Engage for Late-Life Depression and Comorbid Executive Dysfunction

NCT05356611 | Recruiting

• 1 other identifier: UNLV-2022-74
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression in Old Age; Psychotherapy; Mild Cognitive Impairment; Executive Dysfunction

Keywords

Older Adults; Late-Life Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

  Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.

• Behavioral Activation for Depression Scale (BADS)

  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.

Other Outcomes (4)

• Iowa Gambling Task - 2nd Edition

  Baseline, Week 9, and Week 36 follow-up.

• Hopkins Verbal Learning Memory Test-Revised

  Baseline, Week 9, and Week 36 follow-up.

• Stroop Color-Word Interference Test

  Baseline, Week 9, and Week 36 follow-up.

Study Arms (1)

Engage Treatment

EXPERIMENTAL

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

Interventions

Engage BEHAVIORAL

Engage is a 9-week, behavioral-based, psychotherapy treatment protocol for late-life depression.

Engage Treatment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Study Sites (1)

University of Nevada

Las Vegas, Nevada, 89154, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

engage 8200

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Brenna R Renn, PhD

CONTACT

7028950596; brenna.renn@unlv.edu

Matthew S Schurr, MA

CONTACT

7026957708; schurm1@unlv.nevada.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 2, 2022
• Study Start: September 24, 2023
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)