Builders of Emotional Regulation: Acceptability, Feasibility, and Effectiveness of the Group Unified Protocol for Treating Emotional Disorders in Online and In-Person Modalities
2026. július 15. frissítette: Liliana Pedro, University of Coimbra
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.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
54
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Coimbra District
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Coimbra, Coimbra District, Portugália, 3000-115
- Faculty of Psychology and Education Sciences
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Nem
Leírás
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: Unified Protocol in synchronous online group
Participants received 12 weekly 90-minute sessions of the Unified Protocol (UP) delivered in a synchronous online group format via Zoom.
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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.
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Aktív összehasonlító: Unified Protocol in in-person group
Participants received 12 weekly 90-minute sessions of the Unified Protocol (UP) delivered in in-person group format.
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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.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Changes from baseline in depressive symptoms
Időkeret: Baseline, week 12 (end of treatment), and 3- and 6-month follow-up
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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.
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Baseline, week 12 (end of treatment), and 3- and 6-month follow-up
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Changes from baseline in anxiety symptoms
Időkeret: Baseline, week 12 (end of treatment), and 3- and 6-month follow-up
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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.
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Baseline, week 12 (end of treatment), and 3- and 6-month follow-up
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Changes from baseline in severity and degree of impairment of depressive symptoms
Időkeret: Baseline, week 12 (end of treatment), and 3- and 6-month follow-up
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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.
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Baseline, week 12 (end of treatment), and 3- and 6-month follow-up
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Changes from baseline in severity and degree of impairment of anxiety symptoms
Időkeret: Baseline, week 12 (end of treatment), and 3- and 6-month follow-up
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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.
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Baseline, week 12 (end of treatment), and 3- and 6-month follow-up
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Changes from baseline in transdiagnostic mechanisms
Időkeret: Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
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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).
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Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
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Changes from baseline in emotional regulation
Időkeret: Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
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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.
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Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
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Changes from baseline in mindfulness
Időkeret: Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
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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.
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Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
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Changes from baseline in behavioral ativation
Időkeret: Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
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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.
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Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
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Changes from baseline in quality of life
Időkeret: Baseline, week 12 (end of treatment), and 3- and 6-month follow-up
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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.
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Baseline, week 12 (end of treatment), and 3- and 6-month follow-up
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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Group processes
Időkeret: Week 6 (mid-intervention) and week 12 (end of treatment)
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Measured with the Group Questionnaire (GQ).
CG comprises 30 items, rated on a 7-point Likert scale ranging from 0 (totally disagree) to 7 (totally agree).
Items are organized into three subscales: Positive bonding (higher scores indicating a stronger sense of belonging, cohesion, and empathy within the group); Positive Working (higher scores reflecting greater collaboration and agreement regarding therapeutic goals and tasks); and Negative Relationship (higher scores indicating greater trust and empathy and lower levels of distance among group members).
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Week 6 (mid-intervention) and week 12 (end of treatment)
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Changes in Therapeutic Alliance in group therapy
Időkeret: Week 6 (mid-treatment) and week 12 (end of treatment)
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Measured with Working Alliance Inventory - Short Revised - Group Version (WAI-SR-GV).
WAI-SR-GV comprises 12 items rated on a 5-point Likert scale ranging from 1 (seldom) to 5 (always), with higher scores indicating stronger therapeutic alliance.
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Week 6 (mid-treatment) and week 12 (end of treatment)
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Treatment acceptability and satisfaction
Időkeret: Week 12 (end of treatment), 3- and 6-months follow-up
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Measured with an adaptation of the Satisfaction with Treatment Questionnaire (STQ; Larsen et al., 1979).
The questionnaire comprises 13 items and was used to assess participants' satisfaction with the intervention, including perceived quality, usefulness of the techniques learned, discomfort experienced during the program, satisfaction with the program duration, and satisfaction with the group delivery format.
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Week 12 (end of treatment), 3- and 6-months follow-up
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Treatment adherence
Időkeret: Week 12 (end of treatment), 3- and 6- months follow-up
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Adherence indicators included the number of sessions attended, attendance rate across the intervention, and completion of homework assignments.
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Week 12 (end of treatment), 3- and 6- months follow-up
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Treatment usefulness
Időkeret: Week 12 (end of treatment), 3- and 6- months follow-up
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Measured with the Questionnaire for the Evaluation of the UP Components.
The questionnaire consists of nine items rated on a 10-point Likert scale ranging from 0 (Not at all) to 10 (Very much), with higher scores indicating greater perceived usefulness.
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Week 12 (end of treatment), 3- and 6- months follow-up
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Beliefs about group therapy
Időkeret: Baseline and week 12 (end of treatment)
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Measured with the Group Therapy Survey-Revised (GTS-R).
17-item Portuguese version validated by the research team (Pedro et al., 2026) was used.
Items are rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree) and assess beliefs about group therapy efficacy, non-endorsement of myths about group therapy, and comfort with group therapy.
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Baseline and week 12 (end of treatment)
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Attitudes toward online therapy
Időkeret: Baseline and week 12 (end of treatment)
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Measured with the Online Counseling Attitudes Scale (OCAS); it comprises 10-item, rated on a 6-point Likert scale (1 = strongly disagree to 6 = strongly agree) and assess the perceived value of and discomfort with online counseling.
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Baseline and week 12 (end of treatment)
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Attitudes toward in-person therapy
Időkeret: Baseline and week 12 (end of treatment)
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Measured with the Face-to-face Counseling Attitudes Scale (FCAS).
This self-report measure comprises 10 items, rated on a 6-point Likert scale (1 = strongly disagree to 6 = strongly agree) and assess the perceived value of and discomfort with face-to-face counseling.
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Baseline and week 12 (end of treatment)
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Együttműködők
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2023. május 4.
Elsődleges befejezés (Tényleges)
2025. augusztus 8.
A tanulmány befejezése (Tényleges)
2025. augusztus 8.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. július 15.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. július 15.
Első közzététel (Tényleges)
2026. július 20.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. július 20.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. július 15.
Utolsó ellenőrzés
2026. július 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 2021.04854.BD (Egyéb támogatási/finanszírozási szám: Fundação para a Ciência e a Tecnologia (FCT))
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
NEM
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