Depression and Quality of Life Related to the Coronavirus PandemicNCT04424212
ICBT for Mental Health Problems Related to the Coronavirus Pandemic
A study testing Intervention group CoronaCope in people with Depression and Quality of Life Related to the Coronavirus Pandemic, run by Linkoeping University at 1 site in Sweden.
Trial summary
The study seeks to investigate the effects of a guided internet-based cognitive behavioral therapy (ICBT) programme a on adult mental health problems related to the current coronavirus pandemic. ICBT will be compared to a wait-list control group. Participants will be recruited in Sweden with a nationwide recruitment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression and Quality of Life Related to the Coronavirus Pandemic
- What is being tested?
- Intervention group CoronaCope
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSweden
- Study dates
- 10 Jun 2020to 1 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experience mental health problems that are caused or exacerbated by the corona pandemic and/or its consequences
- 18 years or older.
- Adequate ability to understand and speak Swedish.
- Access to the internet and a smartphone/computer.
Who cannot join
- Other ongoing psychological treatment or counselling that interfere with trial treatment.
- Recent (within the past 3 months) changes in the dose of psychotropic medication.
- Any severe psychiatric or somatic conditions that would interfere with trial treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CoronaCope - Internet-based Cognitive Behavioural Therapy for Adults Suffering From Mental Health Problems Related to the Coronavirus Pandemic
The study seeks to investigate the effects of a guided internet-based cognitive behavioral therapy (ICBT) programme a on adult mental health problems related to the current coronavirus pandemic. ICBT will be compared to a wait-list control group.
Participants will be recruited in Sweden with a nationwide recruitment.
Read the detailed description
The study is set up as a randomized controlled trial. Quality of life, depressive symptoms, anxiety, sleep problems and traumatic stress will be measured. Given uncertainties regarding the psychological effects of Covid-19 pandemic a transproblematic tailored treatment approach will be used that has been tested in several previous trials. However, the present program has been adapted for the target population of people who are affected by the societal and individual consequences of the pandemic. The study does not focus on people who have or have had the corona virus.
- Being tested
- Intervention group CoronaCope
- Keywords
- Corona, COVID-19, Internet-delivered cognitive-behavioral therapy (ICBT), Depression, Quality of life
- Medical subject headings
- Depression, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group CoronaCopeBehavioural
Intervention based on cognitive behavioural therapy principles and adapted to the coronavirus pandemic situation. Intervention's main purpose is to mental health issues such as depressive symtoms, stress, worry and anxiety related to the coronavirus pandemic and increase quality of life in the current situation. Intervention contains psycho-educational elements as well as examples and exercises.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention group CoronaCope | Experimental | ICBT, were participants receive 8 out of 15 possible modules depending on their current problems and needs, 7 week long internet intervention for reducing mental health issues related to the coronavirus pandemic. Receives: Behavioral: Intervention group CoronaCope |
| Control group | No intervention | Participants in the control group will be instructed to wait. Once intervention group will be finished, participants in control group will be able to access the same intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Becks Depression Inventory-II
Measure of depressive symptoms. Possible range for the total sum: 0 to 63 (created by summing up the score from each item) with a higher score indicating a higher level of depressive symptoms. Clinical ranges for minimal, mild, moderate and severe major depressive disorder are considered to be 0-13, 13-19, 20-28, and 29-63 points.
Measured: Change between baseline and end of treatment after seven weeks.
Brunnsviken Brief Quality of Life Scale
Measure of quality of life, total score ranging from 0 to 96 with a higher score indicating a higher quality of life. The scores of each of the six primary questions regarding perceived quality of life within an area of life are multiplied with the score of an item measuring the perceived importance of the area in question.
Measured: Change between baseline and end of treatment after seven weeks.
Secondary outcomes (9)
Patient Health Questionnaire
Measure of depressive symptoms. Possible range for the total sum: 0 to 27 (created by summing up the score from each item) with a higher score indicating higher levels of depression. Clinical cut-offs for mild, moderate, moderately severe and severe major depressive disorder are considered to be 5, 10, 15, and 20 points.
Measured: Change between baseline and end of treatment after seven weeks.
Alcohol Use Disorder Identification Test
The Alcohol Use Disorders Identification Test is a 10-item screening tool to assess alcohol consumption, drinking behaviors, and alcohol-related problems. 10 items and scores ranging from 0-40 with higher scores indicating a higher level of alcohol use.
Measured: Change between baseline and end of treatment after seven weeks.
Insomnia Severity Index
Measure of insomnia severity and symptoms of disordered sleep. The total score can range between 0 (no sleep problems) to 28 (severe sleep problems and insomnia) with higher scores indicating severer levels of sleeping problems. Norm score ranges include low likelihood of sleep problems (0 to 7 points), some sleep problems (8 to 14 points), moderate sleep problems (15 to 21 points), severe sleep problems (22 to 28 points).
Measured: Change between baseline and end of treatment after seven weeks.
The CoRonavIruS Health Impact Survey
Screening for health impact and exposure of the coronavirus pandemic, with higher scores indicating a more severe impact from the coronavirus pandemic.
Measured: At baseline
Impact of Event Scale-Revised
Assesses subjective distress caused by traumatic events. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The Impact of Event Scale-Revised yields a total score (ranging from 0 to 88) with a higher score indicate more severe distress caused by the traumatic events.
Measured: Change between baseline and end of treatment after seven weeks.
Perceived Stress Scale
It is a measure of the degree to which situations in one's life are appraised as stressful. It contains 10 items that are scored on a range between 0 (never) to 4 (very often). The total score can range from 0-56 and a higher score reflects higher levels of perceived stress.
Measured: Change between baseline and end of treatment after seven weeks.
Becks Depression Inventory-II
Same as during the treatment phase.
Measured: Change between posttreatment and 12-month follow-up.
Brunnsviken Brief Quality of Life Scale
Same as during the treatment phase.
Measured: Change between posttreatment and 12-month follow-up.
Dimensions of Anger Reactions (DAR-5) Questionnaire
The DAR-5 measures anger and its frequency, intensity, duration, level of aggression and impact on functioning during the last 4 weeks. The total severity score range between 5-25. Higher scores indicate that you are experiencing psychological distress and functional impairment as a result of your anger.
Measured: Change between posttreatment and 12-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start10 Jun 2020
- Primary completion10 Sep 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression and Quality of Life Related to the Coronavirus PandemicStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe 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
- Parallel groups
- Model description
- Participants will be randomly allocated to either control or intervention group. Participants in the control group will receive the same treatment once the intervention group has finished the treatment.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Gerhard Andersson, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424212
- Sponsor's protocol ID
- CoronaCope
- Status last verified
- Jan 2022
- First submitted
- 4 Jun 2020
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoronaCope - Internet-based Cognitive Behavioural Therapy for Adults Suffering From Mental Health Problems Related to the Coronavirus Pandemic
- ClinicalTrials.gov ID
- NCT04424212
- Acronym / sponsor ID
- CoronaCope
- Keywords
- Corona, COVID-19, Internet-delivered cognitive-behavioral therapy (ICBT), Depression, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 9 Jun 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 study seeks to investigate the effects of a guided internet-based cognitive behavioral therapy (ICBT) programme a on adult mental health problems related to the current coronavirus pandemic. ICBT will be compared to a wait-list control group.
Participants will be recruited in Sweden with a nationwide recruitment.
Detailed description
The study is set up as a randomized controlled trial. Quality of life, depressive symptoms, anxiety, sleep problems and traumatic stress will be measured. Given uncertainties regarding the psychological effects of Covid-19 pandemic a transproblematic tailored treatment approach will be used that has been tested in several previous trials. However, the present program has been adapted for the target population of people who are affected by the societal and individual consequences of the pandemic. The study does not focus on people who have or have had the corona virus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to either control or intervention group. Participants in the control group will receive the same treatment once the intervention group has finished the treatment.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention group CoronaCope | Experimental | Behavioral: Intervention group CoronaCopeICBT, were participants receive 8 out of 15 possible modules depending on their current problems and needs, 7 week long internet intervention for reducing mental health issues related to the coronavirus pandemic. |
| Control group | No intervention | –Participants in the control group will be instructed to wait. Once intervention group will be finished, participants in control group will be able to access the same intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Experience mental health problems that are caused or exacerbated by the corona pandemic and/or its consequences
- 18 years or older.
- Adequate ability to understand and speak Swedish.
- Access to the internet and a smartphone/computer.
Key exclusion criteria (3 listed)
- Other ongoing psychological treatment or counselling that interfere with trial treatment.
- Recent (within the past 3 months) changes in the dose of psychotropic medication.
- Any severe psychiatric or somatic conditions that would interfere with trial treatment
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 |
|---|---|---|
| Intervention group CoronaCopeIntervention based on cognitive behavioural therapy principles and adapted to the coronavirus pandemic situation. Intervention's main purpose is to mental health issues such as depressive symtoms, stress, worry and anxiety related to the coronavirus pandemic and increase quality of life in the current situation. Intervention contains psycho-educational elements as well as examples and exercises. | Behavioural | Experimental: Intervention group CoronaCope |
Primary outcome
Becks Depression Inventory-II
Time frame: Change between baseline and end of treatment after seven weeks.
Measure of depressive symptoms. Possible range for the total sum: 0 to 63 (created by summing up the score from each item) with a higher score indicating a higher level of depressive symptoms. Clinical ranges for minimal, mild, moderate and severe major depressive disorder are considered to be 0-13, 13-19, 20-28, and 29-63 points.
Brunnsviken Brief Quality of Life Scale
Time frame: Change between baseline and end of treatment after seven weeks.
Measure of quality of life, total score ranging from 0 to 96 with a higher score indicating a higher quality of life. The scores of each of the six primary questions regarding perceived quality of life within an area of life are multiplied with the score of an item measuring the perceived importance of the area in question.
9 secondary outcomes
Patient Health Questionnaire
Time frame: Change between baseline and end of treatment after seven weeks.
Alcohol Use Disorder Identification Test
Time frame: Change between baseline and end of treatment after seven weeks.
Insomnia Severity Index
Time frame: Change between baseline and end of treatment after seven weeks.
The CoRonavIruS Health Impact Survey
Time frame: At baseline
Impact of Event Scale-Revised
Time frame: Change between baseline and end of treatment after seven weeks.
Perceived Stress Scale
Time frame: Change between baseline and end of treatment after seven weeks.
Becks Depression Inventory-II
Time frame: Change between posttreatment and 12-month follow-up.
Brunnsviken Brief Quality of Life Scale
Time frame: Change between posttreatment and 12-month follow-up.
Dimensions of Anger Reactions (DAR-5) Questionnaire
Time frame: Change between posttreatment and 12-month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
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.
Gerhard Andersson, PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group CoronaCope in people with Depression and Quality of Life Related to the Coronavirus Pandemic, run by Linkoeping University 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 19 Jan 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Becks Depression Inventory-II (time frame: Change between baseline and end of treatment after seven weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2022.