Computer-Based Intervention for Depression

Overseen By Emily L Belleau, PhD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Mclean Hospital

Must not be taking: Psychotropics, Neuroleptics, Benzodiazepines, others

Disqualifiers: Head trauma, Seizure disorder, Serious illness, others

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

Compensation: Varies

Number of Visits: 4

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how stress and a sense of control affect depression in female teens. Participants will complete computer tasks during a brain scan to examine the brain's response to stress and control. The research targets females aged 14-18 diagnosed with major depressive disorder who are not currently on certain medications. Healthy individuals without a history of mental disorders are also needed for comparison. This study could help predict how stress impacts real-world coping skills and happiness.

As an unphased study, this trial offers participants the chance to contribute to groundbreaking research that could enhance mental health strategies for teens.

Do I need to stop my current medications for this trial?

Yes, if you are part of the MDD sample, you must stop taking psychotropic medications for at least 2 weeks (6 weeks for fluoxetine, 6 months for neuroleptics, 2 weeks for benzodiazepines, and 2 weeks for any other antidepressants) before joining the trial.

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

Research has shown that computer-based mental health programs can be safe and effective. For example, one study found that a digital program improved mood in adults with depression by targeting a part of the brain that manages attention and behavior. This suggests the approach can be both well-tolerated and helpful.

However, concerns exist about using digital platforms. Some reports mention possible risks, such as increased depression and sleep problems in young people. These issues often relate to how technology is used rather than the specific treatment itself.

Overall, computer-based mental health programs are promising. They offer a way to help many people easily and safely. However, like any tool, they need careful use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for depression that often involve medication or talk therapy, the computer-based intervention is unique because it uses computer tasks designed to manipulate brain activity while participants undergo an fMRI brain scan. This method allows researchers to directly observe changes in brain function in real-time, potentially leading to a deeper understanding of how depression affects the brain. Researchers are excited about this approach because it could pave the way for more personalized treatments by identifying specific brain patterns associated with depression, offering a new avenue for intervention that goes beyond symptom management.

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

Research has shown that computer programs assisting cognitive-behavior therapy (CBT) for depression can be as effective as in-person therapy. One study linked a shorter CBT schedule combined with home computer exercises to reduced depression symptoms and improved brain function. Other digital mental health tools have also proven effective in reducing symptoms of depression and anxiety. Another study found that digital treatments significantly improved depression and anxiety, enhancing overall quality of life. These findings suggest that computer-based treatments, such as the Computer Task Manipulation studied in this trial, can be a promising way to help with depression, especially for young people. ^{6 7 8 9 10}

Who Is on the Research Team?

Emily L Belleau, PhD

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

This trial is for female adolescents aged 14-18 with major depressive disorder, not on psychotropic meds for at least 2 weeks, and no first-degree relatives with depression or bipolar. They must be right-handed, English-speaking, in the follicular phase of their menstrual cycle for fMRI scanning, and have a personal cell-phone.

Inclusion Criteria

I am a woman.

None of my immediate family has had depression, bipolar disorder, or psychosis.

No history or current diagnosis of any DSM-5 psychiatric or substance/alcohol-related disorder (as diagnosed with the KSADS)

Exclusion Criteria

I have taken medication that affects dopamine levels.

Pregnancy

I have had a head injury that made me lose consciousness.

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 completion of questionnaires and assessments

1 session

1 visit (in-person)

fMRI and Surveys

Participants undergo an fMRI brain scan and complete surveys on their cell phone in the following week

1 week

1 visit (in-person) for fMRI, surveys completed remotely

3-Month Follow-up

Diagnostic interview, assessments, and questionnaires completed three months after the fMRI scan, with additional surveys on cell phone

1 week

1 visit (in-person), surveys completed remotely

6-Month Follow-up

Diagnostic interview, assessments, and questionnaires completed six months after the fMRI scan, with additional surveys on cell phone

1 week

1 visit (in-person), surveys completed remotely

What Are the Treatments Tested in This Trial?

Interventions

• Computer Task Manipulation

Trial Overview The study uses functional magnetic resonance imaging (fMRI) to understand how stress affects perceived control in the brain of adolescent females with depression. It involves a 'value of control task' during the scan to track neural responses.

How Is the Trial Designed?

Group I: Computer Task Manipulation Experimental Treatment 1 Intervention

Participants will complete computer tasks while undergoing an fMRI brain scan

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials

221

Recruited

22,500+

Published Research Related to This Trial

Internet interventions based on cognitive behavioral therapy have been shown to effectively reduce symptoms of depression, with medium-to-large effect sizes (d=0.58-0.78) when guided by a therapist, and small-to-medium effect sizes (d=0.25-0.36) for self-help formats compared to usual care.

These interventions could help address the treatment gap for individuals with depression, as many do not receive adequate care, suggesting a promising avenue for integrating these tools into mental health care systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet interventions for depression: new developments. Schröder, J., Berger, T., Westermann, S., et al.[2022]

In a study of 97 participants with comorbid depression and substance misuse, intensive motivational interviewing and cognitive behavior therapy (MI/CBT) significantly improved depression symptoms compared to a brief intervention alone, with both live and computer-based formats showing effectiveness at the 12-month follow-up.

Computer-based therapy for depression and substance use was found to be at least as effective as live therapy, particularly in reducing cannabis use and hazardous substance use, suggesting that integrated computer-based interventions could be a viable option in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based psychological treatment for comorbid depression and problematic alcohol and/or cannabis use: a randomized controlled trial of clinical efficacy. Kay-Lambkin, FJ., Baker, AL., Lewin, TJ., et al.[2022]

In a study of 274 participants with depression and substance use issues, integrated cognitive behavior therapy and motivational interviewing (CBT/MI) delivered by computer with brief therapist assistance (CAC) showed equal or better effectiveness in reducing alcohol consumption compared to traditional therapist-delivered CBT/MI.

Supportive counseling (person-centered therapy) was less effective in reducing depression and alcohol use compared to both computer-assisted and therapist-delivered CBT/MI, highlighting the importance of structured therapeutic approaches for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician-assisted computerised versus therapist-delivered treatment for depressive and addictive disorders: a randomised controlled trial. Kay-Lambkin, FJ., Baker, AL., Kelly, B., et al.[2022]

Computer-assisted cognitive-behavior therapy (CCBT) for major depressive disorder (MDD) shows a moderately large effect size (g = 0.502) compared to control conditions, indicating its efficacy in reducing depressive symptoms.

Providing clinician support during CCBT significantly enhances its effectiveness, with a higher effect size (g = 0.673) compared to self-guided CCBT (g = 0.239), suggesting that support plays a crucial role in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Assisted Cognitive-Behavior Therapy for Depression: A Systematic Review and Meta-Analysis. Wright, JH., Owen, JJ., Richards, D., et al.[2022]

Digital interventions for depression have a significant medium effect size (g = .52) compared to control conditions, based on a systematic review of 83 studies involving 15,530 participants.

Interventions with human therapeutic guidance are more effective (g = .63) than self-help interventions (g = .34), and there is no significant difference in outcomes between digital interventions and traditional face-to-face therapy, suggesting that digital options can be a viable alternative for treating depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital interventions for the treatment of depression: A meta-analytic review. Moshe, I., Terhorst, Y., Philippi, P., et al.[2021]

Computer technology, including Internet-based programs like Good Days Ahead, Beating the Blues, and MoodGYM, shows promise as effective treatments for depression, potentially serving as substitutes or complements to traditional therapy.

Preliminary studies indicate that these computer-assisted therapies can yield outcomes similar to standard therapy, although the research has methodological limitations that affect the reliability of these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-assisted cognitive-behavior therapy for depression. Eells, TD., Barrett, MS., Wright, JH., et al.[2022]

A study involving 340 adults undergoing routine psychotherapy showed that adding an Internet intervention (Deprexis) significantly reduced depression symptoms and improved quality of life, with lasting effects observed at a 6-month follow-up.

The combined treatment approach led to greater therapeutic progress and higher rates of clinical improvement, regardless of the type of face-to-face therapy used, suggesting that blended treatment strategies can enhance outcomes for patients with mild to moderate depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate and long-term effectiveness of adding an Internet intervention for depression to routine outpatient psychotherapy: Subgroup analysis of the EVIDENT trial. Schuster, R., Laireiter, AR., Berger, T., et al.[2022]

A 14-week therapist-guided Internet-delivered program for major depression showed significant improvements in depressive symptoms among 105 patients, with effect sizes of 0.96 post-treatment and 1.21 at a 6-month follow-up.

While 48% of participants reported clinically reliable improvement, there is still a need to enhance the treatment's usability, as a significant number of patients experienced no reliable change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of guided Internet-delivered treatment for major depression in routine mental healthcare - An open study. Nordgreen, T., Blom, K., Andersson, G., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12240849/

Neuroimaging changes in major depression with brief ... A shortened CBT schedule coupled with home computer exercises was associated with decreased depression symptoms and augmented PFC connectivity ...

2. nature.com nature.com/articles/s44184-025-00136-8

Development of the treatment prediction model in ... We introduce an artificial intelligence model to personalize treatment in major depression, which was deployed in the Artificial Intelligence in Depression: ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10131603/

Effectiveness of Digital Mental Health Tools to Reduce ... Digital mental health tools are moderately to highly effective in reducing depression and anxiety symptoms in LMICs.

4. nature.com nature.com/articles/s41746-025-01511-7

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.

5. withpower.com withpower.com/trial/phase-depressive-disorder-3-2021-8c03c

Computer-Based Intervention for Depression Research shows that computer-assisted cognitive-behavior therapy (CBT) for depression can be as effective as traditional therapy. Programs like Good Days Ahead ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5447822/

Computer Administered Safety Planning for Individuals at ... The aim of this study was to design, build, and test the usability of a Web-based, self-administered safety planning application.

7. hhs.gov hhs.gov/sites/default/files/sg-youth-mental-health-social-media-advisory.pdf

Social Media and Youth Mental Health This Advisory calls attention to the growing concerns about the effects of social media on youth mental health. It explores and describes the current ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12231431/

E-mental Health in the Age of AI: Data Safety, Privacy ... It features prominently in delivering timely, effective mental health services by using technologies, at a low cost to reach a large population.

9. nature.com nature.com/articles/s41398-021-01386-8

A digital intervention targeting cognitive control network ... A remotely deployed neuroscience-informed video game-like intervention improves both CCN functions and mood in middle-aged and older adults with MDD.

10. ntia.gov ntia.gov/sites/default/files/reports/kids-online-health-safety/2024-kohs-report.pdf

Online Health and Safety for Children and Youth 36 The risks of harm raised by the research to date, including potentially increased levels of depression, loss of sleep, and inability to ...