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Engage for Late-Life Depression and Comorbid Executive Dysfunction

Primary Purpose

Depression in Old Age, Psychotherapy, Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Engage
Sponsored by
University of Nevada, Las Vegas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression in Old Age focused on measuring Older Adults, Late-Life Depression

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of NevadaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Engage Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Behavioral Activation for Depression Scale (BADS)
Measure of behavioral activation (target mechanism). Scores range from 0 to 54, with higher scores indicating more dysfunction.
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.

Full Information

First Posted
April 26, 2022
Last Updated
May 8, 2023
Sponsor
University of Nevada, Las Vegas
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1. Study Identification

Unique Protocol Identification Number
NCT05356611
Brief Title
Engage for Late-Life Depression and Comorbid Executive Dysfunction
Official Title
Engage: A Treatment for Late-Life Depression and Comorbid Executive/Cognitive Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 5, 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Las Vegas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression in Old Age, Psychotherapy, Mild Cognitive Impairment, Executive Dysfunction
Keywords
Older Adults, Late-Life Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Engage Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Engage
Intervention Description
Engage is a 9-week, behavioral-based, psychotherapy treatment protocol for late-life depression.
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale
Description
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.
Time Frame
Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.
Secondary Outcome Measure Information:
Title
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Description
Measure of disability and functioning. Scores range from 0 to 100, with higher scores indicating worse disability.
Time Frame
Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.
Title
Behavioral Activation for Depression Scale (BADS)
Description
Measure of behavioral activation (target mechanism). Scores range from 0 to 54, with higher scores indicating more dysfunction.
Time Frame
Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.
Title
Social Problem-Solving Inventory Revised-Short Form
Description
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.
Time Frame
Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.
Other Pre-specified Outcome Measures:
Title
Iowa Gambling Task - 2nd Edition
Description
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.
Time Frame
Baseline, Week 9, and Week 36 follow-up.
Title
Hopkins Verbal Learning Memory Test-Revised
Description
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.
Time Frame
Baseline, Week 9, and Week 36 follow-up.
Title
Stroop Color-Word Interference Test
Description
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.
Time Frame
Baseline, Week 9, and Week 36 follow-up.
Title
Trail Making Test A & B
Description
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.
Time Frame
Baseline, Week 9, and Week 36 follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brenna R Renn, PhD
Phone
7028950596
Email
brenna.renn@unlv.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew S Schurr, MA
Phone
7026957708
Email
schurm1@unlv.nevada.edu
Facility Information:
Facility Name
University of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89154
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brenna R Renn, PhD
Phone
702-895-0596
Email
brenna.renn@unlv.edu
First Name & Middle Initial & Last Name & Degree
Matthew S Schurr, MA

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Engage for Late-Life Depression and Comorbid Executive Dysfunction

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