Depressive SymptomsNCT05673382
CrisisCope: ICBT for Psychological Symptoms Related to Life Crises.
A study testing Internet-based cognitive behavioral therapy in people with Depressive Symptoms and Anxiety Symptoms, run by Linkoeping University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Symptoms, Anxiety Symptoms
- What is being tested?
- Internet-based cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 19 Jan 2023to 24 Jun 2024
- 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 psychological symptoms related to one or more life crises.
- 18 years or older
- Adequate ability to speak, read and write Swedish
- Having access to the internet and a smartphone, computer or other device
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Behavioral Sciences and Learning, Linköping University
Linköping, Östergötland County, 58183
About this study
Official title: CrisisCope: Internet-based CBT Intervention for Distress Related to Life Crises.
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.
Read the detailed description
The study is a randomized controlled trial about the effects of ICBT aiming to target psychological symptoms related to one or more life crises. Primary outcome measures are depressive symptoms (measured with Beck Depression inventory-II) and anxiety symptoms (measured with Generalized Anxiety Disorder-7). Other outcome measures used will for example be about adaptability, stress symptoms, sleep problems, post traumatic stress symptoms and quality of life.
Because the psychological impact of a life crisis can be diverse, between different people and between different kinds of crises, a transdiagnostic individually tailored treatment will be used that has been tested in several previous trials. This treatment has been adopted to target psychological symptoms related to life crises.
- Conditions
- Depressive Symptoms, Anxiety Symptoms
- Being tested
- Internet-based cognitive behavioral therapy
- Keywords
- Life crises, Randomized controlled trial, Internet-based cognitive behavioral therapy (ICBT), Internet intervention, Depression, Anxiety
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based cognitive behavioral therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
A measure of general psychological adjustment, consisting of six items. The items are on a seven-point response scale with higher scores indicating lower general psychological adjustment.
Measured: 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
Measure of depressive symptoms. Possible range for the total sum is 0 to 27 (created by summing up the scores 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 respectively.
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Perceived Stress Scale-14
A questionnaire that aims to measure symptoms of stress. It contains of 14 items that are scored on a range between 0 (never) and 4 (very often). The total score range is between 0-56 and a higher score reflects higher levels of perceived stress.
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Insomnia Severity Index
Measure of insomnia severity and symptoms of disordered sleep. Norm score ranges include low likelihood of sleep problems (0-7 points), some sleep problems (8-14 points), moderate sleep problems (15-21 points), severe sleep problems (22-28 points).
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Alcohol Use Disorder Identification Test
A ten-item scoring tool to assess alcohol consumption, drinking behaviors, and alcohol-related problems. Scores are ranging from 0-40 with higher scores indicating a higher level of alcohol use.
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Impact of Events Scale-Revised
Assesses subjective distress caused by traumatic events.Items are rated on a five-point scale from 0 (not at all) to 4 (extremely). Total score range between 0-88, with a higher score indicating more severe distress caused by the traumatic events.
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Brunnsviken Brief Quality of Life Scale
Measure of quality of life with a total score ranging from 0 to 96 with a higher score indicating 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: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
InCharge Financial Distress/Financial Well-Being Scale
A measure aiming to measure distress related to the individual's economic situation. It consists of eight questions where the respondent gets to answer on a scale from 1 to 10.
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Medical Outcome Study Social Support Survey
A 12-item questionnaire aiming to measure the individual's perceived social support that is answered on a five-point scale (1-5). Besides the 12 items, the questionnaire also includes a question about how many family members and friends that the individual experience to have, who he/she can talk to. Total score range between 12 to 60.
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Posttraumatic Growths Inventory-Short form
A questionnaire consisting of 10 items, aiming to investigate the individual's experience of positive change in relation to challenging life events. Each item are answered on a six-point scale ranging between 0 to 5, resulting in a total score range between 0-60.
Measured: Change between baseline, end of treatment after eight 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 posted6 Jan 2023
- Study start19 Jan 2023
- Primary completion21 Apr 2023
- Study completion24 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies 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
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Gerhard Andersson, PhD, Principal investigator, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673382
- Sponsor's protocol ID
- CrisisCope
- Status last verified
- Apr 2023
- First submitted
- 4 Jan 2023
- Last updated
- 5 Oct 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 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CrisisCope: Internet-based CBT Intervention for Distress Related to Life Crises.
- ClinicalTrials.gov ID
- NCT05673382
- Acronym / sponsor ID
- CrisisCope
- Conditions
- Depressive Symptoms, Anxiety Symptoms
- Keywords
- Life crises, Randomized controlled trial, Internet-based cognitive behavioral therapy (ICBT), Internet intervention, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 24 Jun 2024 (estimated)
- First posted
- 6 Jan 2023 (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 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.
Detailed description
The study is a randomized controlled trial about the effects of ICBT aiming to target psychological symptoms related to one or more life crises. Primary outcome measures are depressive symptoms (measured with Beck Depression inventory-II) and anxiety symptoms (measured with Generalized Anxiety Disorder-7). Other outcome measures used will for example be about adaptability, stress symptoms, sleep problems, post traumatic stress symptoms and quality of life.
Because the psychological impact of a life crisis can be diverse, between different people and between different kinds of crises, a transdiagnostic individually tailored treatment will be used that has been tested in several previous trials. This treatment has been adopted to target psychological symptoms related to life crises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Internet-based cognitive behavioral therapyEight 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Experience psychological symptoms related to one or more life crises.
- 18 years or older
- Adequate ability to speak, read and write Swedish
- Having access to the internet and a smartphone, computer or other device
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Internet-based cognitive behavioral therapyThe 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. | Behavioural | Treatment group |
Primary outcome
Beck Depression Inventory-II
Time frame: Change between Baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
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.
Generalized Anxiety Disorder-7
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
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
10 secondary outcomes
Brief Adjustment Scale-6
Time frame: 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
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Perceived Stress Scale-14
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Insomnia Severity Index
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Alcohol Use Disorder Identification Test
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Impact of Events Scale-Revised
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Brunnsviken Brief Quality of Life Scale
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
InCharge Financial Distress/Financial Well-Being Scale
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Medical Outcome Study Social Support Survey
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Posttraumatic Growths Inventory-Short form
Time frame: Change between baseline, end of treatment after eight 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 5 Oct 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.
Gerhard Andersson, PhD principal investigator
University Hospital, Linkoeping
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based cognitive behavioral therapy in people with Depressive Symptoms and Anxiety Symptoms, 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 4 inclusion and 5 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 5 Oct 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory-II (time frame: Change between Baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.). The study lists 2 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 5 Oct 2023.