148 Participants Needed

Stress Dynamics for Depression

EB
Overseen ByEmily Belleau
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how stress affects the brain in teenage girls who may be at risk for major depressive disorder (MDD) due to a parent's history with the condition. Researchers use computer tasks (referred to as Computer Task Manipulation) and brain scans to examine how stress might alter brain activity and whether these changes can predict future depression. The trial is designed for right-handed girls aged 13-15 who speak English fluently and have a biological parent with a history of depression. Participants must have a cell phone for assessments. Those with certain medical devices, metal in their bodies, or who are currently experiencing depression are not eligible. As an unphased trial, this study provides a unique opportunity to contribute to understanding stress and brain activity in teens.

Will I have to stop taking my current medications?

The trial requires that participants have no lifetime use of any psychotropic medication (drugs that affect mood, perception, or behavior). If you are currently taking such medications, you would not be eligible to participate.

What prior data suggests that this computer task manipulation is safe?

Research has shown that digital mental health tools, such as computer-based tasks, are generally safe for most people. In one study, 4.8% of participants reported worsening depression due to the digital program, a small but significant figure. However, other studies indicate that these tools can help reduce symptoms of depression and anxiety and improve quality of life.

Some participants might feel mentally tired, especially if they already use the internet excessively. Overall, evidence suggests that computer tasks are generally well-tolerated in mental health care.12345

Why are researchers excited about this trial?

Researchers are excited about the Computer Task Manipulation for depression because it offers a non-invasive and innovative approach to understanding and potentially treating the condition. Unlike traditional treatments like antidepressants or psychotherapy, which focus on chemical imbalances or behavioral adjustments, this method uses computer tasks and fMRI brain scans to directly observe and influence brain activity. This approach could reveal new insights into how stress impacts the brain and ultimately lead to more targeted and effective interventions for depression.

What evidence suggests that this computer task manipulation is effective for stress dynamics in depression?

Research has shown that computer-based therapies, such as the Computer Task Manipulation tested in this trial, effectively treat depression. For example, one study found that computer-assisted cognitive-behavioral therapy (CBT) matched the effectiveness of traditional therapy. Another study reported that depressive symptoms decreased by nearly 50% after just eight weeks of this treatment. Digital mental health tools have significantly reduced depression and anxiety, particularly in low- and middle-income countries. These findings suggest that using computer tasks to study stress in teenagers at risk for depression could offer important insights and potentially effective treatments.678910

Who Is on the Research Team?

EB

Emily Belleau, Ph.D.

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

This trial is for female adolescents aged 13-15 who are right-handed, have normal vision and hearing (or corrected to normal), can consent in English, and own a cell phone. They must also have a biological parent with a history of major depressive episodes.

Inclusion Criteria

I am fluent in English.
I have a personal cell phone to use for health assessments.
I can sign a consent form myself or electronically.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Clinical diagnostic interview and assessments conducted virtually or in-person

1 session
1 visit (virtual or in-person)

fMRI and Initial Monitoring

fMRI brain scan and two-week monitoring using smartphone and smartwatch technology

2 weeks
1 visit (in-person for fMRI)

6-Month Follow-up

Diagnostic interview and assessments with two-week monitoring using smartphone and smartwatch

2 weeks
1 visit (in-person or virtual)

12-Month Follow-up

Diagnostic interview and assessments with two-week monitoring using smartphone and smartwatch

2 weeks
1 visit (in-person or virtual)

18-Month Follow-up

Diagnostic interview and assessments with two-week monitoring using smartphone and smartwatch

2 weeks
1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Computer Task Manipulation
Trial Overview The study investigates how stress affects the brain in young females at high risk for depression due to parental history. It uses neuroimaging, smartphone and smartwatch tracking of real-world stress responses, and behavioral tasks.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Computer Task ManipulationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials
221
Recruited
22,500+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Citations

Efficacy of computer- and/or internet-based cognitive ...The results of this meta-analysis support the efficacy of computer- and/or internet-based CBT self-help programs with minimal weekly guidance up to only 10 min
Neuroimaging changes in major depression with brief ...Our observed mean improvement of 49% by MADRS criteria and 48% by BDI criteria in the CCBT intervention after eight weeks is a fairly typical ...
Internet-based cognitive behavior therapy for major ...Intent-to-treat analyses revealed significantly greater reductions in depressive symptoms in iCBT compared with MAC participants, using both the self-report ...
Effectiveness of Digital Mental Health Tools to Reduce ...Conclusions: Digital mental health tools are moderately to highly effective in reducing depression and anxiety symptoms in LMICs. Thus, they ...
Computer-Based Intervention for DepressionResearch shows that computer-assisted cognitive-behavior therapy (CBT) for depression can be as effective as traditional therapy. Programs like Good Days Ahead ...
The Safety of Digital Mental Health InterventionsAt follow-up, 14.8% of the participants showed worse depression. Subjective deterioration attributed to the program was at 4.8%. A total of 4 AEs ( ...
Computer use at work is associated with self-reported ...This study aimed to investigate the association between computer use at work and self-reported depressive and anxiety disorder (DAD)
Increased task-induced mental fatigue in problematic ...Our results indicate that participants with higher PIU level are likely to feel more fatigued after a prolonged task. We also revealed task- and PIU-dependent ...
Randomized controlled study of a digital data driven ...Specifically, we observed significant reductions in both depression and anxiety symptoms, accompanied by an improvement in quality of life.
Soft computing analysis of the factors associated with stress ...This paper identifies eight key factors of SAD, workplace pressure to poor sleep quality ( – ), and explores six targeted interventions.
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