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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment called Behavioral Activation, which helps teens with depression by encouraging activities like socializing or exercising. The goal is to determine if this telehealth approach effectively reduces depression symptoms. Teens already enrolled in a specific study in Texas who experience depression or suicidal thoughts might be suitable if they can join online sessions for eight weeks.

As an unphased trial, this study offers teens a unique chance to access innovative telehealth treatment and contribute to important mental health research.

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 prior data suggests that this protocol is safe for teens with depression?

Studies have shown that Behavioral Activation (BA) effectively treats depression in young people. Research indicates that BA can be successfully delivered online and is well-received by teens. In trials, BA improved mood by encouraging activities that are fun and meaningful, such as socializing or exercising.

Evidence suggests BA is a safe option with few reports of negative side effects. It has been tested in various settings, including through an app in rural South Africa, and was found to be both practical and acceptable among users. These trials suggest that BA is a promising and safe way to help teens with depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Behavioral Activation for teen depression because it offers a fresh approach compared to traditional methods like medication and talk therapy. This technique, derived from cognitive-behavioral therapy, focuses on increasing a teen's engagement in activities they find enjoyable and meaningful, such as socializing or participating in hobbies. Unlike other treatments that might take weeks or focus on altering thought patterns, Behavioral Activation aims to quickly boost mood by encouraging positive actions, potentially leading to faster improvements in depressive symptoms. Additionally, the use of telehealth makes it more accessible, allowing teens to receive support from the comfort of their own homes.

What evidence suggests that Behavioral Activation might be an effective treatment for teen depression?

Research has shown that behavioral activation, the treatment under study in this trial, effectively treats depression in young people. Studies indicate that it reduces depressive symptoms by encouraging teens to engage in positive activities, such as hobbies or socializing. Reviews of past studies report good results in lowering depression symptoms. This method can be implemented quickly and online, making it easily accessible. Both trained therapists and other trained helpers have successfully used it. Overall, behavioral activation shows promise in helping teens feel better by involving them in activities they enjoy. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11618157/

Is behavioural activation an effective treatment for ... BA shows sufficient promise as an intervention for reducing depression symptoms in children and adolescents to justify the need for further RCTs.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6445819/

Behavioral activation for children and adolescents The RCTs reported largely positive outcomes. Meta-analysis of depression scores indicated that BA may be effective; however, high heterogeneity ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589979124000362

Behavioral activation to prevent depression in at-risk ... BA interventions aims to reduce depressive symptoms by increasing engagement in positive activities and reducing behaviors that sustain depression (Dimidjian ...

4. acamh.onlinelibrary.wiley.com acamh.onlinelibrary.wiley.com/doi/10.1002/jcv2.70030

Evaluating Brief Behavioural Activation for depression in ... Brief Behavioural Activation (Brief BA) is a successful, values-based intervention for managing depression in neurotypical adolescents. This ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06273995

NCT06273995 | Telehealth Behavioral Activation for Teens Research has shown that behavioral activation is an effective intervention for depressed youth. Additionally, it has been shown as a promising intervention that ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2949732925000730

A Behavioral Activation Digital Intervention Incorporating ... The Kuamsha app is a feasible and acceptable treatment for depression among adolescents in rural South Africa.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6107350/

The Adolescent Behavioral Activation Program This study aimed to examine implementation feasibility and initial treatment outcomes of a behavioral activation based treatment for adolescent depression.