Rheumatic DiseasesNCT05698251
Reducing Uncertainty Distress in Long Term Health Conditions
A study testing Uncertainty distress model in people with Rheumatic Diseases, run by Newcastle University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- Uncertainty distress model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Mar 2022to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- Does the new treatment model help participants reduce uncertainty distress associated with their health condition?
- Is it a practical treatment that can be ran within a hospital setting?
- 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.
Read the 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.
- Conditions
- Rheumatic Diseases
- Being tested
- Uncertainty distress model
- Keywords
- Uncertainty
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uncertainty distress modelBehavioural
Psychological therapy intervention based on elements of traditional Cognitive Behaviour Therapy (CBT) for anxiety, illness uncertainty and intolerance of uncertainty.
| Study group | Role | What they receive |
|---|---|---|
| Reducing uncertainty distress: Psychological therapy intervention | Experimental | 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. Receives: Behavioral: Uncertainty distress model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily from baseline to follow up (approximately 24 weeks)
Secondary outcomes (7)
Changes in Patient Health Questionnaire (PHQ9) score
Depression Questionnaire. Scores range from 0 (minimum) to 27 (maximum). Lower scores indicate better outcome
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre and post treatment (Week 0 and approximately week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start16 Mar 2022
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Case Design
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust, Northumberland, Tyne and Wear NHS Foundation Trust
- Responsible party
- Principal investigator, Sarah Kay, Newcastle University
- Investigators
- Mark Freeston, ProfPsy, Study director, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698251
- Sponsor's protocol ID
- RES-21-015
- Other IDs
- 21/ES/0063, 293383
- Status last verified
- Feb 2023
- First submitted
- 23 Dec 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 2292449Freeston 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.
PubMed 34191941Kuang, 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.
PubMed 29052657
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting an Intervention Using Single Case Design to Reduce Uncertainty Distress in Those With Long Term Health Conditions
- ClinicalTrials.gov ID
- NCT05698251
- Acronym / sponsor ID
- RES-21-015
- Conditions
- Rheumatic Diseases
- Keywords
- Uncertainty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust, Northumberland, Tyne and Wear NHS Foundation Trust
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the new treatment model help participants reduce uncertainty distress associated with their health condition?
- Is it a practical treatment that can be ran within a hospital setting?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Case Design
| Arm | Type | Receives |
|---|---|---|
| Reducing uncertainty distress: Psychological therapy intervention | Experimental | Behavioral: Uncertainty distress modelUp 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uncertainty distress modelPsychological therapy intervention based on elements of traditional Cognitive Behaviour Therapy (CBT) for anxiety, illness uncertainty and intolerance of uncertainty. | Behavioural | Reducing uncertainty distress: Psychological therapy intervention |
Primary outcome
Changes in daily diary measures
Time frame: Daily from baseline to follow up (approximately 24 weeks)
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.
7 secondary outcomes
Changes in Patient Health Questionnaire (PHQ9) score
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Pre and post treatment (Week 0 and approximately week 24)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Background: PubMed 2292449Mishel 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.
- Background: PubMed 34191941Freeston 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.
- BackgroundKuang, K. (2018). Reconceptualizing uncertainty in illness: commonalities, variations, and the multidimensional nature of uncertainty. Annals of the International Communication Association, 42(3), 181-206.
- BackgroundKuang, K., & Wilson, S. R. (2017). A meta-analysis of uncertainty and information management in illness contexts. Journal of Communication, 67(3), 378-401.
- Background: PubMed 29052657Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Freeston, ProfPsy study director
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uncertainty distress model in people with Rheumatic Diseases, run by Newcastle University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in daily diary measures (time frame: Daily from baseline to follow up (approximately 24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05698251, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.