The Living With a Long-Term Condition Study

Study Overview
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Brief Summary
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Psychological distress (anxiety and depression) is common in and experienced differently by people living with long-term health conditions (LTCs). Being able to measure whether psychological distress is related to living with a LTC would allow researchers and clinicians to provide interventions specifically tailored to the challenges of living with a LTC and therefore provide the most appropriate support for these patients. Such a measure would also be useful in research to identify the presence of illness-related distress in different patient groups. This project will therefore create a new measure of illness-related distress that has applications for both research and clinical practice. This will involve the psychometric validation of the new illness-related distress measure to test how valid and reliable the measure is. The aim of the project is to provide initial validation of the Illness Related Distress Scale in a community sample, recruited through online platforms. The objective of the study is to gather initial validity and reliability data for the scale.

Detailed Description
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Background: see brief summary Project information: This study will be conducted online with participants from the UK. A series of standardised questionnaires will be used alongside the new questionnaire. Participants will be those who self-select to complete our survey by responding to advertisements. The invitation will include a link to the Qualtrics survey which includes the Participant Information Sheet, Eligibility Screening, Consent Form and Baseline Questionnaire. After completing eligibility screening and consent, participants will complete the baseline questionnaire which will include brief demographics (highest education level, long-term condition diagnoses, ethnicity age and gender), the new measure we are testing (the Illness Related Distress Scale), as well as the Patient Health Questionnaire (PHQ-8), Generalised Anxiety Disorder Scale (GAD-7), the Work and Social Adjustment Scale (WSAS). The baseline questionnaire will only include the Inflammatory Bowel Disease Distress Scale (IBD-DS) and Diabetes Distress Scale (DDS) if participants indicate that they have a diagnosis of the relevant condition. At 1 week follow-up, participants will be sent a Qualtrics link to complete our 1-week follow-up questionnaire which will include the new Illness-Related Distress Scale only. Participants: We are aiming to recruit 600-700 participants for the study.

Official Title
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Testing the Reliability and Validity of a New Measure for Illness-related Distress.

Conditions
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Asthma, Atrial Fibrillation, Cerebrovascular Disorders, Stroke, CKD, Copd, Fibromyalgia, Pain, Heart Diseases, Heart Disease Chronic, Dementia, Diabetes, Epilepsy, Heart Failure, High Blood Pressure, Hypertension, Hiv, AIDS, IBD, IBS, Liver Diseases, Long COVID, Lupus Erythematosus, Multiple Sclerosis, Obesity, Osteoarthritis, Arthritis, Rheumatoid Arthritis, Osteoporosis, Parkinson Disease, Sickle Cell Disease, Hepatitis, Endometriosis, PCOS, Neurological Disorder, POTS - Postural Orthostatic Tachycardia Syndrome, MND (Motor Neurone DIsease), Cystic Fibrosis, Migraine, Spondylitis, Celiac Disease, Hidradenitis Suppurativa, Eczema, ME/CFS, Cancer

Intervention / Treatment
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* Diagnostic Test: Living with LTC Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over the age of 18 Self-reported diagnosis of a Long-Term Condition UK resident Possession of an email address to enable all study procedures Sufficient command of written and spoken English to understand study procedures Exclusion Criteria: Under the age of 18 Not living in the UK No self-reported diagnosis of an LTC Inability to complete questionnaires in English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants<br>Participants will answer two short questionnaires, 1 week apart. | Diagnostic Test: Living with LTC Questionnaire<br>* A questionnaire that will ask about demographic information, mental wellbeing and distress related to chronic illness.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Illness-related distress | 31 item questionnaire developed by the research team designed to assess illness-related distresss. | Week 0 and Week 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Eight-item Patient Health Questionnaire - 8 (PHQ-8) Minimum=0, maximum=24, with higher scores indicating greater depression. | Week 0 | 
| Anxiety | Seven-item Generalised Anxiety Disorder Scale (GAD-7). Minimum=0, maximum=21, with higher scores indicating greater anxiety. | Week 0 | 
| Functional impairment | Five-item Work and Social Adjustment Scale (WSAS). Minimum=0, maximum=50, with higher scores indicating greater functional impairment. | Week 0 | 
| Diabetes Related Distress Scale | Diabetes Related Distress Scale (DDS-17), a 17 item self-report diabetes related distress questionnaire. Minimum=17, maximum=102, with higher scores indicating greater distress. | Week 0 | 
| IBD Distress Scale | IBD Distress Scale, a 28 item self-report IBD related distress questionnaire. Minimum=29, maximum=145, with higher scores indicating greater distress. | Week 0 | 
| Cognitive and Behavioural Responses to Symptoms | Cognitive Behavioural Responses to Symptoms Questionnaire, 40 item self-report questionnaire consisting of seven subscales with items scored on a 5 point scale. Higher scores correspond with stronger presence of the specific cognitive/behavioural response. The seven subscales refer to 1) fear avoidance, 2) catastrophising, 3) damage beliefs, 4) embarassment avoidance 5) symptom focussing 6) all-or-nothing behaviour and 7) avoidance/resting behaviour. | Week 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mental health, depression, anxiety, chronic illness