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

• ClinicalTrials.gov Identifier: NCT04341922
• Recruitment Status: Unknown
• First Posted: April 10, 2020
• Last Update Posted: October 19, 2020
• Sponsor: Karolinska Institutet
• Information provided by (Responsible Party): Erik Andersson, Karolinska Institutet

Tracking Information

• First Submitted Date: April 7, 2020
• First Posted Date: April 10, 2020
• Last Update Posted Date: October 19, 2020
• Actual Study Start Date: May 9, 2020
• Actual Primary Completion Date: August 20, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 7, 2020)

• 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.

Original Primary Outcome Measures (submitted: April 9, 2020)

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 Generalized Anxiety disorder. 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.

Current Secondary Outcome Measures (submitted: May 7, 2020)

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

Original Secondary Outcome Measures (submitted: April 9, 2020)

• 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.
• Adapted Covid-19 version of the Work and Social Adjustment Scale (WSAS) [ Time Frame: Baseline (week 0), 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) [ 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.
• 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.
• 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.
• Patient Satisfaction Questionnaire (PSQ) [ Time Frame: Post treatment (week 3) ]
  A self-rated scale to assess treamtent satisfaction.
• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Dysfunctional Worry

Intervention

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).

Study Arms

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

• Publications *: 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.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: April 9, 2020): 670
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 10, 2021
• Actual Primary Completion Date: August 20, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT04341922
• Other Study ID Numbers: 2020-01719
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Erik Andersson, Karolinska Institutet
• Original Responsible Party: Same as current
• Current Study Sponsor: Karolinska Institutet
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Erik M Andersson, PhD; Karolinska Institutet

• PRS Account: Karolinska Institutet
• Verification Date: October 2020