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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to ascertain the feasibility and effectiveness of an 8-week social engagement program aimed at reducing depression and increasing social engagement among seniors who are transitioning out of Adult Protective Services (APS) for either elder abuse or self-neglect.

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 data supports the effectiveness of the treatment Stepped-care social and mental health engagement for depression?

Research shows that the stepped care model, which involves gradually increasing treatment intensity, is effective in treating anxiety disorders and can potentially improve the reach and availability of mental health services. However, its effectiveness in improving depressive symptoms compared to usual care is not significantly different. ^{1 2 3 4 5}

Is the Stepped-care model safe for treating depression?

The Stepped-care model, used for treating depression and anxiety, has been studied in various trials and is generally considered safe for humans. It involves gradually increasing treatment intensity based on individual needs, and no significant safety concerns have been reported in the studies reviewed. ^{2 3 6 7 8}

How is the Stepped-care model treatment for depression different from other treatments?

The Stepped-care model for depression is unique because it uses a sequential approach, starting with less intensive treatments and only moving to more intensive ones if needed, based on the severity of the individual's symptoms. This method aims to provide the right level of care at the right time, potentially making it more efficient and accessible, especially in communities with limited resources. ^{1 2 7 8 9}

Research Team

Jason Burnett, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

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

Developing stepped care treatment for depression (STEPS): study protocol for a pilot randomised controlled trial. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Stepped care for the treatment of depression: a systematic review and meta-analysis. [2021]

3. England 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. [2018]

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

The effectiveness of enhanced evidence-based care for depressive disorders: a meta-analysis of randomized controlled trials. [2021]

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

Delivering stepped care: an analysis of implementation in routine practice. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Graduate mental health worker case management of depression in UK primary care: a pilot study. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The clinical effectiveness of stepped care systems for depression in working age adults: a systematic review. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Preliminary results of adapting the stepped care model for depression management in Vietnam. [2022]

9. England 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. [2021]