跳至主要内容
临床试验/NCT07822074
NCT07822074已完成不适用

Randomized Controlled Trial of Spanish Brief Group Neuroscience-Informed Cognitive-Behavior Therapy for Anxiety

Oregon State University2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年6月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
2
主要终点
PROMIS Anxiety Short Form 6a - Spanish (PROMIS-A-SF-S)

研究概览

简要总结

The goal of this clinical trial is to learn if a brief neuroscience-informed cognitive-behavior therapy (nCBT) group intervention works to reduce anxiety for Spanish-speaking Latino/a adults. The main questions it aims to answer are:

  • To what extent does group neuroeducation on the nCBT Waves Model reduce anxiety compared to a waitlist condition?
  • To what extent does group neurooeducation on the nCBT Waves Model enhance body awareness and self-compassion compared to a waitlist condition?
  • To what extent is anxiety reduction predicted by enhancements in body awareness and self-compassion, alongside the working alliance and credibility/expectancy? Researchers will compare outcomes for the brief nCBT group intervention to a waitlist control condition to see if the intervention results in superior anxiety reduction compared to the effect of time.

Participants will:

  • Attend three weekly psychoeducational group sessions.
  • Complete homework assignments following group meetings such as tracking anxiety symptoms at home.
  • Complete questionnaires about anxiety as well as body awareness, self-compassion, the therapeutic relationship, and participant perceptions of the intervention's credibility and belief in a positive outcome.

详细描述

Anxiety is an anticipatory reaction to perceived threats, and may involve behavioral, cognitive, emotional, and physiological responses (Abend et al., 2020). Among U.S. Latino/a adults, 12.9% reported having an anxiety diagnosis (Powla et al., 2026). Yet the proportion of U.S. mental health facilities offering treatment in Spanish declined from 40.5% in 2014 to 33.3% in 2019, a net loss of 1,163 facilities (Pro et al., 2022). More recent data show that fewer than 10% of Latino/a adults received counseling in the prior year, while 5% reported needing therapy but were prohibited by cost (Powla et al., 2026). A treatment gap therefore exists from the confluence of limited Spanish-language services alongside financial and other structural barriers. Brief, community-based interventions that are culturally and linguistically responsive may help expand access to anxiety support for diverse Latino/a communities.

Cultural adaptation of an intervention improves fit with a population while preserving its core principles. Bernal et al. (1995) identified eight dimensions of fit, including language, metaphors, content, concepts, goals, methods, and context. Barrera et al. (2013) described adaptation as an iterative process of gathering information, testing modifications, and refining the intervention. A meta-analysis of 13 randomized controlled trials (RCTs) found a small but significant benefit of culturally adapted psychotherapy for depression and anxiety among Latino/a participants (Nelson et al., 2020). An RCT by Alegría et al. (2025) found that a 10-session Spanish-language culturally adapted psychoeducational intervention reduced anxiety and depression relative to enhanced usual care in a predominantly Latino/a adult sample. Cultural adaptation of a psychoeducational intervention thus holds promise in treating anxiety for Latino/a adults.

Psychoeducation is an intervention that combines teaching information about mental health symptoms and treatment with skills practice. Neuroscience-informed psychoeducation, or neuroeducation, is a content-specific variant of psychoeducation that uses accessible information about brain structure and function to help clients understand their experiences and practice regulation strategies (Miller, 2016). Although emerging research has begun to examine neuroeducation, it has received limited direct evaluation as a distinct clinical intervention (Rezapour et al., 2025). Because neuroeducation retains the same structure of psychoeducation, the broader evidence supporting psychoeducation provides indirect empirical foundation for use.

Group psychoeducation interventions for Spanish-speaking adults may retain effectiveness even when delivered in brief, time-limited formats. Peris-Baquero et al. (2025) reported that a five-session psychoeducational group intervention had similar efficacy to an eight-session format in reducing anxiety. Zhou et al. (2025) found that a brief CBT psychoeducational group reduced anxiety with gains maintained at three-month follow-up. Collado et al. (2014) found that a brief behavioral activation intervention delivered in Spanish improved treatment outcomes among Latino/a adults, with high rates of attendance and satisfaction. Brief psychoeducational group interventions for Spanish speakers, including CBT groups, thus appear both efficient and effective.

Neuroscience-informed Cognitive-Behavior Therapy Neuroscience-informed cognitive-behavior therapy (nCBT; Field et al., 2015, 2025) integrates dual processing theory (Kahneman, 2003) with rational emotive behavior therapy (Ellis, 1991) to explain how preconscious, bottom-up limbic processing (Wave1) and conscious, top-down cognitive appraisal (Wave2) each contribute to behavioral, emotional, and physiological responses to activating events. The model targets both waves therapeutically, helping clients increase awareness of and self-compassion toward reflective responses while developing reappraisal skills. The intervention includes neuroeducation on the Waves model.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18 years or older.
  • identification as Latino/a.
  • Spanish fluency.
  • Ability to attend three group sessions.

排除标准

  • Less than 18 years of age.
  • identification with non-Latino/a ethnic group.
  • not fluent in Spanish.
  • Inability to attend three group sessions.

研究组 & 干预措施

Brief group neuroeducation on nCBT Waves Model

Experimental

Brief, culturally-adapted, Spanish-language neuroscience-informed cognitive behavioral therapy neuroeducational group intervention on the nCBT Waves Model lasting for three weekly sessions, each 90 minutes.

干预措施: Brief group neuroeducation (Behavioral)

Waitlist

No Intervention

Waitlisted participants, who do not receive any intervention until the study period concludes.

结局指标

主要结局

PROMIS Anxiety Short Form 6a - Spanish (PROMIS-A-SF-S)

时间窗: From enrollment to the end of treatment at 4 weeks.

The PROMIS-A-SF-S (Patient-Reported Outcomes Measurement Information System, 2012; Teresi et al., 2016) measures anxiety symptoms over the past 7 days with higher scores indicating greater anxiety severity. Participants rate each item on a five-point Likert scale from 1 (never) and 5 (always). The PROMIS-A-SF has strong internal consistency (Cronbach's α = .97).

次要结局

  • Body Awareness Questionnaire - Spanish Version (BAQ-S)(From enrollment to the end of treatment at 4 weeks.)
  • Self-Compassion Scale - Short Form, Spanish Version (SCS-SF-S)(From enrollment to the end of treatment at 4 weeks.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验