Engage for Late-Life Depression and Comorbid Executive Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Nevada, Las Vegas
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Engage
BehavioralEngage is a 9-week, behavioral-based, psychotherapy treatment protocol for late-life depression.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Engage TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.Secondary outcomes
1
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.
Time frame
Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.2
Behavioral Activation for Depression Scale (BADS)
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.3
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.
Time frame
Assessed at Baseline, Week 6, Week 9, and Week 36 follow-up.Other outcomes
1
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.
Time frame
Baseline, Week 9, and Week 36 follow-up.2
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.
Time frame
Baseline, Week 9, and Week 36 follow-up.3
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.
Time frame
Baseline, Week 9, and Week 36 follow-up.4
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.
Time frame
Baseline, Week 9, and Week 36 follow-up.Sponsors and contacts
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Source ClinicalTrials.gov