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Reward Function and Therapy for Late-Life Depression

Primary Purpose

Major Depressive Disorder

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Engage Therapy

Supportive Therapy

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, major depressive disorder, mental health, mood disorder, geriatric, late-life

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Weill Cornell MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Engage Therapy

Supportive Therapy

Arm Description

Participants receive Engage therapy for 9 weeks.

Participants receive supportive therapy for 9 weeks.

Outcomes

Primary Outcome Measures

Change in neural response to rewarding stimuli

Neural responses will be measured using electroencephalographic (EEG) activity recorded during tasks with rewarding stimuli.

Secondary Outcome Measures

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. 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.

Full Information

NCT ID

NCT03688139

First Posted

September 26, 2018

Last Updated

February 27, 2023

Sponsor

Weill Medical College of Cornell University

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT03688139

Brief Title

Reward Function and Therapy for Late-Life Depression

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 14, 2019 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

depression, major depressive disorder, mental health, mood disorder, geriatric, late-life

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Engage Therapy

Arm Type

Experimental

Arm Description

Participants receive Engage therapy for 9 weeks.

Arm Title

Supportive Therapy

Arm Type

Active Comparator

Arm Description

Participants receive supportive therapy for 9 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Engage Therapy

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Supportive Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in neural response to rewarding stimuli

Description

Neural responses will be measured using electroencephalographic (EEG) activity recorded during tasks with rewarding stimuli.

Time Frame

Change from baseline to week 9

Secondary Outcome Measure Information:

Title

Change in behavioral activation

Description

Time Frame

Change from baseline to week 9

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jennifer N Bress, PhD

Phone

914-997-8683

jeb2061@med.cornell.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer N Bress, PhD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weill Cornell Medicine

City

White Plains

State/Province

New York

ZIP/Postal Code

10605

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jennifer N Bress, PhD

Phone

914-997-8683

jeb2061@med.cornell.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Reward Function and Therapy for Late-Life Depression

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