Clinical trial NCT03134950: Improving Care for Youth With FAP: A Stepped Care CBT Delivery Approach
Official title: Improving Care for Youth With Functional Abdominal Pain: A Stepped Care Cognitive Behavioral Therapy (CBT) Delivery Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Abdominal Pain Syndrome
Anxiety
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: American Pain Society
name: Children's Hospital Medical Center, Cincinnati
First posted: 2017-05-01
Enrollment: 139
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project aims to test a stepped care behavioral intervention approach for youth with functional abdominal pain (FAP) that is feasible to administer in medical settings. Screening and a brief intervention (i.e. psychoeducation and relaxation training) are provided to youth with FAP with more than minimal functional disability (FDI score \>7) during their medical visit as part of enhanced usual care (EUC). Patients are re-assessed after two weeks. Those that fail to respond to EUC (as evidenced by FDI score \>7) are eligible to undergo a baseline assessment and then are randomized to receive either 1) a more intensive and tailored CBT approach, Aim to Decrease Anxiety and Pain Treatment (ADAPT), provided by a trained psychologist, or 2) medical treatment as usual (TAU). It is hypothesized that youth who participate in ADAPT will have lower average pain rating scores, less pain-related functional disability, and less anxiety symptoms (if elevated) at post-assessment as compared to youth receiving medical TAU.

Detailed description: The goal of this project is to pilot test different levels of behavioral intervention for patients diagnosed with FAP who are presenting for pediatric gastroenterology care. Patients are screened during their medical visit. Those with more than minimal levels of functional disability (Functional Disability Inventory (FDI) score \>7), receive Enhanced Usual Care (EUC), brief pain-focused psychoeducation administered as part of their medical visit. As part of EUC, patients receive access to a web module for home use that reiterates educational material and offers relaxation training tools for home practice (i.e., audio recordings). Two weeks following EUC, patient outcomes are re-assessed with a focus on pain-related disability. Those who fail to respond to EUC (i.e., FDI remains \>7) are invited to complete the next phase of the study. Eligible participants undergo a baseline assessment consisting of a diagnostic interview and child measures pertaining to pain, anxiety, depressive symptoms, and pain-related worries. Caregivers complete forms about their child's pain history, child disability, and child worries. Caregivers also complete a form about their own stress symptoms. After baseline assessment, patients are randomized to medical treatment as usual (TAU) or ADAPT, a tailored CBT delivered by a trained psychologist. ADAPT content differs based on the individual needs of the patient (i.e., all patients receive 4 pain-focused coping skills sessions, and those who present with clinical levels of anxiety receive 2 additional sessions to address anxiety symptoms). Participants complete 4 or 6 sessions (2 in person sessions and 2-4 web modules with phone support). Approximately six weeks after randomization, the patient and caregiver undergo follow-up assessment to assess pain, anxiety, and disability. It is hypothesized that youth who participate in ADAPT will have lower average pain rating scores, less pain-related functional disability, and lower levels of anxiety symptoms (if elevated) at post-assessment as compared to youth receiving medical TAU.

Eligibility criteria: Inclusion Criteria:

* diagnosed with functional abdominal pain by a pediatric gastroenterologist
* clinically significant disability evidenced by a total score of \> 7 on the Functional Disability Inventory (FDI) that remains elevated (\>2) after 2 weeks

Exclusion Criteria:

* significant medical condition(s) with an identifiable organic cause (e.g., Inflammatory Bowel Diseases such as Ulcerative Colitis and Chron's Disease)
* documented developmental delay, severe cognitive impairment, or a thought disorder
* evidence of severe depressive symptoms (CDI 2: T score \>80) and/or active suicidal ideation

Primary outcomes:
measure: Functional Disability Inventory - Child Version (FDI-C)
timeFrame: through study completion, an average of 8 weeks
Secondary outcomes:
measure: Screen for Child Anxiety Related Disorders - Child Report (SCARED-C)
timeFrame: through study completion, an average of 8 weeks
measure: Pain Intensity via a Visual Analog Scale (VAS)
timeFrame: through study completion, an average of 8 weeks
measure: Anxiety Disorder Interview Schedule - Child Version (ADIS)
timeFrame: through study completion, an average of 8 weeks
measure: Child Depression Inventory 2 Self Report (CDI-2)
timeFrame: through study completion, an average of 8 weeks
measure: Pain Catastrophizing Scale for Children, Child Version (PCS-C)
timeFrame: through study completion, an average of 8 weeks
measure: Functional Gastrointestinal Disorders (FGIDs) Questionnaire
timeFrame: through study completion, an average of 8 weeks
measure: Children's Somatization Inventory (CSI-24)
timeFrame: through study completion, an average of 8 weeks
measure: Depression Anxiety Stress Scales (DASS21)
timeFrame: through study completion, an average of 8 weeks
measure: Children's Global Assessment Scale (C-GAS)
timeFrame: through study completion, an average of 8 weeks
measure: Affective Reactivity Index (ARI)
timeFrame: through study completion, an average of 8 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Michigan State University
name: Natoshia Cunningham, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kalomiris AE, Ely SL, Love SC, Mara CA, Cunningham NR. Child-Focused Cognitive Behavioral Therapy for Pediatric Abdominal Pain Disorders Reduces Caregiver Anxiety in Randomized Clinical Trial. J Pain. 2022 May;23(5):810-821. doi: 10.1016/j.jpain.2021.12.001. Epub 2021 Dec 11.
citation: Cunningham NR, Kalomiris A, Peugh J, Farrell M, Pentiuk S, Mallon D, Le C, Moorman E, Fussner L, Dutta RA, Kashikar-Zuck S. Cognitive Behavior Therapy Tailored to Anxiety Symptoms Improves Pediatric Functional Abdominal Pain Outcomes: A Randomized Clinical Trial. J Pediatr. 2021 Mar;230:62-70.e3. doi: 10.1016/j.jpeds.2020.10.060. Epub 2020 Oct 31.