[Federal Register Volume 88, Number 122 (Tuesday, June 27, 2023)]
[Notices]
[Pages 41616-41619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13581]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Nonpharmacologic
Treatment for Maternal Mental Health Conditions
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for Supplemental Evidence and Data Submissions
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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review on Nonpharmacologic
Treatment for Maternal Mental Health Conditions, which is currently
being conducted by the AHRQ's Evidence-based Practice Centers (EPC)
Program. Access to published and unpublished pertinent scientific
information will improve the quality of this review.
DATES: Submission Deadline on or before July 27, 2023.
ADDRESSES:
Email submissions: [email protected].
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement,
Agency for
[[Page 41617]]
Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.): Center for Evidence and
Practice Improvement, Agency for Healthcare Research and Quality, ATTN:
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: Kelly Carper, Telephone: 301-427-1656
or Email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Nonpharmacologic
Treatment for Maternal Mental Health Conditions. AHRQ is conducting
this systematic review pursuant to Section 902 of the Public Health
Service Act, 42 U.S.C. 299a.
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on Nonpharmacologic Treatment for Maternal Mental Health
Conditions, including those that describe adverse events. The entire
research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/mental-health-pregnant/protocol.
This is to notify the public that the EPC Program would find the
following information on Nonpharmacologic Treatment for Maternal Mental
Health Conditions helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this indication. In the list, please indicate whether
results are available on ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
[ssquf] For completed studies that do not have results on
ClinicalTrials.gov, a summary, including the following elements: study
number, study period, design, methodology, indication and diagnosis,
proper use instructions, inclusion and exclusion criteria, primary and
secondary outcomes, baseline characteristics, number of patients
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including a study number, the study period,
design, methodology, indication and diagnosis, proper use instructions,
inclusion and exclusion criteria, and primary and secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this indication and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on indications not
included in the review cannot be used by the EPC Program. This is a
voluntary request for information, and all costs for complying with
this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 4 weeks. If
you would like to be notified when the draft is posted, please sign up
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
The systematic review will answer the following questions. This
information is provided as background. AHRQ is not requesting that the
public provide answers to these questions.
Key Questions (KQ)
KQ 1: What are the effectiveness and comparative effectiveness and
harms of nonpharmacologic treatments for mental health conditions in
perinatal individuals?
(a) Depressive disorders
(b) Bipolar disorder
(c) Anxiety disorders
(d) Post-traumatic stress disorder
(e) Obsessive-compulsive disorder
KQ 2: What are the comparative effectiveness and harms of
nonpharmacologic treatments compared with pharmacologic treatment alone
for mental health conditions in perinatal individuals?
(a) Depressive disorders
(b) Bipolar disorder
(c) Anxiety disorders
(d) Post-traumatic stress disorder
(e) Obsessive-compulsive disorder
Population(s)
Perinatal individuals
[cir] Individuals who are pregnant or postpartum (up to 12 months
after delivery) with new or preexisting diagnosis of depression
disorder, bipolar disorder, anxiety disorders, post-traumatic stress
disorder (PTSD), obsessive-compulsive disorder (OCD)
[cir] Diagnoses must be confirmed via clinical interview or
validated screening tool (e.g., Edinburgh Postnatal Depression Scale
[EPDS]; Patient Health Questionnaire-9 [PHQ-9) with a commonly accepted
threshold
[cir] EXCLUDE: studies that evaluate patients with depressive or
anxiety symptoms in contrast with diagnoses of depression or anxiety,
including studies that include patients with screening tool values
below a threshold consistent with diagnosis
[cir] EXCLUDE: populations in which the primary condition is phobia
of pregnancy (i.e., tokophobia)
[cir] EXCLUDE: studies with mixed populations (e.g., perinatal and
non-perinatal, mental health condition and non-mental health
condition), unless >=90% of the studied population represent an
eligible population for the review. This exclusion criterion does not
apply to populations with multiple eligible mental health conditions;
studies of perinatal individuals with two or more conditions (e.g.,
studies targeting individuals with both depression and anxiety) will be
included.
