Unified Protocol Group Treatment in a University Outpatient Clinic

NCT ID: NCT07129941

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-08
• Study Completion Date: 2034-12-31

Brief Summary

This clinical trial aims to evaluate the effectiveness and underlying processes of change of the Unified Protocol (UP) for treating emotional disorders in a university outpatient clinic. The study will involve 140 patients receiving UP treatment in a group format, delivered either by experienced or novice therapists, along with a non-clinical control group of 45 participants. Participants will self-refer on the basis of advertisement about the study through flyers, posters, project website, social media or local news media. Outcomes will be assessed through self-report measures of well-being, symptoms, emotion regulation, and the non-specific factors of treatment credibility and therapeutic alliance. Additionally, psychophysiological measures of heart rate variability and interoception will be used to explore processes influencing treatment response. Qualitative interviews will complement the quantitative data by capturing participants' perspectives on the treatment and experiences of what contributed to change.

Detailed Description

Background Anxiety and depression are the most common mental disorders, incurring vast personal and societal costs. While effective evidence-based treatments exist, healthcare systems struggle to meet the growing demand for services. A key challenge in delivering care is that most treatments are diagnosis specific. This complicates training and implementation due to clinicians having to learn multiple treatment manuals. In addition, these single-disorder treatments may also often have poor applicability to the complex symptoms and patterns of comorbidity typically seen in real-world clinical settings. As a response to these challenges, several transdiagnostic treatment protocols have been developed to target psychological processes underlying different diagnoses. One such model is the "Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP) developed by David Barlow and colleagues. UP addresses the functional processes that maintain emotional disorders, such as negative reactions to emotions and avoidance behaviors.

The Unified Protocol (UP) has shown non-inferiority to diagnosis-specific CBT and superiority to treatment as usual in both individual and group formats. Meta-analyses confirm its effectiveness for comorbid emotional disorders and suggest potential for cost-effective, scalable implementation.

Knowledge gaps

• Norwegian Setting: Only one small feasibility study of UP has been conducted in Norway. A larger naturalistic trial is needed to assess outcomes (quality of life, functioning, symptoms) and potential negative effects in a public health context.
• Processes of Change: More research is needed to identify active treatment mechanisms (e.g., emotion regulation, mindfulness, cognitive flexibility) and their association with outcomes in group UP. Non-specific factors such as credibility and group alliance also require investigation.
• Psychophysiological Measures: UP's impact on objective emotion regulation markers (e.g., heart rate variability, interoception) is unexplored. Inclusion of such measures can reduce bias and clarify underlying mechanisms.
• Novice Therapists: The ability of graduate psychology students to deliver UP with high fidelity in group format remains unclear and merits further investigation.

Study objectives This study aims to explore outcomes, processes of change, and user experiences of UP group treatment for patients with emotional disorders in a naturalistic clinical sample in a Norwegian setting. Additionally, it will compare the clinical sample to a healthy control group to better understand how transdiagnostic characteristics serve as vulnerability or resilience factors in the development of emotional disorders. Lastly, the study examines whether novice therapists can be trained to deliver the treatment with high levels of fidelity based on ratings of adherence and competence.

Main aims and research questions i. Assessing treatment effectiveness: To determine whether UP group treatment leads to improvements in key clinical outcomes, identify factors that influence these outcomes, and assess any negative treatment effects.

Research questions:

• Does UP group treatment lead to improvements in quality of life, everyday functioning, emotion regulation, and self-reported symptoms?
• To what extent do clinical and demographic factors impact treatment adherence and outcome?
• What type and frequency of negative treatment effects do participants report?

ii. Examining processes of change: To investigate the role of emotion regulation, interoception, and UP skill use as predictors and mediators of treatment outcomes, using both self-report and objective measures.

Research questions:

• Specific factors: To what extent do changes in UP-relevant skills and processes (e.g., emotion regulation, acceptance, cognitive flexibility, and interoception) predict or mediate outcomes?
• Non-specific factors: To what extent do treatment expectations and group alliance predict outcomes?

iii. Understanding patients' experience of UP: To explore patients' experience of UP treatment through in-depth qualitative interviews.

Research questions:

• How do participants describe their experience of benefits and challenges with the UP program?
• How do participants describe their experience of change during and after the treatment?

iv.) Understanding transdiagnostic factors in emotional vulnerability and resilience: To explore whether individuals with emotional disorders differ cross-sectionally from healthy controls.

Research question:

• Do patients with emotional disorders differ significantly from healthy controls on measures of emotion regulation, acceptance, cognitive flexibility, and psychophysiological markers (interoception, heart rate variability)?

v.) Examining UP group therapy delivered by novices: To assess whether novice therapists can be trained to deliver UP with high fidelity.

Research question:

• Can novice therapists (i.e., graduate students in clinical psychology under supervision) be trained to high levels of fidelity in delivering the UP group treatment?

Conditions

Emotional Disorders; Anxiety; Depression - Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Unified Protocol group treatment

The Unified Protocol (UP) is a time-limited modular treatment addressing core emotion regulation difficulties in patients with emotional disorders. There will be 8-10 patients and two or three therapists in the group. Treatment consists of one individual session of diagnostic assessment, and one or two individual preparation sessions (case formulation and goal setting), and 12 weekly 2 ½ hour group treatment sessions.

Group Type: EXPERIMENTAL

Unified Protocol

Intervention Type: BEHAVIORAL

The Unified Protocol is a transdiagnostic intervention for emotional disorders here delivered in a group format

Interventions

Unified Protocol

The Unified Protocol is a transdiagnostic intervention for emotional disorders here delivered in a group format

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 18-40
• Fulfilling diagnostic criteria for an anxiety disorder and/or unipolar depression (ICD F.3x - 4x)
• Motivated for short-term treatment in group format

Exclusion Criteria

• Suicidality
• Self-harm
• Severe psychiatric disorder (bipolar disorder, psychosis)
• Substance use disorders
• Use of anxiolytic medication (i.e., benzodiazepines)
• Unstable antidepressant medication (i.e., stable dosage <6 months)
• Other ongoing psychological treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jon Vøllestad, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

Department of Clinical Psychology

Bergen, Vestland, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Jon Vøllestad, Ph.D.

Role: CONTACT

jon.vollestad@uib.no

0047 95 21 32 86

Elisabeth Schanche, Ph.D.

Role: CONTACT

elisabeth.schanche@uib.no

0047 97 77 42 17

Facility Contacts

Jon Vøllestad, Ph.D.

Role: primary

jon.vollestad@uib.no

0047 95 21 32 86

Elisabeth Schanche, Ph.D.

Role: backup

elisabeth.schanche@uib.no

0047 97 77 42 17

Other Identifiers

REK-ID 840156

Identifier Type: -

Identifier Source: org_study_id