- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01132976
The Personal Concerns Inventory Study (PCI) (PCI)
March 21, 2024 updated by: Nottinghamshire Healthcare NHS Trust
The Addition of a Goal-based Motivational Interview to Standardised Treatment as Usual to Reduce Dropouts From a Service for Patients With Personality Disorder: A Feasibility Study
Services for people with personality disorders are challenged by how to engage clients in therapy.
High non-completion rates have major cost-efficiency implications, but more worrying is that drop-out may be associated with negative outcomes for clients.
The investigators have developed a motivational intervention that helps people focus on their valued and attainable life goals and consider how therapy could help with goal attainment.One way to improve retention in treatment is to deliver pre-therapy motivational preparation interviews.
The primary aim of our proposed research is to gather information to determine whether a randomised controlled trial of a goal-based motivational intervention is feasible in a community personality disorder treatment service.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators aim to work with community adults with personality disorder.
Referrals to Nottinghamshire NHS Trust's community personality disorder service will be eligible for inclusion.
After initial assessment for suitability for the service, patients will be randomised to receive the motivational interview plus treatment as usual or treatment as usual only.
The investigators aim to recruit 100 participants over 1½ years.
The comparison is between a motivational intervention called the Personal Concerns Inventory plus treatment as usual and and treatment as usual only in the client preparation phase.
The feasibility measures are (1) the recruitment rate to a goal-based motivational interview plus treatment as usual or treatment as usual only, and (2) the acceptability of the intervention to clients and therapists.
The investigators will also develop measures to assess the processes by which the intervention may have an effect, and assess the cost of the intervention compared with treatment as usual.
Study Type
Interventional
Enrollment (Actual)
76
Phase
- 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
-
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Nottingham, United Kingdom, NG7 6LB
- Nottinghamshire Personality Disorder & Development Network, Mandala Centre
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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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Referred to the Nottinghamshire Personality Disorder and Development Network
- Opted to attend group sessions within the Nottinghamshire Personality Disorder and Development Network
- Aged 18 or over.
- Proficiency in spoken English
- Capacity to provide valid informed consent
Exclusion Criteria:
- Currently enrolled in another trial
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: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Goal-based motivational interview
Participants randomised to this group will receive the goal based motivational interview - Personal Concerns Inventory (PCI) in addition to treatment as usual.
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This is a pre-treatment, goal-based motivational interview which helps to patients identify their life goals, and goal-value.
The interview will last approximately 2 hours and will be carried out face to face with a therapist across one or two sessions.
|
|
Other: Treatment as usual
Participants randomly allocated to this group will receive treatment as usual only, ie no specific motivational intervention.
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No specific motivational interview
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment
Time Frame: 18 months
|
A randomised controlled trial will be considered feasible if the recruitment rate to the project is 54% of all referrals (95% CI 54-64).
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18 months
|
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Acceptability to patients
Time Frame: 18 months
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80% of clients find the intervention acceptable in terms of its practicability and usefulness (95% CI 80-91)
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18 months
|
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Acceptability to staff
Time Frame: 18 months
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80% therapists report finding the intervention helpful (95% CI 80-100)
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18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Treatment Engagement Rating Scale (TER; Drieschner & Boomsma, 2008)
Time Frame: 20 weeks after intervention
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This is a therapist rating scale with items addressing the client's participation, constructive use of sessions, opennness, efforts to change, making sacrifices, goal directedness, and reflection.
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20 weeks after intervention
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Client Service Receipt Inventory
Time Frame: 20 weeks after intervention
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Client self-report of receipt of services
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20 weeks after intervention
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Treatment attendance
Time Frame: 20 weeks after intervention
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Percentage sessions attended of sessions offered
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20 weeks after intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mary McMurran, Professor, University of Nottingham
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gibbon S, Khalifa NR, Cheung NH, Vollm BA, McCarthy L. Psychological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007668. doi: 10.1002/14651858.CD007668.pub3.
- Bakari M, Munseri P, Francis J, Aris E, Moshiro C, Siyame D, Janabi M, Ngatoluwa M, Aboud S, Lyamuya E, Sandstrom E, Mhalu F. Experiences on recruitment and retention of volunteers in the first HIV vaccine trial in Dar es Salam, Tanzania - the phase I/II HIVIS 03 trial. BMC Public Health. 2013 Dec 9;13:1149. doi: 10.1186/1471-2458-13-1149.
- McMurran M, Cox WM, Whitham D, Hedges L. The addition of a goal-based motivational interview to treatment as usual to enhance engagement and reduce dropouts in a personality disorder treatment service: results of a feasibility study for a randomized controlled trial. Trials. 2013 Feb 17;14:50. doi: 10.1186/1745-6215-14-50.
- McMurran M, Cox WM, Coupe S, Whitham D, Hedges L. The addition of a goal-based motivational interview to standardised treatment as usual to reduce dropouts in a service for patients with personality disorder: a feasibility study. Trials. 2010 Oct 14;11:98. doi: 10.1186/1745-6215-11-98.
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
December 1, 2009
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
May 26, 2010
First Submitted That Met QC Criteria
May 27, 2010
First Posted (Estimated)
May 28, 2010
Study Record Updates
Last Update Posted (Actual)
March 25, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PB-PG-1207-15046
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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