ICBT for Mental Health Problems Related to the Climate Crisis

Study Overview
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Brief Summary
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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.

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 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.

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

Conditions
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Depression and Quality of Life

Intervention / Treatment
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* Behavioral: Cognitive Behavioural Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based Cognitive Behavior Therapy<br>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. | Behavioral: Cognitive Behavioural Therapy<br>* 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.<br>|
| No Intervention: Wait-list control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Becks Depression Inventory-II | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 |