This department is offering a grant to support confirmatory efficacy testing for non-pharmacological therapeutic and preventive interventions for mental disorders in adults and children. The trials should provide high scientific utility and support ‘go/no-go’ decisions for further development. Interventions can include behavioral, cognitive, interpersonal, and device-based approaches. The grant aims to fund trials with a compelling scientific rationale, evidence of engaging mechanism of action, preliminary efficacy signal, and addressing unmet therapeutic needs. The focus is on determining the intervention’s potential for significant clinical benefit through sufficiently-powered efficacy trials.
Opportunity ID: 290650
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-MH-17-614 |
| Funding Opportunity Title: | Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.242 — Mental Health Research Grants |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Dec 13, 2016 |
| Last Updated Date: | Nov 14, 2017 |
| Original Closing Date for Applications: | Oct 15, 2018 |
| Current Closing Date for Applications: | Nov 14, 2017 |
| Archive Date: | Dec 14, 2017 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Small businesses For profit organizations other than small businesses Native American tribal governments (Federally recognized) Special district governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) County governments State governments City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Funding Opportunity Announcement (FOA) is to support confirmatory efficacy testing of non-pharmacological therapeutic and preventive interventions for mental disorders in adults and children through an experimental therapeutics approach. Under this FOA, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support “go/no-go” decisions about further development, effectiveness testing, or dissemination of the intervention. Interventions to be studied include, but are not limited to behavioral, cognitive, interpersonal, and device-based (both invasive/surgically implanted as well as noninvasive/transcranial) approaches, or a combination thereof. Interventions appropriate for efficacy testing must be based on a compelling scientific rationale, previous demonstration that the intervention engages and alters the hypothesized mechanism of action, a preliminary efficacy signal, and must address an unmet therapeutic need. Support will be provided for a trial of the intervention’s efficacy that includes measurement of the hypothesized mechanism of action and the relationship between change in the mechanism and change in functional or clinical effects. Ultimately, this FOA is intended to support a sufficiently-powered efficacy trial to determine the intervention’s potential for significant clinical benefit. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-17-614.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Expired and Re-issued as RFA-MH-18-707 | Nov 14, 2017 | |
| Nov 14, 2017 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-MH-17-614 |
| Funding Opportunity Title: | Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.242 — Mental Health Research Grants |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Dec 13, 2016 |
| Last Updated Date: | Nov 14, 2017 |
| Original Closing Date for Applications: | Oct 15, 2018 |
| Current Closing Date for Applications: | Nov 14, 2017 |
| Archive Date: | Dec 14, 2017 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Small businesses For profit organizations other than small businesses Native American tribal governments (Federally recognized) Special district governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) County governments State governments City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Funding Opportunity Announcement (FOA) is to support confirmatory efficacy testing of non-pharmacological therapeutic and preventive interventions for mental disorders in adults and children through an experimental therapeutics approach. Under this FOA, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support “go/no-go” decisions about further development, effectiveness testing, or dissemination of the intervention. Interventions to be studied include, but are not limited to behavioral, cognitive, interpersonal, and device-based (both invasive/surgically implanted as well as noninvasive/transcranial) approaches, or a combination thereof. Interventions appropriate for efficacy testing must be based on a compelling scientific rationale, previous demonstration that the intervention engages and alters the hypothesized mechanism of action, a preliminary efficacy signal, and must address an unmet therapeutic need. Support will be provided for a trial of the intervention’s efficacy that includes measurement of the hypothesized mechanism of action and the relationship between change in the mechanism and change in functional or clinical effects. Ultimately, this FOA is intended to support a sufficiently-powered efficacy trial to determine the intervention’s potential for significant clinical benefit. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-17-614.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-MH-17-614 |
| Funding Opportunity Title: | Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.242 — Mental Health Research Grants |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Nov 14, 2017 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Oct 15, 2018 |
| Archive Date: | Nov 15, 2018 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts County governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) State governments Public and State controlled institutions of higher education City or township governments Private institutions of higher education Special district governments For profit organizations other than small businesses Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Funding Opportunity Announcement (FOA) is to support confirmatory efficacy testing of non-pharmacological therapeutic and preventive interventions for mental disorders in adults and children through an experimental therapeutics approach. Under this FOA, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support “go/no-go” decisions about further development, effectiveness testing, or dissemination of the intervention. Interventions to be studied include, but are not limited to behavioral, cognitive, interpersonal, and device-based (both invasive/surgically implanted as well as noninvasive/transcranial) approaches, or a combination thereof. Interventions appropriate for efficacy testing must be based on a compelling scientific rationale, previous demonstration that the intervention engages and alters the hypothesized mechanism of action, a preliminary efficacy signal, and must address an unmet therapeutic need. Support will be provided for a trial of the intervention’s efficacy that includes measurement of the hypothesized mechanism of action and the relationship between change in the mechanism and change in functional or clinical effects. Ultimately, this FOA is intended to support a sufficiently-powered efficacy trial to determine the intervention’s potential for significant clinical benefit. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-17-614.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH OER Webmaster FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-D | Use for due dates on or after May 25, 2016 | PKG00229722 | Jan 15, 2017 | Nov 15, 2017 | View |
Package 1
Mandatory forms
290650 RR_SF424_2_0-2.0.pdf
290650 PHS398_CoverPageSupplement_3_0-3.0.pdf
290650 RR_OtherProjectInfo_1_3-1.3.pdf
290650 PerformanceSite_2_0-2.0.pdf
290650 RR_KeyPersonExpanded_2_0-2.0.pdf
290650 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
290650 RR_Budget_1_3-1.3.pdf
290650 RR_SubawardBudget30_1_3-1.3.pdf
290650 PHS398_ModularBudget_1_2-1.2.pdf
290650 PHS_Inclusion_Enrollment_Report-1.0.pdf
290650 PHS_AssignmentRequestForm-1.0.pdf
Share This Post, Choose Your Platform!
About the Author: osnqt
