Generalized Anxiety Disorder (GAD)ORIGAMINCT07201844
The Effect of Patient Preference for Treatment Model in Internet Delivered Cognitive Behavior Therapy for Generalized Anxiety Disorder
A study testing Metacognitive Internet delivered Cognitive Behavior Therapy and Intolerance of uncertainty based Internet delivered Cognitive Behavior Therapy in people with Generalized Anxiety Disorder (GAD), run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The goal of this clinical trial is to investigate the effect of allowing patients to choose between two internet-based cognitive behavioral treatments (ICBT) for generalized 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 (GAD)
- What is being tested?
- Metacognitive Internet delivered Cognitive Behavior Therapy and Intolerance of uncertainty based Internet delivered Cognitive Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteSweden
- Study dates
- 26 Aug 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 or older.
- Meet diagnostic criteria for GAD according to DSM-5, as assessed by a psychologist on a video-call.
- Self-rated score ≥ 7 on GAD-7.
- Can read and speak Swedish fluently.
- Have access to a smartphone, tablet, or computer and a Swedish BankID which allows access to the video-calls and treatment platform.
- Have the time and possibility to participate in the 10 week treatment.
- Consents to participate.
Who cannot join
- Patients that are judged to be in greater need of another psychiatric treatment for another psychiatric diagnosis (for example severe depression) and/or is judged to have a high risk of suicide.
- Current drug or alcohol abuse.
- Current severe somatic health concern or social vulnerability if this is judged to be too great an obstacle for the patient to carry out the treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Internet Psychiatry Clinic, Psychiatry Southwest, SLSO, Region Stockholm, Stockholm, Huddinge 14135
Stockholm, Sverige, 14132
Erik Forsell, PhD, +46704903681, erik.g.s.forsell@gmail.com
Nathalie Lybert, MSc
About this study
Official title: ORIGAMI: Internetbaserad Behandling för GAD. Effekten av Att få välja Behandling själv Samtbehandlarens förmåga Att Matcha Patienter Till rätt Behandling. En Randomiserad kontrolleradprövning.
The goal of this clinical trial is to investigate the effect of allowing patients to choose between two internet-based cognitive behavioral treatments (ICBT) for generalized anxiety disorder (GAD). The goal is also to examine psychologists' ability to predict which of the two treatments the patient will benefit most from.
The main questions it aims to answer are:
Read more
- Do patients who are randomized to choose their treatment improve more in their GAD symptoms compared to patients who are randomly assigned to a treatment?
- Does allowing patients to choose their treatment increase treatment adherence, compared to being randomly assigned to a treatment?
- Does allowing patients to choose their treatment increase treatment satisfaction and credibility, compared to being randomly assigned to a treatment?
- Does allowing patients to choose their treatment increase patients' sense of agency related to the treatment process, compared to being randomly assigned to a treatment?
- Do patients who receive a treatment that matches the psychologist's prediction of which treatment would fit the patient best show better treatment outcomes (primarily reduction in GAD symptoms over time, but also secondary outcomes such as satisfaction), compared to patients who receive a treatment that does not match the psychologist's prediction?
Participants included in the trial will be randomized to one of two conditions: 1) read short descriptions of the two treatment programs and based on that choose the preferred treatment, 2) randomly being allocated to one of the two treatments. The two internet-based treatment programs which the patients can choose between or be randomly allocated to are: 1) Intolerance of uncertainty-based ICBT and 2) Metacognition-based ICBT. Both programs consist of 8 treatment modules and run for 10 weeks. Patients in both conditions receive continuous support by a psychologist through a built-in message function on the treatment platform. The patient will receive feedback from the psychologist on their assignments and exercises and the psychologist will respond to the participants' messages.
Read the detailed description
A randomized trial will be conducted within the Internet Psychiatry Clinic in Stockholm. An option will be added to the online sign-up form giving potential patients the option to participate in a treatment for GAD as part of this study. Based on information provided in the sign-up-form and an assessment via video-call with a psychologist, patients will be included/excluded.
Included patients will be randomized (2:1:1) to either 1) read short descriptions of the two treatment programs and based on that choose the preferred treatment or 2) being randomly assigned to one of the two treatments. In both conditions, a psychologist will make a prediction regarding which of the two treatments the patient will benefit most from, based on their clinical assessment of the patient. The treatment effect for patients who were either randomly assigned to, or chose, a treatment that matches the psychologist's prediction will be compared with the treatment effect for patients who were either randomly assigned to, or chose, a treatment that does not match the psychologist's prediction.
The two internet-based treatment programs which the patients can choose between or be randomly allocated to are: 1) Intolerance of uncertainty-based ICBT and 2) Metacognition-based ICBT. These programs will be conducted as part of regular care at the Internet Psychiatry Clinic in Stockholm, meaning that each patient will undergo the regular assessment process at the clinic. Both programs are ICBT programs of similar scope, consisting of 8 modules to be completed during 10 weeks. During this time patients read written material which instructs them to do specific exercises and answer specific questions. The patient can message a psychologist at the clinic via a built-in message function on the treatment platform.
Primary outcome to assess treatment effect in this study is change in GAD-symptoms (measured with GAD-7) from pre-treatment to post-treatment. Secondary outcome measures to assess treatment effect is patients' satisfaction with the treatment program post-treatment (measured with Client satisfaction questionnaire), how credible the patient consider the treatment program to be (measured with Treatment Credibility Questionnaire 2 weeks after treatment start) and patients' sense of agency related to their treatment process (measured with Therapeutic Agency Inventory 4 weeks after treatment start). Patients' adherence to the treatment program will be assessed by the number of completed modules by the end of treatment.
A power analysis has shown that n=200 in each arm gives at least 80% power to detect a minimally clinically significant effect of d=.24. Based on similar treatments at the Internet Psychiatry Clinic the investigators expect around 10% drop-out meaning that the aim is to include 440 patients in total to get 200 in each arm.
Hypothesis 1: Patients who are allowed to choose their preferred treatment will exhibit a greater treatment effect (specified above) compared to patients who are randomly assigned to a treatment.
Hypothesis 2: Patients will 1) have a higher sense of agency in their treatment process, 2) be more satisfied with the treatment, 3) be more adherent to the treatment and 4) will rate the treatment as more credible if they themselves get to choose treatment compared to random assignment.
Hypothesis 3: Patients who receive a treatment that matches the psychologist's prediction will exhibit a greater treatment effect (specified above), compared to patients who receive a treatment that does not match the psychologist's prediction.
- Conditions
- Generalized Anxiety Disorder (GAD)
- Being tested
- Metacognitive Internet delivered Cognitive Behavior Therapy, Intolerance of uncertainty based Internet delivered Cognitive Behavior Therapy
- Keywords
- Internet interventions, Digital mental health services, cognitive behaviour therapy, patient preferences, psychiatry
- Medical subject headings
- Generalized Anxiety Disorder, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive Internet delivered Cognitive Behavior TherapyBehavioural
Specialist Guided Internet delivered Cognitive Behavior Therapy based on the metacognitive model of excessive worry
Intolerance of uncertainty based Internet delivered Cognitive Behavior TherapyBehavioural
Specialist Guided Internet delivered Cognitive Behavior Therapy based on the Intolerance of uncertainty model of excessive worry
| Study group | Role | What they receive |
|---|---|---|
| Treatment choice | Experimental | Patients have been randomized to getting to read about and then choose one of the two treatments Receives: Behavioral: Metacognitive Internet delivered Cognitive Behavior Therapy; Behavioral: Intolerance of uncertainty based Internet delivered Cognitive Behavior Therapy |
| Random assignment to treatment | Experimental | Patients have been directly randomized into one of the two treatments Receives: Behavioral: Metacognitive Internet delivered Cognitive Behavior Therapy; Behavioral: Intolerance of uncertainty based Internet delivered Cognitive Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Generalized Anxiety Disorder - score (GAD-7)
Measures generalized anxiety symptoms. 7 items. Scores range from 0-21 with higher scores indicating more generalized anxiety
Measured: Measured weakly from treatment start (pre-treatment) to 10 weeks after treatment start (post-treatment).
Secondary outcomes (7)
Therapeutic Agency Inventory (adapted to the clinic)
Measures patients' sense of agency related to their treatment process. 15 items. Scores range from 0-75 with higher scores indicating a higher degree of agency.
Measured: 4 weeks after treatment start.
Penn-State Worry Questionnaire (PSWQ)
Measures trait worry. 16 items. Scores range from 16-80 with higher scores indicating more worry.
Measured: At start of treatment (pre-treatment) and at 10 weeks after treatment start (post-treatment).
Client satisfaction questionnaire (adapted to the clinic)
Measures satisfaction with treatment. 8 items. Scores range from 8-32 with higher scores indicating more satisfaction with the treatment.
Measured: 10 weeks after treatment start (post-treatment).
Treatment Credibility Questionnaire (adapted to the clinic)
Measures treatment rationale credibility. 5 items. Scores range from 0-50 with higher scores indicating higher treatment credibility.
Measured: 2 weeks after treatment start.
Montomery-Asberg Depression Rating Scale - Self-rated (MADRS-S)
Measures depression symptoms. 9 items. Scores range from 0 to 54 with higher scores indicating more depression symptoms.
Measured: Measured weakly from treatment start (pre-treatment) to 10 weeks after treatment start (post-treatment).
