Clinical trial NCT05698251: Reducing Uncertainty Distress in Long Term Health Conditions
Official title: Piloting an Intervention Using Single Case Design to Reduce Uncertainty Distress in Those With Long Term Health Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatic Diseases
Keywords: Uncertainty
Lead sponsor: Newcastle University
Sponsor class: OTHER
Collaborators: name: Newcastle-upon-Tyne Hospitals NHS Trust
name: Northumberland, Tyne and Wear NHS Foundation Trust
First posted: 2023-01-26
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Case Design
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Long Term Health Condition (Rheumatic Disease)
* Minimum of 12 months since diagnosis
* Difficulties adjusting to long term health condition
* Willingness to engage with a psychological treatment to manage distress associated with health condition
* Fluent English Speaker

Exclusion Criteria:

* Multiple long term health conditions
* Progressive health conditions
* Experiencing mental health difficulties that might interfere with ability to engage in time limited psychological therapy such as Major Depressive Episode and/or severe and enduring mental health problems, comorbid substance misuse, suicidality
* Diagnosis of Autism Spectrum Disorder (ASD)
* Non- English Speaker

Primary outcomes:
measure: Changes in daily diary measures
timeFrame: Daily from baseline to follow up (approximately 24 weeks)
Secondary outcomes:
measure: Changes in Patient Health Questionnaire (PHQ9) score
timeFrame: Baseline (Week 0), start of therapy (Week 2-4 depending on randomisation to baseline length) prior to each therapy session (weekly from weeks 2-4 to approximately weeks 18-20) end of therapy (approximately week 20) and follow up (approximately week 24)
measure: Changes in Generalised Anxiety Disorder (GAD7) score
timeFrame: Baseline (Week 0), start of therapy (Week 2-4 depending on randomisation to baseline length) prior to each therapy session (weekly from weeks 2-4 to approximately weeks 18-20) end of therapy (approximately week 20) and follow up (approximately week 24)
measure: Changes in Brief Pain Inventory (BPI score)
timeFrame: At 5 time points: Baseline (Week 0), Start of Treatment (Between week 2- week 4 dependent on randomisation to baseline) , Mid treatment (Approximately week 12), End of treatment (Approximately week 20) and Follow up (Approximately week 24)
measure: Changes in scores on Mishels Illness Uncertainty Scale Community version (MUIS-C)
timeFrame: At 5 time points: Baseline (Week 0), Start of Treatment (Approximately week 4) , Mid treatment (Approximately week 12), End of treatment (Approximately week 20) and Follow up (Approximately week 24)
measure: Changes in scores on Intolerance of Uncertainty Scale (IUS)- short form
timeFrame: At 5 time points: Baseline (Week 0), Start of Treatment (Approximately week 4) , Mid treatment (Approximately week 12), End of treatment (Approximately week 20) and Follow up (Approximately week 24)
measure: Changes in scores on Intolerance of Uncertainty Behaviours in Everyday Life Questionnaire (IUBEL)
timeFrame: At 5 time points: Baseline (Week 0), Start of Treatment (Approximately week 4) , Mid treatment (Approximately week 12), End of treatment (Approximately week 20) and Follow up (Approximately week 24)
measure: Changes in scores on International Adjustment Disorder Questionnaire (IADQ)
timeFrame: Pre and post treatment (Week 0 and approximately week 24)
Other outcomes:
Locations:
city: Newcastle
country: United Kingdom
facility: Royal Victoria Hospital (RVI)
Study officials:
affiliation: Newcastle University
name: Mark Freeston, ProfPsy
role: STUDY_DIRECTOR
References:
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citation: Freeston M, Tiplady A, Mawn L, Bottesi G, Thwaites S. Towards a model of uncertainty distress in the context of Coronavirus (COVID-19). Cogn Behav Therap. 2020 Jul 7;13:e31. doi: 10.1017/S1754470X2000029X. eCollection 2020.
citation: Kuang, K. (2018). Reconceptualizing uncertainty in illness: commonalities, variations, and the multidimensional nature of uncertainty. Annals of the International Communication Association, 42(3), 181-206.
citation: Kuang, K., & Wilson, S. R. (2017). A meta-analysis of uncertainty and information management in illness contexts. Journal of Communication, 67(3), 378-401.
citation: Zhang Y. Uncertainty in Illness: Theory Review, Application, and Extension. Oncol Nurs Forum. 2017 Nov 1;44(6):645-649. doi: 10.1188/17.ONF.645-649.