Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000251628
Ethics application status
Not yet submitted
Date submitted
20/02/2014
Date registered
10/03/2014
Date last updated
10/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Remediation Therapy (CRT): is it a feasible and acceptable psychological treatment for borderline personality disorder (BPD)?
Scientific title
In consumers with Borderline Personality Disorder, does Cognitive Remediation Therapy (CRT) improve cognitive and social functioning?
Secondary ID [1] 284095 0
Nil Known
Universal Trial Number (UTN)
U1111-1153-3107
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder 291168 0
Condition category
Condition code
Public Health 291502 291502 0 0
Health service research
Mental Health 291592 291592 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Remediation Therapy (CRT) is a psychological treatment which aims to improve cognitive functioning and has shown to be effective in reducing cognitive dysfunction and improving social function mainly in people with a diagnosis of schizophrenia (McGurk et al, 2007). It is distinct from Cognitive Behavioural Therapy in targeting cognitive skills (e.g. working memory, long-term memory, cognitive flexibility, planning, organisational ability) rather than thoughts, beliefs, or affect.

Reeder and colleagues (2012) have designed and completed initial feasibility testing for a computerised CRT package for Schizophrenia: CIRCuiTS (Computerised Interactive Remediation of Cognition – Training for Schizophrenia). This is a modular package including tasks of a wide range of cognitive functions (particularly executive function and memory), designed to allow therapy programmes to be flexibly designed to incorporate only relevant tasks.

With the latter taken into consideration a new CIRCuiTS program will be developed to only include excercises known to target the cognitive deficits identified in consumers with BPD. The aim of the new CIRCuits program seeks to target the specific cognitive deficits found in consumers with BPD (from phase 1) to improve attention, memory, and planning.

The new (CRT) CIRCuiTS program will be piloted to 30 consumers to assess the acceptability and feasibility. Participation involves taking part in a group run CIRCuiTS program delivered by a trained advanced CRT practitioner. The program involves 45 minutes working on a computer program that focuses on cognitive skills and 15 minutes discussing how these computer programs relate to thinking skills needed in day to day life. Participants will be required to attend twice a week for around 20 weeks.
Intervention code [1] 288788 0
Treatment: Other
Comparator / control treatment
There is no control group within this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291476 0
1.To identify cognitive targets for intervention with CRT (a psychological therapy which aims to improve cognitive skills such as problem-solving and memory), by investigating associations between cognitive functions known to be frequently impaired in BPD and social functioning, symptoms and costs of care. Participants will complete a pre-treatment battery of questionnaires that assess mental health diagnosis and symptoms, participants’ ability to reason, solve problems and remember items, assess perceptions about the way they think and solve problems, and participants' perceptions about their social functioning, and the costs of care associated living with a mental illness.

The measures used to assess this outcome include:
1) Premorbid IQ: Test of Premorbid Functioning
2) Executive function : Computerised neurocognitive tests from the Cambridge Neuropsychological Test Automated Battery (CANTAB).
3) Social function: Work and Social Adjustment Scale (Mundt et al, 2002); Global Assessment of Functioning (Endicott et al, 1976. Symptoms: BPD Severity Index (Arntz et al, 2003); Brief Symptom Inventory (Derogatis, 2001); The Depression Anxiety and Stress Scale- 21 Item (Lovibond & Lovibond, 1995); Impact of Events Scale – Revised (Weiss and Marmar, 1996); Barratt Impulsiveness Scale (Patton et al, 1996)
4) Costs of care: Client Service Receipt Inventory (Beecham and Knapp, 1992)
Timepoint [1] 291476 0
3 months Pre-treatment.
Primary outcome [2] 291477 0
2. To investigate self-perception of cognitive performance in people with BPD and the perceived relevance and importance of a psychological treatment which aims to improve cognitive skills.

This outcome is assess as part of the pre-treatment battery of questionnaires and includes the use of:
1)The Self-perception of cognitive function: Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS) (Stip et al, 2003) and,
2) A qualitative interview exploring participant's perceptions of the perceived relevance and importance of the CRT program.

Timepoint [2] 291477 0
3 Months Pre-treatment.
Secondary outcome [1] 306858 0
3. To adapt CIRCuiTS for people with BPD based on findings from Phase 1.

This outcome will be assessed utilising SPSS statistical software to determine the frequency and severity of cognitive deficits identified in consumers with BPD. The CIRCuiTS program will be be adapted to specifically target the cognitive deficits identified from the findings.
Timepoint [1] 306858 0
1 Month Pre-Treatment
Secondary outcome [2] 307010 0
4. To pilot a new computerised CRT programme (CIRCuiTS), specifically adapted for BPD with nine individual cases, to assess (a) acceptability and (b) feasibility.

The outcome will be assessed on and case by case basis using qualitative information from participant feedback and conducted interviews. Paired samples t-tests will be utilised to compare pre-treatment and post-treatment data to establish whether the CIRCuits program is a feasible and effective treatment for improving cognitive skills in BPD consumers.
Timepoint [2] 307010 0
3 months post preliminary assessment/screening (treatment) and 1 month post completion of the 20 week intervention (post-treatment follow-up).

Eligibility
Key inclusion criteria
Patients aged 18-65, who are attending/being treated by Metro South Addiction and Mental Health Services. Inclusion criterion requires a confirmed diagnosis of BPD according to the McLean Screening Instrument for BPD (Zanarini et al, 2003).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criterion includes evidence of an organic brain disorder, or head injury.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited from the Mood ACU of Addiction and Mental Health Services at Metro South, Queensland Health. Potential participants will be identified by treating teams within this service, and advised of the study. The treating teams will be requested to arrange a convenient time for the participant to meet with the Associate Investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The design of the proposed research is a mixed-method within-subjects repeated measures design.

Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using SPSS v19 statistical package. Variables will be examined to determine the normality of distributions, missing information, and outliers.

1. Pearson’s correlations and linear regression will be used to investigate the extent to which cognitive functioning can be used to predict a) social functioning, b) symptoms, and c) costs of care. Cognitive variables with high correlations will be incorporated into the CIRCuiTS for people with BPD.

2. Paired samples t-tests will be utilised to compare data collected pre-treatment/ post-treatment to establish whether the CIRCuits program is a feasible and effective treatment for improving cognitive skills in BPD consumers.



Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2014
Actual
Date of last participant enrolment
Anticipated
6/06/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2092 0
Princess Alexandra Hospital - Woolloongabba

Funding & Sponsors
Funding source category [1] 288726 0
Self funded/Unfunded
Name [1] 288726 0
Country [1] 288726 0
Primary sponsor type
Government body
Name
Queensland Health
Address
Metro South Addiction and Mental Health Services
519 Kessel Rd, MacGregor QLD, 4109
Country
Australia
Secondary sponsor category [1] 287426 0
None
Name [1] 287426 0
Address [1] 287426 0
Country [1] 287426 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290564 0
Metro South Health Service District Human Research Committee (EC00167)
Ethics committee address [1] 290564 0
Centres for Health Research, level 7
Translational Research Institute Building
Princess Alexandra Hospital
Ipswich Road, Woolloongabba, Qld 4102
Ethics committee country [1] 290564 0
Australia
Date submitted for ethics approval [1] 290564 0
13/03/2014
Approval date [1] 290564 0
Ethics approval number [1] 290564 0

Summary
Brief summary
Aims: The proposed research aims to (i) identify cognitive targets for intervention with Cognitive Remediation Therapy (CRT) in people with Borderline Personality Disorder (BPD), and (ii) to investigate self-perceptions of cognitive performance, and the perceived relevance and importance of a psychological treatment that aims to improve cognitive skills. In addition, the proposed research aims to (iii) adapt CIRCuiTS for people with BPD based on the established cognitive targets and (iv) to pilot the new CRT (CIRCuiTS) program to assess the acceptability, and feasibility.

Method: The design of the proposed research is a within groups study. Participants will be 30 BPD patients aged 18-65, who are attending/being treated by Metro South Addiction and Mental Health Services. Inclusion criterion requires a confirmed diagnosis of BPD according to the McLean Screening Instrument for BPD (Zanarini et al, 2003). Exclusion criterion includes evidence of an organic brain disorder, or head injury. All participants will be give an information letter, and written informed consent to take part. If participants do not have the capacity to consent but wish to participate, their guardian will be asked to consent to the patients participation in the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46258 0
Dr Frances Dark
Address 46258 0
Metro South Addiction and Mental Health Services
519 Kessel Rd, MacGregor QLD, 4109
Country 46258 0
Australia
Phone 46258 0
+61731678430
Fax 46258 0
Email 46258 0
[email protected]
Contact person for public queries
Name 46259 0
Dr Frances Dark
Address 46259 0
Metro South Addiction and Mental Health Services
519 Kessel Rd, MacGregor QLD, 4109
Country 46259 0
Australia
Phone 46259 0
+61731678430
Fax 46259 0
Email 46259 0
[email protected]
Contact person for scientific queries
Name 46260 0
Dr Frances Dark
Address 46260 0
Metro South Addiction and Mental Health Services
519 Kessel Rd, MacGregor QLD, 4109
Country 46260 0
Australia
Phone 46260 0
+61731678430
Fax 46260 0
Email 46260 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.