Does Five Session CAT Consultancy Lead to Improved Outcomes?

July 1, 2019 updated by: Amrit Sinha

Does Five Session CAT (Cognitive Analytic Therapy) Consultancy Lead to Improve Outcomes for Patients and Care Coordinators?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Rotherham, United Kingdom
        • Rotherham Doncaster and South Humber NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amrit Sinha

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Health Service, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 160787

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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