Telehealth Behavioral Activation for Teens

Depression Clinical Trial

Official title:

Telehealth Behavioral Activation for Teens

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06273995
• Other study ID #: H-54233
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 1, 2029

Study information

• Verified date: March 2024
• Source: Baylor College of Medicine
• Contact: Emily Bivins, B.S.
• Phone: 713-798-1709
• Email: emily.bivins[@]bcm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 1, 2029
• Est. primary completion date: March 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Participants must be enrolled in the Texas Youth Depression Suicide Research Network (TX-YDSRN) Registry Study;

2. Be between the ages of 12- 18 or currently enrolled in high school;

3. Have a caregiver that is willing to participate in the program;

4. Be able to commit to weekly sessions for eight weeks;

5. Be currently experiencing depressive symptoms;

6. Be able to participate in telehealth services within the state of Texas;

7. 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);

8. 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;

9. Be willing to dedicate appropriate time to complete scheduled study assessment and measures and attend intervention sessions (both parent/LAR/guardian and youth)

10. Be able to provide a reliable means of contact.

Exclusion Criteria:

1. Have an acute medical or psychological condition(s) that that would, in the judgment of the study medical clinician, make participation difficult or unsafe;

2. 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);

3. 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;

4. Have a parent/LAR/guardian who is deemed cognitively unable to provide consent (if youth participant, aged 12-17).

Related Conditions & MeSH terms

• Depression
• Depression in Adolescence
• Depression Mild
• Depression Moderate
• Depression Severe
• Depressive Disorder
• Suicide
• Suicide and Self-harm

Intervention

Other:
• Behavioral Activation
All participants will undergo behavioral activation treatment for 8-10 weeks

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	University of Texas

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. Erratum In: JAMA Pediatr. 2022 Apr 4;:null. JAMA Pediatr. 2023 Mar 1;177(3):323. — View Citation

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. — View Citation

Reinert, 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. Erratum In: Behav Ther. 2021 Nov;52(6):1558. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)	Baseline (before treatment), post-treatment (session/week 11)
Secondary	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)	Baseline (before treatment), post-treatment (session/week 11)