A Online-delivered Cognitive-behavioral Intervention for Dysfunctional Worry Related to the Covid-19 Pandemic

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of a Brief Online-delivered Cognitive-behavioral Intervention for Dysfunctional Worry Related to the Covid-19 Pandemic: A Randomized Controlled Trial

Conditions
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Dysfunctional Worry

Intervention / Treatment
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* Behavioral: Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemic


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA The following 2 criteria must be met: Worrying about Covid-19 and its possible consequences (e.g. risk of getting ill, fear of death, economy, family, etc.) every day, often several times a day The worry about Covid-19 is perceived as difficult to control In addition, at least one of the following negative consequences of worrying: The worry about Covid-19 takes so much time and energy that it is difficult to concentrate on anything else (work, family, hobbies, etc.) Trouble sleeping due to Covid-19 worries Constantly checking the news and social media to follow developments about Covid-19 Marked loss of work productivity due to worries about Covid-19 Difficulties finding joy in everyday situations because of worry about Covid-19 ≥ 18 years of age Resident in Sweden Daily access to a computer or other device with internet connection EXCLUSION CRITERIA Non Swedish speaking Severe depression, defined as >28 points on the MADRS-S Suicidal risk defined as 5 points or above on item 9 on the MADRS-S Family member in the same household who is included in the study

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: Online Cognitive-Behavioral intervention<br>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 | Behavioral: Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemic<br>* 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).<br>|
| No Intervention: Wait-list<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Åsberg 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19, internet-delivered, cognitive behavioral intervention