Clinical trial NCT04341922: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Dysfunctional Worry
Keywords: Covid-19
internet-delivered
cognitive behavioral intervention
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 670
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: • Covid-19-adapted version of the self-rated Generalized Anxiety Disorder Scale-7 (GAD-7)
timeFrame: 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 outcomes:
measure: Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)
timeFrame: Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up.
measure: Adapted Covid-19 version of the Work and Social Adjustment Scale (WSAS)
timeFrame: 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.
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up.
measure: Adapted Swedish version of the CoRonavIruS Health Impact Survey (CRISIS)
timeFrame: Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up.
measure: Intolerance of uncertainty Scale (IUS)
timeFrame: Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up.
measure: Patient Satisfaction Questionnaire (PSQ)
timeFrame: Post treatment (week 3)
measure: Adverse events (AE)
timeFrame: Post treatment (week 3)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Erik M Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.