Anxiety Clinical Trial
Official title:
Improving Quality of Care With a Digital Behavioral Program in IBD Patient Centered Medical Home
NCT number | NCT03186872 |
Other study ID # | PRO17020464 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 15, 2017 |
Est. completion date | May 29, 2019 |
Verified date | January 2020 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Anxiety disorders and depression are more prevalent in patients living with inflammatory bowel disease (IBD) than in healthy controls. Approximately 40% of IBD patients have elevated anxiety. Given the robust effectiveness of cognitive behavioral approaches for anxiety disorders and the paucity or mixed findings of cognitive behavioral approaches for anxiety in IBD, an integrated behavioral approach and combining face to face and online cognitive behavioral modalities is recommended for IBD patients with anxiety.
Status | Completed |
Enrollment | 90 |
Est. completion date | May 29, 2019 |
Est. primary completion date | May 29, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Individuals who are seeking medical care at UPMC IBD Patient Centered Medical Home (PCMH); age 21-55; GAD7 score >/= 8, English speaking and capable of understanding the informed consent and providing consent; access to a Smartphone Exclusion Criteria: - No psychotherapy within PCMH within past 6 months including with the psychologist• Stable on psychiatric meds for 4 weeks• Personality pathology or PTSD (captured from DSM-V cross cutting symptoms inventory already being used as part of routine care screening in this clinic)• Severe mood disorder (PHQ8 > 14) or evidence of active suicidality or psychosis (brief screen conducted by SWer in clinic using DSM-V cross cutting symptom inventory) to assess for psychosis, etc. will serve as our study screener • No smartphone |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | Mount Sinai Hospital, New York |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | ACE Measure | ACe questionnaire about health and health care is completed at time points throughout the study. | 12 months | |
Other | Ulcerative Colitis Activity Index (UCAI)/Harvey Bradshaw (HB) | The UCAI/HB questionnaires about IBD related chronic pain are completed at time points throughout the study. The subject completes the appropriate questionnaire based on IBD diagnosis. | 12 months | |
Primary | GAD7 Score (Anxiety) | GAD7 anxiety questionnaires are completed at time points throughout the study. | 12 months | |
Secondary | PHQ-8 (Depression) | The PHQ-8 questionnaire about depression is completed at different time points throughout the study. | 12 months |
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