[cir] EXCLUDE: Studies of patients with substance use disorders,
exclusively.
Intervention
Nonpharmacologic modalities
To be included, studies must evaluate one or more
nonpharmacological modalities such as those listed below. Although the
list sought to be comprehensive, it is not intended to be restrictive
to modalities not appearing on the list. If a study otherwise meets
eligibility criteria and describes a nonpharmacological intervention
involving a form of psychotherapy or complementary/alternative therapy
(aside from those specified for exclusion) it will be considered for
inclusion.
Note that the list of modalities includes treatments for any of the
mental health conditions under consideration, recognizing that not all
therapies are appropriate for all conditions.
Psychotherapies
[cir] Cognitive behavior therapy (CBT)
[ssquf] Examples: trauma-focused CBT, mindfulness-based, cognitive
processing therapy, cognitive restructuring, cognitive remediation
therapy, stress inoculation training
[cir] Acceptance and commitment therapy (ACT)
[cir] Psychodynamic therapy
[[Page 41618]]
[cir] Interpersonal psychotherapy (IPT)
[cir] Supportive therapy
[cir] Dialectical behavioral therapy (DBT)
[cir] Exposure therapy
[ssquf] Example: Narrative Exposure Therapy (NET), prolonged
exposure therapy
[cir] Eye movement desensitization and reprocessing therapy
[cir] Imagery rehearsal therapy
[cir] Social rhythm therapy
Psychoeducation
[cir] Trauma affect regulation
[cir] Problem solving
Other
[cir] Electroconvulsive therapy (ECT)
Complementary/alternative therapies
[cir] Mindfulness
[cir] Exercise
[cir] Relaxation
[cir] Yoga
[cir] Tai Chi
[cir] Self-hypnosis and relaxation
[cir] Acupuncture
[cir] Bright light therapy
[cir] Sleep therapy
[cir] Writing, art, music therapy
EXCLUDE: studies with interventions that are poorly specified
or not structured programs (i.e., cannot be reasonably replicated in
practice or future research)
EXCLUDE: unsupervised peer-to-peer or social media
interventions
EXCLUDE: interventions delivered through ingestion or
parenterally, and surgical or invasive interventions (with the
exception of acupuncture or ECT) (e.g., omega-3 fatty acid, St. John's
wort, kava, valerian, theanine)
EXCLUDE: interventions designed to address issues other than
the mental health conditions of interest (e.g., diet changes, weight
loss, lactation training, reintroduction of sexual activity)
EXCLUDE: interventions focused on the processes of delivering
of care (e.g., collaborative care model)
Mechanisms of Delivery
The above intervention modalities may be delivered in diverse ways
in different settings, by different personnel, with different
intensities. We will include studies of the above that directly compare
different mechanisms of delivery below. We have purposefully separated
the content of modalities of interest from means by which they may be
delivered since mechanisms of delivery (e.g., telehealth) are not
interventions in their own right.
Number of participants
[cir] Individuals
[cir] Group
Type of participants
[cir] Individual
[cir] Couple
[cir] Family
Type of provider
[cir] Professional (e.g., psychotherapist, exercise instructor)
[cir] Community based non-professional or peer
[cir] Not applicable (i.e., self-administered)
Type of modality
[cir] In-person
[cir] Online via computer
[cir] Online via mobile app
Duration
[cir] `Brief', `short-term'
[cir] `Prolonged'
[cir] N.B. many studies use diverse labels to signify the duration of
the intervention delivered. The meaning of these labels will be
extracted as part of our intervention extraction process. We will not
exclude studies based on their duration.
Outcomes
Outcomes in bold font, with footnote ``a'' will be prioritized
(i.e., will be included in Evidence Profiles).
