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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH133953 | 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 investigators hypothesized that during the 9-week course of Engage & Connect treatment there will be an increase in brain functions of the Positive Valence System which in turn will lead to reduction in suicidality.
Social disconnection peaks in middle and late life and leads to an increased risk of suicide, persistent depression, and poor response to psychosocial interventions. There is a critical need to develop a mechanistic understanding of the link between social disconnection and suicidality, identify biological targets, and address targets with scalable interventions. The investigators developed a novel psychotherapy, Engage & Connect, aimed to improve functions of the Positive Valence System (PVS) that are impaired in suicidality through increased engagement in rewarding social activities. This study will use state-of-the-art precision imaging methods and clinical measures to evaluate brain- and behavioral changes in the PVS during psychotherapy.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Engage & Connect" Psychotherapy | Experimental | Engage & Connect is a remotely-delivered psychotherapy, aimed to increase engagement in rewarding social activities and in turn, reduce suicidality. In Engage & Connect, depressed middle-aged and older adults with suicidal ideation 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 and aging processes. 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 functional connectivity of the Positive Valence System | Change in resting state fMRI connectivity of functional networks representing structures previously associated with the Positive Valence System (Dorsal anterior cingulate cortex [dACC], the Subgenual Anterior Cingulate Cortex [sgACC], and the basal forebrain/nucleus accumbens [NAcc]). The investigators will also test between-network connectivity between the positive valence system and the default mode-, salience-, and fronto-parietal networks. Functional connectivity within- and between-network will be measured with a correlational score of 0 to 1, with 0 being the lowest and 1 being the highest. | Baseline, midtreatment (week 6) and post treatment (week 9) |
| Change in STAR task reaction time following social feedback | "The Social Task for Assessment of Reward" is a computerized task that measures response to social rewards. Reaction time will be measures in milliseconds. | Baseline, midtreatment (week 6), and post treatment (week 9) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nili Solomonov, PhD | Contact | (914) 682-9100 | 1012497 | nis2051@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nili Solomonov, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | Recruiting | 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. The investigators will also share the fMRI tasks and analytic code by request with all interested researchers.
After the investigators publish the main results, they will make de-identified data available to other researchers, under a data-sharing agreement overseen by the DSMB, and in compliance with policy of the IRB and NIMH.
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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| Symptom Review and Psychoeducation (SRP) | Behavioral | 9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D059020 | Suicidal Ideation |
| D003865 | Depressive Disorder, Major |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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