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

Primary Purpose

Dysfunctional Worry

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemic
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysfunctional Worry focused on measuring Covid-19, internet-delivered, cognitive behavioral intervention

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention: Online Cognitive-Behavioral intervention

Wait-list

Arm Description

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

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).

Outcomes

Primary Outcome Measures

• 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.

Secondary Outcome Measures

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.
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.
Insomnia Severity Index (ISI)
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)
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.
Intolerance of uncertainty Scale (IUS)
A 12-item self-rated scale to assess intolerance of uncertainty. Total score ranging from 12 to 60.
Patient Satisfaction Questionnaire (PSQ)
A self-rated scale to assess treamtent satisfaction.
Adverse events (AE)
A self-rated questionnaire with free text options to assess adverse events du to the intervention.

Full Information

First Posted
April 7, 2020
Last Updated
October 15, 2020
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT04341922
Brief Title
A Online-delivered Cognitive-behavioral Intervention for Dysfunctional Worry Related to the Covid-19 Pandemic
Official Title
Evaluation of a Brief Online-delivered Cognitive-behavioral Intervention for Dysfunctional Worry Related to the Covid-19 Pandemic: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 9, 2020 (Actual)
Primary Completion Date
August 20, 2020 (Actual)
Study Completion Date
September 10, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysfunctional Worry
Keywords
Covid-19, internet-delivered, cognitive behavioral intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
670 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention: Online Cognitive-Behavioral intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Wait-list
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemic
Intervention Description
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).
Primary Outcome Measure Information:
Title
• Covid-19-adapted version of the self-rated Generalized Anxiety Disorder Scale-7 (GAD-7)
Description
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.
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.
Secondary Outcome Measure Information:
Title
Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)
Description
A 9-item self-rated scale to assess symtoms of depression.Total score ranging from 0 to 54.
Time Frame
Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up.
Title
Adapted Covid-19 version of the Work and Social Adjustment Scale (WSAS)
Description
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.
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.
Title
Insomnia Severity Index (ISI)
Description
A 7-item self-rated scale to asess severity of insomnia symtoms. Total score ranging from 0 to 28.
Time Frame
Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up.
Title
Adapted Swedish version of the CoRonavIruS Health Impact Survey (CRISIS)
Description
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.
Time Frame
Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up.
Title
Intolerance of uncertainty Scale (IUS)
Description
A 12-item self-rated scale to assess intolerance of uncertainty. Total score ranging from 12 to 60.
Time Frame
Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up.
Title
Patient Satisfaction Questionnaire (PSQ)
Description
A self-rated scale to assess treamtent satisfaction.
Time Frame
Post treatment (week 3)
Title
Adverse events (AE)
Description
A self-rated questionnaire with free text options to assess adverse events du to the intervention.
Time Frame
Post treatment (week 3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik M Andersson, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
17177
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
33212440
Citation
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.
Results Reference
derived

Learn more about this trial

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

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