Generalized Anxiety DisorderNCT07382323
Metacognitive Therapy Compared to Cognitive-behavioral Therapy
A study testing Transdiagnostic metacognitive therapy and Disorder-specific cognitive-behavioral therapy in people with Generalized Anxiety Disorder and Social Anxiety Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This is a qualitative study of participants who have taken part in a randomized controlled trial comparing transdiagnostic metacognitive therapy and disorder-specific cognitive-behavioral therapy for anxiety disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder, Social Anxiety Disorder, Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Transdiagnostic metacognitive therapy and Disorder-specific cognitive-behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 28 Jan 2026to Dec 2026
- 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
- Age 18 years or older,
- A principal diagnosis of generalized anxiety disorder, social anxiety disorder, or posttraumatic stress disorder,
- No change in dose during the last six weeks if on pharmacological treatment, and
- Ability to read and speak Swedish.
Who cannot join
- A current diagnosis of psychotic disorder, bipolar disorder, neurocognitive disorder, or moderate to severe substance use disorder,
- Acute suicide risk, or
- Concurrent psychological 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
Northern Stockholm Psychiatry Clinic
Stockholm
About this study
Official title: Transdiagnostic Metacognitive Therapy Compared to Disorder-specific Cognitive-behavioral Therapy for Anxiety Disorders: a Qualitative Study
This is a qualitative study of participants who have taken part in a randomized controlled trial comparing transdiagnostic metacognitive therapy and disorder-specific cognitive-behavioral therapy for anxiety disorders. The purpose of the study is to explore participant perceptions of the respective treatment models to facilitate implementation and dissemination of the treatments.
- Conditions
- Generalized Anxiety Disorder, Social Anxiety Disorder, Posttraumatic Stress Disorder (PTSD)
- Being tested
- Transdiagnostic metacognitive therapy, Disorder-specific cognitive-behavioral therapy
- Medical subject headings
- Generalized Anxiety Disorder, Phobia, Social, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiagnostic metacognitive therapyBehavioural
Metacognitive therapy focuses on metacognitions.
Disorder-specific cognitive-behavioral therapyBehavioural
Cognitive-behavioral therapy focuses on cognitions and/or behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Transdiagnostic metacognitive therapy | Experimental | Metacognitive therapy in a transdiagnostic format; a single treatment protocol is used for all three anxiety disorders Receives: Behavioral: Transdiagnostic metacognitive therapy |
| Disorder-specific cognitive-behavioral therapy | Active comparator | Cognitive-behavioral therapy in a disorder-specific format; each of the three anxiety disorders is treated using a separate treatment protocol Receives: Behavioral: Disorder-specific cognitive-behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative interview data
Participant responses based on questions posed in an interview
Measured: Up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start28 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Bohman, Karolinska Institutet
- Investigators
- Benjamin Bohman, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382323
- Sponsor's protocol ID
- KI-2025-07875-02
- Status last verified
- Aug 2026
- First submitted
- 25 Jan 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets analyzed in this study are not publicly available due to legal and ethical restrictions under Swedish data protection regulations. Requests for access may be directed to the Data Protection Officer at Stockholm Health Care Services, and are subject to approval by the relevant data governance authorities. Requests to access the datasets should be directed to gdpr.slso@regionstockholm.se.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic Metacognitive Therapy Compared to Disorder-specific Cognitive-behavioral Therapy for Anxiety Disorders: a Qualitative Study
- ClinicalTrials.gov ID
- NCT07382323
- Acronym / sponsor ID
- KI-2025-07875-02
- Conditions
- Generalized Anxiety Disorder, Social Anxiety Disorder, Posttraumatic Stress Disorder (PTSD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Feb 2026 (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.
This is a qualitative study of participants who have taken part in a randomized controlled trial comparing transdiagnostic metacognitive therapy and disorder-specific cognitive-behavioral therapy for anxiety disorders. The purpose of the study is to explore participant perceptions of the respective treatment models to facilitate implementation and dissemination of the treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transdiagnostic metacognitive therapy | Experimental | Behavioral: Transdiagnostic metacognitive therapyMetacognitive therapy in a transdiagnostic format; a single treatment protocol is used for all three anxiety disorders |
| Disorder-specific cognitive-behavioral therapy | Active comparator | Behavioral: Disorder-specific cognitive-behavioral therapyCognitive-behavioral therapy in a disorder-specific format; each of the three anxiety disorders is treated using a separate treatment protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older,
- A principal diagnosis of generalized anxiety disorder, social anxiety disorder, or posttraumatic stress disorder,
- No change in dose during the last six weeks if on pharmacological treatment, and
- Ability to read and speak Swedish.
Key exclusion criteria (3 listed)
- A current diagnosis of psychotic disorder, bipolar disorder, neurocognitive disorder, or moderate to severe substance use disorder,
- Acute suicide risk, or
- Concurrent psychological 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 |
|---|---|---|
| Transdiagnostic metacognitive therapyMetacognitive therapy focuses on metacognitions. | Behavioural | Transdiagnostic metacognitive therapy |
| Disorder-specific cognitive-behavioral therapyCognitive-behavioral therapy focuses on cognitions and/or behaviors. | Behavioural | Disorder-specific cognitive-behavioral therapy |
Primary outcome
Qualitative interview data
Time frame: Up to 13 weeks
Participant responses based on questions posed in an interview
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 18 Aug 2026.
- Individual participant dataSharing planned: Yes. The datasets analyzed in this study are not publicly available due to legal and ethical restrictions under Swedish data protection regulations. Requests for access may be directed to the Data Protection Officer at Stockholm Health Care Services, and are subject to approval by the relevant data governance authorities. Requests to access the datasets should be directed to gdpr.slso@regionstockholm.se.
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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.
Benjamin Bohman principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdiagnostic metacognitive therapy and Disorder-specific cognitive-behavioral therapy in people with Generalized Anxiety Disorder and Social 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 4 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 18 Aug 2026. 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?
Contact Benjamin Bohman (0701713443 ext. +46, benjamin.bohman@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative interview data (time frame: Up to 13 weeks). 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 18 Aug 2026.