Tele-PROTECT Therapy for Depression

Overseen By Jo Anne Sirey, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Suicidal ideation, Language barrier, others

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

Compensation: Varies

Number of Visits: 4

Duration: 9 weeks

140 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a video-based therapy called Tele-PROTECT for older adults in NYC who have been abused and are depressed. The therapy helps participants feel better by engaging them in enjoyable activities and setting safety goals. The aim is to see if this approach reduces depression and increases safety.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the Tele-PROTECT treatment for depression?

Research shows that internet-based therapies, especially those guided by a therapist, can effectively reduce depression symptoms. These treatments have been found to be as effective as face-to-face therapy, with significant improvements in depressive symptoms over time. ^{1 2 3 4 5}

Is Tele-PROTECT Therapy for Depression safe for humans?

Research on video-based therapy for depression, similar to Tele-PROTECT, shows it is generally safe and effective, with no significant differences in dropout rates compared to in-person therapy. This suggests that video-based therapy is a feasible and safe alternative for treating depression. ^{6 7 8 9 10}

How is Tele-PROTECT Therapy different from other treatments for depression?

Tele-PROTECT Therapy is unique because it is delivered via video, making it more accessible for people who may have difficulty attending in-person sessions. This approach is comparable in effectiveness to traditional face-to-face therapy, offering a flexible and convenient option for managing depression. ^{2 9 11 12 13}

Research Team

Jo Anne Sirey, Ph.D

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for English or Spanish-speaking NYC residents aged 60+ who are experiencing mild to moderate depression (PHQ-9≥10) and need elder abuse services. They must be able to consent and not have severe medical illnesses, active suicidal thoughts, or certain mental health conditions beyond depression or anxiety.

Inclusion Criteria

I am 60 years old or older.

I am considered capable of making my own health decisions.

Depression, i.e., PHQ-9≥10 (by elder abuse staff), represents mild to moderate severity of depression and has a sensitivity of 88% and a specificity of 88% for major depression

Exclusion Criteria

Elder abuse emergency and or referral out of elder abuse agency.

My Mini-MOCA score is below 11.

I cannot speak English or Spanish.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 9 weeks of telehealth psychotherapy delivered by a Master's level mental health clinician, assigned to either 'Tele-PROTECT' or 'DepEd' psychotherapy

9 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at weeks 3, 6, 9, and 12

3 weeks

4 follow-up assessments

Implementation

Qualitative data collection via surveys, interviews, and focus groups to identify barriers and facilitators to the implementation of Tele-PROTECT

Year 3 of study duration

Treatment Details

Interventions

• DepEd
• Tele-PROTECT

Trial Overview The study compares Tele-PROTECT, a video-delivered psychotherapy, with a control condition providing education on depression (DepEd). Participants will receive 9 weeks of therapy from Weill Cornell Medicine clinicians and undergo assessments over a period of up to 12 weeks.

Participant Groups

Group I: Tele-PROTECT (Effectiveness Aim, Abuse Impact Aim) Experimental Treatment 1 Intervention

This group of participants will receive the Tele-PROTECT intervention, a behavioral intervention for depressed elder abuse (EA) victims designed to work in synergy with EA resolution services that provide safety planning, support services, and links to legal services.

Group II: Stakeholder Groups (Implementation Aim) Active Control 1 Intervention

To address the Implementation Aim of the study, investigators will conduct qualitative data via surveys, interviews, and focus groups. Qualitative data from NAPSA surveys, interviews, and focus groups will be analyzed to identify barriers and facilitators to the implementation of Tele-PROTECT in elder abuse agencies nation-wide using a mixed methods design with multiple stakeholder groups (e.g., EA directors, staff) in collaboration with the National Adult Protective Services Association (NAPSA).

Group III: Depression Education (DepEd) (Effectiveness Aim, Abuse Impact Aim) Active Control 1 Intervention

This group of participants will receive the Depression Education intervention, an intervention designed with active therapeutic ingredients (education, support, empathy) and designed to be what a good clinician providing education would do with an individual with depression.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

New York City Department for the Aging

Collaborator

Trials

4

Recruited

280+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

Internet interventions based on cognitive behavioral therapy have been shown to effectively reduce symptoms of depression, with medium-to-large effect sizes (d=0.58-0.78) when guided by a therapist, and small-to-medium effect sizes (d=0.25-0.36) for self-help formats compared to usual care.

These interventions could help address the treatment gap for individuals with depression, as many do not receive adequate care, suggesting a promising avenue for integrating these tools into mental health care systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet interventions for depression: new developments. Schröder, J., Berger, T., Westermann, S., et al.[2022]

An online, therapist-supported cognitive behavioral therapy (CBT) program for depression showed high engagement levels among 80 university students over an 8-week period, indicating that integrating therapist support can enhance user participation.

Participants experienced a significant reduction in depressive symptoms, with self-reported scores on the Beck Depression Inventory-II decreasing from an average of 25.47 to 15.53, demonstrating the program's efficacy with a large effect size (d=1.17).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A service-based evaluation of a therapist-supported online cognitive behavioral therapy program for depression. Sharry, J., Davidson, R., McLoughlin, O., et al.[2022]

In a study of 239 patients with recurrent depression, those receiving internet-based cognitive therapy (mobile CT) alongside standard treatment showed a small but significant reduction in depressive symptoms over 3 months compared to those receiving standard treatment alone.

The mobile CT group experienced a decrease of 1.60 points on the Inventory of Depressive Symptomatology per month, indicating that this approach may be an effective addition to traditional treatment for managing residual symptoms in patients in remission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Three-Month Effect of Mobile Internet-Based Cognitive Therapy on the Course of Depressive Symptoms in Remitted Recurrently Depressed Patients: Results of a Randomized Controlled Trial. Kok, G., Burger, H., Riper, H., et al.[2019]

In a randomized controlled trial involving 63 participants referred to secondary mental health care for depression, the addition of a coach to a Web-based therapy (The Journal) did not significantly improve depression scores compared to usual care with an information leaflet after 12 weeks.

Participants using The Journal attended fewer outpatient appointments on average, but this difference was not statistically significant, highlighting potential challenges in engagement and adherence to Web-based therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based Therapy Plus Support by a Coach in Depressed Patients Referred to Secondary Mental Health Care: Randomized Controlled Trial. Hatcher, S., Whittaker, R., Patton, M., et al.[2020]

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 second version of the Help for Depression (HDep) web-based intervention showed moderate levels of satisfaction and acceptability among users, with 98.9% of participants reporting high levels of depressive symptoms, indicating a need for effective online support in low- and middle-income countries.

Factors such as gender, age, employment status, and previous therapy experiences influenced user satisfaction and acceptability, suggesting that tailoring web-based interventions to specific user demographics could enhance their effectiveness and adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction and Acceptability Ratings of a Web-Based Self-help Intervention for Depression: Retrospective Cross-sectional Study From a Resource-Limited Country. Lara, MA., Patiño, P., Tiburcio, M., et al.[2022]

An 8-week cognitive-behavioral therapy (CBT) intervention for childhood depression was effective in both face-to-face and telemedicine formats, with an overall response rate of 82% based on assessments.

Children receiving therapy via videoconferencing showed a faster decline in depression scores compared to those receiving face-to-face treatment, suggesting that telemedicine can be a viable and effective option for delivering mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating childhood depression over videoconferencing. Nelson, EL., Barnard, M., Cain, S.[2022]

The COVID-19 pandemic has increased the prevalence of depression, highlighting the need for accessible mental health services, including the use of telemedicine and digital therapeutics (DTx) as effective treatment options.

