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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04487730

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arms

53.5

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a randomized controlled trial. Participants will be randomly assigned to 9-weeks of either "Engage-S" Psychotherapy or "Symptom Review and Psychoeducation" (SRP) PsychotherapyThis is a randomized controlled trial. Participants will be randomly assigned to 9-weeks of either "Engage-S" Psychotherapy or "Symptom Review and Psychoeducation" (SRP) Psychotherapy

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 15, 2020

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: "Engage & Connect" Psychotherapy "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.	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. 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", 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.

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. 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 fMRI Connectivity of the Positive Valence System [Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)]
Calculated from fMRI scan. Validation of target engagement.

Secondary Outcome Measures

Change in Montgomery Asberg Depression Rating Scale (MADRS) [Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)]
10-item Clinician rated measure of depression severity. Scores range from 0 (no depression) to 60 (severe depression).
Change in Behavioral Activation for Depression Scale (BADS) [Baseline, Mid-treatment (Week 5) and Post Treatment (Week 9)]
25-item measure self-report measure of behavioral activation. Scores range from 0 (very low behavioral activation) to 150 (high behavioral activation).

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Ages aged 50-85 [stratified so that 50% are older than 65]
Diagnosis of unipolar major depressive disorder without psychotic features, determined by the SCID
Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 20.
Mini Mental Status Exam (MMSE) ≤ 1 SD 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.
Capacity to provide written 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 of lorazepam daily up to seven times per week.
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.
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.