- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04424212
ICBT for Mental Health Problems Related to the Coronavirus Pandemic
January 15, 2022 updated by: Gerhard Andersson, Linkoeping University
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Östergötland
-
Linköping, Östergötland, Sweden, 58330
- Linköping University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: Intervention group CoronaCope
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.
|
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.
|
No Intervention: Control group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change between baseline and end of treatment after seven weeks.
|
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.
|
Change between baseline and end of treatment after seven weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire
Time Frame: Change between baseline and end of treatment after seven weeks.
|
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.
|
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.
|
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.
|
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.
|
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).
|
Change between baseline and end of treatment after seven weeks.
|
The CoRonavIruS Health Impact Survey
Time Frame: At baseline
|
Screening for health impact and exposure of the coronavirus pandemic, with higher scores indicating a more severe impact from the coronavirus pandemic.
|
At baseline
|
Impact of Event Scale-Revised
Time Frame: Change between baseline and end of treatment after seven weeks.
|
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.
|
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.
|
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.
|
Change between baseline and end of treatment after seven weeks.
|
Becks Depression Inventory-II
Time Frame: Change between posttreatment and 12-month follow-up.
|
Same as during the treatment phase.
|
Change between posttreatment and 12-month follow-up.
|
Brunnsviken Brief Quality of Life Scale
Time Frame: Change between posttreatment and 12-month follow-up.
|
Same as during the treatment phase.
|
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.
|
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.
|
Change between posttreatment and 12-month follow-up.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 10, 2020
Primary Completion (Actual)
September 10, 2021
Study Completion (Actual)
October 1, 2021
Study Registration Dates
First Submitted
June 4, 2020
First Submitted That Met QC Criteria
June 8, 2020
First Posted (Actual)
June 9, 2020
Study Record Updates
Last Update Posted (Actual)
January 19, 2022
Last Update Submitted That Met QC Criteria
January 15, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CoronaCope
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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