Telehealth Behavioral Activation for Teens

March 18, 2024 updated by: Eric A Storch, Baylor College of Medicine
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral Activation (BA)
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
All participants will undergo behavioral activation treatment for 8-10 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire 9-modified for adolescents (PHQ-A)
Time Frame: During treatment (every session (week) 1-10)
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)
Time Frame: During treatment (every session (week) 1-10)
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)
Time Frame: Baseline (before treatment), post-treatment (session/week 11)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: Baseline (before treatment), post-treatment (session/week 11)
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)
Duke Social Support Index (DSSI)
Time Frame: Baseline (before treatment), post-treatment (session/week 11)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

University of Texas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Actual)

February 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-54233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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