- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03998072
Does Five Session CAT Consultancy Lead to Improved Outcomes?
Does Five Session CAT (Cognitive Analytic Therapy) Consultancy Lead to Improve Outcomes for Patients and Care Coordinators?
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Rotherham, United Kingdom
- Rotherham Doncaster and South Humber NHS Foundation Trust
-
Contact:
- Kevin Williamson
- Phone Number: 01302798456
- Email: kevin.williamson@nhs.net
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- they are indicated as unsuitable for individual therapy,
- there is a poor or challenging relationship between the patient and the care coordinator(s)
- the care coordinator(s) feels a sense of 'stuckness' with the case
- the patient is chaotic
Exclusion Criteria:
- actively psychotic
- severely misusing substances
- have poor appointment attendance
- indicating that they are actively suicidal and unwilling to commit to trying to stay safe.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
|
Five session consultancy with patients and care coordinators using cognitive analytic therapy
|
NO_INTERVENTION: Treatment as usual (waiting list control)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
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)
|
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. |
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
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)
|
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. |
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)
|
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. |
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)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 160787
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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