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Improving Quality of Care With a Digital Behavioral Program in IBD Patient Centered Medical Home

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ClinicalTrials.gov Identifier: NCT03186872
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : May 31, 2018
Sponsor:
Collaborator:
Mount Sinai Hospital, New York
Information provided by (Responsible Party):
Marc Schwartz, University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anxiety Irritable Bowel Disease Behavioral: Digital behavioral program app Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparison between cognitive behavioral app and care as usual.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Improving Quality of Care With a Digital Behavioral Program in IBD Patient Centered Medical Home
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
No Intervention: Care as usual
Participants randomized to this group will continue to see the IBD medical home team as usual
Experimental: Digital behavioral program
Participants randomized to this group will see the IBD medical home team and will utilize the cognitive behavioral app as the intervention.
Behavioral: Digital behavioral program app
mobile app utilizing cognitive behavioral techniques to help alleviate anxiety
Other Name: Lantern




Primary Outcome Measures :
  1. GAD7 Score (Anxiety) [ Time Frame: 12 months ]
    GAD7 anxiety questionnaires are completed at time points throughout the study.


Secondary Outcome Measures :
  1. PHQ-8 (Depression) [ Time Frame: 12 months ]
    The PHQ-8 questionnaire about depression is completed at different time points throughout the study.


Other Outcome Measures:
  1. ACE Measure [ Time Frame: 12 months ]
    ACe questionnaire about health and health care is completed at time points throughout the study.

  2. Ulcerative Colitis Activity Index (UCAI)/Harvey Bradshaw (HB) [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186872


Contacts
Contact: Meredith Strassburger, MSW 412-578-9530 strassburgermb2@upmc.edu
Contact: Katheryn McAuliff, BA 412-578-9527 mcauliffk@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Meredith Strassburger, MSW    412-578-9530    strassburgermb2@upmc.edu   
Contact: Katheryn McAuliff, BA    412-578-9527    mcauliffk@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Mount Sinai Hospital, New York
Investigators
Principal Investigator: Marc Schwartz, MD University of Pittsburgh
Study Director: Eva Szigethy, MD, PhD University of Pittsburgh

Responsible Party: Marc Schwartz, Assistant Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03186872     History of Changes
Other Study ID Numbers: PRO17020464
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD data will not be shared. Data is shared at the aggregate level.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases