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}

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

McLean Hospital Belmont, MA

Who Is Running the Clinical Trial?

Mclean Hospital Lead Sponsor

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] To compare computer-delivered and therapist-delivered treatments for people with depression and comorbid addictive disorders.

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

Computer-Assisted Cognitive-Behavior Therapy for Depression: A Systematic Review and Meta-Analysis. [2022] To evaluate the efficacy of computer-assisted forms of cognitive-behavior therapy for major depressive disorder (MDD) and examine the role of clinician support and other factors that might affect outcomes.

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

Computer-assisted cognitive-behavior therapy for depression. [2022] This article reviews the use of computer technology in treating depression as a substitute or adjunct for standard therapy. It discusses advantages and disadvantages of introducing computer technology as a treatment option, problems and barriers to expanded use, the varieties of computer-assisted psychotherapy for major depression, and relevant research. Three specific Internet-based programs are described, assessed and compared: Good Days Ahead, Beating the Blues, and MoodGYM. The authors conclude that these and similar programs are promising. Preliminary outcome studies suggest that these programs produce outcome similar to standard therapy, although methodological shortcomings limit confidence in these findings. Suggestions are offered for practitioners considering the addition of computer assistance to their treatment of depression.

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] To evaluate computer- versus therapist-delivered psychological treatment for people with comorbid depression and alcohol/cannabis use problems.

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] To examine immediate and long-term effectiveness of an adjunctive Internet intervention for depression in a large sample of patients undergoing routine psychotherapy.

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

Internet interventions for depression: new developments. [2022] A wide range of Internet interventions, mostly grounded in methods of cognitive behavioral therapy, have been developed and tested for several mental disorders. The evidence to date shows that these interventions are effective in reducing symptoms of depression. Metaanalyses report small-to-medium effect sizes when Internet interventions are delivered as stand-alone self-help interventions (d=0.25-0.36), and medium-to-large effect sizes when delivered as therapist-guided interventions (d=0.58-0.78), both compared with usual care. Only a minority of people suffering from depression receive adequate treatment, and Internet interventions might help bridge the large treatment gap. This review summarizes the current body of evidence and highlights pros and cons of Internet interventions. It also outlines how they could be implemented in mental health care systems and points out unresolved questions, as well as future directions, in this research field.

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

Effectiveness of guided Internet-delivered treatment for major depression in routine mental healthcare - An open study. [2020] Depression is one of the most prevalent mental health disorders and is estimated to become the leading cause of disability worldwide by 2030. Increasing access to effective treatment for depression is a major societal challenge. In this context, the increasing use of computers in the form of laptops or smartphones has made it feasible to increase access to mental healthcare through digital technology. In this study, we examined the effectiveness of a 14-week therapist-guided Internet-delivered program for patients with major depression undergoing routine care. From 2015 to 2018, 105 patients were included in the study. For depressive symptoms, we identified significant within-group effect sizes (post-treatment: d&#8239;=&#8239;0.96; 6-month follow-up: d&#8239;=&#8239;1.21). We also found significant effects on secondary anxiety and insomnia symptoms (d&#8239;=&#8239;0.55-0.92). Clinically reliable improvement was reported by 48% of those undergoing the main parts of the treatment, whereas 5% of the participants reported a clinically significant deterioration. However, a large proportion of patients showed no clinically reliable change. In summary, the study identified large treatment effects, but also highlighted room for improvement in the usability of the treatment.

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

Digital interventions for the treatment of depression: A meta-analytic review. [2021] The high global prevalence of depression, together with the recent acceleration of remote care owing to the COVID-19 pandemic, has prompted increased interest in the efficacy of digital interventions for the treatment of depression. We provide a summary of the latest evidence base for digital interventions in the treatment of depression based on the largest study sample to date. A systematic literature search identified 83 studies (N = 15,530) that randomly allocated participants to a digital intervention for depression versus an active or inactive control condition. Overall heterogeneity was very high (I2 = 84%). Using a random-effects multilevel metaregression model, we found a significant medium overall effect size of digital interventions compared with all control conditions (g = .52). Subgroup analyses revealed significant differences between interventions and different control conditions (WLC: g = .70; attention: g = .36; TAU: g = .31), significantly higher effect sizes in interventions that involved human therapeutic guidance (g = .63) compared with self-help interventions (g = .34), and significantly lower effect sizes for effectiveness trials (g = .30) compared with efficacy trials (g = .59). We found no significant difference in outcomes between smartphone-based apps and computer- and Internet-based interventions and no significant difference between human-guided digital interventions and face-to-face psychotherapy for depression, although the number of studies in both comparisons was low. Findings from the current meta-analysis provide evidence for the efficacy and effectiveness of digital interventions for the treatment of depression for a variety of populations. However, reported effect sizes may be exaggerated because of publication bias, and compliance with digital interventions outside of highly controlled settings remains a significant challenge. (PsycInfo Database Record (c) 2021 APA, all rights reserved).