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Completed

NCT Number: NCT03688139

Reward Function and 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).

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

White Plains, New York, 10605, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Late Positive Potential to Rewarding Stimuli

    Time frame: Change from baseline to week 9

    The late positive potential (LPP) is an electroencephalographic (EEG)-derived measure of emotional engagement with positively valanced images.

  2. Change in the Reward Positivity

    Time frame: Change from baseline to week 9

    The reward positivity (RewP) is an electroencephalographic (EEG)-derived response to rewarding feedback from a guessing task.

  3. Change in P1

    Time frame: Change from baseline to week 9

    The P1 is an electroencephalographic (EEG)-derived measure of early visual attention that is elicited by visual stimuli.

  4. 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. 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.

Secondary outcomes

  1. Change in Anhedonia

    Time frame: Change from baseline to week 9

    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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Sep 28, 2018
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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