NCT03852745

Brief Summary

This study will recruit persons with Inflammatory Bowel Disease. The investigators will contact people in an ongoing study (called IMAGINE) to recruit persons with high levels of stress, anxiety, or depression who are interested in a web-based program focused on skills in managing stress, anxiety and depression (a self-directed psychosocial intervention). The goal is to develop an internet-based psychosocial intervention to help persons with inflammatory bowel disease to cope with high levels of stress, anxiety or depression.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 1, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 18, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 29, 2021

Status Verified

November 1, 2020

Enrollment Period

3.7 years

First QC Date

August 1, 2018

Last Update Submit

September 27, 2021

Conditions

Inflammatory Bowel DiseaseAnxietyDepression

Keywords

cognitive behavioral therapy, online intervention

Outcome Measures

Primary Outcomes (2)

  • Change in Hospital Anxiety and Depression Scale (HADS)

    scale measuring anxiety and depression (14 items); likert scale 0 (not at all) to 3 (most of the time); higher scores(summed) indicate presence of anxiety or depression

    Baseline, 6 weeks, 12 weeks, 24 weeks

  • Change in Perceived Stress Scale 4 (PSS-4)

    scale measuring psychological stress (4 items); likert scale 0 (never) to 4 (very often); higher scores indicate higher levels of perceived stress

    Baseline, 6 weeks, 12 weeks, 24 weeks

Secondary Outcomes (4)

  • Change in Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29)

    Baseline, 6 weeks, 12 weeks, 24 weeks

  • Change in Clinical Global Impression - Improvement scale (CGI-I)

    Baseline, 6 weeks, 12 weeks, 24 weeks

  • Change in the Work and Social Adjustment Scale (WSAS)

    Baseline, 6 weeks, 12 weeks, 24 weeks

  • Change in Inflammatory Bowel Disease Symptom Inventory - Short Form (IBDSI)

    Baseline, 6 weeks, 12 weeks, 24 weeks

Study Arms (1)

Cognitive Behavioral Therapy

OTHER

Online cognitive behavioral therapy intervention for 2 hours a week for 12 weeks.

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

cognitive behavioral therapy; focus on learning skills including acceptance and commitment

Cognitive Behavioral Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with inflammatory bowel disease - Crohn's disease or ulcerative colitis
  • A score on a scale measuring perceived stress, anxiety or depression indicating the presence of a clinically significant problem
  • Regular access to a personal computer and Internet to allow access to the program
  • Ability to read and write English

You may not qualify if:

  • Presence of significant suicidal ideation or suicidal intent within the last six months
  • Presence of self-harming behavior in the last six months
  • Currently active substance use disorder (last six months)
  • Psychotic disorder (last six months)
  • Eating disorder (last six months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba - College of Medicine

Winnipeg, Manitoba, R3E 0W2, Canada

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesAnxiety DisordersDepression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Patricia Furer, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: cognitive behavior therapy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2018

First Posted

February 25, 2019

Study Start

April 18, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

September 29, 2021

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)