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Clinical Trials/ACTRN12623000383662
ACTRN12623000383662
Completed
未知

An Online Mindfulness-Based Intervention for Psychological Distress Associated with Inflammatory Bowel Disease in Adults: A Feasibility Trial of the Mind4IBD Program

Deakin University0 sites50 target enrollmentApril 14, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
Inflammatory Bowel Disease
Sponsor
Deakin University
Enrollment
50
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 14, 2023
End Date
May 20, 2024
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • \- Diagnosis of IBD (including Ulcerative Colitis or Crohn's Disease subtypes). IBD diagnosis needs to be established by a health professional using standard criteria. Participants will need to provide evidence of their diagnosis, this can include a letter from a doctor (e.g., GP or Gastroenterologist), results of endoscopy, or any other medical document confirming their diagnosis. Screening for this will take place after consent has been obtained and evidence will be destroyed after verifying participants study eligibility.
  • \- Evidence of moderate to high psychological distress. This will be verified by a score between 16\-29 on K10\. Screening for distress will take place after consent has been obtained.
  • \- Able to communicate in English.
  • \- Access to the internet to participate in the online intervention.
  • \- Live in Australia
  • ; \- Adults aged 18 years or older.
  • \- Diagnosis of IBD (including Ulcerative Colitis or Crohn's Disease subtypes). IBD diagnosis needs to be established by a health professional using standard criteria. Participants will need to provide evidence of their diagnosis, this can include a letter from a doctor (e.g., GP or Gastroenterologist), results of endoscopy, or any other medical document confirming their diagnosis. Screening for this will take place after consent has been obtained and evidence will be destroyed after verifying participants study eligibility.
  • \- Evidence of moderate to high psychological distress. This will be verified by a score between 16\-29 on K10\. Screening for distress will take place after consent has been obtained.
  • \- Able to communicate in English.

Exclusion Criteria

  • \- No/low psychological distress (represented by scores \<16 on K10\) or very high psychological distress (represented by scores \>29 on K10\). It is anticipated that participants with more severe distress would require a more intensive therapeutic approach before benefiting from the current intervention. These participants will receive a message embedded in the Qualtrics screening process to indicate they are not eligible to participate in the study due to screening for severe distress, and it will be recommended that they seek additional support from other appropriate providers. In the same manner participants with no distress will also receive a message stating that they are not eligible to participate in the study due to screening for no distress. ; \- No/low psychological distress (represented by scores \<16 on K10\) or very high psychological distress (represented by scores \>29 on K10\). It is anticipated that participants with more severe distress would require a more intensive therapeutic approach before benefiting from the current intervention. These participants will receive a message embedded in the Qualtrics screening process to indicate they are not eligible to participate in the study due to screening for severe distress, and it will be recommended that they seek additional support from other appropriate providers. In the same manner participants with no distress will also receive a message stating that they are not eligible to participate in the study due to screening for no distress.

Outcomes

Primary Outcomes

Not specified

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