Neural Mechanisms of Treatment Response to ADAPT

Michigan State University

Status: Completed

Conditions: Anxiety; Functional Abdominal Pain Syndrome

Treatments: Behavioral: ADAPT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03518216

K23AT009458 (U.S. NIH Grant/Contract)

2017-4545

Details and patient eligibility

About

Complex functional abdominal pain disorders (FAPD) with co-occurring anxiety are highly prevalent in children, can be very disabling, and are not responsive to currently available treatments. This research aims to better understand the neural mechanisms involved in a promising nonpharmacological treatment for FAPD to ultimately guide the development of more targeted treatment approaches for afflicted youth.

Full description

Functional abdominal pain disorders (FAPD) are among the most common chronic pain conditions of childhood and are associated with significant functional disability, pain, and comorbid anxiety that adversely impacts treatment outcomes. Thus, the PI developed a psychological intervention, Aim to Decrease Anxiety and Pain Treatment (ADAPT; F32HD078049), that targets both pain and anxiety using cognitive behavioral therapy and mindfulness meditation approaches to improve patient outcomes. Preliminary testing has shown that ADAPT reduces pain and anxiety in youth with FAPD. In this study, brain mechanisms implicated in the modulation of pain and response to ADAPT will be investigated. Participants with FAPD and comorbid anxiety will be randomized to either ADAPT or a waitlist control (each condition will last for approximately 6 weeks). Participants will undergo fMRIs to explore changes in functional connectivity and regional brain activation during visceral pain induction (via the water load symptom provocation task; WL-SPT). In Aim 1, functional connectivity patterns associated with a subjective response to pain induction in youth with FAPD who receive ADAPT will be compared to the waitlist control. Conventional blood oxygenation level dependent (BOLD) fMRI will be used to assess functional connectivity to capture moment-to-moment fluctuations in activity. In Aim 2, changes in regional brain activation for those receiving ADAPT will be compared to those in the waitlist condition. The novel arterial spin label (ASL) MRI technique will be used to gain inferences into regional brain activity. In line with the NCCIH funding priorities, this study seeks to increase understanding of the mechanisms through which mind and body approaches impact clinical outcomes in chronic pain and anxiety. Results will advance the field by providing crucial information needed for the refinement and testing of a tailored mind body intervention for FAPD and comorbid anxiety.

Enrollment: 49 patients

Sex: All

Ages: 11 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Children (boys and girls) between 11 and 16 years of age and their parent/primary caregiver.
• Meets criteria for FAPD based on physician diagnosis of FAPD and ROME IV FAPD criteria
• Meets criteria for presence of clinically significant anxiety (based on the Generalized Anxiety Disorders-7 [GAD-7] cut-off score ≥10).
• Sufficient English language ability necessary to complete study measures and protocol.

Exclusion Criteria

• Children with significant medical condition(s) with an identifiable organic cause including those that may include abdominal pain symptoms (e.g., Inflammatory Bowel Diseases).
• Children with a documented developmental delays, autism spectrum disorder, a previously diagnosed thought disorder (i.e., psychosis), or bipolar disorder.
• Significant visual, hearing, or speech impairment.
• Organic brain injury.
• Participants who are currently in psychological therapy for pain or anxiety.
• Participants with severe depressive symptoms (cut-score ≥20) on the Patient Health Questionnaire 9 [PHQ-9] or active suicidal ideation.
• Exclusionary criteria specific to the fMRI component of the study:
• Participants with an implant such as a cochlear implant device, a pacemaker or neurostimulator containing electrical circuitry or generating magnetic signals. Participants with any significant ferrous material in their body that could pose the potential for harm in the fMRI environment or cause signal suppression of key regions (i.e. orthodontia).
• Female participants who report current/suspected pregnancy.
• Participants with evidence of claustrophobia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

49 participants in 2 patient groups

ADAPT

Experimental group

Description:

Participants randomized to ADAPT will complete Aim to Decrease Anxiety and Pain Treatment (ADAPT), a remotely delivered tailored intervention that integrates mindfulness meditation with cognitive behavioral therapy. It consists of 6 sessions and blends pain and anxiety coping strategies. The first 2 sessions are interactive with a trained psychological provider and the following 4 sessions are web-based. Each web-based session is followed by therapist support.

Treatment:

Behavioral: ADAPT

Waitlist Control

No Intervention group

Description:

Participants randomized to waitlist control will receive medical treatment as usual. These participants will be given the opportunity to complete ADAPT upon completion of the post assessment.