The Personal Concerns Inventory Study (PCI) (PCI)
Primary Purpose
Personality Disorders
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Personal Concerns Inventory
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Personality Disorders focused on measuring Personality disorders, Personal Concerns Inventory, Non completion
Eligibility Criteria
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
Sites / Locations
- Nottinghamshire Personality Disorder & Development Network, Mandala Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Goal-based motivational interview
Treatment as usual
Arm Description
Participants randomised to this group will receive the goal based motivational interview - Personal Concerns Inventory (PCI) in addition to treatment as usual.
Participants randomly allocated to this group will receive treatment as usual only, ie no specific motivational intervention.
Outcomes
Primary Outcome Measures
Recruitment
A randomised controlled trial will be considered feasible if the recruitment rate to the project is 54% of all referrals (95% CI 54-64).
Acceptability to patients
80% of clients find the intervention acceptable in terms of its practicability and usefulness (95% CI 80-91)
Acceptability to staff
80% therapists report finding the intervention helpful (95% CI 80-100)
Secondary Outcome Measures
The Treatment Engagement Rating Scale (TER; Drieschner & Boomsma, 2008)
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.
Client Service Receipt Inventory
Client self-report of receipt of services
Treatment attendance
Percentage sessions attended of sessions offered
Full Information
NCT ID
NCT01132976
First Posted
May 26, 2010
Last Updated
September 19, 2012
Sponsor
Nottinghamshire Healthcare NHS Trust
Collaborators
University of Nottingham, Bangor University
1. Study Identification
Unique Protocol Identification Number
NCT01132976
Brief Title
The Personal Concerns Inventory Study (PCI)
Acronym
PCI
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nottinghamshire Healthcare NHS Trust
Collaborators
University of Nottingham, Bangor University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Personality Disorders
Keywords
Personality disorders, Personal Concerns Inventory, Non completion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Goal-based motivational interview
Arm Type
Active Comparator
Arm Description
Participants randomised to this group will receive the goal based motivational interview - Personal Concerns Inventory (PCI) in addition to treatment as usual.
Arm Title
Treatment as usual
Arm Type
Other
Arm Description
Participants randomly allocated to this group will receive treatment as usual only, ie no specific motivational intervention.
Intervention Type
Behavioral
Intervention Name(s)
Personal Concerns Inventory
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
No specific motivational interview
Primary Outcome Measure Information:
Title
Recruitment
Description
A randomised controlled trial will be considered feasible if the recruitment rate to the project is 54% of all referrals (95% CI 54-64).
Time Frame
18 months
Title
Acceptability to patients
Description
80% of clients find the intervention acceptable in terms of its practicability and usefulness (95% CI 80-91)
Time Frame
18 months
Title
Acceptability to staff
Description
80% therapists report finding the intervention helpful (95% CI 80-100)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
The Treatment Engagement Rating Scale (TER; Drieschner & Boomsma, 2008)
Description
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.
Time Frame
20 weeks after intervention
Title
Client Service Receipt Inventory
Description
Client self-report of receipt of services
Time Frame
20 weeks after intervention
Title
Treatment attendance
Description
Percentage sessions attended of sessions offered
Time Frame
20 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary McMurran, Professor
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nottinghamshire Personality Disorder & Development Network, Mandala Centre
City
Nottingham
ZIP/Postal Code
NG7 6LB
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
32880104
Citation
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.
Results Reference
derived
PubMed Identifier
24321091
Citation
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.
Results Reference
derived
PubMed Identifier
23414174
Citation
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.
Results Reference
derived
PubMed Identifier
20946651
Citation
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.
Results Reference
derived
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The Personal Concerns Inventory Study (PCI)
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