Digital therapeutics have been shown to improve remission rates and reduce depressive symptoms in clinical trials, but their implementation in real-world settings is necessary to ensure broader access to effective mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the potential of digital therapies in implementing the standard of care for depression in Europe. Courtet, P., Amiot, O., Baca-Garcia, E., et al.[2023]

Video-based psychotherapy is as effective as in-person therapy for reducing depressive symptoms, based on a meta-analysis of randomized controlled trials involving various studies from 2000 to 2021.

There were no significant differences in attrition rates between video and in-person therapy, suggesting that patients are equally likely to complete treatment in both formats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teletherapy Versus In-Person Psychotherapy for Depression: A Meta-Analysis of Randomized Controlled Trials. Giovanetti, AK., Punt, SEW., Nelson, EL., et al.[2022]

The study will evaluate the efficacy of the internet-based self-management tool iFightDepression (iFD) as an add-on to standard treatment for 310 participants with mild to moderate depression over 8 weeks, with a follow-up period of 12 weeks.

The primary outcome will be measured using the Hamilton Depression Rating Scale, aiming to determine if iFD can enhance the effectiveness of conventional treatments and provide a cost-effective solution for reaching more patients in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and methods of the iFightDepression study: A double-blind, randomized controlled trial evaluating the efficacy of an internet-based self-management tool for moderate to mild depression. Justicia, A., Elices, M., Cebria, AI., et al.[2018]

Telephone-administered psychotherapy significantly reduces depressive symptoms compared to control conditions, with a moderate effect size of 0.26 based on 12 trials.

The treatment shows a strong effect from pretreatment to posttreatment, with a large effect size of 0.81, and has a lower attrition rate (7.56%) compared to traditional face-to-face therapy, indicating better retention in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Telephone-Administered Psychotherapy on Symptoms of Depression and Attrition: A Meta-Analysis. Mohr, DC., Vella, L., Hart, S., et al.[2022]

Taping therapy, which involves placing medical tapes on specific acupoints and trigger points, showed promising results in treating severe depressive symptoms in three patients, leading to significant improvements in their conditions.

All three patients reported rapid relief from depressive symptoms and were able to discontinue their psychiatric medications, suggesting that taping therapy may be a viable alternative treatment for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic depression treated successfully with novel taping therapy: a new approach to the treatment of depression. Han, CH., Hwang, HS., Lee, YJ., et al.[2020]

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. England pubmed.ncbi.nlm.nih.gov

Internet interventions for depression: new developments. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

A service-based evaluation of a therapist-supported online cognitive behavioral therapy program for depression. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Three-Month Effect of Mobile Internet-Based Cognitive Therapy on the Course of Depressive Symptoms in Remitted Recurrently Depressed Patients: Results of a Randomized Controlled Trial. [2019]

4. Canada pubmed.ncbi.nlm.nih.gov

Web-based Therapy Plus Support by a Coach in Depressed Patients Referred to Secondary Mental Health Care: Randomized Controlled Trial. [2020]

5. England pubmed.ncbi.nlm.nih.gov

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

6. Canada pubmed.ncbi.nlm.nih.gov

Satisfaction and Acceptability Ratings of a Web-Based Self-help Intervention for Depression: Retrospective Cross-sectional Study From a Resource-Limited Country. [2022]

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

Treating childhood depression over videoconferencing. [2022]

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

Understanding the potential of digital therapies in implementing the standard of care for depression in Europe. [2023]

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

Teletherapy Versus In-Person Psychotherapy for Depression: A Meta-Analysis of Randomized Controlled Trials. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Rationale and methods of the iFightDepression study: A double-blind, randomized controlled trial evaluating the efficacy of an internet-based self-management tool for moderate to mild depression. [2018]

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

The Effect of Telephone-Administered Psychotherapy on Symptoms of Depression and Attrition: A Meta-Analysis. [2022]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Chronic depression treated successfully with novel taping therapy: a new approach to the treatment of depression. [2020]

13. 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]