Reducing Uncertainty Distress in Long Term Health Conditions

NCT05698251 | Completed

• 3 other identifiers: RES-21-01521/ES/0063293383
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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. 1.Does the new treatment model help participants reduce uncertainty distress associated with their health condition?
2. 2.Is it a practical treatment that can be ran within a hospital setting?
3. 3.Is the treatment acceptable to participants?

Conditions

Rheumatic Diseases

Keywords

Uncertainty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Changes in Patient Health Questionnaire (PHQ9) score

  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

  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)

  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)

  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

  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)

Study Arms (1)

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.

Behavioral: Uncertainty distress model

Interventions

Uncertainty distress model BEHAVIORAL

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

Reducing uncertainty distress: Psychological therapy intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Newcastle University: lead
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator
• Northumberland, Tyne and Wear NHS Foundation Trust: collaborator

Study Sites (1)

Royal Victoria Hospital (RVI)

Newcastle, NE1 4LP, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 2292449 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.

  PMID: 34191941 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.

  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.

  PMID: 29052657 BACKGROUND

MeSH Terms

Conditions

Rheumatic Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mark Freeston, ProfPsy

  Newcastle University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Single Case Design

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 26, 2023
• Study Start: March 16, 2022
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)