PAR-25-268
Investigator Initiated Clinical Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth (R01 Clinical Trial Required)
Summary
PAR-25-268: Remote Clinical Trials of Complementary and Integrative Health Interventions
Research Focus
This funding opportunity supports fully remote, powered clinical trials testing complementary and integrative health interventions in NCCIH priority areas. The funder seeks rigorous efficacy, effectiveness, or pragmatic randomized controlled trials with no in-person contact between research staff and participants. Interventions may include mind and body approaches (meditation, mindfulness, yoga, tai chi, qi gong, guided imagery, acupressure, music or art therapy), nutritional approaches (botanicals, probiotics, dietary supplements), or combinations thereof. Trials should employ mobile health (mHealth) technologies—such as phone delivery, apps, video platforms, web-based systems, or wearable devices—to reach geographically distributed participants and address health disparities. Applications must demonstrate strong preliminary feasibility and safety data, clear clinical rationale for remote delivery versus in-person trials, and evidence of intervention promise. The research should contribute to symptom management or prevention/treatment of conditions like chronic pain, mild depression, and anxiety.
At a Glance
- Who can apply: Investigators at eligible institutions; early consultation with NCCIH scientific contacts strongly encouraged.
- Funding & project length: Not stated; standard R01 amounts apply (see NIH guidelines).
- Award mechanism: R01 Research Project Grant (clinical trial required); minimum 90-percent statistical power required.
- Key dates: Applications due February 20, 2025 (and subsequent cycles through October 2026); earliest start July 2025; NOFO expires November 18, 2026.
- Best fit for: Researchers in complementary/integrative medicine, behavioral health, or primary care testing remotely delivered mind-body or nutritional interventions via mHealth platforms in defined patient populations.
Key Facts
Deadline
Tue, November 17, 2026
Posted
Thu, November 21, 2024
Award / Year (direct costs)
$500,000
Max Total
$2,500,000
Max Duration
5 years
Keywords
Research Areas
Gotchas (7)
Clinical trial design must have minimum 90-percent power to test primary hypothesis; this is a specific quantitative requirement that differs from typical NIH language and could be missed if applicant
95%
Source Text
“Trials supported under this NOFO are expected to contribute to research topics relevant to the mission of NCCIH and be designed with a minimum of 90-percent power to test the primary hypothesis.”
NCCIH explicitly will NOT support studies with waitlist comparator conditions due to lack of rigor and expectancy effects; this is a programmatic restriction that could disqualify an otherwise well-de
98%
Source Text
“Due to lack of rigor and potential expectancy effects, NCCIH will not support studies proposing a waitlist comparator condition.”
Intervention must be delivered in fully remote manner with zero in-person contact between research staff and study participants; this is a strict requirement that differs from typical R01 clinical tri
99%
Source Text
“For this NOFO, the proposed trial must study an intervention that can be delivered in a fully remote manner, and all data collected remotely (i.e., no in-person contact between research staff and study participants).”
Preliminary data on feasibility and safety of remotely delivered approach is required, along with evidence of clinical benefit promise; this is a prerequisite that may disqualify applications lacking
96%
Source Text
“Applicants must provide justification for the remotely delivered approach and provide preliminary data on the feasibility and safety of the approach, along with evidence that the intervention has promise of clinical benefit.”
Proposed trial must recruit representative sample for population and condition of interest and conduct all study activities (recruitment, intervention delivery, data collection) remotely; this compreh
97%
Source Text
“The application should propose to recruit a representative sample for the population and condition of interest, and to conduct all study activities, including recruitment, intervention delivery, and data collection, remotely.”
Strong rationale required for fully remotely delivered design versus multi-site in-person clinical trial; applicant must justify why remote delivery is necessary, not just convenient, which is a highe
92%
Source Text
“Applications to this NOFO should be based on a strong rationale for the need of a fully remotely delivered design as opposed to a multi-site in-person clinical trial.”
NCCIH strongly encourages pre-submission consultation with Scientific/Research contacts prior to application submission; while not mandatory, this is emphasized more strongly than typical and could af
85%
Source Text
“Prior to submitting an application, NCCIH strongly encourages consultation with the NCCIH Scientific/Research contacts relevant to the area of science for which they are planning to develop an application. Early contact provides an opportunity for NCCIH staff to discuss the scope and goals, and to provide information and guidance.”