CrisisCope: ICBT for Psychological Symptoms Related to Life Crises.

NCT ID: NCT05673382

Last Updated: 2023-10-05

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-19

Study Completion Date

2024-06-24

Brief Summary

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The aim with this study is to investigate the effects of internet-based cognitive behavioral therapy (ICBT) on psychological symptoms related to one or more life crises. The target group is adults (18 years or older) who have symptoms of depression, anxiety, stress, or other psychological distress related to one or more life crises. The ICBT consists of eight modules during eight weeks with weekly support by a therapist and the treatment group will be compared to a wait-list control condition. Participants will be recruited in Sweden with nationwide recruitment.

Detailed Description

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The study is a randomized controlled trial about the effects of ICBT aiming to target psychological symptoms related to one or more life crises. Primary outcome measures are depressive 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 adaptability, stress symptoms, sleep problems, post traumatic stress symptoms and quality of life.

Because the psychological impact of a life crisis can be diverse, between different people and between different kinds of crises, a transdiagnostic individually tailored treatment will be used that has been tested in several previous trials. This treatment has been adopted to target psychological symptoms related to life crises.

Conditions

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Depressive Symptoms Anxiety Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

After recruitment finished, participants will be randomized to either intervention condition (treatment group) or control condition (wait-list). Participants in the control condition will receive the same treatment once the treatment group has finished the treatment and outcome measures has been collected from both groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

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.

Group Type EXPERIMENTAL

Internet-based cognitive behavioral therapy

Intervention Type BEHAVIORAL

The intervention (the treatment) within this study is based on cognitive behavioral therapy principles and adapted to target psychological symptoms related to life crises. The 20 modules that the intervention consists of include psycho-educational texts as well as examples and exercises.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Internet-based cognitive behavioral therapy

The intervention (the treatment) within this study is based on cognitive behavioral therapy principles and adapted to target psychological symptoms related to life crises. The 20 modules that the intervention consists of include psycho-educational texts as well as examples and exercises.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Experience psychological symptoms related to one or more life crises.
* 18 years or older
* Adequate ability to speak, read and write 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
* Ongoing addiction
* Acute suicidality
* Other ongoing psychological treatment
* Recent (within the past three months) changes in dose of psychotropic medication or planned change during the treatment weeks
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

University Hospital, Linkoeping

Locations

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Department of Behavioral Sciences and Learning, Linköping University

Linköping, Östergötland County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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CrisisCope

Identifier Type: -

Identifier Source: org_study_id

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