AnxietyNCT07822074
Randomized Controlled Trial of Spanish Brief Group Neuroscience-Informed Cognitive-Behavior Therapy for Anxiety
A study testing Brief group neuroeducation in people with Anxiety, run by Oregon State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Brief group neuroeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jun 2025to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 years or older.
- identification as Latino/a.
- Spanish fluency.
- Ability to attend three group sessions.
Who cannot join
- Less than 18 years of age.
- identification with non-Latino/a ethnic group.
- not fluent in Spanish.
- Inability to attend three group sessions.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Centro San Juan Diego
Denver, Colorado, 80205
Commún Denver
Denver, Colorado, 80236
About this study
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.
Read more
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.
Read the detailed description
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.
nCBT has preliminary research support. In an uncontrolled study, counselors and clients described nCBT as credible and reported perceived improvement, particularly for anxiety and depression (Field et al., 2016). A feasibility study subsequently demonstrated that adherence and fidelity to core nCBT components could be rated consistently, supporting the model's capacity for standardized delivery (Field et al., 2019). A more recent study found evidence for anxiety reduction over a longer treatment duration of 20 sessions (Martin et al., 2026). Efficacy testing is needed as these studies did not include random assignment nor waitlist comparison.
Body Awareness and Self-Compassion in nCBT The Waves Model conceptualizes body awareness and self-compassion as regulatory processes associated with anxiety. Body awareness refers to interoceptive attentiveness to physiological experiences. Participants practice noticing and describing activation before responding. This adaptive noticing differs from anxiety sensitivity or threat-focused vigilance, in which arousal is interpreted catastrophically. Maladaptive sensitivity and vigilance can be associated with higher anxiety (Clemente et al., 2024), including among Latino/a adults (Zvolensky et al., 2015). The Waves model thus trains participants in a specific version of interoceptive body awareness that enhances positive experiences and regulation. Interoceptive sensibility has been found to mediate changes in anxiety (De Lima-Araujo et al., 2022).
Self-compassion involves responding to self-experiences with kindness rather than harsh intropunitive judgment, recognizing suffering as a common human experience (Neff, 2003). It may help tolerate activation while mitigating shame, self-criticism, and avoidance. A meta-analysis of randomized trials found that self-compassion interventions increased self-compassion and reduced anxiety, with stronger effects in group formats (Ferrari et al., 2019).
Measuring both body awareness and self-compassion in addition to anxiety as outcomes therefore tests two theoretically important constructs that are associated with anxiety reduction. Currently no studies have examined interventions that enhance body awareness and self-compassion as mechanisms for anxiety reduction among Spanish-speaking populations.
Working Alliance, Credibility, and Expectancy Outcomes in a brief group may depend not only on what is taught but also on how participants experience the intervention. Working alliance in groups refers to the participant-facilitator bond and agreement on goals and tasks. Positive working alliances are associated with improved outcomes in adult psychotherapy, and both member-leader and member-group alliance are associated with better group outcomes (Lo Coco et al., 2022).
Participant perceptions of treatment credibility and outcomes expectancy are modestly associated with positive therapeutic outcomes in meta-analytic literature (Constantino et al., 2018a; Constantino et al., 2018b). An intervention's credibility refers to whether an intervention appears logical and convincing. Expectancy is the belief that improvement will occur. The research team theorized that these constructs may be particularly relevant when evaluating an unfamiliar neuroscience-informed mode that is delivered in a culturally adapted format. Resonant explanations may support engagement and out-of-session practice. Earlier nCBT participants reported favorable credibility and expectancy (Field et al., 2016). These constructs therefore warranted examination as potential predictors rather than causal mechanisms.
Purpose of Study The purpose of this study was to evaluate whether a nCBT neuroeducational group can reduce anxiety in a scalable brief format suited to Spanish-speaking communities with limited access to counseling. No study has tested a culturally adapted, Spanish-language version of the nCBT Waves Model. This study additionally evaluated the effectiveness of a Spanish-language nCBT neuroeducational group intervention in enhancing body awareness and self-compassion. The study also examined whether treatment credibility, outcomes expectancy, and working alliance predicted change. The study addressed three research questions: (1) To what extent does group neuroeducation on the nCBT Waves Model reduce anxiety compared to a waitlist condition? (2) To what extent does group neurooeducation on the nCBT Waves Model enhance body awareness and self-compassion compared to a waitlist condition? (3) To what extent is anxiety reduction predicted by enhancements in body awareness and self-compassion, alongside the working alliance and credibility/expectancy? The study tested the following hypotheses: (1) Receiving group neuroeducation on the nCBT Waves Model will reduce anxiety to a greater degree than a waitlist condition; (2) Receiving group neuroeducation on the nCBT Waves Model will enhance body awareness and self-compassion to a greater degree than a waitlist condition; (3) A model consisting of body awareness, self-compassion, working alliance, and credibility and expectancy will predict anxiety reduction following nCBT group neuroeducation.
