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Reward Function and Therapy for Late-Life Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688139
Recruitment Status : Active, not recruiting
First Posted : September 28, 2018
Last Update Posted : April 1, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Engage Therapy Behavioral: Supportive Therapy Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Positive Valence System Function and Reward Exposure Therapy for Late-Life Depression
Actual Study Start Date : March 14, 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in neural response to rewarding stimuli [ Time Frame: Change from baseline to week 9 ]
    Neural responses will be measured using electroencephalographic (EEG) activity recorded during tasks with rewarding stimuli.


Secondary Outcome Measures :
  1. Change in behavioral activation [ Time Frame: Change from baseline to week 9 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688139


Locations
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United States, New York
Weill Cornell Medicine
White Plains, New York, United States, 10605
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Jennifer N Bress, PhD Weill Cornell Medicine
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03688139    
Other Study ID Numbers: 1803019076
K23MH116105 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
depression
major depressive disorder
mental health
mood disorder
geriatric
late-life
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders