Personality DisordersPCINCT01132976
The Personal Concerns Inventory Study (PCI)
A study testing Personal Concerns Inventory and Treatment as usual in people with Personality Disorders, run by Nottinghamshire Healthcare NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Personality Disorders
- What is being tested?
- Personal Concerns Inventory and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2009to Jul 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently enrolled in another trial
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottinghamshire Personality Disorder & Development Network, Mandala Centre
Nottingham, NG7 6LB
About this study
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
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.
Read the 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.
- Conditions
- Personality Disorders
- Being tested
- Personal Concerns Inventory, Treatment as usual
- Keywords
- Personality disorders, Personal Concerns Inventory, Non completion
- Medical subject headings
- Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal Concerns InventoryBehavioural
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.
Treatment as usualBehavioural
No specific motivational interview
| Study group | Role | What they receive |
|---|---|---|
| Goal-based motivational interview | Active comparator | Participants randomised to this group will receive the goal based motivational interview - Personal Concerns Inventory (PCI) in addition to treatment as usual. Receives: Behavioral: Personal Concerns Inventory |
| Treatment as usual | Other | Participants randomly allocated to this group will receive treatment as usual only, ie no specific motivational intervention. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 18 months
Acceptability to patients
80% of clients find the intervention acceptable in terms of its practicability and usefulness (95% CI 80-91)
Measured: 18 months
Acceptability to staff
80% therapists report finding the intervention helpful (95% CI 80-100)
Measured: 18 months
Secondary outcomes (3)
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.
Measured: 20 weeks after intervention
Client Service Receipt Inventory
Client self-report of receipt of services
Measured: 20 weeks after intervention
Treatment attendance
Percentage sessions attended of sessions offered
Measured: 20 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startDec 2009
- Primary completionMar 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Personality DisordersStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottinghamshire Healthcare NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Nottingham, Bangor University
- Responsible party
- Sponsor
- Investigators
- Mary McMurran, Professor, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132976
- Sponsor's protocol ID
- PB-PG-1207-15046
- Acronym
- PCI
- Status last verified
- Mar 2024
- First submitted
- 26 May 2010
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 32880104Bakari 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.
PubMed 24321091McMurran 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.
PubMed 23414174McMurran 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.
PubMed 20946651
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01132976
- Acronym / sponsor ID
- PCI / PB-PG-1207-15046
- Conditions
- Personality Disorders
- Keywords
- Personality disorders, Personal Concerns Inventory, Non completion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Nottinghamshire Healthcare NHS TrustOther government
- Collaborators
- University of Nottingham, Bangor University
- Study start
- Dec 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 28 May 2010 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal-based motivational interview | Active comparator | Behavioral: Personal Concerns InventoryParticipants randomised to this group will receive the goal based motivational interview - Personal Concerns Inventory (PCI) in addition to treatment as usual. |
| Treatment as usual | Other | Behavioral: Treatment as usualParticipants randomly allocated to this group will receive treatment as usual only, ie no specific motivational intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Currently enrolled in another trial
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 |
|---|---|---|
| Personal Concerns InventoryThis 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. | Behavioural | Goal-based motivational interview |
| Treatment as usualNo specific motivational interview | Behavioural | Treatment as usual |
Primary outcome
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).
Acceptability to patients
Time frame: 18 months
80% of clients find the intervention acceptable in terms of its practicability and usefulness (95% CI 80-91)
Acceptability to staff
Time frame: 18 months
80% therapists report finding the intervention helpful (95% CI 80-100)
3 secondary outcomes
The Treatment Engagement Rating Scale (TER; Drieschner & Boomsma, 2008)
Time frame: 20 weeks after intervention
Client Service Receipt Inventory
Time frame: 20 weeks after intervention
Treatment attendance
Time frame: 20 weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Derived from this study: PubMed 32880104Gibbon 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.
- Derived from this study: PubMed 24321091Bakari 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.
- Derived from this study: PubMed 23414174McMurran 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.
- Derived from this study: PubMed 20946651McMurran 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.
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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.
Mary McMurran, Professor principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal Concerns Inventory and Treatment as usual in people with Personality Disorders, run by Nottinghamshire Healthcare NHS Trust 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 25 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01132976, which also lists 4 linked publications.
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 25 Mar 2024.