Psychological InterventionNCT03998072
Does Five Session CAT Consultancy Lead to Improved Outcomes?
A study testing Five session cognitive analytic therapy (CAT) consultancy in people with Psychological Intervention and Treatment as Usual, run by Amrit Sinha at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Psychological Intervention, Treatment as Usual
- What is being tested?
- Five session cognitive analytic therapy (CAT) consultancy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2019to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- actively psychotic
- severely misusing substances
- have poor appointment attendance
- indicating that they are actively suicidal and unwilling to commit to trying to stay safe.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Rotherham Doncaster and South Humber NHS Foundation Trust
Rotherham
Kevin Williamson, 01302798456, kevin.williamson@nhs.net
About this study
Official title: 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.
- Conditions
- Psychological Intervention, Treatment as Usual
- Being tested
- Five session cognitive analytic therapy (CAT) consultancy
- Keywords
- psychology, cognitive analytic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Five session cognitive analytic therapy (CAT) consultancyOther
Five session consultancy with patients and care coordinators using cognitive analytic therapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Five session cognitive analytic therapy (CAT) consultancy |
| Treatment as usual (waiting list control) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amrit Sinha
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Responsible party
- Sponsor-investigator, Amrit Sinha, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998072
- Sponsor's protocol ID
- 160787
- Status last verified
- Jul 2019
- First submitted
- 28 May 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Five Session CAT (Cognitive Analytic Therapy) Consultancy Lead to Improve Outcomes for Patients and Care Coordinators?
- ClinicalTrials.gov ID
- NCT03998072
- Acronym / sponsor ID
- 160787
- Conditions
- Psychological Intervention, Treatment as Usual
- Keywords
- psychology, cognitive analytic therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Amrit SinhaUniversity, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will utilise two conditions - intervention and waiting list. Participants on the waiting list will then proceed to the intervention condition.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Five session cognitive analytic therapy (CAT) consultancy |
| Treatment as usual (waiting list control) | No intervention | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- actively psychotic
- severely misusing substances
- have poor appointment attendance
- indicating that they are actively suicidal and unwilling to commit to trying to stay safe.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Five session cognitive analytic therapy (CAT) consultancyFive session consultancy with patients and care coordinators using cognitive analytic therapy | Other | Intervention |
Primary outcome
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.
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.
3 secondary outcomes
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Psychological Intervention
Recruiting
Effects of a Mindful Self-Compassion Intervention on Psychological Adjustment in Breast Cancer Survivors
Breast Cancer
Recruiting
Our Voices Matter: Intervention for Depression in Youth
Depressive Symptoms, Allostatic Load
Not yet recruiting
Hangeoreum: A Self-Paced Web-Based Program for Loneliness and Connectedness Among Korean Immigrants Aged 50 and Older
Loneliness, Korean
Not yet recruiting
Parenting Program for Young Children With Spina Bifida
Spina Bifida
Recruiting
VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
Lewy Bodies Disease, Depression Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Five session cognitive analytic therapy (CAT) consultancy in people with Psychological Intervention and Treatment as Usual, run by Amrit Sinha at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amrit Sinha (01142226650, a.sinha@sheffield.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.