Reducing Uncertainty Distress in Long Term Health Conditions

Piloting an Intervention Using Single Case Design to Reduce Uncertainty Distress in Those With Long Term Health Conditions

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.

Study Overview

• Status: Completed
• Conditions: Rheumatic Diseases
• Intervention / Treatment: Behavioral: Uncertainty distress model

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Newcastle, United Kingdom, NE1 4LP
    • Royal Victoria Hospital (RVI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: Uncertainty distress model; Psychological therapy intervention based on elements of traditional Cognitive Behaviour Therapy (CBT) for anxiety, illness uncertainty and intolerance of uncertainty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in daily diary measures	Idiosyncratic statements regarding uncertainty and distress rated on Likert scale. Minimum score 0, Maximum Score 10. Direction of improved scores are dependent on individual statements.	Daily from baseline to follow up (approximately 24 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Patient Health Questionnaire (PHQ9) score	Depression Questionnaire. Scores range from 0 (minimum) to 27 (maximum). Lower scores indicate better outcome	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)
Changes in Generalised Anxiety Disorder (GAD7) score	Anxiety Questionnaire. Scores range from 0 (minimum) to 21 (maximum). Lower scores indicate better outcome.	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)
Changes in Brief Pain Inventory (BPI score)	Pain measure. Two subscales pain severity and pain interference. Lower scores indicate better outcome.	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)
Changes in scores on Mishels Illness Uncertainty Scale Community version (MUIS-C)	Measure of illness uncertainty. Scores from 23 (minimum) to 115 (maximum). Lower scores indicate better outcome.	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)
Changes in scores on Intolerance of Uncertainty Scale (IUS)- short form	Measure of intolerance of uncertainty. Scores from 12 (minimum) to 60 (maximum). Lower scores indicate better outcome.	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)
Changes in scores on Intolerance of Uncertainty Behaviours in Everyday Life Questionnaire (IUBEL)	Measure of uncertainty behaviours. Two subscales generic and situational subscales. Scores from 0 (minimum) to 96 (maximum) on each subscale. Lower numbers indicate better outcome.	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)
Changes in scores on International Adjustment Disorder Questionnaire (IADQ)	Measure of adjustment to physical illness. Scores from 0 (minimum) to 40 (maximum). Lower numbers indicate better outcome.	Pre and post treatment (Week 0 and approximately week 24)

Collaborators and Investigators

• Sponsor: Newcastle University
• Collaborators: Newcastle-upon-Tyne Hospitals NHS Trust; Cumbria, Northumberland Tyne and Wear NHS Foundation Trust
• Investigators: Study Director: Mark Freeston, ProfPsy, Newcastle University

Publications and helpful links

General Publications

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

Helpful Links

• Research group homepage with details of treatment model and therapy resources

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2022
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: January 15, 2023
• First Posted (Estimate): January 26, 2023

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 15, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Uncertainty
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: RES-21-015; 21/ES/0063 (Other Identifier: East of Scotland Research Ethics Service REC 1); 293383 (Other Identifier: Integrated Research Application System (IRAS))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No