ICBT for Psychological Symptoms Related to the COVID-19 Pandemic Remaining After Societal Opening

NCT05656430 | Completed

• 1 other identifier: PostCoronaCope
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression Symptoms; Anxiety Symptoms

Keywords

COVID-19; Corona; Postpandemic; Internet-based cognitive behavioral therapy (ICBT); Internet intervention; Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• Becks Depression Inventory-II

  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.

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

• Generalized Anxiety Disorder-7

  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.

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

Secondary Outcomes (10)

• Percieved Stress Scale-14

  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.

• Short Health Anxiety Inventory-14

  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.

• Karolinska Exhaustion Disorder Scale 9

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

Other Outcomes (1)

• Knowledge test

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

Study Arms (2)

Treatment group

EXPERIMENTAL

Eight weeks of individually tailored ICBT, were participants receives in total 8 modules out of 20 possible depending on their current problems and described situation with weekly support by a therapist.

Behavioral: Internet-based Cognitive Behavioral Therapy

Control group

NO INTERVENTION

The control group is a wait-list control condition. Participants are instructed to wait. After the treatment group has finished their treatment and post-treatment measures has been collected, the control group receive the same treatment as the treatment group got.

Interventions

Internet-based Cognitive Behavioral Therapy BEHAVIORAL

Intervention based on cognitive behavioural therapy principles and adapted to the coronavirus pandemic situation. The 20 modules that the intervention consists of include psycho-educational texts as well as examples and exercises.

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• years or older
• Adequate ability to speak, read and write in Swedish
• Having access to the internet and a smartphone, computer or other device

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Department of Behavioral Sciences and Learning, Linköping University

Linköping, Östergötland County, 58183, Sweden

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; COVID-19

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gerhard Andersson, PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: After recruitment finished, participants will be randomized to either intervention condition (treatment group) or control condition (wait list). Participants in the control group will receive the same treatment once the intervention group has finished the treatment and outcome measures has been collected.

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: December 19, 2022
• Study Start: February 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: June 9, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

SE (1)