Depression SymptomsPCCNCT05656430
ICBT for Psychological Symptoms Related to the COVID-19 Pandemic Remaining After Societal Opening
A study testing Internet-based Cognitive Behavioral Therapy in people with Depression Symptoms and Anxiety Symptoms, run by Linkoeping University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression Symptoms, Anxiety Symptoms
- What is being tested?
- Internet-based Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2023to 9 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Behavioral Sciences and Learning, Linköping University
Linköping, Östergötland County, 58183
About this study
Official title: Internet-based Cognitive Behavioral Therapy for Psychological Symptoms Related to the COVID-19 Pandemic Remaining After Societal Opening
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.
Read the 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.
- Conditions
- Depression Symptoms, Anxiety Symptoms
- Being tested
- Internet-based Cognitive Behavioral Therapy
- Keywords
- COVID-19, Corona, Postpandemic, Internet-based cognitive behavioral therapy (ICBT), Internet intervention, Depression, Anxiety
- Medical subject headings
- Depression, Anxiety Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based Cognitive Behavioral TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
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).
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
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.
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
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.
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
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.
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
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.
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
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.
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
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.
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
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.
Measured: 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
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.
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Feb 2023
- Primary completion30 Sep 2023
- Study completion9 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression SymptomsStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Gerhard Andersson, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656430
- Sponsor's protocol ID
- PostCoronaCope
- Acronym
- PCC
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2022
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Cognitive Behavioral Therapy for Psychological Symptoms Related to the COVID-19 Pandemic Remaining After Societal Opening
- ClinicalTrials.gov ID
- NCT05656430
- Acronym / sponsor ID
- PCC / PostCoronaCope
- Conditions
- Depression Symptoms, Anxiety Symptoms
- Keywords
- COVID-19, Corona, Postpandemic, Internet-based cognitive behavioral therapy (ICBT), Internet intervention, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 9 Jun 2025 (actual)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Internet-based Cognitive Behavioral TherapyEight 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based Cognitive Behavioral TherapyIntervention 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. | Behavioural | Treatment group |
Primary outcome
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.
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.
10 secondary outcomes
Percieved Stress Scale-14
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Insonnia Severity Index
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Short Health Anxiety Inventory-14
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Alcohol Use Disorder Identification Test
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Karolinska Exhaustion Disorder Scale 9
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Impact of Event Scale-6
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
UCLA loneliness scale 3
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Brunnsviken Brief Quality of Life Scale
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
The Cognitive Failures Questionnaire
Time frame: 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
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Andersson, PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based Cognitive Behavioral Therapy in people with Depression Symptoms and Anxiety Symptoms, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Becks Depression Inventory-II (time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.