ICBT for Mental Health Problems Related to the Coronavirus Pandemic

NCT ID: NCT04424212

Last Updated: 2022-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-10

Study Completion Date

2021-10-01

Brief Summary

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The study seeks to investigate the effects of a guided internet-based cognitive behavioral therapy (ICBT) programme a on adult mental health problems related to the current coronavirus pandemic. ICBT will be compared to a wait-list control group.

Participants will be recruited in Sweden with a nationwide recruitment.

Detailed Description

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The study is set up as a randomized controlled trial. Quality of life, depressive symptoms, anxiety, sleep problems and traumatic stress will be measured. Given uncertainties regarding the psychological effects of Covid-19 pandemic a transproblematic tailored treatment approach will be used that has been tested in several previous trials. However, the present program has been adapted for the target population of people who are affected by the societal and individual consequences of the pandemic. The study does not focus on people who have or have had the corona virus.

Conditions

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Depression and Quality of Life Related to the Coronavirus Pandemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly allocated to either control or intervention group. Participants in the control group will receive the same treatment once the intervention group has finished the treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental: Intervention group CoronaCope

ICBT, were participants receive 8 out of 15 possible modules depending on their current problems and needs, 7 week long internet intervention for reducing mental health issues related to the coronavirus pandemic.

Group Type EXPERIMENTAL

Intervention group CoronaCope

Intervention Type BEHAVIORAL

Intervention based on cognitive behavioural therapy principles and adapted to the coronavirus pandemic situation. Intervention's main purpose is to mental health issues such as depressive symtoms, stress, worry and anxiety related to the coronavirus pandemic and increase quality of life in the current situation. Intervention contains psycho-educational elements as well as examples and exercises.

Control group

Participants in the control group will be instructed to wait. Once intervention group will be finished, participants in control group will be able to access the same intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intervention group CoronaCope

Intervention based on cognitive behavioural therapy principles and adapted to the coronavirus pandemic situation. Intervention's main purpose is to mental health issues such as depressive symtoms, stress, worry and anxiety related to the coronavirus pandemic and increase quality of life in the current situation. Intervention contains psycho-educational elements as well as examples and exercises.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Experience mental health problems that are caused or exacerbated by the corona pandemic and/or its consequences
* 18 years or older.
* Adequate ability to understand and speak Swedish.
* Access to the internet and a smartphone/computer.

Exclusion Criteria

* Other ongoing psychological treatment or counselling that interfere with trial treatment.
* Recent (within the past 3 months) changes in the dose of psychotropic medication.
* Any severe psychiatric or somatic conditions that would interfere with trial treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Gerhard Andersson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerhard Andersson, PhD

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Locations

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Linköping University

Linköping, Östergötland County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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CoronaCope

Identifier Type: -

Identifier Source: org_study_id

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