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Difficulties in Emotion-regulation and Interpersonal Problems During and After the COVID-19 Pandemic

2020年6月19日 更新者:Sverre Urnes Johnson、University of Oslo

Difficulties in Emotion-regulation and Interpersonal Problems, and Their Association With Anxiety and Depression During and After the COVID-19 Pandemic

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.

調査の概要

状態

わからない

詳細な説明

Hypotheses/Research questions:

H1: There will be a significant decrease in emotion-regulation difficulties (DERS) and interpersonal problems from T1 to T2.

Exploratory: Examine the difference in interpersonal problems and DERS among different sub-groups before and after the COVID-19 pandemic

H2: Higher level at T1 and less reduction from T1 to T2 in emotion-regulation difficulties and interpersonal problems will be associated with less reduction in anxiety and depression from T1 to T2, above and beyond, demographic variables (age, gender, education).

Exploratory: Explore the different octants of IIP as predictors of changes for anxiety and depression.

This study is part of 'The Norwegian COVID-19, Mental Health and Adherence Project', involving multiple studies.

Statistical models:

Repeated surveys like the present one typically have high drop-out and substantial missing data. Therefore, we will use mixed models instead of paired t-tests, repeated measures ANOVAs, and ordinary linear regression to analyze the data. Mixed models use maximum likelihood estimation, which is the state of the art approach to handle missing data (Schafer & Graham, 2002). Especially if data are missing at random, which is likely in our survey, mixed models give more unbiased results than the other analytic methods (O'Connel et al., 2017).

In preliminary analyses, and for each of the dependent variables (GAD-7 and PHQ-9, DERS , IIP), the combination of random effects and covariance structure of residuals that gives the best fit for the "empty" model (the model without fixed predictors except the intercept) will be chosen. Akaike's Information Criterion (AIC) will used to compare the fit of different models. Models that give a reduction in AIC greater than 2 will be considered better (Burnham & Anderson, 2004). The program SPSS 25.0 will be used (IBM Corp, 2018).

First, H1 about decrease in DERS and IIP, GAD-7 and PHQ will be tested by using anxiety or depression as dependent variable in a model using time (T1 period = 0, T2 period = 1) as a predictor. Second, demographic group variables will be added as predictors. Third, the initial (T1) levels of DERS and IIP as constant covariates will be added, together with the interactions of these constant covariates with time. These interactions represent tests of H2 about the covariates predicting change in anxiety and depression. Finally, the T2 levels of DERS and IIP as constant covariates will be added, together with the interactions of these constant covariates with time. These interactions represent tests of H2 about the change in the covariates from T1 to T2 predicting change in anxiety and depression from T1 to T2s.

Transformations Depending on degree of skewness compared to theoretical possibilities and interpretations, variables will be assessed in their original and validated format as is recommended practice, as long as this is possible. As this study examines psychopathology levels amongst a general population (and not a clinical population), we do expect a skewed data. We will attempt to assess these variables in their original and validated format as is recommended practice, as long as this is possible. However, if this is not possible to the statistical assumptions behind the analyses, transformation may be needed to apply interval-based methods. Alternatively a non-parametric test will be used.

Inference criteria

Given the large sample size in this study, we pre-define our significance level:

p < 0.01 to determine significance

Missing data Maximum likelihood

Sensitivity analyses Sensitivity analyses will be conducted after selecting a random sample of participants to reflect the proportion of subgroups in the Norwegian adult population.

Exploratory:

Questions addressed in the future paper which is not pre-specified will be defined as exploratory.

研究の種類

観察的

入学 (予想される)

5041

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

14年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

なし

受講資格のある性別

全て

サンプリング方法

確率サンプル

調査対象母集団

General population in Norway.

説明

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 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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:他の
  • 時間の展望:見込みのある

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Patient Health Questionnaire 9 (PHQ-9)
時間枠: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 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
時間枠: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 (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
時間枠: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
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
時間枠: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
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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

協力者

捜査官

  • 主任研究者:Ole Andrè Solbakken, PhD、University of Oslo
  • 主任研究者:Jon Monsen, PhD、University of Oslo

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (予想される)

2020年6月22日

一次修了 (予想される)

2020年7月13日

研究の完了 (予想される)

2020年7月13日

試験登録日

最初に提出

2020年6月19日

QC基準を満たした最初の提出物

2020年6月19日

最初の投稿 (実際)

2020年6月22日

学習記録の更新

投稿された最後の更新 (実際)

2020年6月22日

QC基準を満たした最後の更新が送信されました

2020年6月19日

最終確認日

2020年6月1日

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