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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05925322
• Other study ID #: 23-05026093
• Secondary ID: R01MH133953
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: September 30, 2028

Study information

• Verified date: May 2024
• Source: Weill Medical College of Cornell University
• Contact: Nili Solomonov, PhD
• Phone: (914) 682-9100
• Email: nis2051[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: September 30, 2028
• Est. primary completion date: September 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Suicidal Ideation

Intervention

Behavioral:
• "Engage & Connect" Psychotherapy
9-weeks of weekly psychotherapy sessions focused on social reward exposure
• Symptom Review and Psychoeducation (SRP)
9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)