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Does Five Session CAT Consultancy Lead to Improved Outcomes?

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ClinicalTrials.gov Identifier: NCT03998072
Recruitment Status : Not yet recruiting
First Posted : June 25, 2019
Last Update Posted : July 3, 2019
Sponsor:
Collaborator:
National Health Service, United Kingdom
Information provided by (Responsible Party):
Amrit Sinha, University of Sheffield

Brief 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.

Condition or disease Intervention/treatment Phase
Psychological Intervention Treatment as Usual Other: Five session cognitive analytic therapy (CAT) consultancy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The study will utilise two conditions - intervention and waiting list. Participants on the waiting list will then proceed to the intervention condition.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Five Session CAT (Cognitive Analytic Therapy) Consultancy Lead to Improve Outcomes for Patients and Care Coordinators?
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : September 1, 2020

Arm Intervention/treatment
Experimental: Intervention Other: Five session cognitive analytic therapy (CAT) consultancy
Five session consultancy with patients and care coordinators using cognitive analytic therapy

No Intervention: Treatment as usual (waiting list control)



Primary Outcome Measures :
  1. Personality Structure Questionnaire (PSQ) [ Time Frame: 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 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.


  2. Perceived competence scale [ Time Frame: 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 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.



Secondary Outcome Measures :
  1. Clinical Outcomes in Routine Evaluation (CORE-10) [ Time Frame: 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 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.


  2. Working Alliance Inventory Short-Revised (WAI-SR) [ Time Frame: 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 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.


  3. Doubt Subscale of the Mental Health Professionals Stress Scale (MHPSS) [ Time Frame: 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 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998072


Contacts
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Contact: Amrit Sinha 01142226650 a.sinha@sheffield.ac.uk

Locations
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United Kingdom
Rotherham Doncaster and South Humber NHS Foundation Trust Not yet recruiting
Rotherham, United Kingdom
Contact: Kevin Williamson    01302798456    kevin.williamson@nhs.net   
Sponsors and Collaborators
Amrit Sinha
National Health Service, United Kingdom

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Responsible Party: Amrit Sinha, Research Support Officer, University of Sheffield
ClinicalTrials.gov Identifier: NCT03998072     History of Changes
Other Study ID Numbers: 160787
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amrit Sinha, University of Sheffield:
psychology
cognitive analytic therapy