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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online therapy program called Empower@Home, designed to assist older adults who primarily stay at home and experience symptoms of depression. The trial aims to determine if this internet-based therapy reduces depression symptoms more effectively than regular care with additional support. Participants will either engage with the Empower@Home program, which includes online sessions and phone coaching, or receive friendly phone calls and educational materials. Suitable candidates have moderate depression, are 50 or older, and will not change their outside therapy during the study. As an unphased trial, this study provides a unique opportunity to explore a new approach to managing depression from home.

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 prior data suggests that the Empower@Home program is safe for older adults with depressive symptoms?

Research has shown that online cognitive-behavioral therapy (CBT), such as Empower@Home, is generally safe for most people. Past studies have demonstrated that this therapy effectively reduces symptoms of depression and anxiety. It also addresses other issues like stress and improves quality of life.

Most people find online CBT easy to use, and serious side effects are rare. Some individuals might feel uncomfortable when confronting difficult emotions during therapy, but this is normal and typically improves over time.

Overall, Empower@Home is based on a well-researched and trusted therapy method. It aims to help people manage their depression without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Empower@Home because it offers a unique, accessible approach to treating depression, especially for older adults. Unlike traditional therapies that require in-person visits, Empower@Home is fully online and allows participants to engage in self-paced cognitive behavioral therapy sessions from the comfort of their homes. This program is enhanced with a printed workbook for exercises and homework, and it includes telephone coaching from trained staff, providing support similar to face-to-face interaction. This innovative delivery method can make therapy more accessible and convenient, potentially increasing adherence and effectiveness for those who may find it difficult to attend regular in-person sessions.

What evidence suggests that the Empower@Home program might be an effective treatment for depression?

Research has shown that internet-delivered cognitive behavioral therapy (iCBT) effectively reduces symptoms of depression. One study demonstrated that iCBT significantly reduced depression symptoms, with a strong impact overall and an even greater effect for those with moderate depression. Another study found that nearly half of the participants responded positively to guided iCBT, with benefits lasting 6 to 8 months after treatment. In this trial, participants in the Empower@Home arm will use a similar iCBT method, which may help older adults improve their depression symptoms effectively. ^{2 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 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 am at least 60 years old.

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

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 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 safety and effectiveness after treatment

24 weeks

Remote assessments at 12, 24, and 36 weeks

What Are the Treatments Tested in This Trial?

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.

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+

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+

Published Research Related to This Trial

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]

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 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]

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 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 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]

Citations

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Internet-delivered cognitive behavioural therapy in the ... These data indicate that Internet-delivered CBT could an effective therapy for depression. Physical illness. Internet-delivered CBT for mental health ...

2. 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.

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Full article: Internet-Based Cognitive Behavioral Therapy ... Program completion was 90%. Depression symptoms significantly decreased (Cohen's d = 0.9 overall; d = 1.4 for those with moderate depression at ...

4. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2774861

Internet-Based Cognitive Behavioral Therapy for Depression Overall, 48% of participants receiving guided iCBT responded, while 37% responded in unguided iCBT. When splitting participants into severity ...

5. mental.jmir.org mental.jmir.org/2023/1/e46925

Long-Term Efficacy of Internet-Based Cognitive Behavioral ... The depression outcomes followed up between 6-8 months after treatment also showed statistically significant improvements in depression symptoms ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5540163/

Internet-based cognitive behavior therapy for major ... Thus, the iCBT program was effective in reducing depressive symptoms across the range of mild to moderate MDD represented in our sample, which is consistent ...

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. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2021.598317/full

Maintaining Outcomes of Internet-Delivered Cognitive ... Conclusions: Internet interventions for depression are not only effective in the short term, but also exert long-term effects. Their effects are likely to ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2214782921001214

Exploration of client experiences during and after treatment Overall, client communications suggest that ICBT is accepted and perceived as beneficial among PSP. These results informed rapid improvements to the ICBT ...