Engage for Late-Life Depression and Comorbid Executive Dysfunction

Sponsor
University of Nevada, Las Vegas (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05356611
Collaborator
(none)
30
1
1
18
1.7

Study Details

Study Description

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. We are testing the feasibility of Engage as a treatment method for late life depression in older adults with cognitive decline. Our 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 we find a feasible mental health treatment program that can be effective in the presence of cognitive decline.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Engage
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Engage: A Treatment for Late-Life Depression and Comorbid Executive/Cognitive Dysfunction
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Hamilton Depression Rating Scale [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.

Secondary Outcome Measures

  1. World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) [Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.]

    Measure of disability and functioning

  2. Behavioral Activation for Depression Scale (BADS) [Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.]

    Measure of behavioral activation (target mechanism)

  3. Social Problem-Solving Inventory Revised-Short Form [Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.]

    measure of problem solving skills

Other Outcome Measures

  1. Iowa Gambling Task - 2nd Edition [Baseline, Week 9, and Week 36 follow-up.]

    Measure of reward response, decision-making and problem solving. Assess changes in target executive functioning skills across treatment.

  2. Hopkins Verbal Learning Memory Test-Revised [Baseline, Week 9, and Week 36 follow-up.]

    Measure of memory. Assess potential changes in memory functioning across treatment.

  3. Stroop Color-Word Interference Test [Baseline, Week 9, and Week 36 follow-up.]

    Measure of processing speed and response inhibition. Assess changes in target executive functioning skills across treatment.

  4. Trail Making Test A & B [Baseline, Week 9, and Week 36 follow-up.]

    Measure of processing speed and set-shifting. Assess changes in target executive functioning skills across treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Nevada Las Vegas Nevada United States 89154

Sponsors and Collaborators

  • University of Nevada, Las Vegas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brenna Renn, Assistant Professor, University of Nevada, Las Vegas
ClinicalTrials.gov Identifier:
NCT05356611
Other Study ID Numbers:
  • UNLV-2022-74
First Posted:
May 2, 2022
Last Update Posted:
May 2, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Brenna Renn, Assistant Professor, University of Nevada, Las Vegas
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 2, 2022