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Clinical Trials/NCT05656430
NCT05656430
Completed
Not Applicable

Internet-based Cognitive Behavioral Therapy for Psychological Symptoms Related to the COVID-19 Pandemic Remaining After Societal Opening

Linkoeping University1 site in 1 country24 target enrollmentFebruary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression Symptoms
Sponsor
Linkoeping University
Enrollment
24
Locations
1
Primary Endpoint
Generalized Anxiety Disorder-7
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

This study aim to investigate the effects of internet-based cognitive behavioral therapy (ICBT) addressing psychological symptoms related to the COVID-19 pandemic and its consequences that remain after societal opening. The target group is adults (18 years or older) who still experience psychological symptoms related to the pandemic and the ICBT consists of eight modules during eight week with weekly support by a therapist. ICBT will be compared to a wait-list control condition. Participants will be recruited in Sweden with nationwide recruitment.

Detailed Description

The study is a randomized controlled trial about the effects of ICBT regarding psychological symptoms related to the COVID-19 pandemic and its consequences remaining after societal opening. Primary outcome measures are depression symptoms (measured with Beck Depression Inventory-II) and anxiety symptoms (measured with Generalized Anxiety Disorder-7). Other outcome measures used will for example be about stress symptoms, sleep problems, post traumatic stress symptoms and quality of life. Because of uncertainties about the psychological effects of COVID-19 pandemic, a transproblematic individually tailored treatment will be used that has been tested in several previous trials and adapted for addressing problems related to the pandemic and its consequences. The study (nor the recruitment within it) has not a focus on whether people have or have not been infected by the COVID-19 virus.

Registry
clinicaltrials.gov
Start Date
February 1, 2023
End Date
June 9, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Linkoeping University
Responsible Party
Principal Investigator
Principal Investigator

Gerhard Andersson

Professor

Linkoeping University

Eligibility Criteria

Inclusion Criteria

  • Experience mental health problems related to the COVID-19 pandemic and/or its consecuences, which are still experienced as a problem (when the pandemic is not considered as dangerous to the society)
  • 18 years or older
  • Adequate ability to speak, read and write in Swedish
  • Having access to the internet and a smartphone, computer or other device

Exclusion Criteria

  • Severe psychiatric or somatic issues that makes participation harder or impossible (which can include the diagnosis postcovid)
  • Ongoing addiction
  • Acute suicidality
  • Other ongoing psychological treatment
  • Recent (within the past 3 months) changes in the dose of psychotropic medication or planned change during the treatment weeks

Outcomes

Primary Outcomes

Generalized Anxiety Disorder-7

Time Frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.

Measure of anxiety symptoms and worry. When summing the points of the seven first questions, the scores are interpreted as mild, moderate and severe anxiety symptoms at 5-10, 11-15 and above 15 respectively.

Becks Depression Inventory-II

Time Frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.

Measure of depressive symptoms. Range for the total sum is between 0 and 63 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 respectively.

Secondary Outcomes

  • Karolinska Exhaustion Disorder Scale 9(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
  • Insonnia Severity Index(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
  • Alcohol Use Disorder Identification Test(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
  • UCLA loneliness scale 3(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
  • Percieved Stress Scale-14(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
  • Short Health Anxiety Inventory-14(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
  • Impact of Event Scale-6(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
  • The Cognitive Failures Questionnaire(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
  • Brunnsviken Brief Quality of Life Scale(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)
  • InCharge Financial Distress/Financial Well-Being Scale(Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.)

Study Sites (1)

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