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Completed

NCT Number: NCT04424212

ICBT for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linköping University

Linköping, Östergötland County, 58330, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention group CoronaCope

Behavioral

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. Becks Depression Inventory-II

    Time frame: Change between posttreatment and 12-month follow-up.

    Same as during the treatment phase.

  8. Brunnsviken Brief Quality of Life Scale

    Time frame: Change between posttreatment and 12-month follow-up.

    Same as during the treatment phase.

  9. 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.

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

CoronaCope - Internet-based Cognitive Behavioural Therapy for Adults Suffering From Mental Health Problems Related to the Coronavirus Pandemic

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2020
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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