ICBT for Mental Health Problems Related to the Climate Crisis

June 26, 2023 updated by: Gerhard Andersson, Linkoeping University

Internet-based Cognitive Behavioural Therapy for Mental Health Problems Related to the Climate Crisis

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

Participants will be recruited in Sweden with a nationwide recruitment.

Study Overview

Status

Recruiting

Detailed Description

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 connected to the climate crisis, 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 directly or indirectly by the societal and individual consequences of the climate crisis.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Östergötland
      • Linköping, Östergötland, Sweden, 58183
        • Recruiting
        • Department of Behavioral Sciences and Learning, Linköping University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Experience mental health problems that are caused or exacerbated by the climate crisis 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet-based Cognitive Behavior Therapy
ICBT, were participants receive 8 out of 15 possible modules, depending on their current problems and needs, 8 week long internet intervention for coping with mental health issues related to the climate crisis.
Intervention based on cognitive behavioural therapy principles and adapted to mental health problems related to the climate crisis. Intervention's main purpose is to increase management of 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.
No Intervention: Wait-list control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Becks Depression Inventory-II
Time Frame: Baseline, 8 weeks and follow-up at 12 months after treatment termination
Measure of depressive symptoms. Possible range for the total sum: 0 to 63 (created by summing up the score from each item) 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.
Baseline, 8 weeks and follow-up at 12 months after treatment termination
Change in Perceived Stress Scale
Time Frame: Baseline, 8 weeks and follow-up at 12 months after treatment termination.
It is a measure of the degree to which situations in one's life are appraised as stressful. It contains 10 items that are scored on a range between 0 (never) to 4 (very often). The total score can range from 0-56 and a higher score reflects higher levels of perceived stress.
Baseline, 8 weeks and follow-up at 12 months after treatment termination.
Change in Generalised Anxiety Disorder 7-item scale
Time Frame: Baseline, 8 weeks and follow-up at 12 months after treatment termination.
Seven item measure of generalized anxiety disorder. Sum score range from 0 to 21, with higher scores indicating more generalized anxiety. Cut-offs for interpretation: 0-5 minimal anxiety, 6-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.
Baseline, 8 weeks and follow-up at 12 months after treatment termination.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Insomnia Severity Index
Time Frame: Baseline, 8 weeks and follow-up at 12 months after treatment termination.
Measure of insomnia severity and symptoms of disordered sleep. The total score can range between 0 (no sleep problems) to 28 (severe sleep problems and insomnia) with higher scores indicating severer levels of sleeping problems. 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).
Baseline, 8 weeks and follow-up at 12 months after treatment termination.
Change in Patient Health Questionnaire
Time Frame: Baseline, 8 weeks and follow-up at 12 months after treatment termination.
Measure of depressive symptoms. Possible range for the total sum: 0 to 27 (created by summing up the score from each item) with a higher score indicating higher levels of depression. Clinical cut-offs for mild, moderate, moderately severe and severe major depressive disorder are considered to be 5, 10, 15, and 20 points.
Baseline, 8 weeks and follow-up at 12 months after treatment termination.
Change in Alcohol Use Disorder Identification Test
Time Frame: Baseline, 8 weeks and follow-up at 12 months after treatment termination.
The Alcohol Use Disorders Identification Test is 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.
Baseline, 8 weeks and follow-up at 12 months after treatment termination.
Change in ClimateCope Index (CCI)
Time Frame: Baseline, 8 weeks and follow-up at 12 months after treatment termination
This scale was constructed by the research group, measuring coping strategies connected to the climate situations. It is a 33 item scale rating from 1 (not at all) to 5 (totally agree), with higher scores indicating more helpful coping strategies.
Baseline, 8 weeks and follow-up at 12 months after treatment termination
Change in Brunnsviken Brief Quality of Life Scale
Time Frame: Baseline, 8 weeks and follow-up at 12 months after treatment termination
Measure of quality of life, 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.
Baseline, 8 weeks and follow-up at 12 months after treatment termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gerhard Andersson, Linkoeping University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2022

Primary Completion (Estimated)

June 27, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

December 20, 2021

First Submitted That Met QC Criteria

December 22, 2021

First Posted (Actual)

December 27, 2021

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ClimateCope

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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