NCT04442282

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

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5,041

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

June 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 22, 2020

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2020

Completed
Last Updated

June 22, 2020

Status Verified

June 1, 2020

Enrollment Period

21 days

First QC Date

June 19, 2020

Last Update Submit

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

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

MeSH Terms

Conditions

Anxiety DisordersDepressionEmotional Regulation

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorSelf-ControlSocial Behavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sverre Urnes Johnson, PhD

CONTACT

Omid Ebrahimi, Mr

CONTACT

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