DepressionNCT06273995
Telehealth Behavioral Activation for Teens
A study testing Behavioral Activation in people with Depression and Suicide and Self-harm, run by Baylor College of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depression, Suicide and Self-harm, Depression in Adolescence
- What is being tested?
- Behavioral Activation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 1 Dec 2029
- Phase
- Interventional
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Eric Storch, Ph.D., 713-798-3080, eric.storch@bcm.edu
About this study
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.
Read the detailed description
Rates of youth depression and suicide are rising worldwide and present a critical public health problem. Between 2007 and 2018, rates of fatal suicide among U.S. youth and young adults increased by 57.4%, becoming the second leading cause of all deaths for Americans between the ages of 10 and 34 in 2020. Similarly, between 2009 and 2019, rates of past year major depressive episodes among adolescents in the United States increased from 8.1% to 15.8% (roughly 1 in 6). Despite these high rates of suicide and depression, Texas is rated 51st in access to mental healthcare in the United States. As untreated youth depression tends to persist and has been related to poorer functioning in adulthood, there is a need to increase access to empirically supported treatment for depressed adolescents.
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.
- Conditions
- Depression, Suicide and Self-harm, Depression in Adolescence, Depression Mild, Depression Moderate, Depression Severe
- Being tested
- Behavioral Activation
- Keywords
- behavioral activation, depression, adolescents
- Medical subject headings
- Depression, Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationOther
All participants will undergo behavioral activation treatment for 8-10 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Behavioral Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: Baseline (before treatment), post-treatment (session/week 11)
Secondary outcomes (2)
Strengths and Difficulties Questionnaire (SDQ)
Behavioral screening; 3-point Likert scale (0= Not at all; 2= Certainly True), Score range 0-40 (higher scores indicate more difficulties)
Measured: Baseline (before treatment), post-treatment (session/week 11)
Duke Social Support Index (DSSI)
Social Support; Multiple Likert scales ((1 = None; 3= More than 2 people)(1= Hardly ever; 3= Most of the time)), Score range 10 -20 (higher scores indicate a higher level of social support)
Measured: Baseline (before treatment), post-treatment (session/week 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, open-label behavioral activation
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas
- Responsible party
- Principal investigator, Eric A Storch, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273995
- Sponsor's protocol ID
- H-54233
- Status last verified
- Aug 2026
- First submitted
- 13 Feb 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37088508Copeland 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.
PubMed 32758528Curtin 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.
PubMed 33054915Daly 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.
PubMed 34663534Garnett MF, Curtin SC, Stone DM. Suicide Mortality in the United States, 2000-2020. NCHS Data Brief. 2022 Mar;(433):1-8.
PubMed 35312475Kanter 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.
PubMed 20677369Lebrun-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.
PubMed 35285883McCauley 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.
PubMed 25602170Reinert, M, Fritze, D. & Nguyen, T. (2021). "The State of Mental Health in America 2022"
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
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.
PubMed 33051037Uphoff 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.
PubMed 32628293