Design To test the hypotheses, the research team will conduct a randomized controlled trial with wait-list control and use stratified randomization to assign participants to the intervention or waitlist control condition. The study will be conducted in a naturalistic community setting, strengthening ecological validity and relevance. We obtained Institutional Review Board approval prior to study initiation.
Participants The research team will confirm eligibility and collect baseline measures prior to stratified randomization. At pre-registration, interested community members complete a signed informed consent document, a demographics questionnaire, and anxiety screening measure (PROMIS Anxiety Short Form, Spanish Version or PROMIS-A-SF-S; Teresi et al., 2016). The study has four inclusion criteria: (a) age 18 years or older, (b) identification as Latino/a, (c) Spanish fluency, (c) ability to attend three group sessions.
Randomized Assignment The research team will screen participants for eligibility at two community sites and enrolled them in the study over the course of a six month study period. The team will implement stratified randomization using gender, age, and baseline anxiety as variables to ensure consistency between groups. This approach strengthens internal validity and reduces the likelihood of baseline imbalances due to chance (Sidani \& O'Rourke, 2022).
To support single-blinding, the research team will not disclose assigned condition at the time of inclusion and waitlist participants will not know their assignment. Because of the short study duration (28 days) and facilitation of multiple concurrent groups, community members were unlikely to know their assignment on the basis of conversations with other members. Wait-list participants will receive the group intervention only after the initial study period ends.
The nCBT Waves Model Psychoeducation Intervention The intervention consists of three 90-minute neuroeducational group sessions that follow three sequential phases from the nCBT treatment manual (Beeson et al., 2017). Session 1 corresponds with the first phase, Attending to Physiological Reactions, and focuses on developing therapeutic rapport, assessing needs, and conceptualizing treatment. Session 2 corresponds with the second phase, Build the Brain from the Bottom-Up, and focuses on helping participants prevent and regulate, rather than reactively respond to, Wave1 physiological activation and dysregulation. Session 3 corresponds with the third phase, Connect Bottom to the Top, and introduces strategies for tolerating activation and reappraising Wave1 responses.
Intervention Fidelity To support intervention fidelity, an original nCBT model co-author will provide a two-day, 12-hour virtual nCBT training to the counselor who delivered the intervention. The co-author will observe the counselor's demonstration with a simulated client to determine competency and readiness using an nCBT treatment fidelity measure (Field et al., 2019). The co-author will also review the group materials before the study began, and will meet with the counselor on a regular basis throughout the study to review implementation and monitor fidelity.
Cultural Adaptation and Piloting To prepare study materials for participant use, the research team refined the intervention through several stages in alignment with Barrera et al. (2013). First, the team developed group outlines and handouts that aligned most closely with the nCBT Waves Model. Second, the team evaluated the comprehensibility and cultural relevance of all materials and translated them into Spanish. Third, the team assessed all eight dimensions of cultural fit per Bernal et al. (1995), such as language, metaphors, content, concepts, goals, methods, and context. Fourth, Spanish-speaking clinicians outside the study then reviewed the translated materials and handouts, and the team revised them to incorporate feedback. Fifth, the team conducted a final check of cultural and linguistic fit by piloting the curriculum and handouts with community members.
The research team also piloted the instrument packet. Spanish-speaking doctoral counseling students reviewed materials and completed the instruments to provide feedback. The team adjusted materials post-piloting by reducing the number of items in the instrument packet. For example, the team selected a briefer body awareness instrument.
Power Analysis The research team conducted a power analysis using G*Power 3.1.9.4 (Faul et al., 2007) to determine the minimum sample size required for a large effect size with 80% power at an alpha level of .05, for three tests: (a) repeated-measures ANCOVA, (b) Welch's independent samples t-test, and (c) multiple regression with four predictors. The team selected a large effect because psychotherapy studies with a waitlist condition often yield large between-group effects (Cuijpers et al., 2024). Minimum required sample sizes were 52 for ANCOVA, 42 for t-test, and 36 for multiple regression.
Procedure The research team will recruit participants in partnership with two community-based agencies serving Spanish-speaking communities in the Mountain West region of the United States. The team will distribute recruitment information through flyers posted in high-traffic community locations. In addition, the team will ask agency staff to share flyers with established community members and partner organizations. The flyers will provide information about the group structure, study duration, participant incentives, and contact information. The team will hold orientation meetings at both sites to explain the study purpose, potential benefits, risks, expectations, and eligibility criteria. Participants will receive contact information for the research team in the event of an emergency.
