CrisisCope: ICBT for Psychological Symptoms Related to Life Crises.

NCT05673382 | Unknown

• 1 other identifier: CrisisCope
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depressive Symptoms; Anxiety Symptoms

Keywords

Life crises; Randomized controlled trial; Internet-based cognitive behavioral therapy (ICBT); Internet intervention; Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• Beck Depression Inventory-II

  Measure of depressive symptoms. Range for the total sum is between 0 and 63 with a higher score 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, 14-19, 20-28, and 29-63 respectively.

  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

  Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.

Secondary Outcomes (10)

• Brief Adjustment Scale-6

  Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination. Also, every week during the treatment weeks.

• Patient Health Questionnaire-9

  Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.

• Perceived Stress Scale-14

  Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.

• Insomnia Severity Index

  Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.

• Alcohol Use Disorder Identification Test

  Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.

Study Arms (2)

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.

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.

Interventions

Internet-based cognitive behavioral therapy 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.

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Experience psychological symptoms related to one or more life crises.
• years or older
• Adequate ability to speak, read and write Swedish
• Having access to the internet and a smartphone, computer or other device

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Department of Behavioral Sciences and Learning, Linköping University

Linköping, Östergötland County, 58183, Sweden

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Gerhard Andersson, PhD

  University Hospital, Linkoeping

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 6, 2023
• Study Start: January 19, 2023
• Primary Completion: April 21, 2023
• Study Completion: June 24, 2024
• Last Updated: October 5, 2023

Record last verified: 2023-04

Locations

SE (1)