Telehealth Behavioral Activation for Teen Depression

Overseen By Eric Storch, Ph.D.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Acute medical, Psychological, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 10 weeks

250 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on behavioral therapy for depression, so it's best to discuss your medications with the study team.

What data supports the effectiveness of the treatment Behavioral Activation for teen depression?

Research shows that Behavioral Activation (BA) is effective in reducing depression symptoms, and internet-based versions can improve access to treatment. Studies have found that BA can be successfully delivered online, making it a promising option for adolescents who may not have access to traditional therapy. ^{1 2 3 4 5}

Is telehealth behavioral activation safe for treating teen depression?

Behavioral activation, including its internet-based versions, is generally considered safe for treating depression in both adults and young people. Studies have shown it to be feasible and acceptable, with no significant safety concerns reported. ^{2 3 6 7 8}

How is Behavioral Activation treatment for teen depression different from other treatments?

Behavioral Activation (BA) is unique because it focuses on helping teens understand the link between their activities and mood, encouraging them to engage in goal-directed behaviors to improve their mood. Unlike traditional in-person therapy, this treatment can be delivered via the internet, making it more accessible to teens who might not otherwise receive formal treatment. ^{1 2 3 4 9}

Eligibility Criteria

This trial is for teens aged 12-17 in Texas who are experiencing depression or suicidal thoughts and are part of the Youth Depression Suicide Network study. It's designed to help them by teaching skills to increase enjoyable activities.

Inclusion Criteria

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

Be willing to provide consent/assent

Have a caregiver that is willing to participate in the program

Exclusion Criteria

Have an acute medical or psychological condition(s) 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)

I do not have severe mental health symptoms that affect my ability to understand or make decisions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Behavioral Activation therapy virtually to improve depressive symptoms

10 weeks

10 virtual sessions (weekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 virtual session

Treatment Details

Interventions

• Behavioral Activation

Trial Overview The trial tests Behavioral Activation, a therapy from cognitive-behavioral therapy that helps improve mood by increasing engagement in positive activities like socializing, exercising, and hobbies through virtual sessions.

Participant Groups

Group I: Behavioral Activation (BA) Experimental Treatment 1 Intervention

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

Behavioral Activation is already approved in United States, China, European Union for the following indications:

Approved in United States as Behavioral Activation Therapy for:

• Depression
• Anxiety in older adults undergoing cardiac procedures

Approved in China as Behavioral Activation Therapy for:

• Loneliness in older adults
• Depression

Approved in European Union as Behavioral Activation Therapy for:

• Depression
• Anxiety

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

University of Texas

Collaborator

Trials

193

Recruited

143,000+

Findings from Research

A web-based behavioral activation intervention called Bounce Back Now (BBN) was developed to help adolescents with depression, showing promising feasibility based on usability evaluations with 24 adolescents and preliminary data from 2,000 disaster-affected youth.

The intervention received positive feedback from users and demonstrated moderate levels of access, suggesting that web-based approaches could effectively improve treatment access for adolescents who might not seek traditional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility assessment of a brief, web-based behavioral activation intervention for adolescents with depressed mood. Davidson, TM., Yuen, EK., Felton, JW., et al.[2014]

A study involving seven patients with bipolar depression analyzed 2,480 hours of self-reported activities, revealing that movement-related activities were linked to the highest pleasure scores, suggesting that physical activity may enhance mood.

The research demonstrated the feasibility of using a data-driven approach to identify behavioral patterns, which could inform therapists and lead to the development of digital solutions for behavioral activation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data-Driven Learning in High-Resolution Activity Sampling From Patients With Bipolar Depression: Mixed-Methods Study. Rohani, DA., Tuxen, N., Quemada Lopategui, A., et al.[2020]

Internet-based behavioral activation (iBA) significantly reduces depressive symptoms compared to inactive control groups, with a moderate effect size based on a systematic review of 12 randomized controlled trials involving 3274 participants.

iBA also leads to reductions in anxiety and improvements in quality of life and activation, although no significant effects on depressive symptoms were observed at the 6-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Based Behavioral Activation for Depression: Systematic Review and Meta-Analysis. Alber, CS., Krämer, LV., Rosar, SM., et al.[2023]

A feasibility trial involving 32 adolescents with mild-to-moderate depression showed that both therapist-guided and self-guided internet-delivered behavioral activation (I-BA) were acceptable and had large effect sizes in reducing depression symptoms, with Cohen's d values of 2.43 and 2.23, respectively.