Instruments Participants will complete Spanish-language instruments that measured anxiety, body awareness, self-compassion, working alliance, and intervention credibility and outcomes expectancy. They will complete the anxiety, body awareness, and self-compassion measures at the end of each session. They will complete the working alliance and intervention credibility/expectancy measures at the end of the third and final session.
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).
Body Awareness Questionnaire - Spanish Version (BAQ-S) The BAQ-S (Sánchez-Sánchez et al., 2025) measures sensitivity to normal, non-emotive bodily processes. Participants rate items on a seven-point Likert scale from 1 (not at all true of me) to 7 (very true of me). Higher scores indicate greater body awareness. The Spanish version has good internal consistency (Cronbach's α = .82).
Self-Compassion Scale - Short Form, Spanish Version (SCS-SF-S) The SCS-SF-S (García-Campayo et al., 2014) measures perceived self-compassion during difficult moments. Participants rate items on a five-point Likert scale from 1 (almost never) to 5 (almost always). Higher scores indicate greater self-compassion. The Spanish version has good internal consistency (Cronbach's α = .85).
Spanish-Language Working Alliance Inventory-Short for Patients, Revised (WAI-S-P) The WAI-S-P (Andrade-González \& Fernandez-Liria, 2016) measures the therapeutic alliance from the participant's perspective. Participants rate items on a seven-point Likert scale from 1 (seldom/never) to 7 (always). The Spanish version has strong internal consistency (Cronbach's α = .93).
Credibility and Expectancy Questionnaire The CEQ (Devilly \& Borkovec, 2000) contains six items measuring treatment credibility and outcome expectancy. The study used the nCBT-adapted version of the CEQ from Field et al. (2016). Participants rate six items on a 10-point Likert scale from 1 (not at all) to 10 (very much). Participants rate two items as percentages from 0 to 100%. The percentage items are converted to a 1-10 scale to compute a total score for the instrument, consistent with Field et al. (2016). Because no formally validated Spanish version currently appears in the published literature, the research team translated the CEQ into Spanish. The English version has strong internal consistency (Cronbach's α = .90; Devilly \& Borkovec, 2000).
Data Analysis Plan The research team will assign participants a unique identification number to preserve anonymity. The team will clean and prepare the database prior to conducting statistical analyses. The team will use imputation to determine scores of missing data points, following the multiple imputation (MICE) method that uses data from all other participants at the same interval to predict the missing value. A repeated-measures ANCOVA will compare endpoint PROMIS-A-SF-S anxiety scores between groups while controlling for baseline anxiety. A complementary Welch's independent-samples t-test will compare baseline-to-endpoint anxiety change scores (ΔPROMIS-A-SF-S) between groups. For body awareness and self-compassion outcomes, a Welch's independent-samples t-test will compare between-group endpoint scores. The team will calculate calculated effect sizes using Hedges' g for t-tests and partial η² for ANCOVA. A multiple linear regression analysis will test whether changes in body awareness (ΔBAQ-S), self-compassion (ΔSCS-SF-S), working alliance (WAI-S-P), and credibility and expectancy (CEQ) predict anxiety change (ΔPROMIS-A-SF-S).
Assumption Checks The research team will examine assumptions before conducting the ANCOVA, t-test, and regression. These include Shapiro-Wilk distribution of residuals, Levene's test for homogeneity of variance, Q-Q plots for deviation from normality, homogeneity-of-regression-slopes assumption, and correlations, variance inflation factor (VIF) values, tolerance statistics, and Durbin-Watson values.
- Conditions
- Anxiety
- Being tested
- Brief group neuroeducation
- Keywords
- neuroeducation, anxiety, Spanish, nCBT, neuroscience-informed
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief group neuroeducationBehavioural
Also called neuroscience-informed cognitive-behavior therapy, psychoeducation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Brief group neuroeducation |
| Waitlist | No intervention | Waitlisted participants, who do not receive any intervention until the study period concludes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of treatment at 4 weeks.
Secondary outcomes (2)
Body Awareness Questionnaire - Spanish Version (BAQ-S)
The BAQ-S (Sánchez-Sánchez et al., 2025) measures sensitivity to normal, non-emotive bodily processes. Participants rate items on a seven-point Likert scale from 1 (not at all true of me) to 7 (very true of me). Higher scores indicate greater body awareness. The Spanish version has good internal consistency (Cronbach's α = .82).
Measured: From enrollment to the end of treatment at 4 weeks.