Patient Health Questionnaire-9 (PHQ-9)
Measures depression symptoms. 9 items. Scores range from 0-27 with higher scores indicating more depressive symptoms.
Measured: At start of treatment (pre-treatment) and at 10 weeks after treatment start (post-treatment).
World Health Organization Disability Assessment Schedule 2.0
Measures disability/functional impairment. 12 items. Scores range from 0-48 with higher scores indicating a higher degree of impairment.
Measured: At start of treatment (pre-treatment) and at 10 weeks after treatment start (post-treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start26 Aug 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety Disorder (GAD)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Forsell, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201844
- Sponsor's protocol ID
- 2025-03553-01 RCT2
- Other IDs
- 2025
- Acronym
- ORIGAMI
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All IPD will be confidential patient records and as such are not shareable.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORIGAMI: Internetbaserad Behandling för GAD. Effekten av Att få välja Behandling själv Samtbehandlarens förmåga Att Matcha Patienter Till rätt Behandling. En Randomiserad kontrolleradprövning.
- ClinicalTrials.gov ID
- NCT07201844
- Acronym / sponsor ID
- ORIGAMI / 2025-03553-01 RCT2
- Conditions
- Generalized Anxiety Disorder (GAD)
- Keywords
- Internet interventions, Digital mental health services, cognitive behaviour therapy, patient preferences, psychiatry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 1 Oct 2025 (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 trial is to investigate the effect of allowing patients to choose between two internet-based cognitive behavioral treatments (ICBT) for generalized anxiety disorder (GAD). The goal is also to examine psychologists' ability to predict which of the two treatments the patient will benefit most from.
The main questions it aims to answer are:
- Do patients who are randomized to choose their treatment improve more in their GAD symptoms compared to patients who are randomly assigned to a treatment?
- Does allowing patients to choose their treatment increase treatment adherence, compared to being randomly assigned to a treatment?
- Does allowing patients to choose their treatment increase treatment satisfaction and credibility, compared to being randomly assigned to a treatment?
- Does allowing patients to choose their treatment increase patients' sense of agency related to the treatment process, compared to being randomly assigned to a treatment?
- Do patients who receive a treatment that matches the psychologist's prediction of which treatment would fit the patient best show better treatment outcomes (primarily reduction in GAD symptoms over time, but also secondary outcomes such as satisfaction), compared to patients who receive a treatment that does not match the psychologist's prediction?
Participants included in the trial will be randomized to one of two conditions: 1) read short descriptions of the two treatment programs and based on that choose the preferred treatment, 2) randomly being allocated to one of the two treatments. The two internet-based treatment programs which the patients can choose between or be randomly allocated to are: 1) Intolerance of uncertainty-based ICBT and 2) Metacognition-based ICBT. Both programs consist of 8 treatment modules and run for 10 weeks. Patients in both conditions receive continuous support by a psychologist through a built-in message function on the treatment platform. The patient will receive feedback from the psychologist on their assignments and exercises and the psychologist will respond to the participants' messages.
Detailed description
A randomized trial will be conducted within the Internet Psychiatry Clinic in Stockholm. An option will be added to the online sign-up form giving potential patients the option to participate in a treatment for GAD as part of this study. Based on information provided in the sign-up-form and an assessment via video-call with a psychologist, patients will be included/excluded.
Included patients will be randomized (2:1:1) to either 1) read short descriptions of the two treatment programs and based on that choose the preferred treatment or 2) being randomly assigned to one of the two treatments. In both conditions, a psychologist will make a prediction regarding which of the two treatments the patient will benefit most from, based on their clinical assessment of the patient. The treatment effect for patients who were either randomly assigned to, or chose, a treatment that matches the psychologist's prediction will be compared with the treatment effect for patients who were either randomly assigned to, or chose, a treatment that does not match the psychologist's prediction.
The two internet-based treatment programs which the patients can choose between or be randomly allocated to are: 1) Intolerance of uncertainty-based ICBT and 2) Metacognition-based ICBT. These programs will be conducted as part of regular care at the Internet Psychiatry Clinic in Stockholm, meaning that each patient will undergo the regular assessment process at the clinic. Both programs are ICBT programs of similar scope, consisting of 8 modules to be completed during 10 weeks. During this time patients read written material which instructs them to do specific exercises and answer specific questions. The patient can message a psychologist at the clinic via a built-in message function on the treatment platform.
Primary outcome to assess treatment effect in this study is change in GAD-symptoms (measured with GAD-7) from pre-treatment to post-treatment. Secondary outcome measures to assess treatment effect is patients' satisfaction with the treatment program post-treatment (measured with Client satisfaction questionnaire), how credible the patient consider the treatment program to be (measured with Treatment Credibility Questionnaire 2 weeks after treatment start) and patients' sense of agency related to their treatment process (measured with Therapeutic Agency Inventory 4 weeks after treatment start). Patients' adherence to the treatment program will be assessed by the number of completed modules by the end of treatment.
