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| ID | Type | Description | Link |
|---|---|---|---|
| 21/ES/0063 | Other Identifier | East of Scotland Research Ethics Service REC 1 | |
| 293383 | Other Identifier | Integrated Research Application System (IRAS) |
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| Name | Class |
|---|---|
| Newcastle-upon-Tyne Hospitals NHS Trust | OTHER |
| Northumberland, Tyne and Wear NHS Foundation Trust | OTHER |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uncertainty distress model | Behavioral | Psychological therapy intervention based on elements of traditional Cognitive Behaviour Therapy (CBT) for anxiety, illness uncertainty and intolerance of uncertainty. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Freeston, ProfPsy | Newcastle University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Victoria Hospital (RVI) | Newcastle | NE1 4LP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2292449 | Background | 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. | |
| 34191941 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 31, 2023 | |
| Reset | Mar 15, 2024 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 4, 2022 | Dec 19, 2022 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 31, 2023 | Mar 15, 2024 |
| ID | Term |
|---|---|
| D012216 | Rheumatic Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Single Case Design
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| 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) |
| Background | 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. |
| 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. |
| 29052657 | 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. |