Self-Compassion Scale - Short Form, Spanish Version (SCS-SF-S)
The SCS-SF-S (García-Campayo et al., 2014) measures perceived self-compassion during difficult moments. Participants rate items on a five-point Likert scale from 1 (almost never) to 5 (almost always). Higher scores indicate greater self-compassion. The Spanish version has good internal consistency (Cronbach's α = .85).
Measured: From enrollment to the end of treatment at 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start2 Jun 2025
- Primary completion21 Nov 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Field, PhD, Study chair, Oregon State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822074
- Sponsor's protocol ID
- HE-2025-1410
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants did not give consent for their individual data to be publicly shared.
Publications
Zvolensky MJ, Bakhshaie J, Garza M, Valdivieso J, Ortiz M, Bogiaizian D, Robles Z, Vujanovic A. Anxiety sensitivity and subjective social status in relation to anxiety and depressive symptoms and disorders among Latinos in primary care. J Anxiety Disord. 2015 May;32:38-45. doi: 10.1016/j.janxdis.2015.03.006. Epub 2015 Mar 21.
PubMed 25847548Zhou X, Ma J, Zhou J, Kong Y, Liu Z, Wang S, Xia S, Qu C. Effectiveness of brief group cognitive behavioural therapy on improving mental health outcomes - A systematic review and meta-analysis. Psychiatry Res. 2025 Sep;351:116590. doi: 10.1016/j.psychres.2025.116590. Epub 2025 Jun 9.
PubMed 40532304Teresi JA, Ocepek-Welikson K, Kleinman M, Ramirez M, Kim G. Measurement Equivalence of the Patient Reported Outcomes Measurement Information System(R) (PROMIS(R)) Anxiety Short Forms in Ethnically Diverse Groups. Psychol Test Assess Model. 2016;58(1):183-219.
PubMed 28649483Sidani S, O'Rourke H. Quantitative and Qualitative Strategies to Strengthen Internal Validity in Randomized Trials. Can J Nurs Res. 2022 Mar;54(1):87-95. doi: 10.1177/0844562120974197. Epub 2020 Nov 29.
PubMed 33249887Sanchez-Sanchez LC, Klysing A, Steij Stalbrand I, Lundberg T. Validation of the Spanish Version of the Body Awareness Questionnaire (BAQ) and an Exploration of Its Relationship to Meditation and Embodiment Variables. Healthcare (Basel). 2025 Mar 14;13(6):628. doi: 10.3390/healthcare13060628.
PubMed 40150478Rezapour T, McLean KL, Psederska E, Maleki KN, Ekhtiari H, Vassileva J. Neuroscience-informed psychoeducation for addiction: a conceptual and feasibility study. Front Psychiatry. 2025 Feb 12;16:1527828. doi: 10.3389/fpsyt.2025.1527828. eCollection 2025.
PubMed 40012711Patient-Reported Outcomes Measurement Information System. (2012). PROMIS Short Form v1.0 - Anxiety 6a - Spanish [Measurement instrument]. HealthMeasures.
Pro G, Brown C, Rojo M, Patel J, Flax C, Haynes T. Downward National Trends in Mental Health Treatment Offered in Spanish: State Differences by Proportion of Hispanic Residents. Psychiatr Serv. 2022 Nov 1;73(11):1232-1238. doi: 10.1176/appi.ps.202100614. Epub 2022 May 3.
PubMed 35502519Powla P, Maxey N, Griffin T, Pabon-Rodriguez F. Mental Health Treatment Utilization Among Hispanic and Latino Adults in the United States: The Role of Immigration Status, Acculturation, and Socioeconomic Disadvantage. J Immigr Minor Health. 2026 Apr 1. doi: 10.1007/s10903-026-01896-x. Online ahead of print.
PubMed 41920428Peris-Baquero O, Fadrique-Jimenez A, Prieto-Rollan I, Camacho-Guerrero L, Martinez-Lluesma S, Osma J. Brief Versions of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Spanish Primary Care Service: Results of a Feasibility Pilot Study. J Clin Psychol. 2025 Nov;81(11):1103-1117. doi: 10.1002/jclp.70016. Epub 2025 Jul 16.
PubMed 40667676Nelson, A., Ayers, E., Sun, F., & Zhang, A. (2020). Culturally adapted psychotherapeutic interventions for Latino depression and anxiety: A meta-analysis. Research on Social Work Practice, 30(4), 368-381. https://doi.org/10.1177/1049731519899991
Neff, K. D. (2003). The development and validation of a scale to measure self-compassion. Self and Identity, 2(3), 223-250. https://doi.org/10.1080/15298860309027
Miller, R. (2016). Neuroeducation: Integrating brain-based psychoeducation into clinical practice. Journal of Mental Health Counseling, 38(2), 103-115. https://doi.org/10.17744/mehc.38.2.02
Martin, G. C., Manjarrez, A., Tower, J., & Field, T. A. (2026). Longitudinal time-series repeated measures study of neuroscience-informed cognitive behavioral therapy for anxiety. Manuscript submitted for publication.
