Wednesday, October 29, 2025 10/29/2025

ActiveCBT for depression: Transforming treatment through exercise priming

Award Number: R61MH129407
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/01/2023
PERIOD OF PERFORMANCE END DATE: 08/15/2024

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ActiveCBT for depression: Transforming treatment through exercise priming - PROJECT SUMMARY/ABSTRACT Frontline treatments for major depressive disorder (MDD), including cognitive behavioral therapy (CBT), have limited effectiveness, with ~½ of patients not responding to CBT and ½ relapsing within 2 years. Strategies that could increase the potency of MDD treatments are needed. We have previously shown large psychological and neuroplasticity improvements for 75 minutes post-exercise in adults with MDD. This creates a neurologically fertile post-exercise window with the potential to maximize the effects of CBT performed immediately after exercise. We have developed a novel treatment strategy using aerobic exercise to prime a subsequent CBT session (‘ActiveCBT’). Exercise priming is hypothesized to lead to greater engagement of CBT mechanisms of action through both common (e.g., working alliance) and specific (e.g., behavioral activation) factors linked to depression outcomes; this CBT augmentation approach has yet to be empirically tested. Our published and preliminary work show exercise acutely improves psychological (eg, state anhedonia) and neuroplastic (eg, BDNF) markers in MDD, and our n=10 pilot feasibility trial of this project indicates high likelihood for logistical success and plausible effects of exercise priming on target mechanisms. The R61 will consist of an 8-week randomized controlled trial in 40 adults with MDD performing 30-minutes of moderate exercise or quiet rest (ActiveCBT vs. CalmCBT) prior to weekly CBT sessions. Using a time- and attention-matched control, all participants will view a standardized documentary series for these 30 pre-therapy minutes with the only difference between groups being exercise. This project will also employ cutting-edge, machine learning and natural language processing via the Lyssn platform to objectively evaluate therapy. The overall R61 goals are to: 1) demonstrate exercise priming effects on target CBT mechanisms (working alliance and behavioral activation), 2) link psychological and neuroplastic exercise priming to CBT mechanisms, and 3) explore sensitivity of objective machine learning-based markers from Lyssn to ActiveCBT-induced therapy differences. Upon identification of a moderate between-group difference in working alliance and/or behavioral activation favoring ActiveCBT, the R33 will proceed with a 2:1 randomized, controlled trial (n=100), comparing ActiveCBT to CalmCBT. The overall R33 goals are to: 1) confirm effects of exercise priming on target CBT mechanisms, and 2) determine the preliminary efficacy signal of exercise priming, and determine the strength of the efficacy link with CBT mechanisms. Our working hypotheses are that we will confirm higher working alliance and/or behavioral activation in ActiveCBT, with greater depression effects at 8 weeks and 12 weeks later linked to greater working alliance and/or behavioral activation. These trials will establish the potential for a subsequent confirmatory efficacy trial to rigorously test the potential of exercise priming to enhance treatment. If this innovative, biologically-informed approach successfully ‘primes’ subsequent therapy, this could be used to augment other treatments and in other disorders, significantly improving mental health treatment.


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: 2025 ( Subtotal = $0 )
2025	2024	IOWA STATE UNIVERSITY OF SCIENCE AND TECHNOLOGY	1350 BEARDSHEAR HALL	AMES	IA	50011	STORY	USA	Mental Health Research Grants	001	2	9/9/2025	NON-COMPETING CONTINUATION	$516,154
2025	2024	IOWA STATE UNIVERSITY OF SCIENCE AND TECHNOLOGY	1350 BEARDSHEAR HALL	AMES	IA	50011	STORY	USA	Mental Health Research Grants	000	2	7/30/2025	NON-COMPETING CONTINUATION	-$516,154
2025	2024	IOWA STATE UNIVERSITY OF SCIENCE AND TECHNOLOGY	1350 BEARDSHEAR HALL	AMES	IA	50011	STORY	USA	Mental Health Research Grants	003	2	9/25/2025	NON-COMPETING CONTINUATION	$0
2025	2024	IOWA STATE UNIVERSITY OF SCIENCE AND TECHNOLOGY	1350 BEARDSHEAR HALL	AMES	IA	50011	STORY	USA	Mental Health Research Grants	002	2	9/15/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $715,749 )
2024	2024	IOWA STATE UNIVERSITY OF SCIENCE AND TECHNOLOGY	1350 BEARDSHEAR HALL	AMES	IA	50011	STORY	USA	Mental Health Research Grants	001	2	8/15/2024	NON-COMPETING CONTINUATION	$71,574
2024	2024	IOWA STATE UNIVERSITY OF SCIENCE AND TECHNOLOGY	1350 BEARDSHEAR HALL	AMES	IA	50011	STORY	USA	Mental Health Research Grants	000	2	3/14/2024	NON-COMPETING CONTINUATION	$644,175
														Subtotal = $715,749

Issue Date FY: 2023 ( Subtotal = $751,796 )
2023	2023	IOWA STATE UNIVERSITY OF SCIENCE AND TECHNOLOGY	1350 BEARDSHEAR HALL	AMES	IA	50011	STORY	USA	Mental Health Research Grants	001	1	9/7/2023	NEW	$0
2023	2023	IOWA STATE UNIVERSITY OF SCIENCE AND TECHNOLOGY	515 MORRILL RD, 1350 BEARDSHEAR HALL	AMES	IA	50011	STORY	USA	Mental Health Research Grants	000	1	5/23/2023	NEW	$751,796
														Subtotal = $751,796

Grand Total All Awards = $1,467,545

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ActiveCBT for depression: Transforming treatment through exercise priming

Award Number: R61MH129407

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 06/01/2023

PERIOD OF PERFORMANCE END DATE: 08/15/2024

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