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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

2026년 7월 15일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

54

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
행동: 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.
활성 비교기: Unified Protocol in in-person group
Participants received 12 weekly 90-minute sessions of the Unified Protocol (UP) delivered in in-person group format.
행동: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Changes from baseline in depressive symptoms
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Changes from baseline in severity and degree of impairment of depressive symptoms
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Group processes
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Coimbra

협력자

Fundação para a Ciência e a Tecnologia

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 5월 4일

기본 완료 (실제)

2025년 8월 8일

연구 완료 (실제)

2025년 8월 8일

연구 등록 날짜

최초 제출

2026년 7월 15일

QC 기준을 충족하는 최초 제출

2026년 7월 15일

처음 게시됨 (실제)

2026년 7월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 15일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2021.04854.BD (기타 보조금/기금 번호: Fundação para a Ciência e a Tecnologia (FCT))

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Unified Protocol에 대한 임상 시험

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스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Cameroon

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다