Reward Function and Therapy for Late-Life Depression

Positive Valence System Function and Reward Exposure Therapy for Late-Life Depression

The goal of this study is to learn about changes in the brain that occur during Engage, a psychotherapy for depression in older adults, and how they may differ from changes that occur during supportive therapy. Older adults with depression will receive 9 weeks of either Engage or supportive therapy and will complete research assessments before the therapy begins and at weeks 3, 6, and 9 of treatment. Research assessments will include questionnaires, computer tasks, and recordings of electrical brain activity (also called electroencephalography or EEG).

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Engage Therapy; Behavioral: Supportive Therapy

Detailed Description

Late-life depression is prevalent and devastating, and response rates to even the most effective treatments are low. Outcomes may be improved by developing targeted interventions such as Engage - a new, easily disseminated, neurobiologically informed psychotherapy for late-life depression designed to restore impaired function of neural reward systems. This study will use event-related potentials and a panel of other reward system measures to assess target engagement in depressed older adults receiving Engage therapy, with a comparison group of depressed peers receiving supportive therapy. Participants will be randomly assigned to either Engage or supportive therapy and will complete research assessments at baseline and weeks 3, 6, and 9 (end of treatment).

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • White Plains, New York, United States, 10605
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age greater than or equal to 60 years.
• Diagnosis of unipolar major depressive disorder without psychotic features, determined by Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID).
• Montgomery-Asberg Depression Rating Scale (MADRS) score greater than or equal to 20.
• Mini Mental State Exam (MMSE) score greater than or equal to 24.
• Off antidepressants or on a stable dose of an antidepressant for 12 weeks and no intent to change the dose in the next 10 weeks.
• Capacity to provide written consent for both research assessment and treatment.

Exclusion Criteria:

• Intent or plan to attempt suicide in the near future.
• Presence of current psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, or specific phobia.
• History of past psychiatric diagnoses other than major depressive disorder without psychotic features or anxiety disorders (separation anxiety disorder, specific phobia, social phobia, panic disorder, agoraphobia, or generalized anxiety disorder).
• Use of psychotropic drugs or cholinesterase inhibitors other than use of less than or equal to 0.5 mg of lorazepam daily up to five 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 neural systems of interest or ability to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Engage Therapy; Participants receive Engage therapy for 9 weeks.	Behavioral: Engage Therapy; Engage therapy is designed to help individuals with depression become involved in activities they previously enjoyed but have not been participating in since developing depression. In Engage therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding activities of their choice.
Active Comparator: Supportive Therapy; Participants receive supportive therapy for 9 weeks.	Behavioral: Supportive Therapy; Supportive therapy is designed to provide a warm and supportive environment in which individuals with depression can feel comfortable expressing their thoughts and feelings. In supportive therapy, therapists help patients identify themes in their thinking, provide reassurance, emphasize coping skills, and provide guidance as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Late Positive Potential to Rewarding Stimuli	The late positive potential (LPP) is an electroencephalographic (EEG)-derived measure of emotional engagement with positively valanced images.	Change from baseline to week 9
Change in the Reward Positivity	The reward positivity (RewP) is an electroencephalographic (EEG)-derived response to rewarding feedback from a guessing task.	Change from baseline to week 9
Change in P1	The P1 is an electroencephalographic (EEG)-derived measure of early visual attention that is elicited by visual stimuli.	Change from baseline to week 9
Change in Behavioral Activation	Behavioral activation will be measured using the Behavioral Activation for Depression Scale (BADS), a 25-item measure of behaviors targeted in behavioral activation therapies such as Engage. Scores range from 0 to 150, where higher scores on this measure indicate more participation in activities and social interactions, and lower scores indicate more social isolation, rumination, and avoidance of activities.	Change from baseline to week 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anhedonia	Anhedonia will be measured by the clinician-rated Snaith-Hamilton Pleasure Scale (SHAPS-C). The SHAPS-C measures pleasure and enjoyment experienced in response to a variety of situations. Scores range from 14 to 56, where higher scores indicate greater severity of anhedonia and lower scores indicate lower severity of anhedonia.	Change from baseline to week 9

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Jennifer N Bress, PhD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2019
• Primary Completion (Actual): January 18, 2024
• Study Completion (Actual): January 18, 2024

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: depression; mental health; major depressive disorder; geriatric; mood disorder; late-life
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 1803019076; K23MH116105 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data collected during this study will be made available to other researchers after the main results have been published. To ensure data and participant security, we will make the data available to users under a data-sharing agreement.
• IPD Sharing Time Frame: The data will be made available after the main results have been published.
• IPD Sharing Access Criteria: Researchers interested in accessing the data will be asked to provide to the PI, and to the ALACRITY center with which the PI is affiliated, a proposal of hypotheses, variables needed to test these hypotheses, and plans for dissemination of findings. Before researchers are granted access, they will be asked to indicate in a signed document: 1) a commitment to using the data only for research purposes; 2) a plan for securing the data; 3) an agreement to either destroy or return the data once analyses are completed; and 4) and agreement not to share data with other users and to direct all such requests to the PI.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No