Lo Coco G, Gullo S, Albano G, Brugnera A, Fluckiger C, Tasca GA. The alliance-outcome association in group interventions: A multilevel meta-analysis. J Consult Clin Psychol. 2022 Jun;90(6):513-527. doi: 10.1037/ccp0000735. Epub 2022 May 16.
PubMed 35575726
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Spanish Brief Group Neuroscience-Informed Cognitive-Behavior Therapy for Anxiety
- ClinicalTrials.gov ID
- NCT07822074
- Acronym / sponsor ID
- HE-2025-1410
- Conditions
- Anxiety
- Keywords
- neuroeducation, anxiety, Spanish, nCBT, neuroscience-informed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Oregon State UniversityUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
nCBT has preliminary research support. In an uncontrolled study, counselors and clients described nCBT as credible and reported perceived improvement, particularly for anxiety and depression (Field et al., 2016). A feasibility study subsequently demonstrated that adherence and fidelity to core nCBT components could be rated consistently, supporting the model's capacity for standardized delivery (Field et al., 2019). A more recent study found evidence for anxiety reduction over a longer treatment duration of 20 sessions (Martin et al., 2026). Efficacy testing is needed as these studies did not include random assignment nor waitlist comparison.
Body Awareness and Self-Compassion in nCBT The Waves Model conceptualizes body awareness and self-compassion as regulatory processes associated with anxiety. Body awareness refers to interoceptive attentiveness to physiological experiences. Participants practice noticing and describing activation before responding. This adaptive noticing differs from anxiety sensitivity or threat-focused vigilance, in which arousal is interpreted catastrophically. Maladaptive sensitivity and vigilance can be associated with higher anxiety (Clemente et al., 2024), including among Latino/a adults (Zvolensky et al., 2015). The Waves model thus trains participants in a specific version of interoceptive body awareness that enhances positive experiences and regulation. Interoceptive sensibility has been found to mediate changes in anxiety (De Lima-Araujo et al., 2022).
Self-compassion involves responding to self-experiences with kindness rather than harsh intropunitive judgment, recognizing suffering as a common human experience (Neff, 2003). It may help tolerate activation while mitigating shame, self-criticism, and avoidance. A meta-analysis of randomized trials found that self-compassion interventions increased self-compassion and reduced anxiety, with stronger effects in group formats (Ferrari et al., 2019).
Measuring both body awareness and self-compassion in addition to anxiety as outcomes therefore tests two theoretically important constructs that are associated with anxiety reduction. Currently no studies have examined interventions that enhance body awareness and self-compassion as mechanisms for anxiety reduction among Spanish-speaking populations.
Working Alliance, Credibility, and Expectancy Outcomes in a brief group may depend not only on what is taught but also on how participants experience the intervention. Working alliance in groups refers to the participant-facilitator bond and agreement on goals and tasks. Positive working alliances are associated with improved outcomes in adult psychotherapy, and both member-leader and member-group alliance are associated with better group outcomes (Lo Coco et al., 2022).
Participant perceptions of treatment credibility and outcomes expectancy are modestly associated with positive therapeutic outcomes in meta-analytic literature (Constantino et al., 2018a; Constantino et al., 2018b). An intervention's credibility refers to whether an intervention appears logical and convincing. Expectancy is the belief that improvement will occur. The research team theorized that these constructs may be particularly relevant when evaluating an unfamiliar neuroscience-informed mode that is delivered in a culturally adapted format. Resonant explanations may support engagement and out-of-session practice. Earlier nCBT participants reported favorable credibility and expectancy (Field et al., 2016). These constructs therefore warranted examination as potential predictors rather than causal mechanisms.
Purpose of Study The purpose of this study was to evaluate whether a nCBT neuroeducational group can reduce anxiety in a scalable brief format suited to Spanish-speaking communities with limited access to counseling. No study has tested a culturally adapted, Spanish-language version of the nCBT Waves Model. This study additionally evaluated the effectiveness of a Spanish-language nCBT neuroeducational group intervention in enhancing body awareness and self-compassion. The study also examined whether treatment credibility, outcomes expectancy, and working alliance predicted change. The study addressed three research questions: (1) To what extent does group neuroeducation on the nCBT Waves Model reduce anxiety compared to a waitlist condition? (2) To what extent does group neurooeducation on the nCBT Waves Model enhance body awareness and self-compassion compared to a waitlist condition? (3) To what extent is anxiety reduction predicted by enhancements in body awareness and self-compassion, alongside the working alliance and credibility/expectancy? The study tested the following hypotheses: (1) Receiving group neuroeducation on the nCBT Waves Model will reduce anxiety to a greater degree than a waitlist condition; (2) Receiving group neuroeducation on the nCBT Waves Model will enhance body awareness and self-compassion to a greater degree than a waitlist condition; (3) A model consisting of body awareness, self-compassion, working alliance, and credibility and expectancy will predict anxiety reduction following nCBT group neuroeducation.
