Positive Emotion Regulation Intervention for Benzodiazepine Receptor Agonist Deprescribing in Older Adults: Anxiety Lowering and Deprescribing Through Emotion Regulation (ALDER)
Phase: NA
Conditions: Benzodiazepine Dependence, Anxiety Disorders, Sleep Disturbance
Sponsor: Northwestern University

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STU00219362-MOD0002 Approved
Approved by
by NU
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IRB for
for use
use on
on or
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after 12/6/2023
12/6/2023 through
through 10/5/

IRB #: STU00219362-MOD0002 Approved by NU IRB for use on or after 12/6/2023 through 10/5/2024.
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Many federal agencies require that when more than one domestic site engages in non-exempt Human
Research, all sites must rely on the review of one “Single IRB.” If this applies to your study, you must
obtain a Single IRB Letter of Support and IRB Fee Quote from the Northwestern University IRB Office
before the Northwestern University IRB will review your study. Submit a Single IRB Consultation
Request to initiate this process.
**Include the activities of all non-Northwestern affiliated sites in the multi-site/collaborative research
section of the protocol below.
***The federal funding application should include plans for whether award recipients will engage in
Human Research. Based on the funding application, provide an assessment of the activities at each site
and update the table if the planned activities change or if another IRB reviews the activities and makes a
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RELATED STUDIES:
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: STU00219362-MOD0002
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Approved by
by NU
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IRB for
for use
use on
on or
or after
after 12/6/2023
12/6/2023 through
through 10/5/

IRB #: STU00219362-MOD0002 Approved by NU IRB for use on or after 12/6/2023 through 10/5/2024.
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Purpose and rationale of the study:
Deprescribing benzodiazepine receptor agonists, particularly for older adults, is a key public
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Positive emotion regulation is a novel, efficacious approach to maintaining health and well-
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: STU00219362-MOD0002
STU00219362-MOD0002 Approved
Approved by
by NU
NU IRB
IRB for
for use
use on
on or
or after
after 12/6/2023
12/6/2023 through
through 10/5/

IRB #: STU00219362-MOD0002 Approved by NU IRB for use on or after 12/6/2023 through 10/5/2024.
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 Design a type 2 hybrid implementation-effectiveness trial based on stakeholder feedback
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Table 1. Overview of ALDER intervention
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Skills
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: STU00219362-MOD0002
STU00219362-MOD0002 Approved
Approved by
by NU
NU IRB
IRB for
for use
use on
on or
or after
after 12/6/2023
12/6/2023 through
through 10/5/

IRB #: STU00219362-MOD0002 Approved by NU IRB for use on or after 12/6/2023 through 10/5/2024.
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: STU00219362-MOD0002
STU00219362-MOD0002 Approved
Approved by
by NU
NU IRB
IRB for
for use
use on
on or
or after
after 12/6/2023
12/6/2023 through
through 10/5/

IRB #: STU00219362-MOD0002 Approved by NU IRB for use on or after 12/6/2023 through 10/5/2024.
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Approved by
by NU
NU IRB
IRB for
for use
use on
on or
or after
after 12/6/2023
12/6/2023 through
through 10/5/

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boxes above):
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Approved by
by NU
NU IRB
IRB for
for use
use on
on or
or after
after 12/6/2023
12/6/2023 through
through 10/5/

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Approved by
by NU
NU IRB
IRB for
for use
use on
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after 12/6/2023
12/6/2023 through
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Table 1. Overview of ALDER intervention
Week
Skills
Goals
Practice Exercises

Positive
Events,
Savoring,
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Aim 1 (Months 1-3)
Participant Population
# of Participants
Patient focus groups
Patients (over 65 y/o) who are
prescribed a BZRA via NM primary
care clinics*
Up to 20
Clinician interviews
Clinicians who have prescribed a
BZRA to greater than 20 older
adults in the past year*
Up to 20
Aim 2 (Months 3-9)
Single-arm pilot trial
Patients (over 65 y/o) who are
prescribed a BZRA via NM primary
Up to 40
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care clinics with two or more
chronic conditions*
Aim 3 (Months 9-12)
Patient interviews
Aim 2 pilot trial participants*
Up to 40
Clinician interviews
Clinicians at healthcare clinics
where Aim 2 participant receive
healthcare*
Up to 20
*See Enrollment Criteria section for complete list of eligibility requirements.
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12/6/2023 through
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SURJUDPV LQ WKH IXWXUH [Aim 3 clinician recruitment, screener, and consent form, along with
clinician/patient interview guides will be added as a modification prior to beginning this portion of
the study.]
9.0
Research with Vulnerable Populations
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Incomplete Disclosure or Deception:
1$
11.0
Consent Process:
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The online consent forms for Aims 1 and 2 have been uploaded with this submission. Clinician
consent form for Aim 3 will be uploaded for IRB review prior to initiating that phase of the
project. %HFDXVH WKH $LP  FRQVHQW IRUP ZLOO LQFOXGH $LP  SURFHGXUHV D VHSDUDWH FRQVHQW IRU $LP 
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Waiver of Participant Signature on Consent Form:
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Approved by
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for use
use on
on or
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after 12/6/2023
12/6/2023 through
through 10/5/

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for use
use on
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after 12/6/2023
12/6/2023 through
through 10/5/

IRB #: STU00219362-MOD0002 Approved by NU IRB for use on or after 12/6/2023 through 10/5/2024.
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STU00219362-MOD0002 Approved
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IRB for
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use on
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