An interventional study of Metacognitive therapy (MCT) and Unified protocol (UP) in Posttraumatic Stress Disorder (PTSD), Generalized Anxiety Disorder (GAD) and Social Anxiety Disorder (SAD), sponsored by Karolinska Institutet. Not yet recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
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:
Methods:
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 114 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Transdiagnostic MCT, focused on modifying dysfunctional metacognitions and thereby reducing attentional and cognitive processes central to maintaining anxiety disorders.
Behavioral: Metacognitive therapy (MCT)
Transdiagnostic cognitive-behavioral therapy, focused on emotion regulation processes central to the development and maintenance of anxiety disorders, particularly neuroticism.
Behavioral: Unified protocol (UP)
MCT is delivered in weekly face-to-face sessions
UP is delivered in weekly face-to-face sessions
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.
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
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
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
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
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.
Time frame: Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1 year follow-up
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.
Time frame: Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1 year follow-up
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.
Time frame: Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1 year follow-up
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.
Time frame: Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1 year follow-up
World Health Organization Disability Assessment Schedule (WHODAS-12): change over time
Self-reported functional impairment
Time frame: Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1-year follow-up
Difficulties in Emotion Regulation Scale-16 (DERS-16): change over time
Self-reported difficulties in emotion regulation. Process measure.
Time frame: Baseline, weekly during treatment (through up to 18 weeks/sessions) post-treatment (immediately after treatment completion of up to 18 weeks/sessions)
Cognitive Attentional Syndrome (CAS-1): change over time
Self-reported cognitive attentional syndrome and metacognitions. Process measure.
Time frame: Baseline, weekly during treatment (through up to 18 weeks/sessions) post-treatment (immediately after treatment completion of up to 18 weeks/sessions)
Metacognitions Questionnaire-30 (MCQ-30) - subscale danger and uncontrollability: change over time
Self-reported metacognitions. Process measure.
Time frame: Baseline, weekly during treatment (through up to 18 weeks/sessions) post-treatment (immediately after treatment completion of up to 18 weeks/sessions)
Credibility/Expectancy Questionnaire (CEQ): after session 3
Self-reported credibility of treatment and expectancy of improvement
Time frame: After session 3 (between week 3 and 4)
Facilitative Interpersonal Skills scale for Clients (FIS-C): after session 3
Self-reported perspectives on therapist characteristics
Time frame: After session 3 (between week 3 and 4)
Negative Effects Questionnaire (NEQ): after treatment
Self-reported adverse events
Time frame: Post-treatment (immediately after treatment completion of up to 18 weeks/sessions)
Client Satisfaction Questionnaire (CSQ): after treatment
Self-reported satisfaction with treatment
Time frame: Post-treatment (immediately after treatment completion of up to 18 weeks/sessions)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2025; primary completion for Dec 2027, 28 months later.
Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 28 months is below that.
Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic →