Emotional DisorderNCT07715604

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

A study testing Unified Protocol in people with Emotional Disorder and Anxiety, run by University of Coimbra at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Emotional Disorder, Anxiety, Depression
What is being tested?: Unified Protocol
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 sitePortugal
Study dates: 4 May 2023to 8 Aug 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

Faculty of Psychology and Education Sciences
Coimbra, Coimbra District, 3000-115

Other trials in Portugal

About this study

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
Being tested: Unified Protocol
Keywords: Emotional disorders, Unified Protocol, Transdiagnostic intervention, Transdiagnostic mechanisms, Online and in-person formats
Medical subject headings: Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Unified ProtocolBehavioural
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.

Study groups in NCT07715604
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Unified Protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured with the Overall Depression Severity and Impairment Scale (ODSIS). It comprises five items answered on a 5-Likert scale ranging from 0 (e.g., I didn't feel depressed) to 4 (e.g., Constant depression). The total score is the sum of all the items and ranges from 0 to 20.
Measured: 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
Measured with the Overall Anxiety Severity and Impairment Scale. The five items are rated on a 5-Likert scale ranging from 0 (e.g., I didn't feel anxious) to 4 (e.g., Constant anxiety). The total score ranges from 0 to 20.
Measured: Baseline, week 12 (end of treatment), and 3- and 6-month follow-up
Changes from baseline in transdiagnostic mechanisms
Measured with the The Multidimensional Emotional Disorder Inventory (MEDI). MEDI is a 49-item self-reported questionnaire used to assess nine transdiagnostic dimensions: Neurotic temperament, Positive temperament, Depressed mood, Autonomic arousal, Somatic anxiety, Social concerns, Intrusive cognitions, Traumatic reexperiencing, and Avoidance. All items are rated on a 9-point Likert scale ranging from 0 (not characteristic of me) to 8 (extremely characteristic of me).
Measured: Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
Changes from baseline in emotional regulation
Measured with the Difficulties in Emotion Regulation Scale-Short Form (DERS-SF). It comprises 18 items, rated on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always). The total score was calculated as the mean of all items excluding the Awareness items, with higher scores indicating a greater level of emotional dysregulation.
Measured: Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
Changes from baseline in mindfulness
Measured with the Mindful Attention Awareness Scale (MAAS). MAAS is a 15-item self-report questionnaire. Items are rated on a 6-point Likert scale ranging from 1 (almost always) to 6 (almost never). Total scores range from 15 to 90, with higher scores indicating greater mindfulness.
Measured: Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
Changes from baseline in behavioral ativation
Measured with The Behavioral Activation for Depression Scale-Short Form (BADS-SF). It comprises 9 items, rated on a 7-point scale ranging from 0 to 6, with higher total scores indicating greater levels of activation.
Measured: Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
Changes from baseline in quality of life
Measured with the EUROHIS-QOL-8. This self-report scale comprises 8 items, answered on a 5-point Likert scale (from 1- not at all/very dissatisfied to 5 - completely/very satisfied). Higher values represent better-perceived quality of life.
Measured: Baseline, week 12 (end of treatment), and 3- and 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 May 20238 Aug 2025

First posted20 Jul 2026
Study start4 May 2023
Primary completion8 Aug 2025
Study completion8 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Emotional DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07715604
Sponsor's protocol ID: 2021.04854.BD
Other IDs: 2021.04854.BD
Status last verified: Jul 2026
First submitted: 15 Jul 2026
Last updated: 20 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Emotional Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Builders of Emotional Regulation: Acceptability, Feasibility, and Effectiveness of the Group Unified Protocol for Treating Emotional Disorders in Online and In-Person Modalities
ClinicalTrials.gov ID: NCT07715604
Acronym / sponsor ID: 2021.04854.BD
Conditions: Emotional Disorder, Anxiety, Depression
Keywords: Emotional disorders, Unified Protocol, Transdiagnostic intervention, Transdiagnostic mechanisms, Online and in-person formats
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: University of CoimbraUniversity, hospital or other
Collaborators: Fundação para a Ciência e a Tecnologia
Study start: 4 May 2023 (actual)
Primary completion: 8 Aug 2025 (actual)
Study completion: 8 Aug 2025 (actual)
First posted: 20 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Unified Protocol in synchronous online group	Experimental	Behavioral: Unified ProtocolParticipants received 12 weekly 90-minute sessions of the Unified Protocol (UP) delivered in a synchronous online group format via Zoom.
Unified Protocol in in-person group	Active comparator	Behavioral: Unified ProtocolParticipants received 12 weekly 90-minute sessions of the Unified Protocol (UP) delivered in in-person group format.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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);

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Unified ProtocolThe 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.	Behavioural	Unified Protocol in in-person group, Unified Protocol in synchronous online group

Primary outcome

Changes from baseline in depressive symptoms
Time frame: Baseline, week 12 (end of treatment), and 3- and 6-month follow-up
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.
Changes from baseline in anxiety symptoms
Time frame: Baseline, week 12 (end of treatment), and 3- and 6-month follow-up
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.

7 secondary outcomes

Changes from baseline in severity and degree of impairment of depressive symptoms
Time frame: 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
Time frame: Baseline, week 12 (end of treatment), and 3- and 6-month follow-up
Changes from baseline in transdiagnostic mechanisms
Time frame: Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
Changes from baseline in emotional regulation
Time frame: Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
Changes from baseline in mindfulness
Time frame: Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
Changes from baseline in behavioral ativation
Time frame: Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
Changes from baseline in quality of life
Time frame: Baseline, week 12 (end of treatment), and 3- and 6-month follow-up

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
FacebookLink provided by the sponsor.
InstagramLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Unified Protocol in people with Emotional Disorder and Anxiety, run by University of Coimbra at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline in depressive symptoms (time frame: Baseline, week 12 (end of treatment), and 3- and 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07715604.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.