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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01132976
Other study ID # PB-PG-1207-15046
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2009
Est. completion date July 2012

Study information

Verified date March 2024
Source Nottinghamshire Healthcare NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date July 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
No specific motivational interview

Locations

Country Name City State
United Kingdom Nottinghamshire Personality Disorder & Development Network, Mandala Centre Nottingham

Sponsors (3)

Lead Sponsor Collaborator
Nottinghamshire Healthcare NHS Trust Bangor University, University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 18 months
Primary Acceptability to patients 80% of clients find the intervention acceptable in terms of its practicability and usefulness (95% CI 80-91) 18 months
Primary Acceptability to staff 80% therapists report finding the intervention helpful (95% CI 80-100) 18 months
Secondary 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. 20 weeks after intervention
Secondary Client Service Receipt Inventory Client self-report of receipt of services 20 weeks after intervention
Secondary Treatment attendance Percentage sessions attended of sessions offered 20 weeks after intervention
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