Neural Mechanisms of Treatment Response to ADAPT

NCT03518216 | Completed DMC

• 2 other identifiers: 2017-4545K23AT009458
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Functional Abdominal Pain Syndrome; Anxiety

Keywords

cognitive behavioral therapy; mindfulness meditation; fMRI; neuroimaging

Outcome Measures

Primary Outcomes (1)

• Functional Connectivity of Amygdala with the Prefrontal Cortex

  Changes in functional connectivity will be examined using the Blood Oxygenation Level Dependent (BOLD) effect

  through study completion, an average of 9 weeks

Secondary Outcomes (29)

• Regional Brain Activation in Areas Associated with Cognitive, Affective, and Visceral Afferent Aspects of Pain

  through study completion, an average of 9 weeks

• Neuroimaging data linked to pain and anxiety outcomes

  through study completion, an average of 9 weeks

• Pain Intensity/Unpleasantness via Visual Analog Scale

  through study completion, an average of 9 weeks

• State Anxiety

  through study completion, an average of 9 weeks

• Screen for Child Anxiety Related Disorders

  through study completion, an average of 9 weeks

Study Arms (2)

ADAPT

EXPERIMENTAL

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.

Behavioral: ADAPT

Waitlist Control

NO INTERVENTION

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.

Interventions

ADAPT BEHAVIORAL

Aim to Decrease Anxiety and Pain Treatment is a remotely delivered tailored treatment integrating mindfulness meditation and cognitive behavioral therapy. It consists of 6 sessions and blends pain and anxiety coping strategies. The first 2 sessions will be interactive with a trained psychological provider and the following 4 sessions will be web-based. Each web-based session will be followed by therapist support. The intervention is delivered through a HIPAA compliant video platform.

ADAPT

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Michigan State University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Corewell Health West: collaborator

Study Sites (1)

Michigan State University

Grand Rapids, Michigan, 49503, United States

Location

Related Publications (1)

• Cunningham NR, Adler MA, Barber Garcia BN, Abounader T, Miller AK, Monzalvo M, Hashemi I, Cox R, Ely SL, Zhou Y, DeLano M, Mulderink T, Reeves MJ, Peugh JL, Kashikar-Zuck S, Coghill RC, Arnetz JE, Zhu DC. 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). PLoS One. 2024 Mar 18;19(3):e0299170. doi: 10.1371/journal.pone.0299170. eCollection 2024.

  PMID: 38498587 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Natoshia Cunningham, PhD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 8, 2018
• Study Start: July 3, 2018
• Primary Completion: April 3, 2024
• Study Completion: December 31, 2024
• Last Updated: October 30, 2025

Record last verified: 2024-04

Locations

US (1)