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DepressionNCT04444505

Trait Versus State: The Differential Impact of Personality Traits, Coping Behaviors and Cognitions on Depression and Anxiety

An observational study of Depression and Anxiety, run by University of Oslo.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression, Anxiety
What is being tested?
Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health
How many people
4,000 participants
Where
No sites listed yet
Study dates
22 Jun 2020to 13 Jul 2020
Phase
Observational
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 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Children and adolescents (individuals below 18)
  • Adults not residing in Norway during the measurement period

About this study

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.

Read more

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.

Read the detailed description

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.

Statistical analysis:

Two hierarchical regression analyses will be conducted. 1) with PHQ-9 as the dependent variable; and 2) the second with GAD-7 at as the dependent variable. Both analyses will include the following variables and the following steps: In step 1, the demographic variables age, gender, and education will be included in the model. In step 2 two, the trait-variables (i.e., all five personality traits measured with BFI-10) will be included. In the final step, the three state-variables positive metacognitions, negative metacognitions (CAS-1), and unhelpful coping strategies (CAS-1) will be included.

Part correlations will be reported for each regression analysis, presenting the effect size of the hypothesized predictors on depression and anxiety. A part (semi-partial) correlation gives the least biased and easiest interpretable estimate of the strength of a predictive relationship (Dudgeon, 2016). It is the correlation between the outcome and the aspects of the predictor unique from all the other predictors. As a type of correlation, its size can be evaluated according to Cohen's (1988) criteria: small >=0.10, medium >=0.30, large >=0.50.

Both analysis include the following 5 trait-predictor variables: Neuroticism (BFI-10), Openness (BFI-10), Conscientiousness (BFI-10), Extroversion-Introversion (BFI-10), and Agreeableness (BFI-10).

The state-predictor variables are as mentioned: positive metacognitions (CAS-1 subscale); negative metacognitions (CAS-1 subscale); unhelpful coping behaviors (CAS-1 subscale).

Multicollinearity and other statistical assumptions will be checked using examined. Multicollinearity will be assessed with common guidelines (VIF < 5 and Tolerance > 0.2; Hocking, 2003; O'Brian, 2007).

If any further analyses or questions are addressed in the forthcoming paper that are not pre-specified in this pre-registered protocol, they will be explicitly defined as exploratory.

Sensitivity analyses and random subsample replications of the main findings will be conducted following selection of a random sample of participants that ensure a proportionate ratio between the collected sample and the adult population of Norway.

Sample size and power calculation:

The present study is part of a larger project with the first part aiming to investigate information source predictors of mental health through regression analyses, and the second part aiming to examine directional relations amongst specific sources of information and their centrality through complex systems approaches (i.e., network analysis). Consequently, power calculations are based on power required for network analyses. Following power analysis guidelines by Fried \& Cramer (2017), it is recommended that the number of participants are three times larger than the number of estimated parameters. However, more conservative recommendations by Roscoe (1975) for multivariate research, recommends sample size that is ten times larger than the number of estimated parameters. Thus, following these two approaches respectively, between 1305 to 4350 participants are required. Data will be collected for three weeks, and participants are based on a representative and random sample of Norwegian adults, randomly selected and provided equal opportunity to partake in the study, providing digital consent.

Missing data:

The TSD system (Services for Sensitive Data), a platform used in Norway to store person-sensitive data verifies participants officially through a kind of national ID number to give them full right to withdraw their data at any time, following the European GDPR (General Data Protection Regulation) laws. Accordingly, participants are allowed to withdraw their own data at any time. The survey includes mandatory fields of response. Participation is voluntarily, and withdrawal of provided data is possible at any moment. The investigators do not expect participants to withdraw their data and thus expect no missing data. However, if participants do withdraw their data, the investigators will conduct state-of-art missing data analyses and investigate whether data is missing at random.

Conditions
Depression, Anxiety
Being tested
Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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

  2. 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).

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2020
  2. Study start22 Jun 2020 (estimated)
  3. Primary completion13 Jul 2020 (estimated)
  4. Study completion13 Jul 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04444505
Sponsor's protocol ID
REK125510-14
Status last verified
Jun 2020
First submitted
19 Jun 2020
Last updated
24 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 11556941
  • 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.

    PubMed 16717171
  • 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.

    PubMed 31447721
  • 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.

    PubMed 35764593

Questions about this trial

What is this clinical trial studying?

An observational study of Depression and Anxiety, run by University of Oslo.

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 3 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: status not confirmed, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Patient Health Questionnaire 9 (time frame: 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). 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 NCT04444505, which also lists 4 linked publications.

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 24 Jun 2020.

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