eCBT for Depression

(AMHI Trial)

Not currently recruiting at 13 trial locations

Overseen By Maria Martik

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: West Virginia University

Disqualifiers: Bipolar disorder, Non-affective psychosis, others

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

Compensation: Varies

Number of Visits: 16

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether remote internet-based Cognitive Behavior Therapy (eCBT) can assist individuals with Major Depressive Disorder (MDD) in rural West Virginia and Kentucky. The study compares regular primary care treatment to primary care plus eCBT, with or without guidance. It targets individuals who have begun new MDD treatment within the last six months and have access to a smartphone or computer. This trial may suit those seeking outpatient treatment for MDD and who do not have conditions like bipolar disorder. As an unphased trial, it offers a unique opportunity to explore innovative treatment options for MDD in a flexible, remote setting.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on providing additional therapy rather than changing existing medication plans.

What prior data suggests that remote internet-based Cognitive Behavior Therapy (eCBT) is safe for treating Major Depressive Disorder?

Research has shown that online Cognitive Behavior Therapy (eCBT) is generally safe and well-received for treating depression. One study found that guided eCBT effectively reduces symptoms of depression and anxiety. Another study supported these results, showing a significant decrease in depression symptoms with eCBT.

In Japan, a series of cases demonstrated that patients using online CBT found it helpful and encountered no major safety issues. This suggests that eCBT can be a safe option across different cultures. Overall, while researchers continue to study eCBT, these findings suggest it is a safe choice for many people with depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about remote Internet-based Cognitive Behavioral Therapy (eCBT) for depression because it offers a unique delivery method compared to traditional in-person therapy. eCBT allows patients to access treatment from anywhere with an internet connection, making it more convenient and potentially increasing adherence. Unlike typical medications for depression that often come with side effects, eCBT focuses on changing thought patterns and behaviors, offering a non-pharmacological approach. Additionally, the guided eCBT option provides extra support, potentially enhancing the effectiveness of the treatment for managing depression.

What evidence suggests that this trial's treatments could be effective for Major Depressive Disorder?

This trial will compare different approaches to treating depression. Some participants will receive primary care treatment as usual, while others will receive primary care treatment with the addition of eCBT or guided eCBT. Studies have shown that online Cognitive Behavioral Therapy (eCBT) can effectively treat depression. Specifically, research indicates that eCBT helps reduce depression symptoms when included in regular care. This treatment allows people to access therapy online, making it easier for those in rural areas. Although in-person CBT might be slightly more effective, eCBT still offers significant benefits. It provides a convenient and accessible way to manage depression for people with limited access to face-to-face therapy. ^{2 4 6 7 8}

Who Is on the Research Team?

Robert Bossarte, PhD

Principal Investigator

University of South Florida

Ronald Kessler, PhD

Principal Investigator

Harvard Medical School (HMS and HSDM)

Are You a Good Fit for This Trial?

This trial is for individuals in rural West Virginia and Kentucky who are literate in English, seeking treatment for Major Depressive Disorder (MDD) for the first time in six months, have access to a smartphone or computer, and are suitable for outpatient treatment. It excludes those with hearing, vision or cognitive impairments that affect research participation.

Inclusion Criteria

Without hearing or vision or cognitive impairment that would interfere with research data collection

I can receive treatment without staying in the hospital.

You have never had bipolar disorder or non-affective psychosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive remote internet-based Cognitive Behavior Therapy (eCBT) for Major Depressive Disorder (MDD) with or without comorbidities

16 weeks

Initial orientation meeting, followed by remote sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Assessments at 16, 26, 39, and 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remote Internet-based Cognitive Behavior Therapy (eCBT)

Trial Overview The study tests if giving primary care doctors access to remote internet-based Cognitive Behavior Therapy (eCBT) can improve MDD treatment outcomes. Participants will receive eCBT through their smart devices or computers.

How Is the Trial Designed?

Group I: Primary Care Treatment Active Control 1 Intervention

The participant will receive treatment as usual as prescribed by the primary care physician for MDD.

Group II: Primary care treatment with guided eCBT Active Control 1 Intervention

The participant will receive treatment as usual as prescribed by the primary care physician with the addition of guided eCBT for MDD.

Group III: Primary care treatment with eCBT Active Control 1 Intervention

The participant will receive treatment as usual as prescribed by the primary care physician with the addition of eCBT for MDD.

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

Self-guided internet-based cognitive behavioral therapy (iCBT) significantly reduces depressive symptoms compared to control groups, with a moderate effect size indicating its efficacy as a treatment option.

The study analyzed data from 3876 participants across 13 trials, showing that adherence to iCBT is linked to better treatment outcomes, suggesting that engagement with the program is crucial for effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Self-guided Internet-Based Cognitive Behavioral Therapy in the Treatment of Depressive Symptoms: A Meta-analysis of Individual Participant Data. Karyotaki, E., Riper, H., Twisk, J., et al.[2022]

Adding scheduled telephone support (STS) to internet-delivered cognitive behavioral therapy (iCBT) significantly improved treatment adherence, with 58% of patients reaching midtreatment compared to 36% in the usual support group.

Patients receiving STS also showed greater improvement in depressive symptoms, with an average decrease of 3.63 points on the Beck Depression Inventory, compared to just 1.1 points in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scheduled Telephone Support for Internet Cognitive Behavioral Therapy for Depression in Patients at Risk for Dropout: Pragmatic Randomized Controlled Trial. Pihlaja, S., Lahti, J., Lipsanen, JO., et al.[2021]

A systematic review of 76 randomized controlled trials involving 11,704 participants found that behavioral activation in internet cognitive behavioral therapy (iCBT) may significantly reduce depression severity, while relaxation techniques could potentially be harmful.

Combining human and automated encouragement in iCBT programs was shown to decrease dropout rates, suggesting that support mechanisms are crucial for maintaining engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dismantling, optimising, and personalising internet cognitive behavioural therapy for depression: a systematic review and component network meta-analysis using individual participant data. Furukawa, TA., Suganuma, A., Ostinelli, EG., et al.[2022]

The Thrive internet-based cognitive behavior therapy (iCBT) intervention significantly reduced depression and anxiety symptoms over 12 months, with improvements in work and social functioning and resilience, as evidenced by substantial reductions in scores on various mental health scales.

Higher adherence to the Thrive program, indicated by more logins and completed lessons, was associated with greater reductions in depression and anxiety symptoms, suggesting that engagement with the program enhances its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twelve-Month Follow-Up to a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention for Rural Adults With Depression Symptoms: Single-Arm Longitudinal Study. Schure, M., McCrory, B., Tuchscherer Franklin, K., et al.[2021]

Computerized cognitive behavior therapy (cCBT) shows potential as an effective treatment for depression in individuals with chronic physical health problems, based on a systematic review of randomized controlled trials, although only one study specifically focused on diabetes was included.

The single study indicated positive outcomes compared to a waiting-list control, but it also faced challenges such as high participant dropout rates, suggesting that cCBT may not be acceptable to all and highlighting the need for more comprehensive research to confirm its efficacy and feasibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive behaviour therapy for depression in people with a chronic physical illness. Sharp, J., Holly, D., Broomfield, N.[2018]

A study involving 141 participants with major depressive disorder found that both clinician-assisted and technician-assisted internet-based cognitive behavioral therapy (iCBT) led to significant reductions in depression scores, demonstrating large effect sizes comparable to traditional face-to-face treatments.

At a 4-month follow-up, participants in the technician-assisted group showed further improvements and had significantly lower depression scores than those in the clinician-assisted group, suggesting that technician guidance can be as effective as clinician guidance in iCBT for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet treatment for depression: a randomized controlled trial comparing clinician vs. technician assistance. Titov, N., Andrews, G., Davies, M., et al.[2022]

A study involving 1,093 university students with subthreshold depression found that all participants experienced significant reductions in depression symptoms after 8 weeks of internet-based cognitive-behavioral therapy (iCBT), regardless of which specific skills were included in their treatment.

No specific iCBT component (like self-monitoring, behavioral activation, cognitive restructuring, assertiveness training, or problem-solving) showed a clear advantage over others in reducing depression, indicating that the overall iCBT approach is effective but the individual components may not be critical for success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Components of smartphone cognitive-behavioural therapy for subthreshold depression among 1093 university students: a factorial trial. Sakata, M., Toyomoto, R., Yoshida, K., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7490682/

Effects of Internet-Based Cognitive Behavioral Therapy in ... This study systematically reviews effectiveness studies of guided iCBT interventions for the treatment of depression or anxiety.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5659300/

The Effectiveness of Internet-Based Cognitive Behavioral ... ICBT's effectiveness has been investigated in treating and managing conditions like depression, generalized anxiety disorder (GAD), panic ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2214782919300107

Effectiveness of guided internet-delivered cognitive ... We conclude that ICBT appears to be an effective treatment for depression when delivered as an integral part of routine psychiatric care.

4. nature.com nature.com/articles/s41746-022-00677-8

A systematic review of digital and face-to-face cognitive ... In 106 studies including n = 11854 patients face-to-face CBT shows superior clinical effectiveness compared to digital CBT when investigating depressive ...

5. jmir.org jmir.org/2019/11/e14754/

Use of a Fully Automated Internet-Based Cognitive ... All outcomes were assessed using self-reported, validated measures automatically administered via the study website. Depression symptom severity ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9417319/

Efficacy and Acceptability of Remote Cognitive Behavioral ... This case series aimed to establish preliminary evidence of whether remote CBT can be an effective therapy for major depression in Japanese clinical settings.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0272735824001399

Do the effects of internet-delivered cognitive-behavioral ... The i-CBTs had small to large effects in reducing anxiety, depression, and PTSD. Long-term efficacy was weaker for insomnia, stronger for ER and QOL and ...

8. mdpi.com mdpi.com/1648-9144/61/3/431

Next-Generation Cognitive-Behavioral Therapy for ... This systematic review aims to present the latest developments in next-generation CBT interventions of digital support tools, teletherapies, and personalized ...