Engage for Late-Life Depression and Comorbid Executive Dysfunction

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05356611
• Other study ID #: UNLV-2022-74
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2023
• Est. completion date: October 2024

Study information

• Verified date: May 2023
• Source: University of Nevada, Las Vegas
• Contact: Brenna R Renn, PhD
• Phone: 7028950596
• Email: brenna.renn[@]unlv.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Depression
• Depression in Old Age
• Depressive Disorder
• Executive Dysfunction
• Mild Cognitive Impairment
• Psychotherapy

Intervention

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

Locations

Country	Name	City	State
United States	University of Nevada	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
University of Nevada, Las Vegas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Other	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.
Primary	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	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.
Secondary	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.
Secondary	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.