Engage Therapy for Late-Life Depression with Executive Dysfunction

Overseen By Matthew S Schurr, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nevada, Las Vegas

Disqualifiers: Suicidal ideation, Psychosis, Bipolar, others

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

Compensation: Varies

Number of Visits: 36

Duration: 9 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new behavioral treatment called Engage, designed for older adults facing depression and cognitive challenges. The researchers aim to determine if this therapy can assist those with both depression and mild cognitive issues, such as memory or thinking problems. The trial seeks participants with noticeable depression symptoms and mild cognitive impairment who can travel to the University of Nevada, Las Vegas for sessions. Participants should not have severe memory issues or currently be in individual therapy. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance mental health care for older adults.

Do I have to stop taking my current medications for the trial?

You can continue taking your current medications as long as the dose has been stable for the past 2 weeks.

What prior data suggests that this method is safe for older adults with cognitive decline?

Research has shown that Engage therapy, a type of behavioral treatment, is generally safe for older adults with depression. In one study, 48 older adults with major depression participated in nine weekly sessions of Engage therapy and were evaluated 36 weeks after starting the treatment. The results showed their depression symptoms improved, indicating the therapy was well-tolerated. No major safety issues or negative effects were reported in these studies, which is reassuring for those considering this treatment. While Engage therapy is still being tested for people with memory problems, current research supports its safety for older adults with depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Engage Therapy because it targets late-life depression with a unique focus on executive dysfunction and mild cognitive impairment. Unlike standard treatments like antidepressants and cognitive-behavioral therapy, Engage Therapy uses a 9-week structured protocol specifically designed for older adults. This approach not only addresses mood symptoms but also aims to improve cognitive functions, potentially offering a more comprehensive solution for those struggling with both depression and cognitive challenges in their later years.

What evidence suggests that Engage is effective for late-life depression with cognitive decline?

Research has shown that Engage, a type of behavioral treatment, effectively treats depression in older adults. Studies have found that increased involvement in meaningful activities during this treatment reduces depression symptoms. This method is particularly beneficial for older adults with both depression and memory or thinking problems. These cognitive issues can complicate traditional therapies, but Engage emphasizes enjoyable activities, which can enhance mood and motivation. Overall, Engage offers a promising alternative treatment for depression in older adults facing cognitive challenges. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 60 or older in the Las Vegas area with mild cognitive impairment and depression, who can travel to UNLV campus. They should score between 18-25 on MoCA and over 5 on GDS-SF without active suicidal thoughts, history of suicide attempts, psychosis, substance abuse disorders, bipolar disorder, intellectual disability or being in psychotherapy.

Inclusion Criteria

I have significant depression symptoms, scoring over 5 on the GDS-SF.

Mild cognitive impairment as evidenced by Scores > 18 and < 25 on the Montreal Cognitive Assessment (MoCA)

Located in Las Vegas or surrounding area

Exclusion Criteria

I am currently in or will start individual psychotherapy soon.

My psychotropic medication dose has been stable for the last 2 weeks.

Currently living in an institutional setting (e.g., assisted living, inpatient, skilled nursing)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implementation of the 9-week Engage protocol in older adults with late-life depression and comorbid executive dysfunction and mild cognitive impairment

9 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

27 weeks

Assessments at Week 36

What Are the Treatments Tested in This Trial?

Interventions

• Engage

Trial Overview The Engage program is being tested as a feasible treatment for late-life depression among older adults with cognitive decline. The study aims to confirm if Engage can be an effective therapy option despite the challenges posed by cognitive impairments in this demographic.

How Is the Trial Designed?

Group I: Engage Treatment Experimental Treatment 1 Intervention

The study is a single-arm study. The single-arm will be implementation of the 9-week protocol of Engage in an older adult population with late-life depression and comorbid executive dysfunction and mild cognitive impairment.

Who Is Running the Clinical Trial?

University of Nevada, Las Vegas

Lead Sponsor

Trials

81

Recruited

14,700+

Published Research Related to This Trial

In a study of 11 elderly patients with treatment-resistant major depression, those with executive dysfunction (ED) at baseline showed a greater reduction in depression symptoms after a 4-week neuroplasticity-based cognitive remediation treatment, indicating that ED can predict a favorable response to this intervention.

This contrasts with findings from pharmacotherapy studies, where ED typically predicts a poorer response, suggesting that nCCR-GD may be a promising alternative for older adults who do not respond to traditional antidepressant treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Executive Dysfunction Predicts Treatment Response to Neuroplasticity-Based Computerized Cognitive Remediation (nCCR-GD) in Elderly Patients with Major Depression. Morimoto, SS., Gunning, FM., Wexler, BE., et al.[2018]

Late-onset depression is linked to cognitive impairment and neurological issues, suggesting it may be a neurological disease rather than just a mood disorder.

The depression-executive dysfunction (DED) syndrome shows that patients often respond poorly to traditional antidepressants, indicating a need for treatments that enhance alertness and psychosocial interventions to improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of executive function in late-life depression. Alexopoulos, GS.[2003]

In a study of 221 older adults with major depression and executive dysfunction undergoing 12 weeks of therapy, about 77.5% showed improvement in depressive symptoms by the 6th week, while 22.5% had persistent symptoms, indicating that most participants benefited from treatment.

Key factors predicting early nonresponse included low perceived social support and high neuroticism, suggesting that addressing these modifiable factors early on could enhance treatment outcomes through personalized interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modifiable predictors of nonresponse to psychotherapies for late-life depression with executive dysfunction: a machine learning approach. Solomonov, N., Lee, J., Banerjee, S., et al.[2022]

In a study of 221 older adults with late-life depression, psychotherapy improved cognitive functioning specifically in information processing speed, as measured by the Stroop Color and Word Test, after 12 weeks of treatment.

While both Problem Solving Therapy and Supportive Therapy were effective in reducing depressive symptoms, there was no significant difference between the two therapies in terms of their impact on overall cognitive functioning, indicating that improvements may be limited to specific areas rather than widespread across all cognitive domains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive outcomes after psychotherapeutic interventions for major depression in older adults with executive dysfunction. Mackin, RS., Nelson, JC., Delucchi, K., et al.[2021]

The neuroplasticity-based computerized cognitive remediation treatment (nCCR-GD) is as effective as escitalopram in reducing depressive symptoms in treatment-resistant older adults, achieving results in just 4 weeks compared to 12 weeks for escitalopram.

Participants undergoing nCCR-GD showed greater improvements in executive function compared to those treated with escitalopram, suggesting that nCCR-GD may better address cognitive deficits associated with geriatric depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroplasticity-based computerized cognitive remediation for treatment-resistant geriatric depression. Morimoto, SS., Wexler, BE., Liu, J., et al.[2022]

Cognitive impairment is common in late-life depression and can significantly affect treatment outcomes, particularly due to executive dysfunction, which impacts overall cognitive performance.

Accurate cognitive assessment is crucial for effective treatment planning, and tailored interventions can improve outcomes based on specific cognitive profiles observed in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis and treatment of depression and cognitive impairment in late life. Morimoto, SS., Kanellopoulos, D., Manning, KJ., et al.[2022]

In a study involving 351 older adults in senior living communities, speed of processing training (SOPT) led to an increase in depressive symptoms among those in assisted living, contrary to expectations.

The results suggest that SOPT programs, like Road Tour/Double Decision, may not be suitable for older adults in assisted living settings and highlight the need for careful monitoring of depression in such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Speed of processing training and depression in assisted and independent living: A randomized controlled trial. Smith, M., Jones, MP., Dotson, MM., et al.[2020]

In a randomized controlled trial involving 221 older adults with major depression and executive dysfunction, problem-solving therapy (PST) was found to be more effective than supportive therapy (ST) in reducing disability, particularly in patients with greater cognitive impairment.

The benefits of PST not only improved depressive symptoms but also led to a sustained reduction in disability even after treatment ended, suggesting it could be a valuable alternative for older patients who may not respond well to medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problem-solving therapy and supportive therapy in older adults with major depression and executive dysfunction: effect on disability. Alexopoulos, GS., Raue, PJ., Kiosses, DN., et al.[2021]

Psychotherapies are effective for late-life depression, but about half of patients still experience depression after treatment, highlighting the need for improved interventions.

The 'Engage & Connect' therapy, which focuses on increasing social engagement, is a promising approach that targets brain networks related to social reward, potentially offering a first-line treatment for late-life depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving social reward responsivity and social connectedness in psychotherapies for late-life depression: Engage & Connect as an example. Solomonov, N.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05356611?draw=2&rank=1

Engage for Late-Life Depression and Comorbid Executive ... The objective is to corroborate Engage as an alternative late life depression treatment method for a sub-population of older adults with cognitive decline.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4818673/

Behavioral Activation and Improvement of Late-Life Major ... During Engage treatment and follow-up, change in behavioral activation is followed by improvement of depressive symptoms and signs. Keywords: Engage, Behavioral ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1041610224025079

Depression, cognitive, and functional outcomes of Problem ... PATH participants had better depression, cognitive, and disability outcomes than ST-CI participants over 6 months. PATH may provide relief to depressed older ...

4. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/370899

Engage for Late-Life Depression and Comorbid Executive ... Engage is a behavioral treatment approach that has shown to be effective in treating late life depression. The investigators are testing the feasibility of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4108572/

Cognitive Outcomes Following Psychotherapeutic ... Performance on other measures of executive functioning, verbal learning, and memory did not change significantly following 12 weeks of psychotherapy treatment.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28647669/

"Engage" therapy: Prediction of change of late-life major ... Conclusion: Change in behavioral activation predicts improvement of depressive symptoms and signs in depressed older adults treated with Engage.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1041610224028060

Preventing late-life depression: a clinical update PST reduced incident depression (major or minor) by 50% (11.6% PST versus 23.2% usual care) at two months. A reduced chance of dropping a valued activity in the ...

8. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.focus.20210006

Late Life Depression: The Essentials and ... The co-occurrence of alcohol use disorders and depression increases the potential for poor mental and general health outcomes among older adults ...

9. nature.com nature.com/articles/s41398-019-0514-6

Mechanisms and treatment of late-life depression Problem solving therapy was more effective that supportive therapy in reducing depression and disability in older adults with DED, a syndrome ...