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The purpose of this study is to investigate if a brief online-delivered cognitive-behavioral intervention can reduce the degree of dysfunctional worry related to the Covid-19 pandemic, compared to a wait-list control condition.
Worries about the immediate and long-term consequences of the ongoing Covid-19 pandemic are largely justified in the current climate of uncertainty. However, dysfunctional worry, that is, pervasive worry that is disproportionate in its intensity or duration, and that significantly interferes with every-day problem-solving or goal-driven behavior, is clearly counterproductive. Research has also indicated that repeated media exposure to a community crisis can lead to increased anxiety and heightened stress responses, that can give a downstream effect on health, and misplaced health-protective and help-seeking behaviors which, in turn, may overburden health care facilities. There is an urgent need to develop a brief, scalable intervention to target such dysfunctional worry in the general population.
The current randomized controlled trial will evaluate the feasibility and efficacy of a brief online-delivered cognitive behavioral intervention designed to target dysfunctional worry related to the Covid-19 pandemic. 670 individuals are randomized to intervention or to waiting-list. The hypothesis is that the brief self-guided intervention will show significant within-group reductions in self-rated worry from baseline (week 0) to post-treatment (week 3), and that these improvements will be larger than those seen in the wait-list control group. The wait-list group will be crossed over to receive the intervention after three weeks (post-treatment). All participants will be followed-up one month and one year after the end of the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: Online Cognitive-Behavioral intervention | Experimental | The three-week intervention is a structured self-guided program without therapist support, administered via a secure web platform and organized in five brief modules. The treatment is provided through an encrypted online platform (login through BankID and double authentication) provided by the eHealth Core facility at Karolinska Institutet |
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| Wait-list | No Intervention | The wait-list controlled composes of no intervention for three weeks. Participants randomized to the wait-list group will be crossed over to receive the Online Cognitive-Behavioral intervention after three weeks (post-treatment). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemic | Behavioral | The intervention focuses on 1) teaching participants how to discriminate between functional and dysfunctional worry (what are solvable problems vs. what is worry, i.e. unsolvable thoughts?) 2) providing participants with skills to solve functional worry topics (e.g. set time and make a workable plan to be prepared for possible negative outcomes [e.g. becoming unemployed]), 3) helping participants to reduce unhelpful behaviors that may reinforce worry (e.g., limit excessive news consumption, refrain from assurance seeking behaviors), 4) providing participants with skills to approach dysfunctional worry (e.g., not engage in worrisome thoughts, just leave them), and 5) increase the behavioral repertoire (take walks, engage in activities that promote health without putting oneself at risk to become infected). |
| Measure | Description | Time Frame |
|---|---|---|
| • Covid-19-adapted version of the self-rated Generalized Anxiety Disorder Scale-7 (GAD-7) | A 7-item self-rated scale to assess symtom severity of worry. Total score ranging from 0 to 21. Effects will be expressed as the change from baseline to last post-treatment value (Week 0-Week 3) period. Effects will also be assessed at one month and one year post-treatment. | Basline (week 0), during treatment (week 1 and week 2), post treatment (week 3), at one-month after treatment and also one year follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery Ã…sberg Depression Rating Scale - Self report (MADRS-S) | A 9-item self-rated scale to assess symtoms of depression.Total score ranging from 0 to 54. | Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up. |
| Adapted Covid-19 version of the Work and Social Adjustment Scale (WSAS) |
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INCLUSION CRITERIA
The following 2 criteria must be met:
In addition, at least one of the following negative consequences of worrying:
≥ 18 years of age
Resident in Sweden
Daily access to a computer or other device with internet connection
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Erik M Andersson, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Stockholm | 17177 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33212440 | Derived | Wahlund T, Mataix-Cols D, Olofsdotter Lauri K, de Schipper E, Ljotsson B, Aspvall K, Andersson E. Brief Online Cognitive Behavioural Intervention for Dysfunctional Worry Related to the COVID-19 Pandemic: A Randomised Controlled Trial. Psychother Psychosom. 2021;90(3):191-199. doi: 10.1159/000512843. Epub 2020 Nov 19. |
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A 5-item self-rated scale adapted to measure impact of the Covid-19 pandemic on work and social functioning. Total score ranging from 0 to 40. |
| Basline (week 0), during treatment (week 1 and week 2), post treatment (week 3), at one-month after treatment and also one year follow up. |
| Insomnia Severity Index (ISI) | A 7-item self-rated scale to asess severity of insomnia symtoms. Total score ranging from 0 to 28. | Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up. |
| Adapted Swedish version of the CoRonavIruS Health Impact Survey (CRISIS) | A self-rated scale to assess Coronavirus/covid-19 health/exposure status, life changes, changes in daily behaviors, impact on emotions/worries, changes in media use past two weeks and changes in substance use due to coronavirus/covid-19 crisis. The scale has bees translated to Swedish and adopted to a Swedish context. | Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up. |
| Intolerance of uncertainty Scale (IUS) | A 12-item self-rated scale to assess intolerance of uncertainty. Total score ranging from 12 to 60. | Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up. |
| Patient Satisfaction Questionnaire (PSQ) | A self-rated scale to assess treamtent satisfaction. | Post treatment (week 3) |
| Adverse events (AE) | A self-rated questionnaire with free text options to assess adverse events du to the intervention. | Post treatment (week 3) |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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