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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH116105 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The goal of this study is to learn about changes in the brain that occur during Engage, a psychotherapy for depression in older adults, and how they may differ from changes that occur during supportive therapy. Older adults with depression will receive 9 weeks of either Engage or supportive therapy and will complete research assessments before the therapy begins and at weeks 3, 6, and 9 of treatment. Research assessments will include questionnaires, computer tasks, and recordings of electrical brain activity (also called electroencephalography or EEG).
Late-life depression is prevalent and devastating, and response rates to even the most effective treatments are low. Outcomes may be improved by developing targeted interventions such as Engage - a new, easily disseminated, neurobiologically informed psychotherapy for late-life depression designed to restore impaired function of neural reward systems. This study will use event-related potentials and a panel of other reward system measures to assess target engagement in depressed older adults receiving Engage therapy, with a comparison group of depressed peers receiving supportive therapy. Participants will be randomly assigned to either Engage or supportive therapy and will complete research assessments at baseline and weeks 3, 6, and 9 (end of treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Engage Therapy | Experimental | Participants receive Engage therapy for 9 weeks. |
|
| Supportive Therapy | Active Comparator | Participants receive supportive therapy for 9 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engage Therapy | Behavioral | Engage therapy is designed to help individuals with depression become involved in activities they previously enjoyed but have not been participating in since developing depression. In Engage therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding activities of their choice. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Late Positive Potential to Rewarding Stimuli | The late positive potential (LPP) is an electroencephalographic (EEG)-derived measure of emotional engagement with positively valanced images. | Change from baseline to week 9 |
| Change in the Reward Positivity | The reward positivity (RewP) is an electroencephalographic (EEG)-derived response to rewarding feedback from a guessing task. | Change from baseline to week 9 |
| Change in P1 | The P1 is an electroencephalographic (EEG)-derived measure of early visual attention that is elicited by visual stimuli. | Change from baseline to week 9 |
| Change in Behavioral Activation | Behavioral activation will be measured using the Behavioral Activation for Depression Scale (BADS), a 25-item measure of behaviors targeted in behavioral activation therapies such as Engage. Scores range from 0 to 150, where higher scores on this measure indicate more participation in activities and social interactions, and lower scores indicate more social isolation, rumination, and avoidance of activities. | Change from baseline to week 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anhedonia | Anhedonia will be measured by the clinician-rated Snaith-Hamilton Pleasure Scale (SHAPS-C). The SHAPS-C measures pleasure and enjoyment experienced in response to a variety of situations. Scores range from 14 to 56, where higher scores indicate greater severity of anhedonia and lower scores indicate lower severity of anhedonia. | Change from baseline to week 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer N Bress, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | White Plains | New York | 10605 | United States |
The data collected during this study will be made available to other researchers after the main results have been published. To ensure data and participant security, we will make the data available to users under a data-sharing agreement.
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The data will be made available after the main results have been published.
Researchers interested in accessing the data will be asked to provide to the PI, and to the ALACRITY center with which the PI is affiliated, a proposal of hypotheses, variables needed to test these hypotheses, and plans for dissemination of findings. Before researchers are granted access, they will be asked to indicate in a signed document: 1) a commitment to using the data only for research purposes; 2) a plan for securing the data; 3) an agreement to either destroy or return the data once analyses are completed; and 4) and agreement not to share data with other users and to direct all such requests to the PI.
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Participants were recruited through community referrals, physical ads posted in locations frequented by older adults, a depression screening hotline maintained by the Weill Cornell Institute of Geriatric Psychiatry, and via ads posted on social media. The first participant was enrolled on 3/14/2019, and the last participant was enrolled on 9/26/2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Engage Therapy | Participants receive Engage therapy for 9 weeks. Engage Therapy: Engage therapy is designed to help individuals with depression become involved in activities they previously enjoyed but have not been participating in since developing depression. In Engage therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding activities of their choice. |
| FG001 | Supportive Therapy | Participants receive supportive therapy for 9 weeks. Supportive Therapy: Supportive therapy is designed to provide a warm and supportive environment in which individuals with depression can feel comfortable expressing their thoughts and feelings. In supportive therapy, therapists help patients identify themes in their thinking, provide reassurance, emphasize coping skills, and provide guidance as needed. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Engage Therapy | Participants receive Engage therapy for 9 weeks. Engage Therapy: Engage therapy is designed to help individuals with depression become involved in activities they previously enjoyed but have not been participating in since developing depression. In Engage therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding activities of their choice. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Late Positive Potential to Rewarding Stimuli | The late positive potential (LPP) is an electroencephalographic (EEG)-derived measure of emotional engagement with positively valanced images. | Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments. | Posted | Mean | Standard Deviation | microvolts | Change from baseline to week 9 |
|
