Metacognitive Therapy vs Unified Protocol for Patients With Comorbid Anxiety Disorders

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Metacognitive therapy (MCT)

    Behavioral

    MCT is delivered in weekly face-to-face sessions

  • Unified protocol (UP)

    Behavioral

    UP is delivered in weekly face-to-face sessions

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: Metacognitive therapy (MCT)Experimental treatment 1 intervention
Group B: Unified protocol (UP)Active comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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

Self-reported anxiety

Time frame
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

Time frame
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

Time frame
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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Region Stockholm

Collaborator

This trial is not recruiting at the moment. You can still explore other options: