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

2026年7月15日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

54

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 葡萄牙
    • Coimbra District
      • Coimbra、Coimbra District、葡萄牙、3000-115
        • Faculty of Psychology and Education Sciences

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
行为的：Unified Protocol
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.
有源比较器：Unified Protocol in in-person group
Participants received 12 weekly 90-minute sessions of the Unified Protocol (UP) delivered in in-person group format.
行为的：Unified Protocol
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Changes from baseline in depressive symptoms
大体时间：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.
Baseline, week 12 (end of treatment), and 3- and 6-month follow-up
Changes from baseline in anxiety symptoms
大体时间：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.
Baseline, week 12 (end of treatment), and 3- and 6-month follow-up

次要结果测量

结果测量
措施说明
大体时间
Changes from baseline in severity and degree of impairment of depressive symptoms
大体时间：Baseline, week 12 (end of treatment), and 3- and 6-month follow-up
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.
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
大体时间：Baseline, week 12 (end of treatment), and 3- and 6-month follow-up
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.
Baseline, week 12 (end of treatment), and 3- and 6-month follow-up
Changes from baseline in transdiagnostic mechanisms
大体时间：Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
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).
Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
Changes from baseline in emotional regulation
大体时间：Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
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.
Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
Changes from baseline in mindfulness
大体时间：Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
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.
Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
Changes from baseline in behavioral ativation
大体时间：Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
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.
Baseline, week 6, week 12 (end of treatment), and 3- and 6-month follow-up
Changes from baseline in quality of life
大体时间：Baseline, week 12 (end of treatment), and 3- and 6-month follow-up
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.
Baseline, week 12 (end of treatment), and 3- and 6-month follow-up

其他结果措施

结果测量
措施说明
大体时间
Group processes
大体时间：Week 6 (mid-intervention) and week 12 (end of treatment)
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).
Week 6 (mid-intervention) and week 12 (end of treatment)
Changes in Therapeutic Alliance in group therapy
大体时间：Week 6 (mid-treatment) and week 12 (end of treatment)
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.
Week 6 (mid-treatment) and week 12 (end of treatment)
Treatment acceptability and satisfaction
大体时间：Week 12 (end of treatment), 3- and 6-months follow-up
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.
Week 12 (end of treatment), 3- and 6-months follow-up
Treatment adherence
大体时间：Week 12 (end of treatment), 3- and 6- months follow-up
Adherence indicators included the number of sessions attended, attendance rate across the intervention, and completion of homework assignments.
Week 12 (end of treatment), 3- and 6- months follow-up
Treatment usefulness
大体时间：Week 12 (end of treatment), 3- and 6- months follow-up
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.
Week 12 (end of treatment), 3- and 6- months follow-up
Beliefs about group therapy
大体时间：Baseline and week 12 (end of treatment)
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.
Baseline and week 12 (end of treatment)
Attitudes toward online therapy
大体时间：Baseline and week 12 (end of treatment)
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.
Baseline and week 12 (end of treatment)
Attitudes toward in-person therapy
大体时间：Baseline and week 12 (end of treatment)
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.
Baseline and week 12 (end of treatment)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Coimbra

合作者

Fundação para a Ciência e a Tecnologia

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年5月4日

初级完成 (实际的)

2025年8月8日

研究完成 (实际的)

2025年8月8日

研究注册日期

首次提交

2026年7月15日

首先提交符合 QC 标准的

2026年7月15日

首次发布 (实际的)

2026年7月20日

研究记录更新

最后更新发布 (实际的)

2026年7月20日

上次提交的符合 QC 标准的更新

2026年7月15日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2021.04854.BD (其他赠款/资助编号：Fundação para a Ciência e a Tecnologia (FCT))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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