Builders of Emotional Regulation: Acceptability, Feasibility, and Effectiveness of the Group Unified Protocol for Treating Emotional Disorders in Online and In-Person Modalities

NCT07715604 | Completed

• 1 other identifier: 2021.04854.BD
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The Unified Protocol (UP) is a transdiagnostic, emotion-focused, cognitive-behavioral intervention developed to treat emotional disorders. The UP intervenes in the transdiagnostic mechanisms linked to the etiology and maintenance of emotional disorders, promoting adaptive emotional regulation strategies (e.g. conscious awareness of emotions; cognitive flexibility). Originally developed for the in-person and individual format, the UP can be adapted and implemented in the online group format. It offers other advantages, namely reduced waiting lists and treatment costs, an easier implementation and increased access to psychological treatment for the most isolated populations. This clinical trial aims to implement and evaluate the acceptability, feasibility and effectiveness of UP in an online group format in a clinical population with a primary diagnosis of anxiety disorder and/or mood disorder, compared with UP in an in-person group format. It also aims to explore the psychological processes of therapeutic change (e.g., cognitive flexibility) and their potential mediating role in the response to treatment. Additionally, the study seeks to examine group relationship processes (e.g., group cohesion and therapeutic alliance) and participants' attitudes toward different therapy delivery modalities (online versus in-person), as potential factors influencing treatment engagement and outcomes. Participants will be recruited through online advertisements, including social media platforms (e.g., Facebook and Instagram), the UpC3 website (https://upc3.pt), referrals from other mental health services, and flyers and posters displayed at the University of Coimbra. A total of 54 participants with a primary diagnosis of an anxiety disorder and/or mood disorder were randomized (1:1 allocation ratio) to one of two conditions: (1) UP delivered in an online synchronous group format (n = 28) or (2) UP delivered in an in-person group format (n = 26). In both conditions, participants received 12 weekly 2-hour sessions of the UP in group. Outcomes were assessed at baseline (T0), mid-treatment (T1), post-treatment (T2), and at 3-month (T3) and 6-month (T4) follow-up assessments.

Conditions

Emotional Disorder; Anxiety; Depression

Keywords

Emotional disorders; Unified Protocol; Transdiagnostic intervention; Transdiagnostic mechanisms; Online and in-person formats

Outcome Measures

Primary Outcomes (2)

• Changes from baseline in depressive symptoms

  Measured with the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report scale used to measure the severity of depressive symptoms, answered on a 4-point Likert scale, ranging from 0 (Not at all) to 3 (Almost every day). Total scores range from 0 to 27, with higher scores indicating greater depressive severity, and scores above 9 suggest clinically significant depressive symptoms.

  Baseline, week 12 (end of treatment), and 3- and 6-month follow-up

• Changes from baseline in anxiety symptoms

  Measured with the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 (Sousa et al., 2015) is a 7-item self-report scale used to measure the severity of anxiety symptoms, answered on a 4-point Likert scale, ranging from 0 (Not at all) to 3 (Almost every day). Total scores range from 0 to 21, with higher scores indicating greater anxiety severity, and scores equal to or greater than 8 suggesting clinically significant anxiety symptoms.

  Baseline, week 12 (end of treatment), and 3- and 6-month follow-up

Secondary Outcomes (7)

• Changes from baseline in severity and degree of impairment of depressive symptoms

  Baseline, week 12 (end of treatment), and 3- and 6-month follow-up

• Changes from baseline in severity and degree of impairment of anxiety symptoms

  Baseline, week 12 (end of treatment), and 3- and 6-month follow-up

• Changes from baseline in transdiagnostic mechanisms

  Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up

• Changes from baseline in emotional regulation

  Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up

• Changes from baseline in mindfulness

  Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up

Other Outcomes (8)

• Group processes

  Week 6 (mid-intervention) and week 12 (end of treatment)

• Changes in Therapeutic Alliance in group therapy

  Week 6 (mid-treatment) and week 12 (end of treatment)

• Treatment acceptability and satisfaction

  Week 12 (end of treatment), 3- and 6-months follow-up

Study Arms (2)

Unified Protocol in synchronous online group

EXPERIMENTAL

Participants received 12 weekly 90-minute sessions of the Unified Protocol (UP) delivered in a synchronous online group format via Zoom.

Behavioral: Unified Protocol

Unified Protocol in in-person group

ACTIVE COMPARATOR

Participants received 12 weekly 90-minute sessions of the Unified Protocol (UP) delivered in in-person group format.

Behavioral: Unified Protocol

Interventions

Unified Protocol BEHAVIORAL

The Unified Protocol (UP) is a transdiagnostic cognitive-behavioral intervention developed to target the core mechanisms underlying emotional disorders. The intervention consists of eight treatment modules focused on enhancing emotional awareness, cognitive flexibility, reducing emotional avoidance and maladaptive emotion-driven behaviors, increasing tolerance of physical sensations, and promoting emotion-focused exposure.

Unified Protocol in in-person group; Unified Protocol in synchronous online group

Eligibility Criteria

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

You may qualify if:

• age ≥ 18;
• be Fluent in Portuguese;
• a score greater than 9 on the Patient Health Questionnaire-9 (PHQ-9; Ferreira et al., 2019) and/or a score of 8 or higher on the Generalized Anxiety Disorder-7 (GAD-7; Sousa et al., 2015);
• principal diagnosis (most interfering and severe) of an emotional disorder (i.e. anxiety, depression and other related disorder) according to DSM-5 criteria
• be able to attend treatment sessions and assessments, regardless of the therapeutic format (online and in-person);
• participants taking pharmacological treatment will be asked to maintain the same dosages and medications for at least 1 month prior to the start of treatment and during treatment;
• to have access to a computer or mobile phone with Internet and Webcam;

You may not qualify if:

• current diagnosis of severe mental disorder (e.g., bipolar disorder, schizophrenia, eating disorders), moderate to severe substance use disorder or there is suicide risk at the time of assessment
• not being able to participate in more than half of the intervention program sessions
• to have previously received at least 8 sessions of psychological treatment consisting of cognitive-behavioral principles
• currently receiving other psychological treatment.

Sponsors & Collaborators

• University of Coimbra: lead
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (1)

Faculty of Psychology and Education Sciences

Coimbra, Coimbra District, 3000-115, Portugal

Location

Related Links

• Facebook
• Instagram

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M. Sc

Model Details: Once participants meet the inclusion criteria, they will be randomly assigned in a 1:1 ratio to one of two conditions: (1) an experimental group receiving the UP in a group format via videoconference, or (2) a control group receiving the UP in a group format delivered in person. Both conditions will follow the same treatment manual, session structure, duration, and therapist training, differing only in the mode of delivery. Outcomes will be assessed at baseline, mid-treatment, post-treatment, and 3 and 6 months follow-up.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: May 4, 2023
• Primary Completion: August 8, 2025
• Study Completion: August 8, 2025
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)