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

Not Applicable

• Conditions: Dysfunctional Worry
• Interventions: Behavioral: Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemic

• Registration Number: NCT04341922
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-10
• Study Start: 2020-05-09
• Primary Completion: 2020-08-20
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-15
• Last Update Posted: 2020-10-19
• Study Completion: 2021-09-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 670

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention: Online Cognitive-Behavioral intervention	Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemic	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

Primary Outcome Measures

Name	Time	Method
• Covid-19-adapted version of the self-rated Generalized Anxiety Disorder Scale-7 (GAD-7)	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.	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.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction Questionnaire (PSQ)	Post treatment (week 3)	A self-rated scale to assess treamtent satisfaction.
Adverse events (AE)	Post treatment (week 3)	A self-rated questionnaire with free text options to assess adverse events du to the intervention.
Intolerance of uncertainty Scale (IUS)	Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up.	A 12-item self-rated scale to assess intolerance of uncertainty. Total score ranging from 12 to 60.
Adapted Covid-19 version of the Work and Social Adjustment Scale (WSAS)	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.	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.
Insomnia Severity Index (ISI)	Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up.	A 7-item self-rated scale to asess severity of insomnia symtoms. Total score ranging from 0 to 28.
Adapted Swedish version of the CoRonavIruS Health Impact Survey (CRISIS)	Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up.	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.
Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)	Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up.	A 9-item self-rated scale to assess symtoms of depression.Total score ranging from 0 to 54.

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden