Social Reward and Its Effect on Brain Functions in Psychotherapies for Mid- and Late-Life Depression

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Major Depressive Disorder

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04487730

20-04021860

K23MH123864-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Abnormalities in the Positive Valence System (PVS) are associated with depressive symptoms and reduced behavioral activation in mid- and late-life. This study will investigate the engagement of the PVS during exposure to social rewards, part of a novel streamlined psychotherapy for mid- and late-life depression. Use of computational modeling will enable identification of neuroimaging and behavioral profiles associated with greater treatment response, and may guide future personalization of psychotherapy.

Enrollment: 64 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ages aged 50-85 [stratified so that 50% are older than 65]
2. Diagnosis of unipolar major depressive disorder without psychotic features, determined by the SCID
3. Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 20.
4. Mini Mental Status Exam (MMSE) ≤ 1 SD below the mean score for patient's age and education
5. 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.
6. Capacity to provide written consent for research assessment and treatment.

Exclusion criteria

1. Intent or plan to attempt suicide in the near future.
2. History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, or specific phobia.
3. Use of psychotropic drugs or cholinesterase inhibitors other than use of ≤ 0.5 mg of lorazepam daily up to seven times per week.
4. Neurological disorders (dementias, history of stroke, multiple sclerosis, Parkinson's disease, epilepsy, etc.); cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease; metastatic cancer; or debilitated states or less common medical illnesses that may either influence brain systems of interest or ability to participate in the study. Dr. Alexopoulos or another research psychiatrist will review any medical illnesses that does not appear in the list above and determine whether it interferes with the study of positive valence system functions in depression.
5. 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: Triple Blind

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64 participants in 2 patient groups

"Engage & Connect" Psychotherapy

Experimental group

Description:

"Engage \& Connect", a modified adapted version of "Engage". Its principal intervention is "social reward exposure" - facilitating engagement in rewarding and meaningful social activities with significant others. In "Engage-S" therapy, individuals with depression 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. 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)