Depression and Quality of LifeNCT05169736
ICBT for Mental Health Problems Related to the Climate Crisis
A study testing Cognitive Behavioural Therapy in people with Depression and Quality of Life, run by Linkoeping University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression and Quality of Life
- What is being tested?
- Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 7 Feb 2022to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Matilda Berg contact
Sweden1 site, 1 recruiting
- Recruiting
Department of Behavioral Sciences and Learning, Linköping University
Linköping, Östergötland County, 58183
Gerhard Andersson, PhD, +4613285840, gerhard.andersson@liu.se
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression and Quality of Life
- Being tested
- Cognitive Behavioural Therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based Cognitive Behavior Therapy | Experimental | 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. Receives: Behavioral: Cognitive Behavioural Therapy |
| Wait-list control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 8 weeks and follow-up at 12 months after treatment termination.
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 8 weeks and follow-up at 12 months after treatment termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start7 Feb 2022
- Primary completion27 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression and Quality of LifeStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Gerhard Andersson, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169736
- Sponsor's protocol ID
- ClimateCope
- Status last verified
- Jun 2023
- First submitted
- 20 Dec 2021
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Cognitive Behavioural Therapy for Mental Health Problems Related to the Climate Crisis
- ClinicalTrials.gov ID
- NCT05169736
- Acronym / sponsor ID
- ClimateCope
- Conditions
- Depression and Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 27 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based Cognitive Behavior Therapy | Experimental | Behavioral: Cognitive Behavioural TherapyICBT, 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. |
| Wait-list control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural TherapyIntervention 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. | Behavioural | Internet-based Cognitive Behavior Therapy |
Primary outcome
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.
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.
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.
5 secondary outcomes
Change in Insomnia Severity Index
Time frame: 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.
Change in Alcohol Use Disorder Identification Test
Time frame: 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
Change in Brunnsviken Brief Quality of Life Scale
Time frame: Baseline, 8 weeks and follow-up at 12 months after treatment termination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matilda Berg contact
Gerhard Andersson principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy in people with Depression and Quality of Life, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Andersson (+46709465357, gerhard.andersson@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Becks Depression Inventory-II (time frame: Baseline, 8 weeks and follow-up at 12 months after treatment termination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.