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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04341922
Recruitment Status : Unknown
Verified October 2020 by Erik Andersson, Karolinska Institutet.
Recruitment status was:  Active, not recruiting
First Posted : April 10, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Erik Andersson, Karolinska Institutet

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dysfunctional Worry Behavioral: Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemic Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 670 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Brief Online-delivered Cognitive-behavioral Intervention for Dysfunctional Worry Related to the Covid-19 Pandemic: A Randomized Controlled Trial
Actual Study Start Date : May 9, 2020
Actual Primary Completion Date : August 20, 2020
Estimated Study Completion Date : September 10, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Behavioral: 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).
No Intervention: 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).


Outcome Measures
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Primary Outcome Measures :
  1. • Covid-19-adapted version of the self-rated Generalized Anxiety Disorder Scale-7 (GAD-7) [ Time Frame: 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 :
  1. Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S) [ Time Frame: 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.

  2. Adapted Covid-19 version of the Work and Social Adjustment Scale (WSAS) [ Time Frame: 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.

  3. Insomnia Severity Index (ISI) [ Time Frame: 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.

  4. Adapted Swedish version of the CoRonavIruS Health Impact Survey (CRISIS) [ Time Frame: 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.

  5. Intolerance of uncertainty Scale (IUS) [ Time Frame: 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.

  6. Patient Satisfaction Questionnaire (PSQ) [ Time Frame: Post treatment (week 3) ]
    A self-rated scale to assess treamtent satisfaction.

  7. Adverse events (AE) [ Time Frame: Post treatment (week 3) ]
    A self-rated questionnaire with free text options to assess adverse events du to the intervention.


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341922


Locations
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Sweden
Karolinska Institutet
Stockholm, Sweden, 17177
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Erik M Andersson, PhD Karolinska Institutet
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Erik Andersson, PhD, psychologist, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04341922    
Other Study ID Numbers: 2020-01719
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erik Andersson, Karolinska Institutet:
Covid-19
internet-delivered
cognitive behavioral intervention
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases