Engage for Late-Life Depression and Comorbid Executive Dysfunction

Study Overview
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Brief Summary
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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.

Official Title
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Engage: A Treatment for Late-Life Depression and Comorbid Executive/Cognitive Dysfunction

Conditions
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Depression in Old Age, Psychotherapy, Mild Cognitive Impairment, Executive Dysfunction

Intervention / Treatment
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* Behavioral: Engage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 60 or older Ability to read, write, and speak English Located in Las Vegas or surrounding area Ability to travel to UNLV campus by self or possible caregiver for regular study visits Clinically significant symptoms of depression as evidenced by: 1) Scores > 5 on the Geriatric Depression Scale-Short Form (GDS-SF) Mild cognitive impairment as evidenced by: 1) Scores > 18 and < 25 on the Montreal Cognitive Assessment (MoCA) Exclusion Criteria: Active suicidal ideation History of suicide attempt(s) Current symptoms of: 1) Psychosis; 2) Active substance use disorder Reported history of: 1) Bipolar disorder (manic depression); 2) Intellectual disability Currently in or scheduled to initiate individual psychotherapy to avoid treatment interference Psychotropic medication permitted if dose was stable over the past 2 weeks Currently living in an institutional setting (e.g., assisted living, inpatient, skilled nursing) Presence of notable memory-specific cognitive deficits as evidenced by: scores < 9 on the MoCA memory subscale (rendering it difficult to participate in and track/recall events for weekly psychotherapy)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The trial will be a single-arm feasibility trial of Engage for treatment of late-life depression in older adults with comorbid executive/cognitive dysfunction.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Engage Treatment<br>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. | Behavioral: Engage<br>* Engage is a 9-week, behavioral-based, psychotherapy treatment protocol for late-life depression.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale | Measure of depressive symptoms used to assess changes across treatment from baseline to mid-treatment, to post-treatment, and follow up at 36 weeks post-baseline. Scores range from 0 - 54 with higher scores indicating worse depression. | Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | Measure of disability and functioning. Scores range from 0 to 100, with higher scores indicating worse disability. | Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up. | 
| Behavioral Activation for Depression Scale (BADS) | Measure of behavioral activation (target mechanism). Scores range from 0 to 54, with higher scores indicating more dysfunction. | Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up. | 
| Social Problem-Solving Inventory Revised-Short Form | measure of problem solving skills. Total scores range from 0 to 100. When all appropriate items are reverse-scored, higher scores indicate better social problem solving functioning. | Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older Adults, Late-Life Depression