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

Anxiety Symptoms Clinical Trial

— PCC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05656430
• Other study ID #: PostCoronaCope
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 30, 2026

Study information

• Verified date: April 2023
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 30, 2026
• Est. primary completion date: December 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Symptoms
• COVID-19
• Depression
• Depression Symptoms

Intervention

Behavioral:
• Internet-based Cognitive Behavioral Therapy
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.

Locations

Country	Name	City	State
Sweden	Department of Behavioral Sciences and Learning, Linköping University	Linköping	Östergötland

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Knowledge test	Knowledge test about cognitive behavior therapy and how strategies in cognitive behavior therapy can be applied in every day situations. It consists of 16 questions and the respondent gets three answer options while one of the alternatives are correct. The respondent also gets to answer how confident he/she is about the answer (I'm guessing, I'm pretty certain, I'm quite certain).	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Primary	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.
Primary	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	Percieved Stress Scale-14	A questionnaire that aims to measure symptoms of stress. I contains 14 items that are scored on a range betewwn 0 (never) to 4 (very often). The total score range is between 0-56 and a higher score reflects higher levels of perceived stress.	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Secondary	Insonnia Severity Index	Measure of insomnia severity and symptoms of disordered sleep. 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, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Secondary	Short Health Anxiety Inventory-14	Measure of health anxiety, short version, with 14 items which are answered on a scale 0-3. This gives a total scare range of 0-42, where 0-14 indicate low probability of health anxiety, 15-17 is a grey zone and points over 18 indicates high probability for health anxiety.	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Secondary	Alcohol Use Disorder Identification Test	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, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Secondary	Karolinska Exhaustion Disorder Scale 9	A questionnaire aiming to measure fatigue and exhaustion. Maximum score is 54 and people scoring higher than 18 points are considered as being at risk for exhaustion syndrome.	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Secondary	Impact of Event Scale-6	A short version of Impact of Event Scale-R (IES-R), which assesses subjective distress caused by potentially traumatic events. It yields a total score between 0-24 with a higher score indicating more severe distress caused by the traumatic events.	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Secondary	UCLA loneliness scale 3	A short version of the UCLA loneliness scale, aiming to measure with three questions, for example "How often do you feel left out?" and are answered on a scale ranging from 1 (hardly ever) to 3 (often). People who gets the score 3-5 have been grouped as not lonely, while score 6-9 has been grouped as lonely.	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Secondary	Brunnsviken Brief Quality of Life Scale	Measure of quality of life with a 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, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Secondary	The Cognitive Failures Questionnaire	The measure contains 25 questions and are aiming to measure the experience of the frequency of misstakes one does in the every day life because of problems with attention, memory, and emotion regulation. Maximum score are 100, where higher score mirrors experienced problems to a greater extent.	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Secondary	InCharge Financial Distress/Financial Well-Being Scale	A measure aiming to measure distress related to the individual's economic situation. It contains of eight questions where the respondent gets to answer on a scale from 1 to 10.	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.