Reducing Uncertainty Distress in Long Term Health Conditions

NCT ID: NCT05698251

Last Updated: 2023-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-16

Study Completion Date

2022-12-20

Brief Summary

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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

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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.

Conditions

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Rheumatic Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Case Design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reducing uncertainty distress: Psychological therapy intervention

Up to 16 sessions of psychological therapy delivered weekly either face to face or via telehealth . Based on empirically grounded models of anxiety/threat, illness uncertainty and intolerance of uncertainty.

Formulation driven and clinically responsive individualised treatment based on four intervention areas: information management, building safety, reducing overestimation of threat and tolerating uncertainty.

Group Type EXPERIMENTAL

Uncertainty distress model

Intervention Type BEHAVIORAL

Psychological therapy intervention based on elements of traditional Cognitive Behaviour Therapy (CBT) for anxiety, illness uncertainty and intolerance of uncertainty.

Interventions

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Uncertainty distress model

Psychological therapy intervention based on elements of traditional Cognitive Behaviour Therapy (CBT) for anxiety, illness uncertainty and intolerance of uncertainty.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

Sponsor Role collaborator

Northumberland, Tyne and Wear NHS Foundation Trust

OTHER

Sponsor Role collaborator

Newcastle University

OTHER

Sponsor Role lead

Responsible Party

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Sarah Kay

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Freeston, ProfPsy

Role: STUDY_DIRECTOR

Newcastle University

Locations

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Royal Victoria Hospital (RVI)

Newcastle, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Mishel MH. Reconceptualization of the uncertainty in illness theory. Image J Nurs Sch. 1990 Winter;22(4):256-62. doi: 10.1111/j.1547-5069.1990.tb00225.x.

Reference Type BACKGROUND
PMID: 2292449 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34191941 (View on PubMed)

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.

Reference Type BACKGROUND

Kuang, K., & Wilson, S. R. (2017). A meta-analysis of uncertainty and information management in illness contexts. Journal of Communication, 67(3), 378-401.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 29052657 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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21/ES/0063

Identifier Type: OTHER

Identifier Source: secondary_id

293383

Identifier Type: OTHER

Identifier Source: secondary_id

RES-21-015

Identifier Type: -

Identifier Source: org_study_id

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