Reward Function and Therapy for Late-Life Depression

NCT03688139 | Completed Results DMC

• 2 other identifiers: 1803019076K23MH116105
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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).

Conditions

Major Depressive Disorder

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Change in Anhedonia

  Change from baseline to week 9

Study Arms (2)

Engage Therapy

EXPERIMENTAL

Participants receive Engage therapy for 9 weeks.

Behavioral: Engage Therapy

Supportive Therapy

ACTIVE COMPARATOR

Participants receive supportive therapy for 9 weeks.

Behavioral: Supportive Therapy

Interventions

Engage Therapy BEHAVIORAL

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.

Engage Therapy

Supportive Therapy BEHAVIORAL

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.

Supportive Therapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Weill Cornell Medicine

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Psychological Well-Being; Mood Disorders

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Depressive Disorder; Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Jennifer N. Bress
• Organization: Weill Medical College of Cornell University

jeb2061@med.cornell.edu

914-997-8683

Study Officials

• Jennifer N Bress, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 28, 2018
• Study Start: March 14, 2019
• Primary Completion: January 18, 2024
• Study Completion: January 18, 2024
• Last Updated: November 14, 2024
• Results First Posted: November 14, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be made available after the main results have been published.
• 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.

Locations

US (1)