Social and Mental Health Program for Depression

Overseen By Sophia Wasik

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Decision-making impairments, psychiatric illnesses, others

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

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new 8-week program to determine its effectiveness in reducing depression and enhancing social connections for seniors. It targets older adults who have experienced elder abuse or self-neglect and are completing services with Adult Protective Services. The trial includes two groups: one will participate in the new stepped-care social and mental health engagement program, while the other will continue with their usual care. Seniors transitioning from Adult Protective Services to independent living may find this study suitable. As an unphased trial, it provides a unique opportunity for seniors to explore innovative support methods tailored to their needs.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this social and mental health program is safe for seniors?

Research has shown that stepped-care treatment for mental health issues, such as depression, has been studied in various settings. This method adjusts the level of care based on patient needs. Studies have found it effective and generally well-tolerated.

These studies have examined stepped-care programs for depression, anxiety, and stress-related disorders. Results suggest that patients often respond well, with few major side effects reported, indicating safety. The goal is to provide the most helpful treatment with the least burden on the patient, often leading to positive outcomes and minimal risk.

Overall, previous research supports the safety of stepped-care treatment for managing mental health conditions, making it a promising option for those considering joining a trial involving this approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the stepped-care social and mental health program for depression because it offers a fresh approach to managing the condition. Unlike traditional treatments like antidepressants or cognitive-behavioral therapy, this program focuses on enhancing social engagement and mental health support in a structured, step-by-step manner. This method aims to not only alleviate symptoms of depression but also to address social isolation, which is a significant factor in many cases. By potentially integrating community resources and personalized support, it has the potential to offer a more holistic and accessible option for individuals struggling with depression.

What evidence suggests that the stepped-care social and mental health engagement program is effective for reducing depression?

Research has shown that stepped-care programs can effectively reduce depression. This approach uses the most effective treatment with the least resources, aiding in the management of mental health issues like depression and anxiety. A review of 38 studies found stepped care helpful for treating these conditions. Participants in this trial will receive either the stepped-care social and mental health engagement program or usual care. The program begins with simpler treatments and adds more intensive care only if needed, adapting to individual needs. This method could particularly benefit seniors transitioning from Adult Protective Services, as they may gain from structured social and mental engagement. ^{2 4 6 7 8}

Who Is on the Research Team?

Jason Burnett, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for seniors who have experienced depression or social isolation after elder abuse or self-neglect, and are transitioning out of Adult Protective Services. Details on specific inclusion or exclusion criteria were not provided.

Inclusion Criteria

Student: college or university student, enrolled at one of the UTHealth graduate programs in Houston, University of Houston, Texas Southern University, Sam Houston State University, or Rice University, commit to making 8-weekly consecutive calls, complete the required 1-hour training and assessment.

I am an older adult, can consent, speak English or Spanish, live in a community, can use the phone, and am finishing with APS services.

Exclusion Criteria

Student: only engaging in the program to fulfill some educational requirement.

I am an older adult without severe mental health issues or the need for a proxy to make decisions for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week social engagement program aimed at reducing depression and increasing social engagement

8 weeks

Weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for changes in depression, anxiety, loneliness, resilience, and social isolation

1 month

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Stepped-care social and mental health engagement

Trial Overview The study tests an 8-week program designed to reduce depression and boost social engagement in seniors post-APS care. It compares the effectiveness of a stepped-care approach with usual APS care.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 2 Interventions

Group II: Usual Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

US Department of Health and Human Services, Administration on Community Living

Collaborator

Trials

1

Recruited

300+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

Published Research Related to This Trial

The Stepped Care Model (SCM) for treating depression shows significant benefits, particularly for patients with moderately severe symptoms, leading to improved response and remission rates compared to usual care, based on a systematic review of 18 randomized controlled trials.

Patients receiving SCM also experienced a notable enhancement in quality of life and were more likely to be prescribed antidepressants at 6 months, indicating a more proactive treatment approach for those with higher severity of depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepped care for the treatment of depression: a systematic review and meta-analysis. Rivero-Santana, A., Perestelo-Perez, L., Alvarez-Perez, Y., et al.[2021]

In a pilot study involving 62 patients with depression who had not responded well to antidepressants, there was no significant difference in outcomes between usual GP care and case management by graduate mental health workers over 16 weeks.

Both treatment groups reported high client satisfaction, but the study highlighted challenges in patient recruitment and the feasibility of the case management intervention, suggesting further investigation is needed before larger trials can be conducted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Graduate mental health worker case management of depression in UK primary care: a pilot study. McMahon, L., Foran, KM., Forrest, SD., et al.[2021]

Stepped care models for treating depression in working-age adults show recovery rates between 40% and 60%, and response rates around 60%, indicating they are effective treatment options.

When compared to usual care, stepped care systems demonstrated significant advantages, with a median recovery odds ratio of 1.31, suggesting they may provide better outcomes for patients, although further research is needed to confirm their overall superiority.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical effectiveness of stepped care systems for depression in working age adults: a systematic review. Firth, N., Barkham, M., Kellett, S.[2018]

The adapted Stepped Care Model for depression management in Vietnam showed significant effectiveness, with a reduction in mild to moderate depression from 95.5% to 9.3% after 3 months of group psychotherapy involving 359 participants.

Participants experienced a 32% increase in life satisfaction and a notable decrease in anxiety levels, indicating that community-based interventions can be successful in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary results of adapting the stepped care model for depression management in Vietnam. Do, MT., Nguyen, TT., Tran, HTT.[2022]

The STEPS study is a pilot randomized controlled trial involving at least 60 patients with Major Depressive Disorder, designed to assess the feasibility of comparing stepped care treatment to intensive psychological therapy for depression.

This mixed methods study will gather both quantitative data on treatment outcomes and qualitative insights from patient interviews, aiming to inform the design of a larger trial to evaluate the effectiveness and efficiency of stepped care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing stepped care treatment for depression (STEPS): study protocol for a pilot randomised controlled trial. Hill, JJ., Kuyken, W., Richards, DA.[2023]

Stepped care treatment for anxiety disorders was found to be significantly more effective than care-as-usual (CAU), leading to a higher treatment response rate in reducing anxiety symptoms.

However, there was no significant difference in the effectiveness of stepped care compared to CAU for preventing anxiety or depressive disorders and improving depressive symptoms, indicating that while it helps with anxiety treatment, its benefits for depression may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy and Cost-Effectiveness of Stepped Care Prevention and Treatment for Depressive and/or Anxiety Disorders: A Systematic Review and Meta-Analysis. Ho, FY., Yeung, WF., Ng, TH., et al.[2018]

Enhanced evidence-based care (EEC) models, including Collaborative Care and Algorithm-guided Treatment, significantly improve treatment outcomes for depression compared to usual care, with a response rate increase of 30% and remission rate increase of 35% based on a meta-analysis of 29 studies involving 15,255 participants.

Despite the improved effectiveness of EEC, the rate of discontinuation from treatment was similar to that of usual care, indicating that EEC is a safe option for managing depression without increasing dropout rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of enhanced evidence-based care for depressive disorders: a meta-analysis of randomized controlled trials. Xiao, L., Qi, H., Zheng, W., et al.[2021]

The qualitative evaluation of the COMET trial, involving 24 care providers, highlighted that while collaborative care models improved referral processes and fostered communication, significant challenges remained due to communication issues and unclear professional roles.

Care providers expressed a need for better resources and remuneration for collaborative activities, indicating that enhancing interprofessional understanding and clarifying roles are crucial for the success of collaborative and stepped care models in mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do care providers evaluate collaboration? - qualitative process evaluation of a cluster-randomized controlled trial of collaborative and stepped care for patients with mental disorders. Maehder, K., Werner, S., Weigel, A., et al.[2021]

A study of 7,698 patients in the UK revealed significant variability in the implementation of stepped care for depression and anxiety, with the ratio of low to high-intensity treatments differing greatly across four NHS sites.

Less than 10% of patients moved from low-intensity to high-intensity treatments, indicating potential barriers in the treatment pathway that may hinder effective management of depression and anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering stepped care: an analysis of implementation in routine practice. Richards, DA., Bower, P., Pagel, C., et al.[2021]

Citations

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Stepped care for depression is easy to recommend, but harder ... Specific psychological interventions for relapse prevention or for chronically depressed patients were not available. A wide range of influencing factors for ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2468171724000267

Effectiveness of stepped care for mental health disorders Results. Ten systematic reviews incorporating 38 primary studies on depression, anxiety and posttraumatic stress disorder were the source of data. In spite of ...

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Scoping review of stepped care interventions for mental ... Many young people with mental health and/or substance use concerns do not have access to timely, appropriate, and effective services.

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Stepped Care Approach Stepped care is a system of delivering and monitoring mental health treatment so that the most effective, yet least resource intensive treatment, is delivered ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4247766/

Developing stepped care treatment for depression (STEPS) A minimum of 60 patients with Major Depressive Disorder will be recruited from an Improving Access to Psychological Therapies service and randomly allocated to ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12124162/

Proposed Standards for Implementing Stepped Care Models ... We describe the development of standards for implementing SC models in Canadian child and youth mental health (CYMH) contexts using a consensus‐based approach.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032714005199

The clinical effectiveness of stepped care systems for ... Principal outcomes were (a) recovery rates, defined as patients no longer meeting clinical cut-off criteria for the specific outcome measure and (b) treatment ...