Clinical trial NCT04424212: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression and Quality of Life Related to the Coronavirus Pandemic
Keywords: Corona
COVID-19
Internet-delivered cognitive-behavioral therapy (ICBT)
Depression
Quality of life
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2020-06-09
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Becks Depression Inventory-II
timeFrame: Change between baseline and end of treatment after seven weeks.
measure: Brunnsviken Brief Quality of Life Scale
timeFrame: Change between baseline and end of treatment after seven weeks.
Secondary outcomes:
measure: Patient Health Questionnaire
timeFrame: Change between baseline and end of treatment after seven weeks.
measure: Alcohol Use Disorder Identification Test
timeFrame: Change between baseline and end of treatment after seven weeks.
measure: Insomnia Severity Index
timeFrame: Change between baseline and end of treatment after seven weeks.
measure: The CoRonavIruS Health Impact Survey
timeFrame: At baseline
measure: Impact of Event Scale-Revised
timeFrame: Change between baseline and end of treatment after seven weeks.
measure: Perceived Stress Scale
timeFrame: Change between baseline and end of treatment after seven weeks.
measure: Becks Depression Inventory-II
timeFrame: Change between posttreatment and 12-month follow-up.
measure: Brunnsviken Brief Quality of Life Scale
timeFrame: Change between posttreatment and 12-month follow-up.
measure: Dimensions of Anger Reactions (DAR-5) Questionnaire
timeFrame: Change between posttreatment and 12-month follow-up.
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University
state: Östergötland
Study officials:
affiliation: Linkoeping University
name: Gerhard Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References: