Depression and Quality of Life Related to the Coronavirus Pandemic Clinical Trial
Official title:
CoronaCope - Internet-based Cognitive Behavioural Therapy for Adults Suffering From Mental Health Problems Related to the Coronavirus Pandemic
| Verified date | January 2022 |
| Source | Linkoeping University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 76 |
| Est. completion date | October 1, 2021 |
| Est. primary completion date | September 10, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Linköping University | Linköping | Östergötland |
| Lead Sponsor | Collaborator |
|---|---|
| Linkoeping University |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Change between baseline and end of treatment after seven weeks. | |
| Primary | 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. | Change between baseline and end of treatment after seven weeks. | |
| Secondary | 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. | Change between baseline and end of treatment after seven weeks. | |
| Secondary | 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. | Change between baseline and end of treatment after seven weeks. | |
| Secondary | 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). | Change between baseline and end of treatment after seven weeks. | |
| Secondary | 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. | At baseline | |
| Secondary | 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. | Change between baseline and end of treatment after seven weeks. | |
| Secondary | 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. | Change between baseline and end of treatment after seven weeks. | |
| Secondary | Becks Depression Inventory-II | Same as during the treatment phase. | Change between posttreatment and 12-month follow-up. | |
| Secondary | Brunnsviken Brief Quality of Life Scale | Same as during the treatment phase. | Change between posttreatment and 12-month follow-up. | |
| Secondary | 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. | Change between posttreatment and 12-month follow-up. |