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2023-06-28
2023-12-31
2024-01-10
600
NCT06072287
King's College London
King's College London
OBSERVATIONAL
The Living With a Long-Term Condition Study
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-10-02 | N/A | 2023-10-10 |
2023-10-02 | N/A | 2023-10-12 |
2023-10-10 | N/A | 2023-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Participants Participants will answer two short questionnaires, 1 week apart. | DIAGNOSTIC_TEST: Living with LTC Questionnaire
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Natasha Seaton, MSc Phone Number: 0207 188 1189 Email: LTC-study@kcl.ac.uk |
Study Contact Backup Name: Natasha Seaton, MSc Phone Number: 0207 188 1189 Email: natasha.seaton@kcl.ac.uk |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
