Clinical trial NCT05356611: Engage for Late-Life Depression and Comorbid Executive Dysfunction
Official title: Engage: A Treatment for Late-Life Depression and Comorbid Executive/Cognitive Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression in Old Age
Psychotherapy
Mild Cognitive Impairment
Executive Dysfunction
Keywords: Older Adults
Late-Life Depression
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.
Secondary outcomes:
measure: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.
measure: Behavioral Activation for Depression Scale (BADS)
timeFrame: Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.
measure: Social Problem-Solving Inventory Revised-Short Form
timeFrame: Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.
Other outcomes:
measure: Iowa Gambling Task - 2nd Edition
timeFrame: Baseline, Week 9, and Week 36 follow-up.
measure: Hopkins Verbal Learning Memory Test-Revised
timeFrame: Baseline, Week 9, and Week 36 follow-up.
measure: Stroop Color-Word Interference Test
timeFrame: Baseline, Week 9, and Week 36 follow-up.
measure: Trail Making Test A & B
timeFrame: Baseline, Week 9, and Week 36 follow-up.
Locations:
city: Las Vegas
country: United States
facility: University of Nevada
state: Nevada
Study officials:
References: