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Effect of Mindfulness Training on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment

Award Number: R33AT010125
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Project Summary/Abstract: Remotely Delivered Programs Targeting COVID-19 Stress-Related Depression and Substance Use The COVID-19 pandemic presents an unparalleled level of everyday stress and is likely to increase rates of depression and substance use, potentially overwhelming behavioral health treatment capacity. We have developed a new program (CHA MindWell; CHA-MW) to address the anticipated surge in demand for behavioral health services for our safety-net health system’s health system’s diverse and socioeconomically disadvantaged population. It has both a screening/monitoring/referral and an early intervention component: First, we implemented remote computerized adaptive testing (CAT-MH®) to stratify patients at risk of stress- related mental illness into 3 tiers: Minimal symptoms or low-risk (Tier 1), mild-to-moderate symptoms or at-risk but not meeting criteria for in-person treatment (Tier 2), and moderate-to-severe symptoms requiring treatment (Tier 3). In standard CHA-MW, CAT-MH is delivered online by email to participants monthly to determine if they are Tier 3 and referral to mental health treatment is needed. Second, Tier 2 patients are referred to a live, online psychoeducational program - Mindfulness-Based Cognitive Therapy for Resilience (MBCT-R), which is an 8-week group adapted from MBCT, which is effective for treatment of stress, anxiety, and depression (known risk factors for substance use), and preventing relapse among patients with recurrent depression. MBCT-R will therefore have impact both during and after COVID-19. When participants enroll in MBCT-R they receive enhanced CHA-MW (i.e., weekly in addition to monthly CAT-MH monitoring), allowing us to closely determine if a higher level of care becomes necessary. We will randomize Tier 2 patients who have mild-to- moderate symptoms of depression (CAT-Depression Inventory 50-75, PHQ-9 equivalency 10-20) in a 3-arm comparative effectiveness RCT to compare MBCT-R + enhanced CHA-MW weekly monitoring to either: a) enhanced CHA-MW weekly monitoring alone (with rapid referral to mental health treatment if needed), or b) an asynchronous internet CBT (iCBT) application + CHA-MW weekly monitoring. We expect MBCT-R to reduce depression symptoms (primary outcome), stress, and indirectly prevent substance use (secondary outcome). For a sub-study within the RCT, we will collect preliminary data using daily diaries to measure stress-related affective reactivity data (upticks in negative affect and/or reductions in positive affect during stress days) and adaptively sample salivary inflammatory cytokines (IL-6, TNF-a, IL-1b) remotely on 2 high and 2 low stress days before and after the interventions. Because this pragmatic effectiveness trial of a live, online mindfulness- based intervention with naturalistic remote monitoring is already embedded in our safety-net health system, it can be implemented immediately and disseminated rapidly if effective at reducing depression symptoms, and could impact behavioral health systems nationally during and after COVID-19 and future public health crises.


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: 2023 ( Subtotal = $0 )
2023	2022	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	002	3	9/7/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2020	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	000	3	9/5/2023	NON-COMPETING CONTINUATION	$0
2023	2020	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	001	3	9/6/2023	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $700,000 )
2022	2022	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	003	3	9/15/2022	SUPPLEMENT FOR EXPANSION	$700,000
2022	2020	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	002	3	9/14/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2020	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	001	3	9/14/2022	NON-COMPETING CONTINUATION	$0
2022	2020	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	000	3	7/5/2022	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $700,000

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	001	3	12/23/2020	NON-COMPETING CONTINUATION	$0
2021	2020	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	000	3	11/17/2020	SUPPLEMENT FOR EXPANSION	$0
2021	2020	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	002	3	2/8/2021	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $1,560,720 )
2020	2020	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	002	3	9/21/2020	SUPPLEMENT FOR EXPANSION	$696,691
2020	2020	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	000	3	9/3/2020	NON-COMPETING CONTINUATION	$808,010
2020	2019	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	001	2	9/8/2020	EXTENSION WITH OR WITHOUT FUNDS	$56,019
														Subtotal = $1,560,720

Issue Date FY: 2019 ( Subtotal = $819,993 )
2019	2019	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	000	2	9/20/2019	EXTENSION WITH OR WITHOUT FUNDS	$819,993
														Subtotal = $819,993

Grand Total All Awards = $3,080,713

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Effect of Mindfulness Training on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment

Award Number: R33AT010125

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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