Design To test the hypotheses, the research team will conduct a randomized controlled trial with wait-list control and use stratified randomization to assign participants to the intervention or waitlist control condition. The study will be conducted in a naturalistic community setting, strengthening ecological validity and relevance. We obtained Institutional Review Board approval prior to study initiation.
Participants The research team will confirm eligibility and collect baseline measures prior to stratified randomization. At pre-registration, interested community members complete a signed informed consent document, a demographics questionnaire, and anxiety screening measure (PROMIS Anxiety Short Form, Spanish Version or PROMIS-A-SF-S; Teresi et al., 2016). The study has four inclusion criteria: (a) age 18 years or older, (b) identification as Latino/a, (c) Spanish fluency, (c) ability to attend three group sessions.
Randomized Assignment The research team will screen participants for eligibility at two community sites and enrolled them in the study over the course of a six month study period. The team will implement stratified randomization using gender, age, and baseline anxiety as variables to ensure consistency between groups. This approach strengthens internal validity and reduces the likelihood of baseline imbalances due to chance (Sidani \& O'Rourke, 2022).
To support single-blinding, the research team will not disclose assigned condition at the time of inclusion and waitlist participants will not know their assignment. Because of the short study duration (28 days) and facilitation of multiple concurrent groups, community members were unlikely to know their assignment on the basis of conversations with other members. Wait-list participants will receive the group intervention only after the initial study period ends.
The nCBT Waves Model Psychoeducation Intervention The intervention consists of three 90-minute neuroeducational group sessions that follow three sequential phases from the nCBT treatment manual (Beeson et al., 2017). Session 1 corresponds with the first phase, Attending to Physiological Reactions, and focuses on developing therapeutic rapport, assessing needs, and conceptualizing treatment. Session 2 corresponds with the second phase, Build the Brain from the Bottom-Up, and focuses on helping participants prevent and regulate, rather than reactively respond to, Wave1 physiological activation and dysregulation. Session 3 corresponds with the third phase, Connect Bottom to the Top, and introduces strategies for tolerating activation and reappraising Wave1 responses.
Intervention Fidelity To support intervention fidelity, an original nCBT model co-author will provide a two-day, 12-hour virtual nCBT training to the counselor who delivered the intervention. The co-author will observe the counselor's demonstration with a simulated client to determine competency and readiness using an nCBT treatment fidelity measure (Field et al., 2019). The co-author will also review the group materials before the study began, and will meet with the counselor on a regular basis throughout the study to review implementation and monitor fidelity.
Cultural Adaptation and Piloting To prepare study materials for participant use, the research team refined the intervention through several stages in alignment with Barrera et al. (2013). First, the team developed group outlines and handouts that aligned most closely with the nCBT Waves Model. Second, the team evaluated the comprehensibility and cultural relevance of all materials and translated them into Spanish. Third, the team assessed all eight dimensions of cultural fit per Bernal et al. (1995), such as language, metaphors, content, concepts, goals, methods, and context. Fourth, Spanish-speaking clinicians outside the study then reviewed the translated materials and handouts, and the team revised them to incorporate feedback. Fifth, the team conducted a final check of cultural and linguistic fit by piloting the curriculum and handouts with community members.
The research team also piloted the instrument packet. Spanish-speaking doctoral counseling students reviewed materials and completed the instruments to provide feedback. The team adjusted materials post-piloting by reducing the number of items in the instrument packet. For example, the team selected a briefer body awareness instrument.
Power Analysis The research team conducted a power analysis using G*Power 3.1.9.4 (Faul et al., 2007) to determine the minimum sample size required for a large effect size with 80% power at an alpha level of .05, for three tests: (a) repeated-measures ANCOVA, (b) Welch's independent samples t-test, and (c) multiple regression with four predictors. The team selected a large effect because psychotherapy studies with a waitlist condition often yield large between-group effects (Cuijpers et al., 2024). Minimum required sample sizes were 52 for ANCOVA, 42 for t-test, and 36 for multiple regression.
