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

256 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a randomized Type I hybrid effectiveness-implementation trial aimed at evaluating the effectiveness of Empower@Home, an internet-delivered cognitive-behavioral therapy (CBT) program supported by aging service providers, in comparison to enhanced usual care for homebound older adults with depressive symptoms. A total of 256 participants will be randomly assigned to either the treatment group (Empower@Home) or the control group (enhanced usual care) in a 1:1 allocation ratio, with randomization stratified by participating agencies. The primary aim of this study is to determine the clinical effectiveness of the Empower@Home program. It is hypothesized that participants receiving Empower@Home will show greater improvements in depressive symptoms at 12, 24, and 36 weeks after entering the study compared to those receiving enhanced usual care. Additionally, treatment moderators will be explored and a cost-effectiveness analysis will be conducted to assess the economic viability of the intervention. The second aim is to investigate the mechanisms of change facilitated by the intervention using a mixed-methods approach. Causal mediation analysis will examine whether the acquisition of CBT skills, reduction in cognitive distortions, and increased behavioral activation, as well as participant engagement and the therapeutic alliance with the coach, mediate the treatment effects. Qualitative interviews with participants will be conducted to provide deeper insights into these mechanisms and enhance the interpretation of the mediation analysis. The third aim focuses on evaluating the implementation process using the updated Consolidated Framework for Implementation Research (CFIR). This will involve a qualitative process evaluation to identify barriers and facilitators to the implementation of Empower@Home, drawing on perspectives from multiple stakeholders.

Will I have to stop taking my current medications?

The trial information 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 data supports the effectiveness of the treatment Empower@Home for depression?

Research shows that online cognitive-behavioral therapy (CBT) programs, similar to Empower@Home, can effectively reduce depression symptoms. Studies indicate that these programs, even without a live therapist, are highly usable and credible, and can significantly improve depressive symptoms over time. ^{1 2 3 4 5}

How is the Empower@Home treatment for depression different from other treatments?

Empower@Home is unique because it delivers cognitive-behavioral therapy (CBT) over the Internet, allowing patients to receive therapy from home with supportive coaching, which can be as effective as traditional in-person therapy. This approach makes therapy more accessible, especially for those who cannot easily attend in-person sessions. ^{2 4 6 7 8}

Research Team

Xiaoling Xiang

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for homebound older adults experiencing depressive symptoms. Participants should be willing to engage with an online cognitive-behavioral therapy program or receive enhanced usual care through telephone visits. Specific eligibility criteria are not provided, but typically these would include age thresholds and a clinical diagnosis of depression.

Inclusion Criteria

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

I can read and speak English.

I am at least 60 years old.

Exclusion Criteria

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

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

(3) Patients with a terminal illness with less than six months to live or unstable physical health conditions based on self-report

Timeline

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 safety and effectiveness after treatment

24 weeks

Remote assessments at 12, 24, and 36 weeks

Treatment Details

Interventions

• Empower@Home

Trial Overview The study compares the Empower@Home online CBT program against enhanced usual care to see which is more effective at improving depressive symptoms in elderly patients over time. The effectiveness, cost-effectiveness, and implementation process will also be evaluated.

Participant Groups

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+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

NYU Silver School of Social Work

Collaborator

Trials

3

Recruited

3,300+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility study of an interactive multimedia electronic problem solving treatment program for depression: a preliminary uncontrolled trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Enhancing inpatient psychotherapeutic treatment with online self-help: study protocol for a randomized controlled trial. [2022]

3. France pubmed.ncbi.nlm.nih.gov

[Can we do therapy without a therapist? Active components of computer-based CBT for depression]. [2018]

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

Online cognitive behavioral therapy for depressed primary care patients: a pilot feasibility project. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Online Self-Help as an Add-On to Inpatient Psychotherapy: Efficacy of a New Blended Treatment Approach. [2022]

6. Finland pubmed.ncbi.nlm.nih.gov

[Internet-based cognitive-behavioral therapy in the treatment of psychiatric disorders]. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Overcoming Depression on the Internet (ODIN) (2): a randomized trial of a self-help depression skills program with reminders. [2022]

8. England 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. [2021]