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The Personal Concerns Inventory Study (PCI)

This study has been completed.
Sponsor:
Collaborators:
University of Nottingham
Bangor University
Information provided by (Responsible Party):
Professor Mary McMurran, University of Nottingham
ClinicalTrials.gov Identifier:
NCT01132976
First received: May 26, 2010
Last updated: September 19, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Personality Disorders
Behavioral: Personal Concerns Inventory
Behavioral: Treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Nottinghamshire Healthcare NHS Trust:

Primary Outcome Measures:
  • Recruitment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    80% therapists report finding the intervention helpful (95% CI 80-100)


Secondary Outcome Measures:
  • The Treatment Engagement Rating Scale (TER; Drieschner & Boomsma, 2008) [ Time Frame: 20 weeks after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 20 weeks after intervention ] [ Designated as safety issue: No ]
    Client self-report of receipt of services

  • Treatment attendance [ Time Frame: 20 weeks after intervention ] [ Designated as safety issue: No ]
    Percentage sessions attended of sessions offered


Enrollment: 76
Study Start Date: December 2009
Study Completion Date: July 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Personal Concerns Inventory
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 usual
Participants randomly allocated to this group will receive treatment as usual only, ie no specific motivational intervention.
Behavioral: Treatment as usual
No specific motivational interview

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132976

Locations
United Kingdom
Nottinghamshire Personality Disorder & Development Network, Mandala Centre
Nottingham, United Kingdom, NG7 6LB
Sponsors and Collaborators
Nottinghamshire Healthcare NHS Trust
University of Nottingham
Bangor University
Investigators
Principal Investigator: Mary McMurran, Professor University of Nottingham
  More Information

No publications provided by Nottinghamshire Healthcare NHS Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Mary McMurran, Professor, University of Nottingham
ClinicalTrials.gov Identifier: NCT01132976     History of Changes
Other Study ID Numbers: PB-PG-1207-15046
Study First Received: May 26, 2010
Last Updated: September 19, 2012
Health Authority: United Kingdom: National Institute for Health Research

Keywords provided by Nottinghamshire Healthcare NHS Trust:
Personality disorders
Personal Concerns Inventory
Non completion

Additional relevant MeSH terms:
Disease
Personality Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014