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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05925322

Collaborator

(none)

128

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Suicidal Ideation Major Depressive Disorder Depressive Disorder	Behavioral: "Engage & Connect" Psychotherapy Behavioral: Symptom Review and Psychoeducation (SRP)	N/A

Detailed 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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Brain Changes During Social Reward Psychotherapy for Mid- and Late-Life Suicidality: A Precision Imaging Trial

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2028

Anticipated Study Completion Date :

Sep 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: "Engage & Connect" Psychotherapy 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.	Behavioral: "Engage & Connect" Psychotherapy 9-weeks of weekly psychotherapy sessions focused on social reward exposure
Active Comparator: 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 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.	Behavioral: Symptom Review and Psychoeducation (SRP) 9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging

Arm

Intervention/Treatment

Experimental: "Engage & Connect" Psychotherapy

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.

Behavioral: "Engage & Connect" Psychotherapy

9-weeks of weekly psychotherapy sessions focused on social reward exposure

Active Comparator: 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 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.

Behavioral: Symptom Review and Psychoeducation (SRP)

9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging

Outcome Measures

Primary Outcome Measures

Change in resting state functional connectivity of the Positive Valence System [Baseline, midtreatment (week 6) and post treatment (week 9)]
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.
Change in STAR task reaction time following social feedback [Baseline, midtreatment (week 6), and post treatment (week 9)]
"The Social Task for Assessment of Reward" is a computerized task that measures response to social rewards. Reaction time will be measures in milliseconds.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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 1
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 1 standard deviation below the mean score for patient's age and education
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.