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Clinical Trials/NCT05356611
NCT05356611
Recruiting
Not Applicable

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

University of Nevada, Las Vegas1 site in 1 country20 target enrollmentSeptember 24, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression in Old Age
Sponsor
University of Nevada, Las Vegas
Enrollment
20
Locations
1
Primary Endpoint
Hamilton Depression Rating Scale
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 24, 2023
End Date
May 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brenna Renn

Assistant Professor

University of Nevada, Las Vegas

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)

Outcomes

Primary Outcomes

Hamilton Depression Rating Scale

Time Frame: 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 Outcomes

  • Behavioral Activation for Depression Scale (BADS)(Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.)
  • World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)(Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.)
  • Social Problem-Solving Inventory Revised-Short Form(Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.)

Study Sites (1)

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