NCT03998072

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2019

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 25, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

11 months

First QC Date

May 28, 2019

Last Update Submit

July 1, 2019

Conditions

Keywords

psychologycognitive analytic therapy

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (3)

  • Clinical Outcomes in Routine Evaluation (CORE-10)

    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)

    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)

    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)

Study Arms (2)

Intervention

EXPERIMENTAL
Other: Five session cognitive analytic therapy (CAT) consultancy

Treatment as usual (waiting list control)

NO INTERVENTION

Interventions

Five session consultancy with patients and care coordinators using cognitive analytic therapy

Intervention

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • actively psychotic
  • severely misusing substances
  • have poor appointment attendance
  • indicating that they are actively suicidal and unwilling to commit to trying to stay safe.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rotherham Doncaster and South Humber NHS Foundation Trust

Rotherham, United Kingdom

Location

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: The study will utilise two conditions - intervention and waiting list. Participants on the waiting list will then proceed to the intervention condition.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Support Officer

Study Record Dates

First Submitted

May 28, 2019

First Posted

June 25, 2019

Study Start

September 1, 2019

Primary Completion

August 1, 2020

Study Completion

September 1, 2020

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations