Depression in Old AgeNCT05356611
Engage for Late-Life Depression and Comorbid Executive Dysfunction
A study testing Engage in people with Depression in Old Age and Psychotherapy, run by University of Nevada, Las Vegas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression in Old Age, Psychotherapy, Mild Cognitive Impairment
- What is being tested?
- Engage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2023to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Nevada
Las Vegas, Nevada, 89154
Brenna R Renn, PhD, 702-895-0596, brenna.renn@unlv.edu
Matthew S Schurr, MA
About this study
Official title: 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.
- Being tested
- Engage
- Keywords
- Older Adults, Late-Life Depression
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EngageBehavioural
Engage is a 9-week, behavioral-based, psychotherapy treatment protocol for late-life depression.
| Study group | Role | What they receive |
|---|---|---|
| Engage Treatment | Experimental | 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. Receives: Behavioral: Engage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start24 Sep 2023
- Primary completionDec 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brenna Renn, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356611
- Sponsor's protocol ID
- UNLV-2022-74
- Status last verified
- Aug 2024
- First submitted
- 26 Apr 2022
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engage: A Treatment for Late-Life Depression and Comorbid Executive/Cognitive Dysfunction
- ClinicalTrials.gov ID
- NCT05356611
- Acronym / sponsor ID
- UNLV-2022-74
- Keywords
- Older Adults, Late-Life Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 24 Sep 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Engage Treatment | Experimental | Behavioral: EngageThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EngageEngage is a 9-week, behavioral-based, psychotherapy treatment protocol for late-life depression. | Behavioural | Engage Treatment |
Primary outcome
Hamilton Depression Rating Scale
Time frame: 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. Scores range from 0 - 54 with higher scores indicating worse depression.
3 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Engage in people with Depression in Old Age and Psychotherapy, run by University of Nevada, Las Vegas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brenna R Renn, PhD (7028950596, brenna.renn@unlv.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (time frame: Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.