Reveal the Level of Anxiety in Patients With Crohn's Disease Receiving Adalimumab (RELAX)

It has been shown that emotional health issues, such as state anxiety, are more prevalent in patients suffering from inflammatory bowel disease (IBD) compared to physically healthy subjects.

Such findings have to be taken into consideration when making an educated guess that psychological factors such as depression and anxiety in particular interact with the course of Crohns disease. Therefore the treatment of the underlying disease may have a significant influence on the level of psychological disorders.

Several studies have shown that treatment with tumor necrosis factor alpha (TNF-α) antibodies ameliorates the emotional/psychological status of patients, however the impact of adalimumab therapy on anxiety correlated with the status of inflammatory bowel disease (IBD) remains unclear.

The primary objective of this study was to describe and evaluate changes in levels of anxiety assessed by validated patient questionnaires after 6 months of treatment with adalimumab.

Study Overview

• Status: Completed
• Conditions: Anxiety; Severe Crohn's Disease

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Site Reference ID/Investigator# 64830
  • Innsbruck, Austria, 6020
    • Site Reference ID/Investigator# 64832
  • Linz, Austria, A-4010
    • Site Reference ID/Investigator# 64829
  • Salzburg, Austria, A-5020
    • Site Reference ID/Investigator# 64831
  • St. Poelten, Austria, 3100
    • Site Reference ID/Investigator# 64828
  • St. Veit/Glan, Austria, 9300
    • Site Reference ID/Investigator# 79613
  • Vienna, Austria, 1030
    • Site Reference ID/Investigator# 47342
  • Vienna, Austria, 1090
    • Site Reference ID/Investigator# 64833

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The investigational sites were centers with a high level of experience in the treatment of Crohns disease patients.

Description

Inclusion Criteria:

• Patients for whom Adalimumab (Humira) therapy is indicated and has been prescribed according to the product label and who meet the following criteria:

  • Male and female patients aged 18 to 65 years suffering from severe active Crohns Disease, attending a routine medical visit.
  • Able to complete questionnaires.
  • Patients with status active severe Crohns disease which required immunosuppressive treatment
  • Patients must fulfil international and national guidelines for the use of a biologic therapies in Crohns Disease (Chest X-ray and interferon gamma release assay (IGRA) or PPD (purified protein derivative)-skin test negative for tuberculosis).
  • Patients have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
  • Patients who have been prescribed in line with the European Summary of Product Characteristics (SMPC)

Exclusion Criteria:

• The following patients will not be included in this observational study:

  • Previous therapy with TNF-α blocker within the last 8 weeks
  • Active Central Nervous System opportunistic infections or Central Nervous System malignancies.
  • History of Cerebrovascular Accident
  • Abuse of illicit substances (such as psychoactive drugs) within the previous 3 months
  • Change of medication-based treatment of generalized anxiety and panic disorder, psychiatric disorder
  • No informed consent
  • Contraindication to adalimumab (Humira) therapy according to the SMPC
  • Current or planned pregnancy
  • Lactation according to SMPC
  • Planned change of site within the next 24 weeks.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with severe active Crohn's disease; Patients with severe active Crohn's disease for whom adalimumab was prescribed in the usual manner in accordance with the terms of the local marketing authorization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in State Trait Anxiety Index (STAI) State Scores From Baseline to After 6 Months of Treatment With Adalimumab	The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.	Baseline and Visit 3 [Month 6]
Change in State Trait Anxiety Index (STAI) Trait Scores From Baseline to After 6 Months of Treatment With Adalimumab	The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.	Baseline and Visit 3 [Month 6]
Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab	HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.	Baseline and Visit 3 [Month 6]
Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab	HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.	Baseline and Visit 3 [Month 6]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Inflammatory Bowel Disease Questionnaire (sIBDQ) Scores by Visit	The sIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The sIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL). A higher score indicates a better HRQoL.	Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
Harvey-Bradshaw Index (HBI) Scores by Visit	Harvey-Bradshaw Index (HBI) is for use in the assessment and quantification of symptoms and the present level of disease activity of patients with Crohn's disease. It is a validated clinical index for Crohn's disease, including the 5 categories of: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25 with higher scores indicating higher disease activity. The scores were classified as follows: less than 5 is remission, 5 to 7 is mild, 8 to 16 is moderate, and greater than 16 is severe.	Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
State Trait Anxiety Index (STAI) State Scores by Visit	The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.	Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
State Trait Anxiety Index (STAI) Trait Scores by Visit	The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.	Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
Hospital Anxiety and Depression Score (HADS) - Anxiety Scores by Visit	HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.	Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
Hospital Anxiety and Depression Score (HADS) - Depression Scores by Visit	HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.	Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)
• Collaborators: Raffeiner GmbH

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: September 1, 2011
• First Submitted That Met QC Criteria: September 1, 2011
• First Posted (ESTIMATE): September 2, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 2, 2014
• Last Update Submitted That Met QC Criteria: October 31, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: quality of life; anxiety; adalimumab; antibodies; monoclonal; severe crohn's disease; biological products
• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Anxiety Disorders; Crohn Disease
• Other Study ID Numbers: P12-705