Procedure The research team will recruit participants in partnership with two community-based agencies serving Spanish-speaking communities in the Mountain West region of the United States. The team will distribute recruitment information through flyers posted in high-traffic community locations. In addition, the team will ask agency staff to share flyers with established community members and partner organizations. The flyers will provide information about the group structure, study duration, participant incentives, and contact information. The team will hold orientation meetings at both sites to explain the study purpose, potential benefits, risks, expectations, and eligibility criteria. Participants will receive contact information for the research team in the event of an emergency.
Instruments Participants will complete Spanish-language instruments that measured anxiety, body awareness, self-compassion, working alliance, and intervention credibility and outcomes expectancy. They will complete the anxiety, body awareness, and self-compassion measures at the end of each session. They will complete the working alliance and intervention credibility/expectancy measures at the end of the third and final session.
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).
Body Awareness Questionnaire - Spanish Version (BAQ-S) The BAQ-S (Sánchez-Sánchez et al., 2025) measures sensitivity to normal, non-emotive bodily processes. Participants rate items on a seven-point Likert scale from 1 (not at all true of me) to 7 (very true of me). Higher scores indicate greater body awareness. The Spanish version has good internal consistency (Cronbach's α = .82).
Self-Compassion Scale - Short Form, Spanish Version (SCS-SF-S) The SCS-SF-S (García-Campayo et al., 2014) measures perceived self-compassion during difficult moments. Participants rate items on a five-point Likert scale from 1 (almost never) to 5 (almost always). Higher scores indicate greater self-compassion. The Spanish version has good internal consistency (Cronbach's α = .85).
Spanish-Language Working Alliance Inventory-Short for Patients, Revised (WAI-S-P) The WAI-S-P (Andrade-González \& Fernandez-Liria, 2016) measures the therapeutic alliance from the participant's perspective. Participants rate items on a seven-point Likert scale from 1 (seldom/never) to 7 (always). The Spanish version has strong internal consistency (Cronbach's α = .93).
Credibility and Expectancy Questionnaire The CEQ (Devilly \& Borkovec, 2000) contains six items measuring treatment credibility and outcome expectancy. The study used the nCBT-adapted version of the CEQ from Field et al. (2016). Participants rate six items on a 10-point Likert scale from 1 (not at all) to 10 (very much). Participants rate two items as percentages from 0 to 100%. The percentage items are converted to a 1-10 scale to compute a total score for the instrument, consistent with Field et al. (2016). Because no formally validated Spanish version currently appears in the published literature, the research team translated the CEQ into Spanish. The English version has strong internal consistency (Cronbach's α = .90; Devilly \& Borkovec, 2000).
Data Analysis Plan The research team will assign participants a unique identification number to preserve anonymity. The team will clean and prepare the database prior to conducting statistical analyses. The team will use imputation to determine scores of missing data points, following the multiple imputation (MICE) method that uses data from all other participants at the same interval to predict the missing value. A repeated-measures ANCOVA will compare endpoint PROMIS-A-SF-S anxiety scores between groups while controlling for baseline anxiety. A complementary Welch's independent-samples t-test will compare baseline-to-endpoint anxiety change scores (ΔPROMIS-A-SF-S) between groups. For body awareness and self-compassion outcomes, a Welch's independent-samples t-test will compare between-group endpoint scores. The team will calculate calculated effect sizes using Hedges' g for t-tests and partial η² for ANCOVA. A multiple linear regression analysis will test whether changes in body awareness (ΔBAQ-S), self-compassion (ΔSCS-SF-S), working alliance (WAI-S-P), and credibility and expectancy (CEQ) predict anxiety change (ΔPROMIS-A-SF-S).
Assumption Checks The research team will examine assumptions before conducting the ANCOVA, t-test, and regression. These include Shapiro-Wilk distribution of residuals, Levene's test for homogeneity of variance, Q-Q plots for deviation from normality, homogeneity-of-regression-slopes assumption, and correlations, variance inflation factor (VIF) values, tolerance statistics, and Durbin-Watson values.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Brief group neuroeducation on nCBT Waves Model | Experimental | Behavioral: Brief group neuroeducationBrief, 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. |
| Waitlist | No intervention | –Waitlisted participants, who do not receive any intervention until the study period concludes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years or older.
- identification as Latino/a.
- Spanish fluency.
- Ability to attend three group sessions.
Key exclusion criteria (4 listed)
- Less than 18 years of age.
- identification with non-Latino/a ethnic group.
- not fluent in Spanish.
- Inability to attend three group sessions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief group neuroeducationAlso: neuroscience-informed cognitive-behavior therapy, psychoeducationBrief, 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. | Behavioural | Brief group neuroeducation on nCBT Waves Model |
Primary outcome
PROMIS Anxiety Short Form 6a - Spanish (PROMIS-A-SF-S)
Time frame: 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).