Baseline to week 9 of study participation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Engage Therapy | Participants receive Engage therapy for 9 weeks. Engage Therapy: Engage therapy is designed to help individuals with depression become involved in activities they previously enjoyed but have not been participating in since developing depression. In Engage therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding activities of their choice. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall resulting in injury | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer N. Bress | Weill Medical College of Cornell University | 914-997-8683 | jeb2061@med.cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 17, 2024 | Oct 18, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| D000092862 | Psychological Well-Being |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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|
| Supportive Therapy | Behavioral | Supportive therapy is designed to provide a warm and supportive environment in which individuals with depression can feel comfortable expressing their thoughts and feelings. In supportive therapy, therapists help patients identify themes in their thinking, provide reassurance, emphasize coping skills, and provide guidance as needed. |
|
| Withdrawal by Subject |
|
| BG001 | Supportive Therapy | Participants receive supportive therapy for 9 weeks. Supportive Therapy: Supportive therapy is designed to provide a warm and supportive environment in which individuals with depression can feel comfortable expressing their thoughts and feelings. In supportive therapy, therapists help patients identify themes in their thinking, provide reassurance, emphasize coping skills, and provide guidance as needed. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Late Positive Potential | The late positive potential (LPP) is an electroencephalographic (EEG)-derived measure of emotional engagement with positively valanced images. | Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments. | Mean | Standard Deviation | microvolts |
|
| Reward Positivity | The reward positivity (RewP) is an electroencephalographic (EEG)-derived response to rewarding feedback from a guessing task. | Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments. | Mean | Standard Deviation | microvolts |
|
| P1 | The P1 is an electroencephalographic (EEG)-derived measure of early visual attention that is elicited by visual stimuli. | Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments. | Mean | Standard Deviation | microvolts |
|
| Behavioral Activation | Behavioral activation will be measured using the Behavioral Activation for Depression Scale (BADS), a 25-item measure of behaviors targeted in behavioral activation therapies such as Engage. Scores range from 0 to 150, where higher scores on this measure indicate more participation in activities and social interactions, and lower scores indicate more social isolation, rumination, and avoidance of activities. | Two participants dropped out before baseline and some data points are missing due to missed study assessments. | Mean | Standard Deviation | units on a scale |
|
| Anhedonia | Anhedonia will be measured by the clinician-rated Snaith-Hamilton Pleasure Scale (SHAPS-C). The SHAPS-C measures pleasure and enjoyment experienced in response to a variety of situations. Scores range from 14 to 56, where higher scores indicate greater severity of anhedonia and lower scores indicate lower severity of anhedonia. | Two participants dropped out before baseline and some data points are missing due to missed study assessments. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Supportive Therapy | Participants receive supportive therapy for 9 weeks. Supportive Therapy: Supportive therapy is designed to provide a warm and supportive environment in which individuals with depression can feel comfortable expressing their thoughts and feelings. In supportive therapy, therapists help patients identify themes in their thinking, provide reassurance, emphasize coping skills, and provide guidance as needed. |
|
|
|
| Primary | Change in the Reward Positivity | The reward positivity (RewP) is an electroencephalographic (EEG)-derived response to rewarding feedback from a guessing task. | Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments. | Posted | Mean | Standard Deviation | microvolts | Change from baseline to week 9 |
|
|
|
|
| Primary | Change in P1 | The P1 is an electroencephalographic (EEG)-derived measure of early visual attention that is elicited by visual stimuli. | Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments. | Posted | Mean | Standard Deviation | microvolts | Change from baseline to week 9 |
|
|
|
|
| Primary | Change in Behavioral Activation | Behavioral activation will be measured using the Behavioral Activation for Depression Scale (BADS), a 25-item measure of behaviors targeted in behavioral activation therapies such as Engage. Scores range from 0 to 150, where higher scores on this measure indicate more participation in activities and social interactions, and lower scores indicate more social isolation, rumination, and avoidance of activities. | Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to week 9 |
|
|
|
|
| Secondary | Change in Anhedonia | Anhedonia will be measured by the clinician-rated Snaith-Hamilton Pleasure Scale (SHAPS-C). The SHAPS-C measures pleasure and enjoyment experienced in response to a variety of situations. Scores range from 14 to 56, where higher scores indicate greater severity of anhedonia and lower scores indicate lower severity of anhedonia. | Two participants dropped out before baseline and some data points are missing due to poor data quality or missed study assessments. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to week 9 |
|
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 1 |
| 32 |
| EG001 | Supportive Therapy | Participants receive supportive therapy for 9 weeks. Supportive Therapy: Supportive therapy is designed to provide a warm and supportive environment in which individuals with depression can feel comfortable expressing their thoughts and feelings. In supportive therapy, therapists help patients identify themes in their thinking, provide reassurance, emphasize coping skills, and provide guidance as needed. | 0 | 33 | 0 | 33 | 7 | 33 |
| Leg pain requiring surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Abdominal and thoracic pain requiring endoscopy | Gastrointestinal disorders | Non-systematic Assessment |
|
| Panic attack | Psychiatric disorders | Non-systematic Assessment |
|
| Fractured pelvis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hair loss at EEG electrode site | General disorders | Non-systematic Assessment |
|
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| D010549 |
| Personal Satisfaction |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Mixed Models Analysis |
| .96 |
| difference in slopes |
| .00 |
| 2-Sided |
| Other |
This analysis tested the hypothesis that change in SHAPS for each assessment interval would predict severity of anhedonia at the next assessment in Engage but not in Supportive Therapy. |