NIMH is issuing this Notice to highlight its interest in supporting intervention development activities for older adults. Although controlled clinical trial data on age differences in the efficacy of interventions for mental disorders are seldom available, clinical experience suggests that many psychopharmacological agents show reduced efficacy in older adults as well as greater risks for the occurrence of adverse side effects. In older adults with dementia, the increased mortality risks have been deemed significant enough for the FDA to issue a black box warning concerning the use of antipsychotic agents with this patient population. Clinicians treating older adults with mental disorders need better information on the risks and expected benefits of available therapies and on strategies for optimizing outcomes in this age group. More research is needed that evaluates the impact of aging and aging-related chronic illnesses on mental health care in middle-aged to older adults, that conjointly considers both the efficacy/effectiveness and the safety of therapies as equally important components of overall outcome. Research is also needed that develops and advances interventions tailored to the specific needs of older adults with mental disorders in multiple intervention modalities (pharmacological, psychosocial, neurostimulationory device-based) and their combinations. As such, the NIMH is encouraging the submission of such trials through these funding mechanisms, based on the stage of testing needed:

Examples of NIMH studies that are encouraged through this Notice include, but are not limited to those that:

• design and test strategies for increasing the effectiveness of existing interventions administered to older adults with mental disorders (including methods of patient-treatment matching or other approaches to personalizing treatment), particularly in cases where there is evidence of poor or partial response or substandard effectiveness for older adults treated with the intervention(s) in routine clinical practice
• study the efficacy and effectiveness of internet- and computer-assisted intervention modalities tailored for use by older adults with mental disorders (including computerized games and artificial intelligence informed methods)
• investigate strategies for improving the safety of psychopharmacological and/or neurostimulation interventions for older adults with mental disorders, including development of alternatives to currently used agents/devices that have fewer adverse side effects in frail elders
• parameters of improving the safety of psychopharmacological interventions for older adults with mental disorders, including development of alternatives to currently used agents that have fewer adverse side effects in frail elders
• develop and test interventions to enhance emotion regulation by older adults with mood and anxiety disorders, as informed by research on typical patterns of maturational and aging-related changes in affective functioning
• assess the value of combining neurostimulation approaches orinterventions with other intervention modalities in the treatment of older adults with mental disorders, including those with poor to non-response to single modality approaches
• develop and test behavioral and psychosocial interventions to improve management of the neuropsychiatric symptoms and syndromes associated with dementia in Alzheimer’s disease and related neurodegenerative disorders
• develop and test strategies for reducing risk for and preventing suicidal behavior by older adults
• assess the fidelity and effectiveness of interventions for late-life mental disorders when administered under real-world conditions in typical geriatric residential and care settings (senior centers, assisted living facilities, nursing homes, primary care clinics, adult day care centers, etc.)

Application and Submission Information

This notice applies to due dates on or after June 5, 2020 and subsequent receipt dates through September 8, 2023.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

• PA-19-055 - NIH Research Project Grant (Parent R01 Clinical Trial Required)
• PA-19-056 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-19-091 NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
• PA-19-094- Emotion Regulation, Aging, and Mental Disorder (R01 Clinical Trial Not Allowed)
• PA-19-095- Emotion Regulatin, Aging, and Mental Disorder (R21 Clinical Trial Not Allowed)
• PAR-18-941 - Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R21 Clinical Trial Optional)
• PAR-18-942- Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R01 Clinical Trial Optional)
• RFA-MH-18-700- Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (Collaborative R01-Clinical Trial Required)
• RFA-MH-18-701 Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01-Clinical Trial Required)
• RFA-MH-18-702 -Early Stage Testing of Pharmacologic or Device-based Interventions for the Treatment of Mental Disorders (R61/R33-Clinical Trial Required)
• RFA-MH-18-703 -Early Stage Testing of Pharmacologic or Device-based Interventions for the Treatment of Mental Disorders (R33-Clinical Trial Required)
• RFA-MH-18-704 -Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33-Clinical Trial Required)
• RFA-MH-18-705-Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33-Clinical Trial Required)
• RFA-MH-18-706 -Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34-Clinical Trial Required)
• RFA-MH-18-707- Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01-Clinical Trial Required)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-MH-20-027 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will be not be considered for the NOSI initiative.

Please direct all inquiries to the Scientific/Research, Peer Review, and Financial/Grants Management contacts in Section VII of the listed funding opportunity announcements.

Scientific/Research Contact(s)

Jovier D. Evans, PhD.
NIMH/Division of Translational Research
Telephone: {301-443-1369}
Email: [email protected]

Peer Review Contact(s)

Nicholas Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: [email protected]

Financial/Grants Management Contact(s)

Rita Sisco
National Institute of Mental Health
Grants Management Branch
Telephone 301-443-2805
Email: [email protected]