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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03998072
Other study ID # 160787
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date September 1, 2020

Study information

Verified date July 2019
Source University of Sheffield
Contact Amrit Sinha
Phone 01142226650
Email a.sinha@sheffield.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Five session CAT (Cognitive Analytic Therapy) consultancy was developed for patients whom services 'struggle to help', such as those with diagnoses of personality disorder. Five session CAT consultancy works with both patients and care coordinators, utilising key elements of CAT including reciprocal roles and reformulation to inform care planning and case management. The proposed study expands on the existing evidence base by utilising a comparator; a treatment as usual condition. The proposed mixed methods feasibility study will compare outcomes for both patients and care coordinators to assess the effectiveness of the intervention compared to controls in a community mental health team.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 24
Est. completion date September 1, 2020
Est. primary completion date August 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

1. they are indicated as unsuitable for individual therapy,

2. there is a poor or challenging relationship between the patient and the care coordinator(s)

3. the care coordinator(s) feels a sense of 'stuckness' with the case

4. the patient is chaotic

Exclusion Criteria:

1. actively psychotic

2. severely misusing substances

3. have poor appointment attendance

4. indicating that they are actively suicidal and unwilling to commit to trying to stay safe.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Five session cognitive analytic therapy (CAT) consultancy
Five session consultancy with patients and care coordinators using cognitive analytic therapy

Locations

Country Name City State
United Kingdom Rotherham Doncaster and South Humber NHS Foundation Trust Rotherham

Sponsors (2)

Lead Sponsor Collaborator
Amrit Sinha National Health Service, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Personality Structure Questionnaire (PSQ) Primary outcome measure for patients utilised to measure change across multiple time-points.
The PSQ is an 8-item measure of identity disturbance. Each item is rated using a 5-point Likert scale. The maximum score on the scale is 40, indicating a high level of identity disturbance.
Screening (point of referral), start of waiting list (up to 2 weeks), end of waiting list (up to 12 weeks), start of treatment (up to 12 weeks), end of treatment (up to 22 weeks), 8 week follow-up (up to 30 weeks), 12 week follow-up (up to 34 weeks)
Primary Perceived competence scale Primary outcome measure for care coordinators utilised to measure change across multiple time-points.
The Perceived Competence Scale is a four item Likert-scale ranging from 1 to 7. The maximum score for each item is 7, and the maximum overall score for the scale is 28, indicating the highest levels of perceived competence.
Screening (point of referral), start of waiting list (up to 2 weeks), end of waiting list (up to 12 weeks), start of treatment (up to 12 weeks), end of treatment (up to 22 weeks), 8 week follow-up (up to 30 weeks), 12 week follow-up (up to 34 weeks)
Secondary Clinical Outcomes in Routine Evaluation (CORE-10) Secondary outcome measure for patients utilised to measure change across multiple time-points.
The CORE-10 is a ten item questionnaire which measures psychological distress. The maximum score on this measure is 40, indicating the highest level of psychological distress.
Screening (point of referral), start of waiting list (up to 2 weeks), end of waiting list (up to 12 weeks), start of treatment (up to 12 weeks), end of treatment (up to 22 weeks), 8 week follow-up (up to 30 weeks), 12 week follow-up (up to 34 weeks)
Secondary Working Alliance Inventory Short-Revised (WAI-SR) Secondary outcome measure for patients utilised to measure change across multiple time-points.
The WAI-SR is a 12 item scale; items are rated using a 5-point Likert scale. The items can be divided into three constructs, measuring goals, tasks and bond. Each of these domains have scores ranging from 5 to 20. Higher scores indicate better working alliance.
Screening (point of referral), start of waiting list (up to 2 weeks), end of waiting list (up to 12 weeks), start of treatment (up to 12 weeks), end of treatment (up to 22 weeks), 8 week follow-up (up to 30 weeks), 12 week follow-up (up to 34 weeks)
Secondary Doubt Subscale of the Mental Health Professionals Stress Scale (MHPSS) Secondary outcome measure for care coordinators utilised to measure change across multiple time-points.
The doubt subscale is a six-item scale which measures professionals' doubt about their practice. Each item will be scored as 1 if present with a maximum score of 6, indicating high levels of doubt.
Screening (point of referral), start of waiting list (up to 2 weeks), end of waiting list (up to 12 weeks), start of treatment (up to 12 weeks), end of treatment (up to 22 weeks), 8 week follow-up (up to 30 weeks), 12 week follow-up (up to 34 weeks)
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