Computer-Based Intervention for Depression

Recruiting in Palo Alto (17 mi)

Overseen by Emily L Belleau, PhD

Age: < 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mclean Hospital

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

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

Lack of perceived control, particularly during stress, has been critically implicated in major depressive disorder (MDD) and anhedonic symptoms, especially among female adolescents; yet the neural underpinnings of perceived control disruptions in MDD remain poorly understood. Using functional magnetic resonance imaging with a novel "value of control task" in conjunction with a prospective design, this study will provide a comprehensive understanding of stress and perceived control related mechanisms in female adolescents with MDD and will examine stress-induced disruptions in perceived control as a predictor of "real world" expressions of maladaptive coping and anhedonia.

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 data supports the effectiveness of the treatment Computer Task Manipulation 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 and MoodGYM have shown promising results, suggesting that computer-based interventions can help manage depression. ^{1 2 3 4 5}

Is computer-based intervention for depression safe for humans?

Research on computer-based treatments for depression suggests they are generally safe, with only a small percentage of participants experiencing any significant worsening of symptoms. These treatments are often compared to traditional therapy and have shown similar safety profiles. ^{1 3 4 6 7}

How is the Computer Task Manipulation treatment for depression different from other treatments?

Computer Task Manipulation is unique because it uses computer technology to deliver therapy, which can be a substitute or addition to traditional face-to-face therapy. This approach allows for remote access and flexibility, making it more accessible for people who may not be able to attend in-person sessions. ^{1 2 3 4 8}

Research Team

Emily L Belleau, PhD

Principal Investigator

Mclean Hospital

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Computer Task Manipulation (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Susan M. Szulewski

Mclean Hospital

Chief Medical Officer since 2023

MD from University of Medical Sciences in Poznan, Poland; MBA from Heller School at Brandeis University

Dr. Scott L. Rauch

Mclean Hospital

Chief Executive Officer since 2006

MD from Harvard Medical School

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Clinician-assisted computerised versus therapist-delivered treatment for depressive and addictive disorders: a randomised controlled trial. [2022]

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

Computer-Assisted Cognitive-Behavior Therapy for Depression: A Systematic Review and Meta-Analysis. [2022]

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

Computer-assisted cognitive-behavior therapy for depression. [2022]

4. England 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. [2022]

5. Netherlands 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Internet interventions for depression: new developments. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of guided Internet-delivered treatment for major depression in routine mental healthcare - An open study. [2020]

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

Digital interventions for the treatment of depression: A meta-analytic review. [2021]