eCBT for Depression

(AMHI Trial)

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

3360 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Remote Internet-based Cognitive Behavior Therapy (eCBT) for depression?

Research shows that internet-based cognitive behavioral therapy (iCBT) is effective for treating depression, especially when guided by a clinician. In a study, patients using iCBT saw significant improvements in their depression scores compared to those receiving usual treatment alone. ^{1 2 3 4 5}

Is internet-based cognitive behavior therapy (eCBT) safe for humans?

Internet-based cognitive behavior therapy (eCBT) is generally considered safe, with no reported adverse effects, but it's important for clinicians to assess patients for any risk issues and ensure they don't need more immediate help before starting eCBT. ^{5 6 7 8 9}

How is the eCBT treatment for depression different from other treatments?

The eCBT treatment for depression is unique because it is delivered over the internet, making it accessible to people regardless of their location or mobility. It can be self-guided, reducing the need for in-person therapy sessions, and is often available at a lower cost, increasing access to evidence-based therapy. ^{5 6 7 10 11}

What is the purpose of this trial?

This trial will test online therapy sessions for depression in rural West Virginia and Kentucky. The therapy can be done alone or with support from a remote coach. It aims to improve mental health by changing negative thoughts and behaviors, with coaches providing extra help in guided sessions.

Research Team

Robert Bossarte, PhD

Principal Investigator

University of South Florida

Ronald Kessler, PhD

Principal Investigator

Harvard Medical School (HMS and HSDM)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

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

The Effectiveness of Internet-Based Cognitive Behavioral Therapy for the Treatment of Depression in a Large Real-World Primary Care Practice: A Randomized Trial. [2022]

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

Internet treatment for depression: a randomized controlled trial comparing clinician vs. technician assistance. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Components of smartphone cognitive-behavioural therapy for subthreshold depression among 1093 university students: a factorial trial. [2023]

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

The effectiveness of Internet cognitive behavioural therapy (iCBT) for depression in primary care: a quality assurance study. [2022]

5. Canada 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. [2021]

6. Australia pubmed.ncbi.nlm.nih.gov

Internet-based cognitive behaviour therapy for depression and anxiety. [2018]

7. United States 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Computerized cognitive behaviour therapy for depression in people with a chronic physical illness. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Internet-supported versus face-to-face cognitive behavior therapy for depression. [2022]

10. England 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. [2022]

11. Canada 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. [2021]