- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07382323
Metacognitive Therapy Compared to Cognitive-behavioral Therapy
February 2, 2026 updated by: Benjamin Bohman, Karolinska Institutet
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.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Benjamin Bohman
- Phone Number: +46 0701713443
- Email: benjamin.bohman@ki.se
Study Contact Backup
- Name: Nathalie Petersén
- Phone Number: +46 0762082221
- Email: nathalie.petersen@ki.se
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- A current diagnosis of psychotic disorder, bipolar disorder, neurocognitive disorder, or moderate to severe substance use disorder,
- Acute suicide risk, or
- Concurrent psychological treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Transdiagnostic metacognitive therapy
Metacognitive therapy in a transdiagnostic format; a single treatment protocol is used for all three anxiety disorders
|
Metacognitive therapy focuses on metacognitions.
|
|
Active Comparator: Disorder-specific cognitive-behavioral therapy
Cognitive-behavioral therapy in a disorder-specific format; each of the three anxiety disorders is treated using a separate treatment protocol
|
Cognitive-behavioral therapy focuses on cognitions and/or behaviors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative interview data
Time Frame: Up to 13 weeks
|
Participant responses based on questions posed in an interview
|
Up to 13 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Benjamin Bohman, Karolinska Institutet
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
January 25, 2026
First Submitted That Met QC Criteria
January 25, 2026
First Posted (Actual)
February 2, 2026
Study Record Updates
Last Update Posted (Actual)
February 4, 2026
Last Update Submitted That Met QC Criteria
February 2, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KI-2025-07875-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Generalized Anxiety Disorder
-
University of Southern CaliforniaNational Institute of Mental Health (NIMH)RecruitingGeneralized Anxiety Disorder (GAD)United States
-
Florida State UniversityRecruitingAnxiety | Generalized Anxiety Disorder (GAD) | WorryingUnited States
-
Wayne State UniversityNational Institute of Mental Health (NIMH)RecruitingAnxiety Disorders | Generalized Anxiety Disorder (GAD)United States
-
AbbVieRecruitingGeneralized Anxiety Disorder (GAD)United States, Puerto Rico
-
Texas Tech UniversityRecruitingGrief | Anxiety Disorder Generalized | Depression in AdultsUnited States
-
University of California, IrvineNational Center for Complementary and Integrative Health (NCCIH)Not yet recruitingMajor Depressive Disorder | Generalized Anxiety Disorder (GAD)
-
PsyScaleNot yet recruitingMajor Depressive Disorder (MDD) | Generalized Anxiety Disorder (GAD)
-
National Health Research Institutes, TaiwanNot yet recruitingMajor Depressive Disorder (MDD) | Generalized Anxiety Disorder (GAD)
-
Psicofarma, S.A. De C.V.Recruiting
-
Bout Me HealingCompletedSubstance Use Disorder (SUD) | Anxiety Disorder GeneralizedUnited States
Clinical Trials on Transdiagnostic metacognitive therapy
-
Karolinska InstitutetRegion StockholmRecruitingPosttraumatic Stress Disorder (PTSD) | Social Anxiety Disorder (SAD) | Generalized Anxiety Disorder (GAD)Sweden
-
Sorlandet Hospital HFRecruitingGeneralized Anxiety DisorderNorway
-
University of LiverpoolLiverpool University Hospitals NHS Foundation Trust; University of ManchesterTerminatedDepression | Quality of Life | Cancer | AnxietyUnited Kingdom
-
University of LiverpoolMedical Research CouncilCompletedDepression | Cancer | AnxietyUnited Kingdom
-
University of OsloNorwegian University of Science and TechnologyNot yet recruitingPsychological DisordersNorway
-
University of OsloRecruitingMedically Unexplained Symptoms | Sense of CoherenceNorway
-
Norwegian University of Science and TechnologyCompletedBrain Injuries | Post-Concussive Symptom | Post-Concussive SyndromeNorway
-
Norwegian University of Science and TechnologyCompletedMajor Depressive DisorderNorway
-
University of ManchesterManchester University NHS Foundation Trust; Pennine Care NHS Foundation TrustRecruitingDepression | AnxietyUnited Kingdom
-
University Hospital, Strasbourg, FranceTerminated