No serious adverse events were reported, indicating that I-BA is a safe intervention, and the study's positive outcomes suggest that a larger randomized controlled trial could effectively evaluate its efficacy compared to standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapist-guided and self-guided internet-delivered behavioural activation for adolescents with depression: a randomised feasibility trial. Grudin, R., Ahlen, J., Mataix-Cols, D., et al.[2023]

A study involving 128 participants with major depressive episodes found that a Health Action Process Approach (HAPA)-based internet-delivered behavioral activation intervention significantly reduced clinician-rated depressive symptoms compared to a control group, with a strong effect size at 8 weeks (d = 0.79).

The intervention group also showed improvements in self-rated depressive symptoms, behavioral activation, and various motivational and volitional outcomes, indicating that the HAPA framework effectively enhances treatment for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Web-Based Behavioral Activation Intervention on Depressive Symptoms, Activation, Motivation, and Volition: Results of a Randomized Controlled Trial. Mueller-Weinitschke, C., Bengel, J., Baumeister, H., et al.[2023]

A systematic review of nine randomized controlled trials involving 2157 adult participants found that guided Internet-based behavioral activation (BA) is effective in reducing depression and anxiety, showing promising results compared to other treatments like physical activity and psychoeducation.

While Internet-based BA demonstrated non-inferior efficacy to other behavioral therapies and mindfulness, the overall quality of evidence was low to moderate, indicating a need for more rigorous studies to confirm its effectiveness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. Huguet, A., Miller, A., Kisely, S., et al.[2019]

Behavioral activation (BA) shows promise as an effective treatment for anxiety and depression in children and adolescents, with 19 studies reviewed, including 4 randomized-controlled trials that reported positive outcomes.

While initial evidence supports the feasibility and acceptability of BA, the studies have small sample sizes and are primarily conducted in high-income settings, indicating a need for larger, culturally adapted trials in diverse environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation for children and adolescents: a systematic review of progress and promise. Martin, F., Oliver, T.[2022]

In a 9-week randomized controlled trial involving 78 patients with major depression, the study found that both expected mastery and pleasure from behavioral activation tasks were strongly correlated with improvements in depression severity.

The results suggest that the anticipation of pleasure from planned activities may be more important for the effectiveness of behavioral activation than the actual pleasure experienced, highlighting the role of meaningful engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? Furukawa, TA., Imai, H., Horikoshi, M., et al.[2019]

The study involved 10 mental health clinicians and 8 teens who participated in design activities over 10 weeks to create an internet-based intervention for managing teen depression using behavioral activation (BA).

Both teens and clinicians expressed a desire for internet-based support for BA to complement in-person therapy, but they also raised concerns about safety, privacy, and the need for moderation in online groups, highlighting the importance of addressing these issues in the design of digital mental health tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing Asynchronous Remote Support for Behavioral Activation in Teenagers With Depression: Formative Study. Bhattacharya, A., Nagar, R., Jenness, J., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility assessment of a brief, web-based behavioral activation intervention for adolescents with depressed mood. [2014]

2. Canada pubmed.ncbi.nlm.nih.gov

Data-Driven Learning in High-Resolution Activity Sampling From Patients With Bipolar Depression: Mixed-Methods Study. [2020]

3. Canada pubmed.ncbi.nlm.nih.gov

Internet-Based Behavioral Activation for Depression: Systematic Review and Meta-Analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Therapist-guided and self-guided internet-delivered behavioural activation for adolescents with depression: a randomised feasibility trial. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of a Web-Based Behavioral Activation Intervention on Depressive Symptoms, Activation, Motivation, and Volition: Results of a Randomized Controlled Trial. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Behavioral activation for children and adolescents: a systematic review of progress and promise. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? [2019]

9. Canada pubmed.ncbi.nlm.nih.gov

Designing Asynchronous Remote Support for Behavioral Activation in Teenagers With Depression: Formative Study. [2021]