Builders of Emotional Regulation: Acceptability, Feasibility, and Effectiveness of the Group Unified Protocol for Treating Emotional Disorders in Online and In-Person Modalities
15 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
54
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Coimbra District
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Coimbra, Coimbra District, Portugal, 3000-115
- Faculty of Psychology and Education Sciences
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Changes from baseline in depressive symptoms
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Changes from baseline in severity and degree of impairment of depressive symptoms
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Group processes
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
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Publicaties en nuttige links
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
4 mei 2023
Primaire voltooiing (Werkelijk)
8 augustus 2025
Studie voltooiing (Werkelijk)
8 augustus 2025
Studieregistratiedata
Eerst ingediend
15 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
15 juli 2026
Eerst geplaatst (Werkelijk)
20 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
15 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2021.04854.BD (Ander subsidie-/financieringsnummer: Fundação para a Ciência e a Tecnologia (FCT))
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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