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Interoceptive Training Enhanced Mindfulness (ITEM): Acceptability and Measurement

Award Number: R34AT012499
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/05/2024
PERIOD OF PERFORMANCE END DATE: 02/28/2027

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Interoceptive Training Enhanced Mindfulness (ITEM): Acceptability and Measurement - PROJECT SUMMARY/ABSTRACT Anxiety sensitivity (AS), which involves fear that arousal related symptoms will have negative physical, social or psychological ramifications, is an important driver of anxiety, trauma-related and somatic disorders. Cognitive behavioral therapy (CBT), particularly involving interoceptive exposure (IE; i.e., exposure to unwanted internal sensations), has the greatest demonstrated efficacy at reducing AS but can be hard to tolerate. Conversely, mindfulness is sought out for management of multiple mental health problems, but the observed clinical effects are often modest. A hybrid of these two approaches may capitalize on the strengths of each approach. Mindfulness training (MT) may increase the tolerability of exposure, enhance compliance and support extinction learning through increased engagement with the feared stimulus and heightened awareness of the nonoccurrence of feared outcomes. The proposed project, therefore, will refine a novel hybrid intervention, Interoceptive Training Enhanced Mindfulness (ITEM), which combines IE with MT, evaluate its feasibility and acceptability, and develop a multimodal assessment battery for use in subsequent studies. To this end, 12 Veterans with high AS will complete ITEM, providing quantitative and qualitative information about their experience. A panel of experts will use that material to refine the intervention. Following the refinement process, 48 Veterans will be randomized to receive ITEM or IE in six one-on-one sessions delivered via telehealth. They will complete assessments before and after the 6-week intervention period. Outcomes related to engagement and compliance with ITEM and IE will be the primary focus of the pilot randomized controlled trial (RCT). Additionally, we will examine the novel assessment measures to establish an optimal methodology for subsequent efficacy studies. Because multiple mental health (e.g., anxiety, posttraumatic stress disorder, eating disorders and depression) and physical health (e.g., chronic pain, conditions related to toxic exposure) problems are driven by maladaptive reactions to interoceptive cues, this intervention has the potential to ultimately produce wide-spread mental and physical health benefits.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $215,250 )
2026	2026	VETERANS MEDICAL RESEARCH FOUNDATION OF SAN DIEGO	3350 LA JOLLA VILLAGE DR	SAN DIEGO	CA	92161	SAN DIEGO	USA	Research and Training in Complementary and Integrative Health	000	3	3/10/2026	NON-COMPETING CONTINUATION	$215,250
														Subtotal = $215,250

Issue Date FY: 2025 ( Subtotal = $193,725 )
2025	2025	VETERANS MEDICAL RESEARCH FOUNDATION OF SAN DIEGO	3350 LA JOLLA VILLAGE DR	SAN DIEGO	CA	92161	SAN DIEGO	USA	Research and Training in Complementary and Integrative Health	000	2	3/13/2025	NON-COMPETING CONTINUATION	$193,725
2025	2025	VETERANS MEDICAL RESEARCH FOUNDATION OF SAN DIEGO	3350 LA JOLLA VILLAGE DR	SAN DIEGO	CA	92161	SAN DIEGO	USA	Research and Training in Complementary and Integrative Health	001	2	8/5/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $193,725

Issue Date FY: 2024 ( Subtotal = $215,250 )
2024	2024	VETERANS MEDICAL RESEARCH FOUNDATION OF SAN DIEGO	3350 LA JOLLA VILLAGE DR	SAN DIEGO	CA	92161	SAN DIEGO	USA	Research and Training in Complementary and Integrative Health	001	1	7/31/2024	NEW	$0
2024	2024	VETERANS MEDICAL RESEARCH FOUNDATION OF SAN DIEGO	3350 LA JOLLA VILLAGE DR	SAN DIEGO	CA	92161	SAN DIEGO	USA	Research and Training in Complementary and Integrative Health	000	1	4/4/2024	NEW	$215,250
														Subtotal = $215,250

Grand Total All Awards = $624,225

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Interoceptive Training Enhanced Mindfulness (ITEM): Acceptability and Measurement

Award Number: R34AT012499

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/05/2024

PERIOD OF PERFORMANCE END DATE: 02/28/2027

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