Clinical Trials Logo

Clinical Trial Summary

The goal of this pilot intervention study is to develop and test a new psychological therapy model in people with long term health conditions (rheumatic conditions) who are experiencing distress (anxiety or low mood) in relation to the uncertainty that their illness causes. The main questions the study aims to answer are: 1. Does the new treatment model help participants reduce uncertainty distress associated with their health condition? 2. Is it a practical treatment that can be ran within a hospital setting? 3. Is the treatment acceptable to participants? Participants will be asked to attend weekly therapy sessions (up to a maximum of 16 sessions) in the hospital or via telehealth. The sessions will be based on the new treatment model and aimed at helping participants reduce uncertainty where they can and learn to live alongside it where it cannot be reduced. The hope is that if participants can better manage uncertainty this will reduce the distress (anxiety or low mood) that they feel.


Clinical Trial Description

Uncertainty is a natural part of chronic illness and is typically experienced as aversive for most people. Sources of uncertainty in illness can include living with ambiguous symptoms, unpredictability of flare ups, if/when the illness will worsen and how effective treatment will be. Whilst some real-world uncertainty is inevitable in illness, perceived uncertainty can be exacerbated by inconsistent and/or inadequate health information. High levels of illness uncertainty have been associated with greater emotional distress/mood disturbances, poorer adjustment and reduced quality of life. Uncertainty management interventions have traditionally focused on reducing uncertainty through information management strategies. These have been shown to be effective in improving patient knowledge of their condition, improve patient-health professionals communication, mood and coping skills. Research into emotional disorders have identified uncertainty as a transdiagnostic source of distress and studies increasing tolerance of uncertainty have been shown to be effective. To date there is no research combining informational interventions to reduce perceived uncertainty and interventions increasing tolerance of uncertainty in those with chronic health conditions. The aim of this study is pilot a transdiagnostic treatment model combining both elements. The intervention consists of 4 main interventional areas; information management, building safety, addressing overestimation of threat, and tolerating uncertainty. This treatment has the potential to reduce disease distress and burden and potentially reduce health care utilisation if patients are managing their health conditions and associated uncertainty better. Using single case design this study will look to develop and evaluate the new treatment intervention. The aim is to establish whether his treatment is feasible and acceptable to be delivered within a health care setting. Up to 6 participants will be recruited from the Rheumatology department within a hospital setting. Participants will be experiencing distress related to the uncertainty of their diagnosed health condition and willing to engage in a psychological treatment to reduce distress. Treatment will consist of 16 weekly therapy sessions (dependent on clinical need) delivered face to face or via telehealth. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05698251
Study type Interventional
Source Newcastle University
Contact
Status Completed
Phase N/A
Start date March 16, 2022
Completion date December 20, 2022

See also
  Status Clinical Trial Phase
Withdrawn NCT04976972 - A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation N/A
Completed NCT04042792 - Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate
Recruiting NCT05554029 - Coronaphobia in Rheumatic Diseases N/A
Completed NCT02944448 - A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee Phase 2
Completed NCT02694796 - Impact of Web and Smartphone-based Physical Activity Program on Physical Activity Level 12 Months After a Balneotherapy N/A
Completed NCT02269254 - Persona Versus NexGen N/A
Completed NCT02256098 - RSA RCT: ATTUNEā„¢ TKA Versus PFC Sigma TKA N/A
Completed NCT00642837 - A Study on Health - Related Quality of Life in Patients With Rheumatic Diseases Taking Tramadol 37.5mg/Acetaminophen 325mg Tablets Phase 4
Active, not recruiting NCT04704544 - Effectiveness of Tele-rheumatology for Delivering High Quality Rheumatology Care During the COVID-19 Crisis (EVOLVE) N/A
Completed NCT05026853 - Patient-Reported Outcomes Measurement Information System Integration Into Rheumatology Clinical Practice N/A
Active, not recruiting NCT04631965 - Healthcare Transition of Adolescents With Chronic Health Conditions
Recruiting NCT00024479 - Natural History of Rheumatic Diseases in Minority Communities
Completed NCT05031104 - Low-energy Laser Applications in Patients With Juvenile Idiopathic Arthritis N/A
Not yet recruiting NCT04567576 - Predictive Factors for COVID-19 in Rheumatology
Completed NCT02291471 - Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers Phase 1
Completed NCT01227694 - Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis Phase 1/Phase 2
Recruiting NCT01071447 - Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment N/A
Active, not recruiting NCT05618782 - Clinical Trial to Evaluate the Efficacy and Safety of LEVI-04 in Patients With Osteoarthritis of the Knee Phase 2
Active, not recruiting NCT05543642 - The COVID-19 VaccinE Response and Co-Administration in Rheumatology Patients (COVER-CoAd) Phase 4
Active, not recruiting NCT02694185 - Secondary Event Prevention Using Population Risk Management After PCI and for Anti-Rheumatic Medications N/A