NCT06273995

Brief Summary

Behavioral activation is one such empirically supported intervention. Derived from cognitive-behavioral therapy, a well-established treatment for depression, behavioral activation uses psychoeducation and skill-building to increase an individual's engagement in valued and enjoyable activities (e.g., socializing with family and friends, exercising, participating in a hobby) in order to improve depressive symptoms. Research has shown that behavioral activation is an effective intervention for depressed youth. Additionally, it has been shown as a promising intervention that can be conducted in a brief, virtual format and can be effectively implemented by both trained clinicians and trained, non-licensed interventionists. This project will provide Behavioral Activation for youth (12-17) experiencing depression or suicidal ideation who are currently enrolled in the Youth Depression Suicide Network study in Texas.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable depression

Timeline
43mo left

Started Mar 2024

Longer than P75 for not_applicable depression

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Mar 2024Dec 2029

First Submitted

Initial submission to the registry

February 13, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

5 years

First QC Date

February 13, 2024

Last Update Submit

July 18, 2025

Conditions

Keywords

behavioral activationdepressionadolescents

Outcome Measures

Primary Outcomes (3)

  • Patient Health Questionnaire 9-modified for adolescents (PHQ-A)

    Depression; 4-point Likert scale (0= Not at all; 3= Nearly every day), Score range 0-27 (higher scores indicate greater depression severity)

    During treatment (every session (week) 1-10)

  • Behavioral Activation for Depression-Short Form (BAD-SF)

    Behavioral Activation; 6-point Likert scale (0= Not al all; 6= Completely), Score range 0-54 (higher scores indicate higher activation)

    During treatment (every session (week) 1-10)

  • Dimensional Anhedonia Rating Scale (DARS)

    Anhedonia; 5-point Likert scale (0= Not at all; 4= Very much), Score range 0- 68 (higher scores indicate less anhedonia)

    Baseline (before treatment), post-treatment (session/week 11)

Secondary Outcomes (2)

  • Strengths and Difficulties Questionnaire (SDQ)

    Baseline (before treatment), post-treatment (session/week 11)

  • Duke Social Support Index (DSSI)

    Baseline (before treatment), post-treatment (session/week 11)

Study Arms (1)

Behavioral Activation (BA)

EXPERIMENTAL

Behavioral activation is one such empirically supported intervention. Derived from cognitive-behavioral therapy, a well-established treatment for depression, behavioral activation uses psychoeducation and skill-building to increase an individual's engagement in valued and enjoyable activities (e.g., socializing with family and friends, exercising, participating in a hobby) in order to improve depressive symptoms

Other: Behavioral Activation

Interventions

All participants will undergo behavioral activation treatment for 8-10 weeks

Behavioral Activation (BA)

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participants must be enrolled in the Texas Youth Depression Suicide Research Network (TX-YDSRN) Registry Study;
  • Be between the ages of 12- 18 or currently enrolled in high school;
  • Have a caregiver that is willing to participate in the program;
  • Be able to commit to weekly sessions for eight weeks;
  • Be currently experiencing depressive symptoms;
  • Be able to participate in telehealth services within the state of Texas;
  • Be willing to provide consent/assent (parents/legally authorized representative (LAR)/guardian or young adult participant, aged 18 or older, must be willing to provide consent; youth, aged 12-17, must be willing to provide assent);
  • Be able to read, write and speak English or Spanish sufficiently to understand the study procedures and provide written informed consent to participate in the study;
  • Be willing to dedicate appropriate time to complete scheduled study assessment and measures and attend intervention sessions (both parent/LAR/guardian and youth)
  • Be able to provide a reliable means of contact.

You may not qualify if:

  • Have an acute medical or psychological condition(s) that that would, in the judgment of the study medical clinician, make participation difficult or unsafe;
  • Have an acute medical or psychological condition(s) that would result in an inability to accurately complete study requirements (e.g., neurological conditions or significant neurodevelopmental concerns);
  • Have active psychotic or manic symptoms resulting in altered mental status and inability to provide assent or requiring immediate attention and/or higher level of intervention;
  • Have a parent/LAR/guardian who is deemed cognitively unable to provide consent (if youth participant, aged 12-17).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Related Publications (12)

  • Anvari MS, Hampton T, Tong MP, Kahn G, Triemstra JD, Magidson JF, Felton JW. Behavioral Activation Disseminated by Non-Mental Health Professionals, Paraprofessionals, and Peers: A Systematic Review. Behav Ther. 2023 May;54(3):524-538. doi: 10.1016/j.beth.2022.12.007. Epub 2022 Dec 23.

    PMID: 37088508BACKGROUND
  • Copeland WE, Alaie I, Jonsson U, Shanahan L. Associations of Childhood and Adolescent Depression With Adult Psychiatric and Functional Outcomes. J Am Acad Child Adolesc Psychiatry. 2021 May;60(5):604-611. doi: 10.1016/j.jaac.2020.07.895. Epub 2020 Aug 3.

    PMID: 32758528BACKGROUND
  • Curtin SC. State Suicide Rates Among Adolescents and Young Adults Aged 10-24: United States, 2000-2018. Natl Vital Stat Rep. 2020 Sep;69(11):1-10.

    PMID: 33054915BACKGROUND
  • Daly M. Prevalence of Depression Among Adolescents in the U.S. From 2009 to 2019: Analysis of Trends by Sex, Race/Ethnicity, and Income. J Adolesc Health. 2022 Mar;70(3):496-499. doi: 10.1016/j.jadohealth.2021.08.026. Epub 2021 Oct 16.

    PMID: 34663534BACKGROUND
  • Garnett MF, Curtin SC, Stone DM. Suicide Mortality in the United States, 2000-2020. NCHS Data Brief. 2022 Mar;(433):1-8.

    PMID: 35312475BACKGROUND
  • Kanter JW, Manos RC, Bowe WM, Baruch DE, Busch AM, Rusch LC. What is behavioral activation? A review of the empirical literature. Clin Psychol Rev. 2010 Aug;30(6):608-20. doi: 10.1016/j.cpr.2010.04.001.

    PMID: 20677369BACKGROUND
  • Lebrun-Harris LA, Ghandour RM, Kogan MD, Warren MD. Five-Year Trends in US Children's Health and Well-being, 2016-2020. JAMA Pediatr. 2022 Jul 1;176(7):e220056. doi: 10.1001/jamapediatrics.2022.0056. Epub 2022 Jul 5.

    PMID: 35285883BACKGROUND
  • McCauley E, Gudmundsen G, Schloredt K, Martell C, Rhew I, Hubley S, Dimidjian S. The Adolescent Behavioral Activation Program: Adapting Behavioral Activation as a Treatment for Depression in Adolescence. J Clin Child Adolesc Psychol. 2016;45(3):291-304. doi: 10.1080/15374416.2014.979933. Epub 2015 Jan 20.

    PMID: 25602170BACKGROUND
  • Reinert, M, Fritze, D. & Nguyen, T. (2021). "The State of Mental Health in America 2022"

    BACKGROUND
  • Ritschel, L. A., Ramirez, C. L., Cooley, J. L., & Craighead, W. E. (2016). Behavioral activation for major depression in adolescents: Results from a pilot study. Clinical Psychology: Science and Practice, 23, 39-57. https://doi.org/10.1111/cpsp.12140

    BACKGROUND
  • Trombello JM, South C, Sanchez A, Kahalnik F, Kennard BD, Trivedi MH. Two Trajectories of Depressive Symptom Reduction Throughout Behavioral Activation Teletherapy Among Underserved, Ethnically Diverse, Primary Care Patients: A VitalSign6 Report. Behav Ther. 2020 Nov;51(6):958-971. doi: 10.1016/j.beth.2020.01.002. Epub 2020 Jan 11.

    PMID: 33051037BACKGROUND
  • Uphoff E, Ekers D, Robertson L, Dawson S, Sanger E, South E, Samaan Z, Richards D, Meader N, Churchill R. Behavioural activation therapy for depression in adults. Cochrane Database Syst Rev. 2020 Jul 6;7(7):CD013305. doi: 10.1002/14651858.CD013305.pub2.

    PMID: 32628293BACKGROUND

MeSH Terms

Conditions

DepressionSuicideSelf-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Emily Bivins, B.S.

CONTACT

Eric Storch, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single group, open-label behavioral activation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 13, 2024

First Posted

February 23, 2024

Study Start

March 1, 2024

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

July 20, 2025

Record last verified: 2025-07

Locations