Generalized Anxiety DisorderORIGAMINCT05820568
Internet Delivered Cognitive Behavior Therapy Based on Intolerance of Uncertainty
A study testing ICBT-IU in people with Generalized Anxiety Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The goal of this clinical is to pilot test an internet delivered cognitive behavior therapy (ICBT) based on intolerance of uncertainty (one of several existing specific cognitive models for how worry works) in treating generalised anxiety disorder (GAD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- ICBT-IU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSweden
- Study dates
- 2 Nov 2022to 22 May 2023
- 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
- 18 years old or more.
- Diagnosis of GAD based on clinical assessment.
- At least 10 points on GAD-7 at screening.
- Proficient in written Swedish.
- Access to internet enabled device and Swedish BankID for authentication
- Able to make sufficient time for the 10 week long treatment
- Consents to study
Who cannot join
- In need of treatment for other psychiatric diagnosis as priority (eg depression, psychosis) or high risk of suicide based on clinical assessment
- Ongoing risk use of alcohol or drugs
- Ongoing serious somatic of social disease/problem that is deemed to be to much of a hindrance for the completion of the treatment
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Internet Psychiatry Clinic, Psychiatry Southwest, SLSO, Region Stockholm
Stockholm, Huddinge, 14135
About this study
Official title: Effects and Mechanisms of Change of Two Different Treatments Targeting Worry in Generalised Anxiety Disorder: Study 1 - IU Pilot
The goal of this clinical is to pilot test an internet delivered cognitive behavior therapy (ICBT) based on intolerance of uncertainty (one of several existing specific cognitive models for how worry works) in treating generalised anxiety disorder (GAD). The main aims is to:
- Test the preliminary effect of the intervention in lowering symptoms of GAD as measured by the self report scale GAD-7
- Test procedures for recruitment, assessment, treatment and follow up
- Test the acceptability of the intervention as measured by the Client Satisfaction questionnaire-8, dropout and adverse events
Participants will apply for treatment in an online system, be assessed via video by a licensed clinical psychologist and then receive a 10 week long ICBT intervention based on the intolerance of uncertainty model. This is a pilot study for an upcoming randomized controlled trial.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- ICBT-IU
- Keywords
- internet delivered treatment, digital mental health services, psychiatry, cognitive behavior therapy, intolerance of uncertainty
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICBT-IUBehavioural
Internet delivered Cognitive Behavior Therapy for Generalized Anxiety Disorder based on the Intolerance of uncertainty model of worry
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients receiving ICBT-IU Receives: Behavioral: ICBT-IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized Anxiety Disorder 7-item (GAD7)
Symptoms of generalized anxiety disorder measured by the self report measure GAD7. Scores range from 0-21 with higher scores indicating more generalized anxiety
Measured: 10 weeks after treatment start
Secondary outcomes (7)
Treatment credibility
A version of the credibility expectancy questionnaire used at the Internet Psychiatry Clinic in Sweden. Scores range from 5 to 50 with higher scores indicating more credibility.
Measured: 2 weeks into treatment
Satisfaction with treatment
Client Satisfaction Questionnaire 8 item version (CSQ8). Scores range from 8 to 32; scores of 8-13 indicate poor satisfaction, 14-19 fair satisfaction, 20-25 good satisfaction, and 26-32 excellent satisfaction.
Measured: 10 weeks after treatment start
Symptoms of depression including suicidal ideation
Measured with the Montgomery Åsberg Depression Rating Scale- Self report (MADRS-S). Scores range from 0-54 with higher scores indicating more depression
Measured: 10 weeks after treatment start
Intolerance of uncertainty
Measured with the Intolerance of Uncertainty Scale short version (IUS-12). Scores range from 12-60 with higher scores indicating more intolerance of uncertainty.
Measured: 10 weeks after treatment start
Excessive worry
Measured with the Penn State Worry Questionnaore (PSWQ). Scores range from 16-80 points with more points indicating more worry
Measured: 10 weeks after treatment start
Symptoms of depression
Measured with the Patient Health Questionnaire-9 item self report measure (PHQ9).The scale range is 0-27 with higher scores indication more depression.
