Study protocol for a pilot clinical trial to understand neural mechanisms of response to a psychological treatment for pain and anxiety in pediatric functional abdominal pain disorders (FAPD).

BACKGROUND: Functional abdominal pain disorders (FAPD) are the most common chronic pain conditions of childhood and are made worse by co-occurring anxiety. Our research team found that the Aim to Decrease Pain and Anxiety Treatment (ADAPT), a six-session coping skills program using cognitive behavioral therapy strategies, was effective in improving pain-related symptoms and anxiety symptoms compared to standard care. In follow-up, this current randomized clinical trial (RCT) aims to test potential neural mechanisms underlying the effect of ADAPT. Specifically, this two-arm RCT will explore changes in amygdalar functional connectivity (primary outcome) following the ADAPT protocol during the water loading symptom provocation task (WL-SPT). Secondary (e.g., changes in regional cerebral blood flow via pulsed arterial spin labeling MRI) and exploratory (e.g., the association between the changes in functional connectivity and clinical symptoms) outcomes will also be investigated. METHODS: We will include patients ages 11 to 16 years presenting to outpatient pediatric gastroenterology care at a midwestern children's hospital with a diagnosis of FAPD plus evidence of clinical anxiety based on a validated screening tool (the Generalized Anxiety Disorder-7 [GAD-7] measure). Eligible participants will undergo baseline neuroimaging involving the WL-SPT, and assessment of self-reported pain, anxiety, and additional symptoms, prior to being randomized to a six-week remotely delivered ADAPT program plus standard medical care or standard medical care alone (waitlist). Thereafter, subjects will complete a post assessment neuroimaging visit similar in nature to their first visit. CONCLUSIONS: This small scale RCT aims to increase understanding of potential neural mechanisms of response to ADAPT. TRIAL REGISTRATION: ClinicalTrials.gov registration: NCT03518216.

A multi-site pilot randomized clinical trial of the Treatment and Education Approach for Childhood-onset Lupus (TEACH) program: study design and COVID-19 adaptations.

BACKGROUND: Childhood-onset Systemic Lupus Erythematosus (cSLE) is an autoimmune disease associated with fatigue, mood symptoms, and pain. Fortunately, these symptoms are potentially modifiable with psychological intervention such as cognitive-behavioral therapy (CBT). The Treatment and Education Approach for Childhood-onset Lupus (TEACH) program is a CBT intervention developed to target these symptoms for adolescents and young adults with cSLE. This pilot randomized controlled trial (RCT) aims to determine the feasibility and effect of TEACH for youth with cSLE. Adjustments to the study protocol following the COVID-19 pandemic are also described. METHODS: This two-arm multisite RCT will explore the feasibility (primary outcome) and effect (secondary outcome) of a remotely delivered TEACH protocol. Participants will be randomized to a six-week remotely delivered TEACH program plus medical treatment as usual (TAU) or TAU alone. We will include patients ages 12-22 years presenting to rheumatology clinics from six sites. Validated measures of fatigue, depressive symptoms, and pain will be obtained at baseline and approximately eight and 20 weeks later. Protocol adjustments were also made due to the COVID-19 pandemic, in collaboration with the investigative team, which included patients and caregivers. CONCLUSIONS: Findings from this multi-site RCT aim to document the feasibility of TEACH and provide an estimate of effect of a remotely delivered TEACH protocol on fatigue, depression, and pain symptoms in youth with cSLE as compared to standard medical treatment alone. This findings may positively impact clinical care for patients with cSLE. CLINICAL TRIALS: gov registration: NCT04335643.

Engagement during a Mixed In-Person and Remotely Delivered Psychological Intervention for Youth with Functional Abdominal Pain Disorders and Anxiety.

