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

Trial Summary

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 data supports the effectiveness of the treatment Engage for late-life depression with executive dysfunction?

Research on similar treatments, like neuroplasticity-based computerized cognitive remediation (nCCR-GD), shows that targeting executive dysfunction can improve depression symptoms in older adults. This suggests that treatments focusing on executive dysfunction, like Engage, may also be effective for late-life depression. ^{1 2 3 4 5}

Is Engage Therapy for Late-Life Depression with Executive Dysfunction safe for humans?

The Engage Therapy, also known as Engage & Connect, is a psychotherapy aimed at improving social connectedness and has been described as a simple and scalable intervention. While specific safety data for Engage Therapy is not detailed, similar interventions like neuroplasticity-based computerized cognitive remediation (nCCR-GD) have shown high completion rates and are considered safe, with no significant adverse effects reported in studies. ^{1 2 4 6 7}

How is Engage Therapy different from other treatments for late-life depression with executive dysfunction?

Engage Therapy is unique because it focuses on improving executive dysfunction (problems with planning, decision-making, and attention) in older adults with depression, which is often not addressed by standard antidepressants. This approach may involve psychosocial interventions that enhance alertness and behavioral function, potentially leading to better outcomes for those who do not respond well to traditional medication. ^{1 2 4 8 9}

What is the purpose of this trial?

Although there are an increasing number of mental health treatment adaptations for older adults, there are still a number of factors to consider when making these adaptations. Cognitive decline is one such factor that places significant burden on older adults and can interfere with traditional mental health therapies. Engage is a behavioral treatment approach that has shown to be effective in treating late life depression. The investigators are testing the feasibility of Engage as a treatment method for late life depression in older adults with cognitive decline. The objective is to corroborate Engage as an alternative late life depression treatment method for a sub-population of older adults with cognitive decline. Cognitive decline poses a unique mental health treatment barrier that is often over looked in younger populations. With a relatively higher prevalence of cognitive decline in older adulthood, it is imperative that a feasible mental health treatment program that can be effective in the presence of cognitive decline.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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 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]

References

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

Problem-solving therapy and supportive therapy in older adults with major depression and executive dysfunction: effect on disability. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Neuroplasticity-based computerized cognitive remediation for treatment-resistant geriatric depression. [2022]

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

Diagnosis and treatment of depression and cognitive impairment in late life. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Executive Dysfunction Predicts Treatment Response to Neuroplasticity-Based Computerized Cognitive Remediation (nCCR-GD) in Elderly Patients with Major Depression. [2018]

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

Modifiable predictors of nonresponse to psychotherapies for late-life depression with executive dysfunction: a machine learning approach. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

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

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

Speed of processing training and depression in assisted and independent living: A randomized controlled trial. [2020]

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

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

9. England pubmed.ncbi.nlm.nih.gov

Cognitive outcomes after psychotherapeutic interventions for major depression in older adults with executive dysfunction. [2021]