Back to resultsICBT for Mental Health Problems Related to the Coronavirus Pandemic
Primary Purpose
Depression and Quality of Life Related to the Coronavirus Pandemic
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Intervention group CoronaCope
Sponsored by
About this trial
This is an interventional treatment trial for Depression and Quality of Life Related to the Coronavirus Pandemic focused on measuring Corona, COVID-19, Internet-delivered cognitive-behavioral therapy (ICBT), Depression, Quality of life
Eligibility Criteria
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
Sites / Locations
- Linköping University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental: Intervention group CoronaCope
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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).
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.
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.
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.
Becks Depression Inventory-II
Same as during the treatment phase.
Brunnsviken Brief Quality of Life Scale
Same as during the treatment phase.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04424212
Brief Title
ICBT for Mental Health Problems Related to the Coronavirus Pandemic
Official Title
CoronaCope - Internet-based Cognitive Behavioural Therapy for Adults Suffering From Mental Health Problems Related to the Coronavirus Pandemic
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
September 10, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression and Quality of Life Related to the Coronavirus Pandemic
Keywords
Corona, COVID-19, Internet-delivered cognitive-behavioral therapy (ICBT), Depression, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Intervention group CoronaCope
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention group CoronaCope
Intervention Description
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.
Primary Outcome Measure Information:
Title
Becks Depression Inventory-II
Description
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.
Time Frame
Change between baseline and end of treatment after seven weeks.
Title
Brunnsviken Brief Quality of Life Scale
Description
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.
Time Frame
Change between baseline and end of treatment after seven weeks.
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire
Description
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.
Time Frame
Change between baseline and end of treatment after seven weeks.
Title
Alcohol Use Disorder Identification Test
Description
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.
Time Frame
Change between baseline and end of treatment after seven weeks.
Title
Insomnia Severity Index
Description
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).
Time Frame
Change between baseline and end of treatment after seven weeks.
Title
The CoRonavIruS Health Impact Survey
Description
Screening for health impact and exposure of the coronavirus pandemic, with higher scores indicating a more severe impact from the coronavirus pandemic.
Time Frame
At baseline
Title
Impact of Event Scale-Revised
Description
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.
Time Frame
Change between baseline and end of treatment after seven weeks.
Title
Perceived Stress Scale
Description
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.
Time Frame
Change between baseline and end of treatment after seven weeks.
Title
Becks Depression Inventory-II
Description
Same as during the treatment phase.
Time Frame
Change between posttreatment and 12-month follow-up.
Title
Brunnsviken Brief Quality of Life Scale
Description
Same as during the treatment phase.
Time Frame
Change between posttreatment and 12-month follow-up.
Title
Dimensions of Anger Reactions (DAR-5) Questionnaire
Description
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.
Time Frame
Change between posttreatment and 12-month follow-up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Andersson, PhD
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linköping University
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
58330
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
ICBT for Mental Health Problems Related to the Coronavirus Pandemic
We'll reach out to this number within 24 hrs