Improving Care for Youth With FAP: A Stepped Care CBT Delivery Approach
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Anxiety, Anxiety, Pain |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 9 - 14 |
| Updated: | 7/26/2018 |
| Start Date: | July 20, 2015 |
| End Date: | June 2019 |
Improving Care for Youth With Functional Abdominal Pain: A Stepped Care Cognitive Behavioral Therapy (CBT) Delivery Approach
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.
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.
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.
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.
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
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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