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

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Behavioral: Symptom Review and Psychoeducation (SRP); Behavioral: "Engage & Connect" Psychotherapy

• Registration Number: NCT04487730
• Lead Sponsor: Weill Medical College of Cornell University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-23
• Study First Posted: 2020-07-27
• Study Start: 2020-10-15
• Primary Completion: 2024-08-13
• Study Completion: 2024-08-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Symptom Review and Psychoeducation (SRP)	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.
"Engage & Connect" Psychotherapy	"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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States