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

NCT ID: NCT04341922

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 670 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-09
• Study Completion Date: 2021-09-10

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.

Conditions

Dysfunctional Worry

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention: Online Cognitive-Behavioral intervention

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

Group Type: EXPERIMENTAL

Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemic

Intervention Type: 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).

Wait-list

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemic

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Erik Andersson

PhD, psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erik M Andersson, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institutet

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 33212440 (View on PubMed)

Other Identifiers

2020-01719

Identifier Type: -

Identifier Source: org_study_id