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.

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.