Unified Protocol Group Treatment in a University Outpatient Clinic

NCT07129941 | Recruiting

• 1 other identifier: REK-ID 840156
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Disorders; Anxiety; Depression - Major Depressive Disorder

Keywords

Unified Protocol; Transdiagnostic treatment; Emotional disorders; Anxiety; Depression; Group therapy

Outcome Measures

Primary Outcomes (1)

• WHO-5: Wellbeing index

  The WHO-5 is a self-report measure of positive mental health. It consists of five items that are rated on a 6-point scale from 'All of the time' to 'At no time'. High scores indicate a more positive rating of wellbeing

  From enrollment to follow-up at 6 months

Secondary Outcomes (18)

• Work and Social Adjustment Scale

  From enrollment to follow-up at 6 months

• Patient Health Questionnaire (PHQ-9)

  From enrollment to follow-up at 6 months

• Generalized Anxiety Disorder Scale (GAD-7)

  From enrollment to follow-up at 6 months

• Multidimensional Emotional Disorders Inventory (MEDI)

  From enrollment to follow-up at 6 months

• Level of Personality Functioning Scale Brief Form (LPFS-BF)

  From enrollment to follow-up at 6 months

Other Outcomes (2)

• Credibility Rating Scale

  This scale will be administered only at pre-treatment as a possible predictor of change.

• Group Session Rating Scale (GSRS)

  At each treatment session through the 12 weeks of treatment

Study Arms (1)

Unified Protocol group treatment

EXPERIMENTAL

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.

Behavioral: Unified Protocol

Interventions

Unified Protocol BEHAVIORAL

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

Unified Protocol group treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bergen: lead

Study Sites (1)

Department of Clinical Psychology

Bergen, Vestland, 5009, Norway

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jon Vøllestad, Ph.D.

  University of Bergen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jon Vøllestad, Ph.D.

CONTACT

0047 95 21 32 86; jon.vollestad@uib.no

Elisabeth Schanche, Ph.D.

CONTACT

0047 97 77 42 17; elisabeth.schanche@uib.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm uncontrolled naturalistic trial. All eligible patients will receive the Unified Protocol (UP) intervention, but will be randomly assigned to receive treatment from either experienced psychologists or psychology students.

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: August 19, 2025
• Study Start: May 8, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2034
• Last Updated: August 19, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)