NCT03186872

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started May 2017

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2017

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2019

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

June 6, 2017

Last Update Submit

January 7, 2020

Conditions

AnxietyIrritable Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • GAD7 Score (Anxiety)

    GAD7 anxiety questionnaires are completed at time points throughout the study.

    12 months

Secondary Outcomes (1)

  • PHQ-8 (Depression)

    12 months

Other Outcomes (2)

  • ACE Measure

    12 months

  • Ulcerative Colitis Activity Index (UCAI)/Harvey Bradshaw (HB)

    12 months

Study Arms (2)

Care as usual

NO INTERVENTION

Participants randomized to this group will continue to see the IBD medical home team as usual

Digital behavioral program app

EXPERIMENTAL

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

Interventions

Digital behavioral program appBEHAVIORAL

mobile app utilizing cognitive behavioral techniques to help alleviate anxiety

Also known as: Lantern
Digital behavioral program app

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Oser M, Wallace ML, Solano F, Szigethy EM. Guided Digital Cognitive Behavioral Program for Anxiety in Primary Care: Propensity-Matched Controlled Trial. JMIR Ment Health. 2019 Apr 4;6(4):e11981. doi: 10.2196/11981.

    PMID: 30946022DERIVED

MeSH Terms

Conditions

Anxiety DisordersIrritable Bowel Syndrome

Interventions

nano-lantern protein

Condition Hierarchy (Ancestors)

Mental DisordersColonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Marc Schwartz, MD

    University of Pittsburgh Medical Center

    PRINCIPAL INVESTIGATOR

  • Eva Szigethy, MD, PhD

    University of Pittsburgh Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Comparison between cognitive behavioral app and care as usual.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

June 6, 2017

First Posted

June 14, 2017

Study Start

May 15, 2017

Primary Completion

May 29, 2019

Study Completion

May 29, 2019

Last Updated

January 9, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

IPD data will not be shared. Data is shared at the aggregate level.

Locations

US(1)