Online Therapy for Depression

Overseen By Xiaoling Xiang, PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Dementia, Suicide risk, Terminal illness, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online cognitive-behavioral therapy (CBT) program called Empower@Home to determine its effectiveness in reducing depression among older adults with mobility challenges. Participants will either use this online program or receive standard care with friendly calls. The study aims to discover if the online program enhances mood and social activity more than usual care. It suits English-speaking adults over 50 with some mobility issues and mild depression. As an unphased trial, this study provides a unique opportunity to contribute to research that could improve mental health care options for older adults.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does require that if you are receiving outside therapy, you should not increase its frequency during the study.

What prior data suggests that the Empower@Home program is safe for older adults with ambulatory disabilities?

A previous study on the Empower@Home program, an online therapy based on cognitive-behavioral therapy (CBT), showed promising results for safety and effectiveness. Research has shown that online CBT treatments, like Empower@Home, are generally well-received. Participants in similar trials reported satisfaction with the therapy, completed the courses, and experienced reduced symptoms of depression and anxiety.

Another study found that symptoms related to panic and depression decreased with guided online CBT. In that study, participants received about two hours of therapist support, which proved beneficial. These findings suggest that Empower@Home is safe and might improve mental health in older adults. While specific data for Empower@Home is limited, evidence from similar treatments supports its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Empower@Home because it offers a fresh approach to treating depression, especially for older adults. Unlike traditional therapy sessions that require in-person visits, Empower@Home is a self-paced, online program based on cognitive behavioral therapy principles, which allows participants to engage with the material from the comfort of their own homes. This treatment is unique because it combines interactive online sessions with a printed workbook and telephone coaching from trained staff, which is not typically part of standard depression treatments. This accessibility and supportive structure can make therapy more approachable and flexible, potentially leading to better engagement and outcomes for those who might otherwise find it difficult to access traditional therapy.

What evidence suggests that Empower@Home is effective for depression?

Research has shown that online cognitive behavioral therapy (CBT) can effectively treat depression. Studies have found that people who complete these online programs often experience a significant reduction in their depression symptoms. For instance, one study noted a substantial decrease in symptoms, particularly for those with moderate depression. Online CBT has also proven effective when combined with regular mental health care, with participants showing noticeable improvements. In this trial, one group of participants will receive the Empower@Home program, a self-help intervention based on CBT principles, supported by aging service providers. Meanwhile, another group will receive attention calls with friendly visitors. Although adherence to the program can vary, the overall evidence suggests that online CBT, such as Empower@Home, is a promising option for managing depression. ^{5 6 7 8 9}

Who Is on the Research Team?

Xiaoling Xiang

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for older adults with ambulatory disabilities who are experiencing depression. Participants should be able to use the internet and engage in an online therapy program. Specific details on inclusion and exclusion criteria were not provided.

Inclusion Criteria

(4) have at least moderate depressive symptoms at screening (≥ 8 on the Patient Health Questionnaire-9 [PHQ-9])

I am getting home or community services from the place I was recruited.

I am at least 60 years old.

Exclusion Criteria

(1) probable dementia based on the Blessed Orientation and Memory Scale

(5) severe vision impairment based on self-report (i.e., legally blind)

(2) moderate or high risk of suicide based on the 6-item Columbia-Suicide Severity Rating Scale

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Empower@Home program, a 9-session online CBT intervention, with support from aging service providers

12 weeks

Weekly support calls

Follow-up

Participants are monitored for changes in depressive symptoms and social engagement

12 weeks

Remote assessments at 12 and 24 weeks

Long-term follow-up

Participants are further monitored for sustained effects of the intervention

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Empower@Home

Trial Overview

The study compares Empower@Home, an online cognitive-behavioral therapy (CBT) program, with enhanced usual care to see which is more effective at improving depressive symptoms, social engagement, and activities in older adults with mobility issues.

How Is the Trial Designed?

Group I: Empower@Home supported by aging service providers Experimental Treatment 1 Intervention

Participants will be provided with access to a 9-session online program called Empower@Home, a self-help intervention based on cognitive behavioral therapy principles. The intervention has three components: 9 interactive self-paced online sessions, printed workbook that goes along the online sessions for exercises and homework, and telephone coaching by a trained staff from a social service agency serving older adults. Participants will have up to 12 weeks to try to complete the program with the support of a trained coach.

Group II: Attention call with friendly visitors Experimental Treatment 1 Intervention

Participants will receive enhanced care as usual, including care as usual from their social service provider and a psycho-educational handout. In addition, they will receive telephone friendly calls from a research staff every other week to mimic the human interactions provided by coaches in the experimental group.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

A pilot study involving 196 primary care patients found that 20% enrolled in an Internet-delivered cognitive behavioral therapy (CBT) program, indicating that integrating such programs into healthcare systems is feasible.

Participants who completed the program experienced a significant average reduction of 46% in depressive symptoms after four months, along with a decrease in suicidal thoughts, suggesting that Internet-delivered CBT can be an effective treatment for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online cognitive behavioral therapy for depressed primary care patients: a pilot feasibility project. Whiteside, U., Richards, J., Steinfeld, B., et al.[2021]

The study will evaluate the effectiveness of an online self-help program (deprexis®) combined with inpatient psychotherapy in 240 depressed patients, aiming to enhance treatment outcomes and maintain benefits after discharge.

Participants will be assessed at multiple points, with the primary focus on changes in depression scores using the Beck Depression Inventory-II, which will help determine if the online program improves overall mental health compared to standard information access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing inpatient psychotherapeutic treatment with online self-help: study protocol for a randomized controlled trial. Zwerenz, R., Becker, J., Knickenberg, RJ., et al.[2022]

Internet-based cognitive-behavioral therapy (CBT) is an effective self-help program that allows patients to receive psychological support via the Internet, making therapy more accessible, especially for those unable to attend traditional sessions.

This form of therapy has shown particular effectiveness in treating conditions like panic disorder, social phobia, and depression, indicating its potential to reach and help a wider range of individuals in need of mental health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Internet-based cognitive-behavioral therapy in the treatment of psychiatric disorders]. Holmberg, N., Kähkönen, S.[2022]

A randomized trial involving 255 participants showed that a pure self-help Internet program for depression, called ODIN, significantly reduced depression symptoms compared to a usual treatment control group, especially among those with more severe depression at the start.

Participants who received reminders (via postcards or phone calls) to use the ODIN program reported greater improvements, indicating that increasing engagement through reminders can enhance the effectiveness of online self-help interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming Depression on the Internet (ODIN) (2): a randomized trial of a self-help depression skills program with reminders. Clarke, G., Eubanks, D., Reid, E., et al.[2022]

The study evaluates the effectiveness of the online self-help program 'Selfapy' for individuals with mild to severe depressive symptoms, involving 400 participants over a 12-week intervention period.

By comparing an unaccompanied version of the program with a version that includes weekly support from a psychologist, the research aims to determine which approach is more effective in reducing depressive symptoms and improving overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the online-based self-help programme "Selfapy" in patients with unipolar depression: study protocol for a randomized, blinded parallel group dismantling study. Krämer, R., Köhler, S.[2021]

The ePST™ program, a stand-alone multimedia interactive treatment for depression, was well-received by participants, who found it highly usable, acceptable, and credible, with a therapeutic alliance comparable to live therapy.

Among the 29 participants, those who completed at least 4 sessions showed significant improvement in depressive symptoms over the 10-week study, suggesting that ePST™ may be an effective treatment option for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility study of an interactive multimedia electronic problem solving treatment program for depression: a preliminary uncontrolled trial. Berman, MI., Buckey, JC., Hull, JG., et al.[2021]

Computer-delivered Cognitive Behavioral Therapies (C-CBT) are effective for treating depression, showing high effectiveness and adherence among self-referred individuals, based on a review of 22 randomized controlled studies.

Therapist support significantly enhances the effectiveness and adherence of C-CBT, particularly for outpatients referred by clinicians, highlighting the importance of integrating some level of guidance in these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Can we do therapy without a therapist? Active components of computer-based CBT for depression]. Iakimova, G., Dimitrova, S., Burté, T.[2018]

A study involving 229 depressed patients showed that an online self-help program significantly reduced depressive symptoms when combined with inpatient psychotherapy, achieving a moderate effect size of d = 0.44.

The online self-help program also improved anxiety, quality of life, and self-esteem, indicating that integrating digital tools into traditional therapy can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online Self-Help as an Add-On to Inpatient Psychotherapy: Efficacy of a New Blended Treatment Approach. Zwerenz, R., Becker, J., Knickenberg, RJ., et al.[2022]

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