predict mental health outcomes such as symptoms of depression and anxiety throughout the pandemic and beyond, so that levels of emotion regulation difficulties and interpersonal problems early on will predict later symptom status. Similarly reductions in such difficulties during the various phases of the outbreak will be associated with a concurrent reduction in psychological symptoms and reduced symptom levels at later stages.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2020
CompletedFirst Posted
Study publicly available on registry
June 22, 2020
CompletedStudy Start
First participant enrolled
June 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 13, 2020
CompletedJune 22, 2020
June 1, 2020
21 days
June 19, 2020
June 19, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
Patient Health Questionnaire 9 (PHQ-9)
The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer \& Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area.
Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire
The Generalized Anxiety Disorder - 7
The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams \& Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen \& Hoffart, 2019). The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams \& Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen \& Hoffart, 2019).
Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire
Difficulties in Emotion Regulation Scale
6 items from DERS (Gratz \& Roemer, 2004)
Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire
Interpersonal problems
17 Items from IIP-64 (Horowitz et al. 2000)
Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire
Eligibility Criteria
General population in Norway.
You may qualify if:
- Eligible participants are all adults including those of 18 years and above,
- Who are currently living in Norway and thus experiencing identical NPIs, and
- Who provide digital consent to partake in the study.
You may not qualify if:
- Children and adolescents (individuals below 18)
- Adults not residing in Norway during the measurement period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oslolead
- Modum Badcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ole Andrè Solbakken, PhD
University of Oslo
- PRINCIPAL INVESTIGATOR
Jon Monsen, PhD
University of Oslo
- PRINCIPAL INVESTIGATOR
Asle Hoffart, PhD
University of Oslo & Modum Bad
- PRINCIPAL INVESTIGATOR
Omid Ebrahimi, Mr
University of Oslo & Modum Bad
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professer Sverre Urnes Johnson
Study Record Dates
First Submitted
June 19, 2020
First Posted
June 22, 2020
Study Start
June 22, 2020
Primary Completion
July 13, 2020
Study Completion
July 13, 2020
Last Updated
June 22, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share