2 secondary outcomes
Body Awareness Questionnaire - Spanish Version (BAQ-S)
Time frame: From enrollment to the end of treatment at 4 weeks.
Self-Compassion Scale - Short Form, Spanish Version (SCS-SF-S)
Time frame: From enrollment to the end of treatment at 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 25847548Zvolensky MJ, Bakhshaie J, Garza M, Valdivieso J, Ortiz M, Bogiaizian D, Robles Z, Vujanovic A. Anxiety sensitivity and subjective social status in relation to anxiety and depressive symptoms and disorders among Latinos in primary care. J Anxiety Disord. 2015 May;32:38-45. doi: 10.1016/j.janxdis.2015.03.006. Epub 2015 Mar 21.
- Background: PubMed 40532304Zhou X, Ma J, Zhou J, Kong Y, Liu Z, Wang S, Xia S, Qu C. Effectiveness of brief group cognitive behavioural therapy on improving mental health outcomes - A systematic review and meta-analysis. Psychiatry Res. 2025 Sep;351:116590. doi: 10.1016/j.psychres.2025.116590. Epub 2025 Jun 9.
- Background: PubMed 28649483Teresi JA, Ocepek-Welikson K, Kleinman M, Ramirez M, Kim G. Measurement Equivalence of the Patient Reported Outcomes Measurement Information System(R) (PROMIS(R)) Anxiety Short Forms in Ethnically Diverse Groups. Psychol Test Assess Model. 2016;58(1):183-219.
- Background: PubMed 33249887Sidani S, O'Rourke H. Quantitative and Qualitative Strategies to Strengthen Internal Validity in Randomized Trials. Can J Nurs Res. 2022 Mar;54(1):87-95. doi: 10.1177/0844562120974197. Epub 2020 Nov 29.
- Background: PubMed 40150478Sanchez-Sanchez LC, Klysing A, Steij Stalbrand I, Lundberg T. Validation of the Spanish Version of the Body Awareness Questionnaire (BAQ) and an Exploration of Its Relationship to Meditation and Embodiment Variables. Healthcare (Basel). 2025 Mar 14;13(6):628. doi: 10.3390/healthcare13060628.
- Background: PubMed 40012711Rezapour T, McLean KL, Psederska E, Maleki KN, Ekhtiari H, Vassileva J. Neuroscience-informed psychoeducation for addiction: a conceptual and feasibility study. Front Psychiatry. 2025 Feb 12;16:1527828. doi: 10.3389/fpsyt.2025.1527828. eCollection 2025.
- BackgroundPatient-Reported Outcomes Measurement Information System. (2012). PROMIS Short Form v1.0 - Anxiety 6a - Spanish [Measurement instrument]. HealthMeasures.
- Background: PubMed 35502519Pro G, Brown C, Rojo M, Patel J, Flax C, Haynes T. Downward National Trends in Mental Health Treatment Offered in Spanish: State Differences by Proportion of Hispanic Residents. Psychiatr Serv. 2022 Nov 1;73(11):1232-1238. doi: 10.1176/appi.ps.202100614. Epub 2022 May 3.
- Background: PubMed 41920428Powla P, Maxey N, Griffin T, Pabon-Rodriguez F. Mental Health Treatment Utilization Among Hispanic and Latino Adults in the United States: The Role of Immigration Status, Acculturation, and Socioeconomic Disadvantage. J Immigr Minor Health. 2026 Apr 1. doi: 10.1007/s10903-026-01896-x. Online ahead of print.
- Background: PubMed 40667676Peris-Baquero O, Fadrique-Jimenez A, Prieto-Rollan I, Camacho-Guerrero L, Martinez-Lluesma S, Osma J. Brief Versions of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Spanish Primary Care Service: Results of a Feasibility Pilot Study. J Clin Psychol. 2025 Nov;81(11):1103-1117. doi: 10.1002/jclp.70016. Epub 2025 Jul 16.
- BackgroundNelson, A., Ayers, E., Sun, F., & Zhang, A. (2020). Culturally adapted psychotherapeutic interventions for Latino depression and anxiety: A meta-analysis. Research on Social Work Practice, 30(4), 368-381. https://doi.org/10.1177/1049731519899991
- BackgroundNeff, K. D. (2003). The development and validation of a scale to measure self-compassion. Self and Identity, 2(3), 223-250. https://doi.org/10.1080/15298860309027
- Individual participant dataSharing planned: No. Participants did not give consent for their individual data to be publicly shared.
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Field, PhD study chair
Oregon State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief group neuroeducation in people with Anxiety, run by Oregon State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Anxiety Short Form 6a - Spanish (PROMIS-A-SF-S) (time frame: From enrollment to the end of treatment at 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07822074, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.