- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04444505
Trait Versus State: The Differential Impact of Personality Traits, Coping Behaviors and Cognitions on Depression and Anxiety
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Children and adolescents (individuals below 18)
- Adults not residing in Norway during the measurement period
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 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
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 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
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General 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.
- 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.
- 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.
- 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 Jun 21. doi: 10.1097/NMD.0000000000001557. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REK125510-14
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
Clinical Trials on Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health
-
University of OsloModum BadUnknownAdherence to WHO-advised Hygiene-related Behavior | Adherence to Viral Mitigation Protocols
-
University of OsloModum BadUnknownMental Well-being
-
University of OsloModum BadUnknownDepression | Generalized Anxiety | Health Anxiety
-
University of OsloModum BadUnknown
-
University of OsloModum BadUnknownDepression | Anxiety