Scores on psychological assessments \1\ (for each evaluated
condition)
[cir] Including self-assessed symptoms of mental health condition
\b\
Cure/resolution of symptoms or condition \a\
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\a\ Prioritized outcome.
\b\ From perinatal depression core outcome set (recommended 9
core outcomes) Helberg et al. 2021. PMID 34047454.
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Parent-infant bonding a 2
Suicide a b
[cir] Suicidal thoughts \a\
[cir] Attempted suicide \a\
[cir] Death by suicide \a\
Thoughts of harming the baby, including thoughts of extended
suicide a b
Adherence to mental health treatment a b
Satisfaction with intervention \b\
Perceived self-efficacy for parenthood
Perceived self-efficacy for management of mental health
Harms of treatment
Quality of life
Return to work
Maternal clinical outcomes (e.g., preeclampsia, preterm
delivery)
Safe family environment
Fetal/neonatal/pediatric clinical outcomes
[cir] Live birth
[cir] Infant feeding success
[cir] Infant growth
[cir] Pediatric death
[cir] Pediatric development (e.g., neurodevelopmental milestones)
[cir] Pediatric cognitive and academic achievement
[cir] Pediatric social/emotional wellbeing
Prenatal care utilization. E.g., completion of prenatal
visits, completion of recommended prenatal services, unexpected health
care utilization (e.g., emergency department/triage visits), postpartum
care follow-up
Potential Modifiers
Pregnancy status (pregnant, postpartum after live birth,
postpartum after fetal loss or infant death or needing intensive care,
breastfeeding; change of status within study period)
Severity of mental health conditions (e.g., mild, moderate or
severe depression; depression with or without anxiety, psychosis)
Comorbidities, including other mental health conditions
Age
Race/ethnicity
Religion/faith
Birthplace (e.g., immigrant from Latin America vs. U.S.-born)
Gender identification
Sexual orientation
Socioeconomic factors
Geographic region, urbanicity
Patient-provider congruence (e.g., with respect to racial,
ethnic, language, and other socioeconomic factors)
Use of social media
Partner support
Interpersonal violence (including partner violence)
Availability of family leave, paid or unpaid
Drug use
History of abortion
History of pregnancy loss
Intended pregnancy
Parity
Insurance status
Accessibility issues (e.g., internet access, in particular for
telehealth interventions)
COVID-19 pandemic (as defined by study authors)
Setting
Ambulatory with exception of individuals in hospital due to
non-mental health pregnancy or postpartum complications (i.e., exclude
patients in acute inpatient psychiatric setting)
Treatment delivery method (all including in-person,
telehealth, digital)
High-income countries (as defined by World Bank as of May 11,
2023)
Design
Randomized controlled trials
EXCLUDE: Nonrandomized comparative studies
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EXCLUDE: Single group (noncomparative) studies, including case
reports or series
EXCLUDE: Studies with N<10 per arm
EXCLUDE: Studies published only in dissertation or conference
abstract format
We will collect SRs to identify potentially eligible primary
studies (within date restrictions) and possibly to narratively
summarize older studies of earlier foundational nonpharmacological
interventions.
For topics with robust existing SRs (e.g., non-pharmacological
interventions for perinatal depression), we will consider (with
partners and our task order officer [TOO]) updating these SRs (relying
on the published SRs for all data pertaining to the older primary
studies).
Eligibility criteria specific to Key Question 1 (nonpharmacologic
vs. nothing/treatment as usual/usual care or vs. other
nonpharmacologic)
Intervention
May include same pharmacologic co-intervention as comparator
group
Comparators
No nonpharmacologic treatment
Other nonpharmacologic modality
May include same pharmacologic co-intervention as intervention
group
Eligibility criteria specific to Key Question 2 (nonpharmacologic
vs pharmacologic)
Intervention
Nonpharmacologic intervention alone (no use of pharmacologic
therapy)
Comparators
Pharmacologic treatment alone
Dated: June 21, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-13581 Filed 6-26-23; 8:45 am]
BILLING CODE 4160-90-P