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

NCT07822074 | Completed DMC

• 1 other identifier: HE-2025-1410
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Anxiety

Keywords

neuroeducation; anxiety; Spanish; nCBT; neuroscience-informed

Outcome Measures

Primary Outcomes (1)

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

  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).

  From enrollment to the end of treatment at 4 weeks.

Secondary Outcomes (2)

• 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.

Other Outcomes (2)

• Credibility and Expectancy Questionnaire

  One measurement, at the end of treatment at 4 weeks.

• Spanish-Language Working Alliance Inventory-Short for Patients, Revised (WAI-S-P)

  One measurement, at the end of treatment at 4 weeks.

Study Arms (2)

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.

Behavioral: Brief group neuroeducation

Waitlist

NO INTERVENTION

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

Interventions

Brief group neuroeducation BEHAVIORAL

Brief, culturally-adapted, Spanish-language neuroscience-informed cognitive behavioral therapy (nCBT) neuroeducational group intervention lasting for three consecutive weekly sessions, each lasting 90 minutes. Participants complete homework assignments of tracking anxiety and physiological activation/interoceptive awareness between sessions.

Also known as: neuroscience-informed cognitive-behavior therapy, psychoeducation

Brief group neuroeducation on nCBT Waves Model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oregon State University: lead

Study Sites (2)

Centro San Juan Diego

Denver, Colorado, 80205, United States

Location

Commún Denver

Denver, Colorado, 80236, United States

Location

Related Publications (38)

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MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Thomas Field, PhD

  Oregon State University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with two groups, intervention and waitlist control. Participants are randomized into one of the two groups. The waitlisted condition receive the intervention after the study concludes.

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start: June 2, 2025
• Primary Completion: November 21, 2025
• Study Completion: December 15, 2025
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)