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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH123864-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Abnormalities in the Positive Valence System (PVS) are associated with depressive symptoms and reduced behavioral activation in mid- and late-life. This study will investigate the engagement of the PVS during exposure to social rewards, part of a novel streamlined psychotherapy for mid- and late-life depression. Use of computational modeling will enable identification of neuroimaging and behavioral profiles associated with greater treatment response, and may guide future personalization of psychotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Engage & Connect" Psychotherapy | Experimental | "Engage & Connect", a modified adapted version of "Engage". Its principal intervention is "social reward exposure" - facilitating engagement in rewarding and meaningful social activities with significant others. In "Engage-S" therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding social activities of their choice. |
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| Symptom Review and Psychoeducation (SRP) | Active Comparator | In this intervention, the therapist will review the participant's symptoms and provide literature-based clinical explanations and clarifications about the symptoms, the course, and the causes of depression. In SRP, the therapist reviews the depressed individual's symptoms, and level of information on depression, identifies misconceptions, and guides selection of educational material which could benefit the patient. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Engage & Connect" Psychotherapy | Behavioral | 9-weeks of weekly psychotherapy sessions focused on social reward exposure |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Resting State fMRI Connectivity of the Positive Valence System | Calculated from fMRI scan. Validation of target engagement (resting state functional connectivity (rsFC) within the right hemisphere orbital prefrontal cortex (OFC), specifically between the lateral and medial regions of the OFC). | Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montgomery Asberg Depression Rating Scale (MADRS) | 10-item Clinician rated measure of depression severity. Scores range from 0 (no depression) to 60 (severe depression). | Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9) |
| Change in Behavioral Activation for Depression Scale (BADS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nili Solomonov, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10065 | United States |
Individual participant data that underlie the results reported in publications, after de-identification, as well as study protocol, treatment manuals, statistical analysis plan and informed consent. We will also share our fMRI tasks and analytic code by request with all interested researchers.
After we publish the main results, we will make de-identified data available to other researchers, under a data-sharing agreement overseen by the Weill Cornell ALACRITY Center's Executive Committee.
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. All researchers requesting data will commit to using the data solely for research purpose; secure the data; return or destroy it once analyses are completed; do not share it with other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | "Engage & Connect" Psychotherapy | "Engage & Connect", a modified adapted version of "Engage". Its principal intervention is "social reward exposure" - facilitating engagement in rewarding and meaningful social activities with significant others. In "Engage-S" therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding social activities of their choice. "Engage & Connect" Psychotherapy: 9-weeks of weekly psychotherapy sessions focused on social reward exposure |
| FG001 | Symptom Review and Psychoeducation (SRP) | In this intervention, the therapist will review the participant's symptoms and provide literature-based clinical explanations and clarifications about the symptoms, the course, and the causes of depression. In SRP, the therapist reviews the depressed individual's symptoms, and level of information on depression, identifies misconceptions, and guides selection of educational material which could benefit the patient. Symptom Review and Psychoeducation (SRP): 9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | "Engage & Connect" Psychotherapy | "Engage & Connect", a modified adapted version of "Engage". Its principal intervention is "social reward exposure" - facilitating engagement in rewarding and meaningful social activities with significant others. In "Engage-S" therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding social activities of their choice. "Engage & Connect" Psychotherapy: 9-weeks of weekly psychotherapy sessions focused on social reward exposure |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Resting State fMRI Connectivity of the Positive Valence System | Calculated from fMRI scan. Validation of target engagement (resting state functional connectivity (rsFC) within the right hemisphere orbital prefrontal cortex (OFC), specifically between the lateral and medial regions of the OFC). | Participants were excluded from analysis in the event no data were collected at baseline due to participant withdrawal, if the participants were clinically excluded during the study, technical issues with MRI data, or lost to follow-up. | Posted | Mean | Standard Error | rsFC correlation coefficient | Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9) |
|
9 weeks
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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 & Connect" Psychotherapy | "Engage & Connect", a modified adapted version of "Engage". Its principal intervention is "social reward exposure" - facilitating engagement in rewarding and meaningful social activities with significant others. In "Engage-S" therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding social activities of their choice. "Engage & Connect" Psychotherapy: 9-weeks of weekly psychotherapy sessions focused on social reward exposure |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wearable device (watch) irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nili Solomonov | Weill Cornell Medicine | 212-746-5886 | nis2051@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 | May 21, 2024 | May 13, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 13, 2024 | Nov 8, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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This is a randomized controlled trial. Participants will be randomly assigned to 9-weeks of either "Engage-S" Psychotherapy or "Symptom Review and Psychoeducation" (SRP) Psychotherapy
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| Symptom Review and Psychoeducation (SRP) | Behavioral | 9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging |
|
25-item measure self-report measure of behavioral activation. Scores range from 0 (very low behavioral activation) to 150 (high behavioral activation). |
| Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9) |
| Physician Decision |
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| BG001 | Symptom Review and Psychoeducation (SRP) | In this intervention, the therapist will review the participant's symptoms and provide literature-based clinical explanations and clarifications about the symptoms, the course, and the causes of depression. In SRP, the therapist reviews the depressed individual's symptoms, and level of information on depression, identifies misconceptions, and guides selection of educational material which could benefit the patient. Symptom Review and Psychoeducation (SRP): 9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Symptom Review and Psychoeducation (SRP) | In this intervention, the therapist will review the participant's symptoms and provide literature-based clinical explanations and clarifications about the symptoms, the course, and the causes of depression. In SRP, the therapist reviews the depressed individual's symptoms, and level of information on depression, identifies misconceptions, and guides selection of educational material which could benefit the patient. Symptom Review and Psychoeducation (SRP): 9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging |
|
|
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| Secondary | Change in Montgomery Asberg Depression Rating Scale (MADRS) | 10-item Clinician rated measure of depression severity. Scores range from 0 (no depression) to 60 (severe depression). | Participants were excluded from analysis in the event no data were collected at baseline due to participant withdrawal, if the participants were clinically excluded during the study, or lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9) |
|
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| Secondary | Change in Behavioral Activation for Depression Scale (BADS) | 25-item measure self-report measure of behavioral activation. Scores range from 0 (very low behavioral activation) to 150 (high behavioral activation). | Participants were excluded from analysis in the event no data were collected at baseline due to participant withdrawal, if the participants were clinically excluded during the study, lost to follow-up, or did not complete the BADS. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9) |
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| 0 |
| 31 |
| 0 |
| 31 |
| 7 |
| 31 |
| EG001 | Symptom Review and Psychoeducation (SRP) | In this intervention, the therapist will review the participant's symptoms and provide literature-based clinical explanations and clarifications about the symptoms, the course, and the causes of depression. In SRP, the therapist reviews the depressed individual's symptoms, and level of information on depression, identifies misconceptions, and guides selection of educational material which could benefit the patient. Symptom Review and Psychoeducation (SRP): 9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging | 0 | 33 | 0 | 33 | 4 | 33 |
| Hospital Visits (unrelated to research) | General disorders | Non-systematic Assessment |
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| Mid-treatment (Week 5) |
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| Post Treatment (Week 9) |
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| Mid-treatment (Week 5) |
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| Post Treatment (Week 9) |
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