[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 Access to published and unpublished pertinent scientific 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

[[Page 41619]]

 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