PAR-25-274
Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34 Clinical Trial Required)
Summary
Briefing: PAR-25-274 – Feasibility Clinical Trials of Mind and Body Interventions
Research Focus
This R34 planning grant supports feasibility clinical trials of mind and body interventions—complementary and integrative health approaches with physical and/or psychological therapeutic inputs—for NCCIH high-priority research topics. The funder targets conditions where these nonpharmacologic approaches (e.g., for chronic pain, mild depression, anxiety) are widely used but lack rigorous evidence. Feasibility trials should generate preliminary data to fill critical knowledge gaps necessary to design and justify a subsequent full-scale efficacy, effectiveness, pragmatic, or dissemination and implementation trial. Acceptable aims include assessing intervention acceptability and adherence; tailoring or adapting interventions to specific populations, modalities, or settings; refining protocolized multi-component interventions; determining recruitment and retention feasibility; evaluating randomization procedures; and testing remote delivery modalities. Applications must demonstrate that the proposed R34 work is scientifically necessary and that no similar published or completed pilot studies exist with the same population and intervention.
At-a-Glance
- Who can apply: Not stated (see full FOA for institution type and investigator stage eligibility)
- Funding & project length: Not stated
- Award mechanism: R34 Clinical Trial (planning/feasibility grant)
- Key dates: Applications due February 20, 2025 (earliest cycle); expiration November 18, 2026; earliest start July 2025
- Best fit for: Researchers in complementary and integrative health, rehabilitation, behavioral medicine, and pain management seeking to pilot-test mind-body interventions (e.g., mindfulness, yoga, tai chi, acupuncture) before launching larger randomized controlled trials
Note: Applicants are strongly encouraged to contact NCCIH scientific program staff before submission. Applications must use randomized controlled trial design with justified comparator conditions (active control, usual care, sham, or time-and-attention control).
Key Facts
Deadline
Tue, November 17, 2026
Posted
Thu, November 21, 2024
Award / Year (direct costs)
$250,000
Max Total
$500,000
Max Duration
2 years
Keywords
Research Areas
Gotchas (3)
R34 mechanism explicitly requires a randomized controlled trial design with at least one intervention arm and one comparator arm; applicants proposing non-randomized or single-arm feasibility studies
95%
Source Text
“Investigators should propose a randomized controlled trial design with at least one intervention arm and one comparator arm. There should be strong rationale for the comparator condition (e.g., time and attention control, usual care, standard of care, sham condition, and/or active comparator(s)) based on the research question you plan to address in the future powered trial.”
Applications proposing iterative or duplicative studies will be considered of low programmatic relevance and decrease likelihood of funding, but the distinction between necessary feasibility work and
85%
Source Text
“Applications should describe and justify the need for feasibility data and ensure that no other published or completed pilot studies have been performed with a similar population and similar intervention. If it is possible to reference successful demonstration of these benchmarks in completed trials or trials currently underway using the proposed or similar intervention and study population, further single-site feasibility work is not needed. Applications proposing such iterative or duplicative ”
Prior to submission, applicants are strongly encouraged (not just encouraged) to contact NCCIH Scientific/Research contact person; this pre-submission contact appears to be a programmatic expectation
85%
Source Text
“Prior to submitting a grant application, NCCIH strongly encourages consulting with NCCIH Scientific/Research extramural program 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.”