Clinical trial NCT06273995: Telehealth Behavioral Activation for Teens
Official title: Telehealth Behavioral Activation for Teens
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Suicide and Self-harm
Depression in Adolescence
Depression Mild
Depression Moderate
Depression Severe
Keywords: behavioral activation
depression
adolescents
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: University of Texas
First posted: 2024-02-23
Enrollment: 250
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group, open-label behavioral activation
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Patient Health Questionnaire 9-modified for adolescents (PHQ-A)
timeFrame: During treatment (every session (week) 1-10)
measure: Behavioral Activation for Depression-Short Form (BAD-SF)
timeFrame: During treatment (every session (week) 1-10)
measure: Dimensional Anhedonia Rating Scale (DARS)
timeFrame: Baseline (before treatment), post-treatment (session/week 11)
Secondary outcomes:
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Baseline (before treatment), post-treatment (session/week 11)
measure: Duke Social Support Index (DSSI)
timeFrame: Baseline (before treatment), post-treatment (session/week 11)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
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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.
citation: Reinert, M, Fritze, D. & Nguyen, T. (2021). "The State of Mental Health in America 2022"
citation: 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
citation: 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.
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