Engage for Late-Life Depression and Comorbid Executive Dysfunction

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment; Executive Dysfunction; Psychotherapy; Depression in Old Age
• Intervention / Treatment: Behavioral: Engage

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brenna R Renn, PhD; Phone Number: 7028950596; Email: brenna.renn@unlv.edu
• Study Contact Backup: Name: Matthew S Schurr, MA; Phone Number: 7026957708; Email: schurm1@unlv.nevada.edu

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89154
      • Recruiting
      • University of Nevada
      • Contact: Brenna R Renn, PhD; Phone Number: 702-895-0596; Email: brenna.renn@unlv.edu
      • Sub-Investigator: Matthew S Schurr, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Engage Treatment; 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; Engage is a 9-week, behavioral-based, psychotherapy treatment protocol for late-life depression.

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Iowa Gambling Task - 2nd Edition	Measure of reward response, decision-making and problem solving. Assess changes in target executive functioning skills across treatment. Produces multiple scores, generally with higher scores indicating better decision making.	Baseline, Week 9, and Week 36 follow-up.
Hopkins Verbal Learning Memory Test-Revised	Measure of memory. Assess potential changes in memory functioning across treatment. Consists of multiple trials and multiple ranges, with higher scores on each trial indicating better memory.	Baseline, Week 9, and Week 36 follow-up.
Stroop Color-Word Interference Test	Measure of processing speed and response inhibition. Assess changes in target executive functioning skills across treatment. Produces multiple scores across multiple trials and ranges, with higher scores indicating better performance.	Baseline, Week 9, and Week 36 follow-up.
Trail Making Test A & B	Measure of processing speed and set-shifting. Assess changes in target executive functioning skills across treatment. Time limited task, with higher time indicating worse performance.	Baseline, Week 9, and Week 36 follow-up.

Collaborators and Investigators

• Sponsor: University of Nevada, Las Vegas

Study record dates

Study Major Dates

• Study Start (Anticipated): June 5, 2023
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Older Adults; Late-Life Depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Neurocognitive Disorders; Cognition Disorders; Depression; Depressive Disorder; Cognitive Dysfunction
• Other Study ID Numbers: UNLV-2022-74

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be used for the current study. Unidentified data will be available for use within Dr. Brenna Renn's TREATment lab for future lab members to use.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No