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Posttraumatic Stress Disorder (PTSD)NCT06971692

Metacognitive Therapy vs Unified Protocol for Patients With Comorbid Anxiety Disorders

A study testing Metacognitive therapy (MCT) and Unified protocol (UP) in people with Posttraumatic Stress Disorder (PTSD) and Generalized Anxiety Disorder (GAD), run by Karolinska Institutet at 1 site in Sweden.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The primary goal of this randomized controlled trial is to compare the effectiveness of two transdiagnostic psychological treatments, Metacognitive Therapy (MCT) and the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), for patients with complex anxiety. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Metacognitive therapy (MCT) and Unified protocol (UP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteSweden
Study dates
Aug 2025to Dec 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

  • Age 18 years or above
  • Ability to read and speak Swedish
  • A principal diagnosis of post-traumatic stress disorder, generalized anxiety disorder, social anxiety disorder, or panic disorder
  • At least one additional comorbid diagnosis (one of the above diagnoses, or obsessive-compulsive disorder, or major depressive disorder)
  • Patients on psychotropic medication must have been on a stable dose (excluding as-needed medication) for at least six weeks prior to treatment initiation

Who cannot join

  • Current diagnosis of psychosis, bipolar disorder or moderate to severe substance use disorder
  • Medium to high suicide risk
  • Psychiatric, somatic or social problems that require primary intervention other than the treatments offered in the study
  • 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.

Fredrik A Santoft, PhD contact

+46707275474

fredrik.santoft@ki.se

Sweden1 site
  • Psykiatri Nordväst and Psykiatri Sydväst, Region Stockholm

    Stockholm

Other trials in Sweden

About this study

Official title: Transdiagnostic Therapy With Metacognitive Therapy Versus Unified Protocol for Patients With Comorbid Anxiety Disorders: a Randomized Controlled Trial

The primary goal of this randomized controlled trial is to compare the effectiveness of two transdiagnostic psychological treatments, Metacognitive Therapy (MCT) and the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), for patients with complex anxiety.

Read the detailed description

Background:

Anxiety disorders are highly prevalent, impairing quality of life and contributing to substantial economic burden. A large portion of the affected individuals also fulfill the criteria for at least one other anxiety disorder and/or depression. This comorbidity is associated with increased symptom severity and a poorer prognosis. Cognitive-behavioral therapy (CBT) is effective but traditionally relies on a specific manual for every distinct disorder, complicating the management of comorbidity and increasing training needs for therapists. Transdiagnostic therapies target underlying, shared mechanisms across anxiety disorders and depression, and can be used regardless of specific diagnoses. They thereby offer potential for efficient treatment of complex presentations, addressing a wider range of patients' problems with simplified therapist training.

Aims:

The primary aim of the study is to compare the effectiveness of two transdiagnostic therapies, MCT and UP, for patients with comorbid anxiety. Beyond evaluating effectiveness, the project seeks to identify the key factors that drive improvement during treatment. Research questions:

  1. Are there differences in effect between MCT and UP regarding clinician-rated severity of anxiety and depression diagnoses after treatment?
  2. Are there differences in effect between MCT and UP regarding patients' self-reported symptoms of anxiety, depression, and functioning after treatment?
  3. Are there differences in effect between MCT and UP regarding clinician-rated severity of anxiety and depression diagnoses, as well as patients' self-reported symptoms of anxiety, depression, and functioning, at the 1-year follow-up after completed treatment?
  4. Does improvement occur in patients in the way that the treatment methods (MCT and UP, respectively) are intended to work, according to the presumptive mechanisms of change?

Methods:

  • Design and participants: Patients (N = 114) are randomly allocated in a 1:1 ratio to MCT or UP. Patients are consecutively recruited from the regular influx at two psychiatric clinicis in Stockholm, Sweden. See sections Study design and Eligibility.
  • Measurements: Most measures are rated at baseline, post-treatment and at the 1-year follow-up. For the purpose of mediational analyses, procsess measures as well as outcome measures of anxiety and depression are rated weekly during treatment. See section Outcome Measures.
  • Treatment conditions: Treatment (MCT or UP) is delivered in approximately 10-18 weekly face-to-face sessions. See section Arms and Interventions.
  • Data analyses: Analyses of treatment effects, including the primary outcome of pre- to post changes in Clinical Severity Rating (CSR) between conditions, are conducted according to the intention-to treat principle, using multilevel modeling. Model-based effect sizes, with 95% confidence intervals, are also calculated. For assessment of treatment response, disorder-specific measures are used with criteria for reliable change and clinical cut-off, rendering the categories recovered, improved, unchanged, or deteriorated. Remission status is also assessed according to blinded clinician-rated severity of anxiety and depression diagnoses after treatment, where CSR < 4 means that a patient no longer fulfills criteria for a diagnosis. Differences in proportions are evaluated with chi-squared tests. Mediational analyses are conducted by disaggregating potential mediators to their within- and between-person components. To establish a temporal sequence between mediator and outcome, mediator scores are lagged relative to outcome.
Being tested
Metacognitive therapy (MCT), Unified protocol (UP)
Medical subject headings
Stress Disorders, Post-Traumatic, Generalized Anxiety Disorder, Phobia, Social, Panic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metacognitive therapy (MCT)Behavioural

