Builders of Emotional Regulation: Acceptability, Feasibility, and Effectiveness of the Group Unified Protocol for Treating Emotional Disorders in Online and In-Person Modalities
15 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
54
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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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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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Changes from baseline in depressive symptoms
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Changes from baseline in severity and degree of impairment of depressive symptoms
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Group processes
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Patrocinador
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Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
4 de maio de 2023
Conclusão Primária (Real)
8 de agosto de 2025
Conclusão do estudo (Real)
8 de agosto de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
15 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
15 de julho de 2026
Primeira postagem (Real)
20 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2021.04854.BD (Número de outro subsídio/financiamento: Fundação para a Ciência e a Tecnologia (FCT))
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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