Functional abdominal pain disorders (FAPD) are common disabling pain conditions frequently associated with co-occurring mental health problems such as anxiety. Psychological therapies such as cognitive behavioral therapy (CBT) have been shown to be effective. Therefore, it is important to understand participant engagement (i.e., use of intervention tools) to such approaches, and if engagement impacts treatment response. The Aim to Decrease Anxiety and Pain Treatment (ADAPT) is an effective psychological treatment approach using a blend of in-person sessions and interventionist phone support with self-paced web modules to manage pain and anxiety. The current study used a mixed-methods approach to investigate micro-level and macro-level participant engagement during the ADAPT program. In-person/phone session attendance was high (>95%) although scheduling adjustments were common (25.5%). Varied levels of engagement with web tools were observed. Thematic analysis also revealed variability in patterns of use. Additionally, while participants indicated they generally understood how to use certain skills (e.g., problem solving, detective thinking), and these skills were effective in managing symptoms during treatment, these activities were generally underutilized. Further, participant engagement did not predict response to the ADAPT intervention. These findings are important as the demand for accessible psychotherapeutic tools to manage pain and anxiety is likely to remain high.

Going Along With It: Neonatal Intensive Care Nurses' Views of a Donor Milk Practice Change.

BACKGROUND AND PURPOSE: Donor human milk (DHM) is used when a mother's own milk is not available. Donor human milk is available as a frozen pasteurized or commercially sterilized product. An abrupt change in practice in use of donor milk products raised concerns among nurses caring for infants in the neonatal intensive care unit (NICU). The change in practice occurred without the input of nurses and without the sharing of supportive evidence with them. The purpose of this study was to explore NICU nurses' perceptions of the practice change from using frozen pasteurized DHM to using sterilized DHM in this context. STUDY DESIGN AND METHODS: A grounded theory study was conducted in a 38-bed Level III NICU. Nurse participants were interviewed using open-ended questions aimed at eliciting their perceptions of using pasteurized and sterilized DHM. RESULTS: There were nine nurse participants. They described their perceptions of feeling confident about pasteurized DHM to feeling uncertain about sterilized DHM. The core category of going along with it was linked to judging DHM based upon attributes, questioning benefits of sterilized DHM, and preferring past practice of using pasteurized DHM. Nurses noted that they could move from feeling uncertain about the practice change to feeling certain if they had evidence to support the practice change. Barriers to seeking evidence were time, knowledge, and waiting for someone else to do it. CLINICAL IMPLICATIONS: Practice change without interprofessional collaboration is threatened by uncertainty and lack of support for the new practice. Nurses want to give evidence-based care, but they often face barriers to seeking evidence. Removing barriers to evidence-based practice and including nurses as stakeholders in practice change decisions are suggested.

Infertility.

Infertility is defined as failure to achieve pregnancy during one year of frequent, unprotected intercourse. Evaluation generally begins after 12 months, but it can be initiated earlier if infertility is suspected based on history or if the female partner is older than 35 years. Major causes of infertility include male factors, ovarian dysfunction, tubal disease, endometriosis, and uterine or cervical factors. A careful history and physical examination of each partner can suggest a single or multifactorial etiology and can direct further investigation. Ovulation can be documented with a home urinary luteinizing hormone kit. Hysterosalpingography and pelvic ultrasonography can be used to screen for uterine and fallopian tube disease. Hysteroscopy and/or laparoscopy can be used if no abnormalities are found on initial screening. Women older than 35 years also may benefit from ovarian reserve testing of follicle-stimulating hormone and estradiol levels on day 3 of the menstrual cycle, the clomiphene citrate challenge test, or pelvic ultrasonography for antral follicle count to determine treatment options and the likelihood of success. Options for the treatment of male factor infertility include gonadotropin therapy, intrauterine insemination, or in vitro fertilization. Infertility attributed to ovulatory dysfunction often can be treated with oral ovulation-inducing agents in a primary care setting. Women with poor ovarian reserve have more success with oocyte donation. In certain cases, tubal disease may be treatable by surgical repair or by in vitro fertilization. Infertility attributed to endometriosis may be amenable to surgery, induction of ovulation with intrauterine insemination, or in vitro fertilization. Unexplained infertility may be managed with ovulation induction, intrauterine insemination, or both. The overall likelihood of successful pregnancy with treatment is nearly 50 percent.