The National Institute of Mental Health is offering a grant to support confirmatory efficacy testing of non-pharmacological interventions for mental disorders in adults and children. The trials are expected to provide valuable scientific information for decision-making on further development and dissemination of the intervention. Eligible interventions include behavioral, cognitive, interpersonal, and device-based approaches. The grant aims to fund trials measuring the hypothesized mechanism of action and the intervention’s potential for clinical benefit, addressing unmet therapeutic needs. Applications for this grant must be submitted by February 18, 2021.
Opportunity ID: 298665
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-MH-18-707 |
| Funding Opportunity Title: | Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01- Clinical Trial Required) |
| 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 3 |
| Posted Date: | Nov 14, 2017 |
| Last Updated Date: | Oct 14, 2020 |
| Original Closing Date for Applications: | Oct 15, 2018 |
| Current Closing Date for Applications: | Feb 18, 2021 |
| Archive Date: | Mar 20, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts For profit organizations other than small businesses Public and State controlled institutions of higher education City or township governments Special district governments State governments Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) |
| 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-18-707.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 |
|---|---|---|
| updated Close date as per NOT-MH-21-027 | Oct 14, 2020 | |
| Updated expiration date in accordance with NOT-MH-18-048 | Nov 14, 2017 | |
| Sep 05, 2018 |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-MH-18-707 |
| Funding Opportunity Title: | Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01- Clinical Trial Required) |
| 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 3 |
| Posted Date: | Nov 14, 2017 |
| Last Updated Date: | Oct 14, 2020 |
| Original Closing Date for Applications: | Oct 15, 2018 |
| Current Closing Date for Applications: | Feb 18, 2021 |
| Archive Date: | Mar 20, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts For profit organizations other than small businesses Public and State controlled institutions of higher education City or township governments Special district governments State governments Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) |
| 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-18-707.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 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-MH-18-707 |
| Funding Opportunity Title: | Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01- Clinical Trial Required) |
| 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: | Nov 14, 2017 |
| Last Updated Date: | Sep 05, 2018 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Oct 15, 2020 |
| Archive Date: | Nov 14, 2020 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Special district governments Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education County governments City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education For profit organizations other than small businesses |
| 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-18-707.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-18-707 |
| Funding Opportunity Title: | Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01- Clinical Trial Required) |
| 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: | Sep 05, 2018 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Oct 15, 2018 |
| Archive Date: | Nov 20, 2018 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Special district governments Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education County governments City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education For profit organizations other than small businesses |
| 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-18-707.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 | PKG00236213 | Nov 14, 2017 | Nov 15, 2017 | View | |
| FORMS-E | Use for due dates on or before May 24, 2020 | PKG00236221 | Jan 14, 2018 | May 24, 2020 | View | |
| FORMS-F | Use for due dates on or after May 25, 2020 | PKG00259358 | Jan 14, 2018 | Feb 18, 2021 | View |
Package 1
Mandatory forms
298665 RR_SF424_2_0-2.0.pdf
298665 PHS398_CoverPageSupplement_3_0-3.0.pdf
298665 RR_OtherProjectInfo_1_3-1.3.pdf
298665 PerformanceSite_2_0-2.0.pdf
298665 RR_KeyPersonExpanded_2_0-2.0.pdf
298665 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
298665 RR_Budget_1_3-1.3.pdf
298665 RR_SubawardBudget30_1_3-1.3.pdf
298665 PHS398_ModularBudget_1_2-1.2.pdf
298665 PHS_Inclusion_Enrollment_Report-1.0.pdf
298665 PHS_AssignmentRequestForm-1.0.pdf
Package 2
Mandatory forms
298665 RR_SF424_2_0-2.0.pdf
298665 PHS398_CoverPageSupplement_4_0-4.0.pdf
298665 RR_OtherProjectInfo_1_4-1.4.pdf
298665 PerformanceSite_2_0-2.0.pdf
298665 RR_KeyPersonExpanded_2_0-2.0.pdf
298665 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
298665 RR_Budget_1_4-1.4.pdf
298665 RR_SubawardBudget30_1_4-1.4.pdf
298665 PHS398_ModularBudget_1_2-1.2.pdf
298665 PHS_AssignmentRequestForm_2_0-2.0.pdf
Package 3
Mandatory forms
298665 RR_SF424_2_0-2.0.pdf
298665 PHS398_CoverPageSupplement_5_0-5.0.pdf
298665 RR_OtherProjectInfo_1_4-1.4.pdf
298665 PerformanceSite_2_0-2.0.pdf
298665 RR_KeyPersonExpanded_2_0-2.0.pdf
298665 PHS398_ResearchPlan_4_0-4.0.pdf
298665 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
298665 RR_Budget_1_4-1.4.pdf
298665 RR_SubawardBudget30_1_4-1.4.pdf
298665 PHS398_ModularBudget_1_2-1.2.pdf
298665 PHS_AssignmentRequestForm_3_0-3.0.pdf
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