Engage for Late-Life Depression and Comorbid Executive Dysfunction

Not Applicable

Recruiting

• Conditions: Depression in Old Age; Executive Dysfunction; Psychotherapy; Mild Cognitive Impairment
• Interventions: Behavioral: Engage

• Registration Number: NCT05356611
• Lead Sponsor: University of Nevada, Las Vegas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-05-02
• Study Start: 2023-09-24
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-04
• Last Update Posted: 2024-08-06
• Primary Completion: 2024-12
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Engage Treatment	Engage	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.

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale	Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.	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.

Secondary Outcome Measures

Name	Time	Method
Behavioral Activation for Depression Scale (BADS)	Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.	Measure of behavioral activation (target mechanism). Scores range from 0 to 54, with higher scores indicating more dysfunction.
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)	Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.	Measure of disability and functioning. Scores range from 0 to 100, with higher scores indicating worse disability.
Social Problem-Solving Inventory Revised-Short Form	Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.	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.

Trial Locations

Locations (1)

University of Nevada; 🇺🇸 Las Vegas, Nevada, United States