NCT06163599

Brief Summary

The primary aim of our study is to determine the effectiveness of an transdiagnostic telenovela video intervention in reducing anxiety and depressive symptoms using a pre/post-test design with Spanish-speaking Latinxs.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

November 22, 2023

Last Update Submit

July 22, 2024

Conditions

Anxiety Disorders

Keywords

anxiety disordertransdiagnostic TreatmentUnited Protocol

Outcome Measures

Primary Outcomes (1)

  • Generalized Anxiety Disorder-7

    Assesses the presence of anxiety symptoms in the past two weeks. Lower scores mean better outcomes. Scores range from 0 to 35.

    Two weeks

Study Arms (1)

Telenovela Arm

EXPERIMENTAL

The UP telenovela (which is the experimental treatment arm) constitutes of nine videos depicting the main character, Esperanza, who is struggling with anxiety and depression, undergoing therapy involving the UP, and completing worksheets relating to the weekly therapy sessions.

Behavioral: Transdiagnostic Telenovela Intervention

Interventions

Transdiagnostic Telenovela InterventionBEHAVIORAL

The intervention constitutes nine videos depicting the main character, Esperanza, who is struggling with anxiety and depression, undergoing therapy involving the a trandiagnostic treatment, and completing worksheets relating to the weekly therapy sessions.

Telenovela Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Identify as Latinx
  • Prefer behavioral health services in Spanish
  • Meet the DSM criteria for any mild to moderate anxiety disorder
  • Ownership of a smartphone

You may not qualify if:

  • Suicidality
  • Psychosis
  • Bipolar disorder
  • Severe anxiety disorders
  • Severe depressive disorders
  • Homicidality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Clinica @ the UNR Psychological Services Center

Reno, Nevada, 89557, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2023

First Posted

December 11, 2023

Study Start

July 1, 2024

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

July 24, 2024

Record last verified: 2024-07

Locations

US(1)