Dysfunctional WorryNCT04341922
A Online-delivered Cognitive-behavioral Intervention for Dysfunctional Worry Related to the Covid-19 Pandemic
A study testing Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemic in people with Dysfunctional Worry, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Dysfunctional Worry
- What is being tested?
- Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 670 participants
- Where
- 1 siteSweden
- Study dates
- 9 May 2020to 10 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Brief Online-delivered Cognitive-behavioral Intervention for Dysfunctional Worry Related to the Covid-19 Pandemic: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemic
- Keywords
- Covid-19, internet-delivered, cognitive behavioral intervention
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemicBehavioural
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 group | Role | What they receive |
|---|---|---|
| Intervention: Online Cognitive-Behavioral intervention | Experimental | 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 Receives: Behavioral: Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemic |
| Wait-list | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: 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 (7)
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.
Measured: Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up.
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.
Measured: 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.
Insomnia Severity Index (ISI)
A 7-item self-rated scale to asess severity of insomnia symtoms. Total score ranging from 0 to 28.
Measured: Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up.
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.
Measured: Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up.
Intolerance of uncertainty Scale (IUS)
A 12-item self-rated scale to assess intolerance of uncertainty. Total score ranging from 12 to 60.
Measured: Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up.
Patient Satisfaction Questionnaire (PSQ)
A self-rated scale to assess treamtent satisfaction.
Measured: Post treatment (week 3)
Adverse events (AE)
A self-rated questionnaire with free text options to assess adverse events du to the intervention.
Measured: Post treatment (week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start9 May 2020
- Primary completion20 Aug 2020
- Study completion10 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dysfunctional WorryStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 670 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Andersson, Karolinska Institutet
- Investigators
- Erik M Andersson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341922
- Sponsor's protocol ID
- 2020-01719
- Status last verified
- Oct 2020
- First submitted
- 7 Apr 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33212440
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Brief Online-delivered Cognitive-behavioral Intervention for Dysfunctional Worry Related to the Covid-19 Pandemic: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04341922
- Acronym / sponsor ID
- 2020-01719
- Conditions
- Dysfunctional Worry
- Keywords
- Covid-19, internet-delivered, cognitive behavioral intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 670 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 9 May 2020 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 10 Sep 2021 (estimated)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Online Cognitive-Behavioral intervention | Experimental | Behavioral: Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemicThe 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 |
| Wait-list | No intervention | –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). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- The following 2 criteria must be met:
- In addition, at least one of the following negative consequences of worrying:
- ≥ 18 years of age
- Resident in Sweden
- Daily access to a computer or other device with internet connection
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemicThe 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). | Behavioural | Intervention: Online Cognitive-Behavioral intervention |
Primary outcome
• 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.
7 secondary outcomes
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.
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.
Insomnia Severity Index (ISI)
Time frame: Baseline (week 0), post treatment (week 3), at one-month after treatment and also one year follow up.
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.
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.
Patient Satisfaction Questionnaire (PSQ)
Time frame: Post treatment (week 3)
Adverse events (AE)
Time frame: Post treatment (week 3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 33212440Wahlund 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik M Andersson, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemic in people with Dysfunctional Worry, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04341922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.