Brain Changes During Social Reward Psychotherapy for Mid- and Late-Life Suicidality
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorWeill Medical College of Cornell University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.).
Trial design
Design model
Parallel
Treatments tested in this trial
"Engage & Connect" Psychotherapy
Behavioral9-weeks of weekly psychotherapy sessions focused on social reward exposure
Symptom Review and Psychoeducation (SRP)
Behavioral9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: "Engage & Connect" PsychotherapyExperimental treatment 1 intervention
Group B: Symptom Review and Psychoeducation (SRP)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, midtreatment (week 6) and post treatment (week 9)2
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.
Time frame
Baseline, midtreatment (week 6), and post treatment (week 9)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Weill Medical College of Cornell University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov