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Recruiting NCT05356611

Engage for Late-Life Depression and Comorbid Executive Dysfunction

No phase Interventional Depression in Old Age Psychotherapy Mild Cognitive Impairment Executive Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Engage.
Who it may be relevant to
Registry conditions: Depression in Old Age, Psychotherapy, Mild Cognitive Impairment, Executive Dysfunction. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Hamilton Depression Rating Scale [Time frame: Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.]
Secondary outcome measures (3)
  • World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) [Time frame: Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.]
  • Behavioral Activation for Depression Scale (BADS) [Time frame: Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.]
  • Social Problem-Solving Inventory Revised-Short Form [Time frame: Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Nevada — Las Vegas

Identifiers

NCT: NCT05356611 · UNLV-2022-74

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