Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
Study NCT ID:
NCT05698251
Status:
COMPLETED
Last Update Posted:
2023-02-03
First Post:
2022-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reducing Uncertainty Distress in Long Term Health Conditions
Sponsor:
Newcastle University
Organization:
Study Overview
Official Title:
Piloting an Intervention Using Single Case Design to Reduce Uncertainty Distress in Those With Long Term Health Conditions
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed 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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: