Metacognitive Therapy vs Unified Protocol for Patients With Comorbid Anxiety Disorders

NCT06971692 | Not Yet Recruiting

• 1 other identifier: 2024-01509-01
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorder (PTSD); Generalized Anxiety Disorder (GAD); Social Anxiety Disorder (SAD); Panic Disorder (With or Without Agoraphobia)

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (16)

• Overall Anxiety Severity and Impairment Scale (OASIS): change over time

  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

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

  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

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

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

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

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

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

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

Study Arms (2)

Metacognitive therapy (MCT)

EXPERIMENTAL

Transdiagnostic MCT, focused on modifying dysfunctional metacognitions and thereby reducing attentional and cognitive processes central to maintaining anxiety disorders.

Behavioral: Metacognitive therapy (MCT)

Unified protocol (UP)

ACTIVE COMPARATOR

Transdiagnostic cognitive-behavioral therapy, focused on emotion regulation processes central to the development and maintenance of anxiety disorders, particularly neuroticism.

Behavioral: Unified protocol (UP)

Interventions

Metacognitive therapy (MCT) BEHAVIORAL

MCT is delivered in weekly face-to-face sessions

Metacognitive therapy (MCT)

Unified protocol (UP) BEHAVIORAL

UP is delivered in weekly face-to-face sessions

Unified protocol (UP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Psykiatri Nordväst and Psykiatri Sydväst, Region Stockholm

Stockholm, Sweden

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Generalized Anxiety Disorder; Phobia, Social; Panic Disorder

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Anxiety Disorders; Phobic Disorders

Central Study Contacts

Fredrik A Santoft, PhD

CONTACT

+46707275474; fredrik.santoft@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors conducting diagnostic interviews and clinical severity ratings, at post and follow-up assessments, are blinded to treatment condition and baseline diagnostic status. Investigators are blinded to treatment condition in the analysis phase.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lic. psychologist, PhD

Model Details: Participants are consecutively recruited and randomly allocated to conditions using a 1:1 ratio.

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 14, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)