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Recruiting NCT05925322

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

No phase Interventional Depression Suicidal Ideation Major Depressive Disorder Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: "Engage & Connect" Psychotherapy, Symptom Review and Psychoeducation (SRP).
Who it may be relevant to
Registry conditions: Depression, Suicidal Ideation, Major Depressive Disorder, Depressive Disorder. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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

Interventions

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

Primary outcome measures

  • Change in resting state functional connectivity of the Positive Valence System [Time frame: Baseline, midtreatment (week 6) and post treatment (week 9)]
  • Change in STAR task reaction time following social feedback [Time frame: Baseline, midtreatment (week 6), and post treatment (week 9)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Weill Cornell Medicine — New York

Identifiers

NCT: NCT05925322 · 23-05026093 · R01MH133953

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