NCT04444505

Brief Summary

The present study aims to investigate the differential impact of different types of variables on depression and anxiety. In particular, the impact of trait-variables (i.e., personality measured with the brief Big Five Inventory (BFI-10)) are contrasted against state-variables, including unhelpful coping behavior (measured with CAS-1) and cognitions including positive metacognitions and negative metacognitions (both measured with CAS-1). Personality is defined as a set of traits that is relatively consistent over time and situation, and is subsequently less susceptible as a target mechanisms for therapy. Still, researchers have devoted great efforts toward describing personality traits as related to different psychopathological disorders. Consequently, the present study aims to investigate the differential associations of traits (i.e., personality) versus state variables (metacognitions and coping behaviors) on depression and anxiety. The findings of the present study will provide important insights in finding important associations between trait and state variables in relation to psychopathology, providing an important foundation for further directional investigations with temporal data Hypothesis 1: Neuroticism measured with (BFI-10), positive metacognitions, negative metacognitions, and unhelpful coping strategies (the latter three measured with CAS-1), will predict higher levels of depression and anxiety. Research Question 1: How and to what extent are different traits related measured with BFI-10 related to depression and anxiety in the present pandemic sample? Research Question 2: Are the trait or state variables most strongly associated with depressive and anxiety symptoms? This question will be investigated using part correlations in the multiple regression analyses.

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
4,000

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

Study Start

First participant enrolled

June 22, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
20 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 24, 2020

Status Verified

June 1, 2020

Enrollment Period

21 days

First QC Date

June 19, 2020

Last Update Submit

June 22, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Patient Health Questionnaire 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 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks

  • 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).

    Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks

Interventions

Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBoth Biological Sex and self-representation of gender are measured
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adults above 18 years residing in Norway and thus experiencing identical mitigation protocols are invited to participate the study, reaching randomly online with an equal opportunity of participating.

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 will 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

Related Publications (4)

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PMID: 11556941BACKGROUND
  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PMID: 16717171BACKGROUND
  • Johnson SU, Ulvenes PG, Oktedalen T, Hoffart A. Psychometric Properties of the General Anxiety Disorder 7-Item (GAD-7) Scale in a Heterogeneous Psychiatric Sample. Front Psychol. 2019 Aug 6;10:1713. doi: 10.3389/fpsyg.2019.01713. eCollection 2019.

    PMID: 31447721BACKGROUND
  • Nordahl H, Ebrahimi OV, Hoffart A, Johnson SU. Trait Versus State Predictors of Emotional Distress Symptoms: The Role of the Big-5 Personality Traits, Metacognitive Beliefs, and Strategies. J Nerv Ment Dis. 2022 Dec 1;210(12):943-950. doi: 10.1097/NMD.0000000000001557.

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Prospective Studies

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Cohort StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 23, 2020

Study Start

June 22, 2020

Primary Completion

July 13, 2020

Study Completion

July 13, 2020

Last Updated

June 24, 2020

Record last verified: 2020-06