    MCT is delivered in weekly face-to-face sessions

  • Unified protocol (UP)Behavioural

    UP is delivered in weekly face-to-face sessions

Study groups in NCT06971692
Study groupRoleWhat they receive
Metacognitive therapy (MCT)ExperimentalTransdiagnostic MCT, focused on modifying dysfunctional metacognitions and thereby reducing attentional and cognitive processes central to maintaining anxiety disorders.
Receives: Behavioral: Metacognitive therapy (MCT)
Unified protocol (UP)Active comparatorTransdiagnostic cognitive-behavioral therapy, focused on emotion regulation processes central to the development and maintenance of anxiety disorders, particularly neuroticism.
Receives: Behavioral: Unified protocol (UP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Severity Rating (CSR): change over time

    Diagnoses are assigned a dimensional clinical severity rating on a scale from 0 (no symptoms) to 8 (extremely severe symptoms), with a rating of 4 or higher representing the clinical threshold for diagnostic criteria. Observer-assessed.

    Measured: Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1-year follow-up.

Secondary outcomes (16)
  1. Overall Anxiety Severity and Impairment Scale (OASIS): change over time

    Self-reported anxiety

    Measured: Baseline, weekly during treatment (through up to 18 weeks/sessions) post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1-year follow-up

  2. Overall Depression Severity and Impairment Scale (ODSIS): change over time

    Self-reported depression

    Measured: Baseline, weekly during treatment (through up to 18 weeks/sessions) post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1-year follow-up

  3. Generalized Anxiety Disorder-7 (GAD-7): change over time

    Self-reported anxiety

    Measured: Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1-year follow-up

  4. Patient Health Questionnaire-9 (PHQ-9): change over time

    Self-reported depression

    Measured: Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1-year follow-up

  5. Posttraumatic Stress Disorder Checklist-5 (PCL-5): change over time

    Self-reported symptoms of post-traumatic stress. Only for patients with a principal diagnosis of Posttraumatic Stress Disorder.

    Measured: Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1 year follow-up

  6. Penn State Worry Questionnaire (PSWQ): change over time

    Self-reported symptoms of generalized anxiety. Only for patients with a principal diagnosis of Generalized Anxiety Disorder.

    Measured: Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1 year follow-up

  7. Liebowitz Social Anxiety Scale-Self-Report (LSAS-SR): change over time

    Self-reported symptoms of social anxiety. Only for patients with a principal diagnosis of Social Anxiety Disorder.

    Measured: Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1 year follow-up

  8. Panic Disorder Severity Scale-Self-Rated (PDSS-SR): change over time

    Self-reported symptoms of panic. Only for patients with a principal diagnosis of Panic Disorder.

    Measured: Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1 year follow-up

  9. World Health Organization Disability Assessment Schedule (WHODAS-12): change over time

    Self-reported functional impairment

    Measured: Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1-year follow-up

  10. Difficulties in Emotion Regulation Scale-16 (DERS-16): change over time

    Self-reported difficulties in emotion regulation. Process measure.

    Measured: Baseline, weekly during treatment (through up to 18 weeks/sessions) post-treatment (immediately after treatment completion of up to 18 weeks/sessions)

  11. Cognitive Attentional Syndrome (CAS-1): change over time

    Self-reported cognitive attentional syndrome and metacognitions. Process measure.

    Measured: Baseline, weekly during treatment (through up to 18 weeks/sessions) post-treatment (immediately after treatment completion of up to 18 weeks/sessions)

  12. Metacognitions Questionnaire-30 (MCQ-30) - subscale danger and uncontrollability: change over time

    Self-reported metacognitions. Process measure.

    Measured: Baseline, weekly during treatment (through up to 18 weeks/sessions) post-treatment (immediately after treatment completion of up to 18 weeks/sessions)

  13. Credibility/Expectancy Questionnaire (CEQ): after session 3

    Self-reported credibility of treatment and expectancy of improvement

    Measured: After session 3 (between week 3 and 4)

  14. Facilitative Interpersonal Skills scale for Clients (FIS-C): after session 3

    Self-reported perspectives on therapist characteristics

    Measured: After session 3 (between week 3 and 4)

  15. Negative Effects Questionnaire (NEQ): after treatment

    Self-reported adverse events

    Measured: Post-treatment (immediately after treatment completion of up to 18 weeks/sessions)

  16. Client Satisfaction Questionnaire (CSQ): after treatment

    Self-reported satisfaction with treatment

    Measured: Post-treatment (immediately after treatment completion of up to 18 weeks/sessions)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2025
  2. Study startAug 2025 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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
Participants are consecutively recruited and randomly allocated to conditions using a 1:1 ratio.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06971692
Sponsor's protocol ID
2024-01509-01
Status last verified
May 2025
First submitted
25 Apr 2025
Last updated
14 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Metacognitive therapy (MCT) and Unified protocol (UP) in people with Posttraumatic Stress Disorder (PTSD) and 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 14 May 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?

Contact Fredrik A Santoft, PhD (+46707275474, fredrik.santoft@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Severity Rating (CSR): change over time (time frame: Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1-year follow-up.). 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 14 May 2025.

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