Clinical trial NCT05656430: ICBT for Psychological Symptoms Related to the COVID-19 Pandemic Remaining After Societal Opening
Official title: Internet-based Cognitive Behavioral Therapy for Psychological Symptoms Related to the COVID-19 Pandemic Remaining After Societal Opening
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression Symptoms
Anxiety Symptoms
Keywords: COVID-19
Corona
Postpandemic
Internet-based cognitive behavioral therapy (ICBT)
Internet intervention
Depression
Anxiety
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2022-12-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Becks Depression Inventory-II
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Generalized Anxiety Disorder-7
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Secondary outcomes:
measure: Percieved Stress Scale-14
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Insonnia Severity Index
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Short Health Anxiety Inventory-14
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Alcohol Use Disorder Identification Test
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Karolinska Exhaustion Disorder Scale 9
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Impact of Event Scale-6
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: UCLA loneliness scale 3
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Brunnsviken Brief Quality of Life Scale
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: The Cognitive Failures Questionnaire
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: InCharge Financial Distress/Financial Well-Being Scale
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Other outcomes:
measure: Knowledge test
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Locations:
city: Linköping
country: Sweden
facility: Department of Behavioral Sciences and Learning, Linköping University
state: Östergötland
Study officials:
affiliation: Linkoeping University
name: Gerhard Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References: