Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT04444505
Status:
UNKNOWN
Last Update Posted:
2020-06-24
First Post:
2020-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trait Versus State: The Differential Impact of Personality Traits, Coping Behaviors and Cognitions on Depression and Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011446', 'term': 'Prospective Studies'}], 'ancestors': [{'id': 'D015331', 'term': 'Cohort Studies'}, {'id': 'D016021', 'term': 'Epidemiologic Studies'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-07-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-22', 'studyFirstSubmitDate': '2020-06-19', 'studyFirstSubmitQcDate': '2020-06-19', 'lastUpdatePostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Health Questionnaire 9', 'timeFrame': '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', 'description': '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'}, {'measure': 'Generalized Anxiety Disorder 7', 'timeFrame': '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', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression', 'Anxiety']}, 'referencesModule': {'references': [{'pmid': '11556941', 'type': 'BACKGROUND', 'citation': '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': '16717171', 'type': 'BACKGROUND', 'citation': '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': '31447721', 'type': 'BACKGROUND', 'citation': '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': '35764593', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nPersonality 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.\n\nThe 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\n\nHypothesis 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.\n\nResearch 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?\n\nResearch 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.', 'detailedDescription': "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.\n\nResearch 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?\n\nResearch 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.\n\nStatistical analysis:\n\nTwo 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.\n\nPart 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.\n\nBoth 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).\n\nThe state-predictor variables are as mentioned: positive metacognitions (CAS-1 subscale); negative metacognitions (CAS-1 subscale); unhelpful coping behaviors (CAS-1 subscale).\n\nMulticollinearity 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).\n\nIf 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.\n\nSensitivity 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.\n\nSample size and power calculation:\n\nThe 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.\n\nMissing data:\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'genderDescription': 'Both Biological Sex and self-representation of gender are measured', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible participants are all adults including those of 18 years and above,\n* Who are currently living in Norway and thus experiencing identical NPIs, and\n* Who will provide digital consent to partake in the study.\n\nExclusion Criteria:\n\n* Children and adolescents (individuals below 18)\n* Adults not residing in Norway during the measurement period'}, 'identificationModule': {'nctId': 'NCT04444505', 'briefTitle': 'Trait Versus State: The Differential Impact of Personality Traits, Coping Behaviors and Cognitions on Depression and Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'University of Oslo'}, 'officialTitle': 'Trait Versus State: The Differential Impact of Personality Traits, Coping Behaviors and Cognitions on Depression and Anxiety', 'orgStudyIdInfo': {'id': 'REK125510-14'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health', 'type': 'OTHER', 'description': 'Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oslo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Modum Bad', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Omid V. Ebrahimi', 'investigatorAffiliation': 'University of Oslo'}}}}