A power analysis has shown that n=200 in each arm gives at least 80% power to detect a minimally clinically significant effect of d=.24. Based on similar treatments at the Internet Psychiatry Clinic the investigators expect around 10% drop-out meaning that the aim is to include 440 patients in total to get 200 in each arm.
Hypothesis 1: Patients who are allowed to choose their preferred treatment will exhibit a greater treatment effect (specified above) compared to patients who are randomly assigned to a treatment.
Hypothesis 2: Patients will 1) have a higher sense of agency in their treatment process, 2) be more satisfied with the treatment, 3) be more adherent to the treatment and 4) will rate the treatment as more credible if they themselves get to choose treatment compared to random assignment.
Hypothesis 3: Patients who receive a treatment that matches the psychologist's prediction will exhibit a greater treatment effect (specified above), compared to patients who receive a treatment that does not match the psychologist's prediction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment choice | Experimental | Behavioral: Metacognitive Internet delivered Cognitive Behavior Therapy, Behavioral: Intolerance of uncertainty based Internet delivered Cognitive Behavior TherapyPatients have been randomized to getting to read about and then choose one of the two treatments |
| Random assignment to treatment | Experimental | Behavioral: Metacognitive Internet delivered Cognitive Behavior Therapy, Behavioral: Intolerance of uncertainty based Internet delivered Cognitive Behavior TherapyPatients have been directly randomized into one of the two treatments |
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 or older.
- Meet diagnostic criteria for GAD according to DSM-5, as assessed by a psychologist on a video-call.
- Self-rated score ≥ 7 on GAD-7.
- Can read and speak Swedish fluently.
- Have access to a smartphone, tablet, or computer and a Swedish BankID which allows access to the video-calls and treatment platform.
Key exclusion criteria (3 listed)
- Patients that are judged to be in greater need of another psychiatric treatment for another psychiatric diagnosis (for example severe depression) and/or is judged to have a high risk of suicide.
- Current drug or alcohol abuse.
- Current severe somatic health concern or social vulnerability if this is judged to be too great an obstacle for the patient to carry out 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 |
|---|---|---|
| Metacognitive Internet delivered Cognitive Behavior TherapySpecialist Guided Internet delivered Cognitive Behavior Therapy based on the metacognitive model of excessive worry | Behavioural | Random assignment to treatment, Treatment choice |
| Intolerance of uncertainty based Internet delivered Cognitive Behavior TherapySpecialist Guided Internet delivered Cognitive Behavior Therapy based on the Intolerance of uncertainty model of excessive worry | Behavioural | Random assignment to treatment, Treatment choice |
Primary outcome
Change in Generalized Anxiety Disorder - score (GAD-7)
Time frame: Measured weakly from treatment start (pre-treatment) to 10 weeks after treatment start (post-treatment).
Measures generalized anxiety symptoms. 7 items. Scores range from 0-21 with higher scores indicating more generalized anxiety
7 secondary outcomes
Therapeutic Agency Inventory (adapted to the clinic)
Time frame: 4 weeks after treatment start.
Penn-State Worry Questionnaire (PSWQ)
Time frame: At start of treatment (pre-treatment) and at 10 weeks after treatment start (post-treatment).
Client satisfaction questionnaire (adapted to the clinic)
Time frame: 10 weeks after treatment start (post-treatment).
Treatment Credibility Questionnaire (adapted to the clinic)
Time frame: 2 weeks after treatment start.
Montomery-Asberg Depression Rating Scale - Self-rated (MADRS-S)
Time frame: Measured weakly from treatment start (pre-treatment) to 10 weeks after treatment start (post-treatment).
Patient Health Questionnaire-9 (PHQ-9)
Time frame: At start of treatment (pre-treatment) and at 10 weeks after treatment start (post-treatment).
World Health Organization Disability Assessment Schedule 2.0
Time frame: At start of treatment (pre-treatment) and at 10 weeks after treatment start (post-treatment).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No. All IPD will be confidential patient records and as such are not shareable.
Related trials for Generalized Anxiety Disorder (GAD)
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
RecruitingPhase 2
Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
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.
Internet Psychiatry Clinic, Psychiatry Southwest, SLSO, Region Stockholm, Stockholm, Huddinge 14135
Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Internet delivered Cognitive Behavior Therapy and Intolerance of uncertainty based Internet delivered Cognitive Behavior Therapy in people with Generalized Anxiety Disorder (GAD), 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: looking for participants now, as of the sponsor's last update on 1 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Generalized Anxiety Disorder - score (GAD-7) (time frame: Measured weakly from treatment start (pre-treatment) to 10 weeks after treatment start (post-treatment).). 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 1 Oct 2025.