Brain Changes During Social Reward Psychotherapy for Mid- and Late-Life Suicidality

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: Major Depressive Disorder; Suicidal Ideation; Depression; Depressive Disorder

Treatments: Behavioral: "Engage & Connect" Psychotherapy; Behavioral: Symptom Review and Psychoeducation (SRP)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05925322

R01MH133953 (Other Identifier)

23-05026093

Details and patient eligibility

About

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.

Full description

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:

• Be randomly assigned to 9-weekly sessions of either Engage & Connect therapy or Symptom Review and Psychoeducation
• Complete 4 research assessments
• Complete 3 MRI scans

Enrollment: 128 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages aged 50-80 [stratified so that 50% are older than 65]
• Endorsement of Suicidal Ideation [Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders-5 (SCID-5) Suicide Item (Item 9) with a score of 2
• Major Depressive Disorder as determined by the SCID-5
• Depression Rating Scale [Montgomery-Åsberg Depression Rating Scale (MADRS)] score of 16 or greater.
• Mini Mental Status Exam (MMSE) equal or greater than a score of 23
• Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 10 weeks, without individual psychotherapy services during the study period.
• Capacity to provide consent for research assessment and treatment.

Exclusion criteria

• Intent or plan to attempt suicide in the near future.
• History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, or specific phobia.
• Use of psychotropic drugs or cholinesterase inhibitors other than use of 0.5 mg or less of lorazepam daily up to seven times per week.
• Neurological disorders (dementias, amnestic and multidomain Mild Cognitive Impairment, Parkinson's disease, epilepsy, etc.).
• Acute or severe medical illness in the past 3 months (metastatic cancer, multiple sclerosis, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction, cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease, etc.) that may be the primary cause depressive symptoms, influence brain systems of interest, or impact ability to participate in the study.
• Contraindications to MRI scanning including cardiac pacemaker, heart valve replacement, vascular stent, insulin pump, cochlear implant, any other metallic biomedical implant contraindicating to MRI, and claustrophobia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

128 participants in 2 patient groups

"Engage & Connect" Psychotherapy

Experimental group

Description:

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.

Treatment:

Behavioral: "Engage & Connect" Psychotherapy

Symptom Review and Psychoeducation (SRP)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Symptom Review and Psychoeducation (SRP)