ICBT for Mental Health Problems Related to the Climate Crisis

NCT05169736 | Unknown

• 1 other identifier: ClimateCope
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression and Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Change in Insomnia Severity Index

  Baseline, 8 weeks and follow-up at 12 months after treatment termination.

• Change in Patient Health Questionnaire

  Baseline, 8 weeks and follow-up at 12 months after treatment termination.

• Change in Alcohol Use Disorder Identification Test

  Baseline, 8 weeks and follow-up at 12 months after treatment termination.

• Change in ClimateCope Index (CCI)

  Baseline, 8 weeks and follow-up at 12 months after treatment termination

• Change in Brunnsviken Brief Quality of Life Scale

  Baseline, 8 weeks and follow-up at 12 months after treatment termination

Study Arms (2)

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.

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.

Interventions

Cognitive Behavioural Therapy BEHAVIORAL

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.

Internet-based Cognitive Behavior Therapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Department of Behavioral Sciences and Learning, Linköping University

Linköping, Östergötland County, 58183, Sweden

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gerhard Andersson

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerhard Andersson

CONTACT

+46709465357; gerhard.andersson@liu.se

Matilda Berg

CONTACT

matilda.lovisa.berg@gmail.com

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

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: December 27, 2021
• Study Start: February 7, 2022
• Primary Completion: June 27, 2024
• Study Completion: June 1, 2025
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

SE (1)