Measured: 10 weeks after treatment start
WHO Disability Assessment Schedule (WHODAS 2.0) self report (12 items)
A health and disability metric developed by WHO. Scores range from 0-100% and represent the level of disability with 100% being complete disability to function in everyday life.
Measured: 10 weeks after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start2 Nov 2022
- Primary completion22 May 2023
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Erik Forsell, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820568
- Sponsor's protocol ID
- 2022-02380-01-Pilot
- Acronym
- ORIGAMI
- Status last verified
- Sep 2023
- First submitted
- 8 Dec 2022
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanisms of Change of Two Different Treatments Targeting Worry in Generalised Anxiety Disorder: Study 1 - IU Pilot
- ClinicalTrials.gov ID
- NCT05820568
- Acronym / sponsor ID
- ORIGAMI / 2022-02380-01-Pilot
- Conditions
- Generalized Anxiety Disorder
- Keywords
- internet delivered treatment, digital mental health services, psychiatry, cognitive behavior therapy, intolerance of uncertainty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 19 Apr 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 goal of this clinical is to pilot test an internet delivered cognitive behavior therapy (ICBT) based on intolerance of uncertainty (one of several existing specific cognitive models for how worry works) in treating generalised anxiety disorder (GAD). The main aims is to:
- Test the preliminary effect of the intervention in lowering symptoms of GAD as measured by the self report scale GAD-7
- Test procedures for recruitment, assessment, treatment and follow up
- Test the acceptability of the intervention as measured by the Client Satisfaction questionnaire-8, dropout and adverse events
Participants will apply for treatment in an online system, be assessed via video by a licensed clinical psychologist and then receive a 10 week long ICBT intervention based on the intolerance of uncertainty model. This is a pilot study for an upcoming randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: ICBT-IUPatients receiving ICBT-IU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years old or more.
- Diagnosis of GAD based on clinical assessment.
- At least 10 points on GAD-7 at screening.
- Proficient in written Swedish.
- Access to internet enabled device and Swedish BankID for authentication
Key exclusion criteria (3 listed)
- In need of treatment for other psychiatric diagnosis as priority (eg depression, psychosis) or high risk of suicide based on clinical assessment
- Ongoing risk use of alcohol or drugs
- Ongoing serious somatic of social disease/problem that is deemed to be to much of a hindrance for the completion of the 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 |
|---|---|---|
| ICBT-IUInternet delivered Cognitive Behavior Therapy for Generalized Anxiety Disorder based on the Intolerance of uncertainty model of worry | Behavioural | Treatment |
Primary outcome
Generalized Anxiety Disorder 7-item (GAD7)
Time frame: 10 weeks after treatment start
Symptoms of generalized anxiety disorder measured by the self report measure GAD7. Scores range from 0-21 with higher scores indicating more generalized anxiety
7 secondary outcomes
Treatment credibility
Time frame: 2 weeks into treatment
Satisfaction with treatment
Time frame: 10 weeks after treatment start
Symptoms of depression including suicidal ideation
Time frame: 10 weeks after treatment start
Intolerance of uncertainty
Time frame: 10 weeks after treatment start
Excessive worry
Time frame: 10 weeks after treatment start
Symptoms of depression
Time frame: 10 weeks after treatment start
WHO Disability Assessment Schedule (WHODAS 2.0) self report (12 items)
Time frame: 10 weeks after treatment start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Generalized Anxiety Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Active, not recruitingObservational study
BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders
Generalized Anxiety Disorder, Oxygenation Sensitive CMR
RecruitingPhase 3
A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)
Generalized Anxiety Disorder
RecruitingPhase 3
A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment
Generalized Anxiety Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICBT-IU in people with Generalized Anxiety Disorder, run by Karolinska Institutet 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 7 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: finished, as of the sponsor's last update on 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Generalized Anxiety Disorder 7-item (GAD7) (time frame: 10 weeks after treatment start). 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 2 Oct 2023.