The Oxford Science Meeting and a way forward for TC research Design and conception of the Therapeuti

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The Oxford Science Meeting and a way forward for
TC research Design and conception of the
Therapeutic Community Intervention Trial

• Dr Steve Pearce
• Oxford Complex Needs Service
• UK

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Contributors

• Nick Benefield
• Eric Broekaert
• Mike Crawford
• Mark Freestone
• George de Leon
• John Gale
• Rex Haigh
• Kath Harney
• Vanessa Jones

• Eddie Kane
• Vasilli Maglios
• Steve Pearce
• Beatriz Sanchez
• Steve Sizmur
• Peter Tyrer
• Fiona Warren
• Min Yang
• Jenny Yeind

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Purpose

• Is it possible to design and carry out an RCT of
  TC treatment at this point?
• Is this desirable?
• Why has it not been done to date?
• What are the pitfalls and considerations to doing
  so?

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(No Transcript)
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Definitions of Therapeutic Community

• Addiction TC
• a concept TC is a drug free environment in which
  people with addictive (and other) problems live
  together in an organised and structured way in
  order to promote change and make possible a drug
  free life in the outside society (Broekaert
  2006)

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Definitions of Therapeutic Community

• British Model TC
• a consciously designed social environment and
  programme within a residential or day unit in
  which the social an group process is harnessed
  with therapeutic intent. In the therapeutic
  community the community is the primary
  therapeutic instrument (Roberts 1997, 4)

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Definitions of Therapeutic Community

• Combined definition
• A TC is a consciously designed drug free social
  environment in which people with various
  emotional problems live together in an organised
  and structured way. The social and group
  processes of the community are the method itself,
  and through them, change and recovery are
  promoted. In this way, a new life in outside
  society is made possible

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Why has an RCT not been carried out to date?

• Insufficient preparatory work to define the
  nature of the intervention, including necessary
  components
• Uncertainty over necessity of RCT
• Practitioner community conviction/ethical
  concerns
• Complexities around clients selecting each other
• Concern over the effect of randomisation on the
  culture and treatment programme

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Conceptual objections

• Is an RCT necessary in view of TC praxis
  comprising Evidence based treatment (i.e.
  treatment utilising evidence based principles)
• We have no evidence from an RCT as to the
  effectiveness of University or of the good
  family do we really need RCT evidence as to
  the effectiveness of the TC?

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Hierarchy of evidence

• Type I evidence at least one good systematic
  review, including at least one randomized
  controlled trial
• Type II evidence at least one good randomised
  controlled trial
• Type III evidence at least one well designed
  intervention study without randomisation
• Type IV evidence at least one well designed
  observational study
• Type V evidence expert opinion, including the
  opinion of service users and carers

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Difficulties in implementing an RCT of TC
treatment

• TC culture affected by the RCT
• Forensic settings provide particular challenges
  to randomisation
• Day settings possibly easier

• Generalisability
• Day/residential
• Medication/none
• Addiction/PD/other
• Secure/non
• High attrition rates
• from treatment
• from research

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Difficulties in implementing an RCT of TC
treatment

• Ensuring treatment fidelity
• Community of communities accreditation?
• How to measure effect of RCT on the culture?
• Qualitative methods
• Ethical problems
• Is it OK to randomise when such harm can be done?
• Maintaining equipoise among the researchers if
  they are TC practitioners
• Dismantling studies or black box?

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Difficulties in implementing an RCT of TC
treatment

• What is a reasonable and credible control
  condition?
• Not too active, minimal TC elements, but still
  attractive
• Self-selection factor
• Once committed to the idea of joining a TC, why
  would subjects agree to be randomised?
• Credible TAU

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General RCT problems

• Selection of outcome instruments
• Need medium term outcome
• So not a waiting list control
• Need large n (most PD TCs are small)
• Need more than one RCT from more than one centre

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Other practical difficulties

• Can TCs afford to lose (ie not treat) 50 of
  their referrals?
• In TCs that include democratic selection, how
  would this affect a trial?
• Need robust follow-up to maintain gains

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The feasibility of conductingan RCT at HMP
Grendon 2003

• Possible
• Prison service support
• Numbers applying
• Disruption to culture
• Dropout rate up to 33
• part of therapy
• http//www.homeoffice.gov.uk/rds/pdfs2/rdsolr0303.
  pdf

• Advantages to service
• Roadshows
• Early randomisation at application
• Maximise n

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Current research phase of the various types of TC
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Studies of TCs to date

• NHS Centre for Reviews and Dissemination -
  Systematic Literature Review meta-analysis,
  Lees, J, Manning, N, Rawlings, B, 1999
• Post-treatment and in-treatment outcome of
  therapeutic community treatment in secure or
  non-secure democratic therapeutic community
  settings for people with personality disorders or
  mentally disordered offenders
• Included addictions TCs
• Carried out a Meta Analysis with an overall
  summary log odds ratio is -0.567 95 confidence
  interval -0.524 to -0.614 indicates a strong
  positive effect for TC treatment.
• 29 studies 8 RCTs, of which 4 addictions (secure
  and non-secure), 2 non-secure democratic, 2
  secure democratic
• http//www.therapeuticcommunities.org/briefingpape
  r.htm
• http//www.york.ac.uk/inst/crd/pdf/crdreport17.pdf
  

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UK National Lottery board research 1999-2003

• ATC sponsored
• A comparative evaluation of therapeutic
  community effectiveness for people with
  personality disorders
• Started with 313 people (60 TCs).
• Data quality poor.
• By 9 months down to 15 of original numbers.
• Much better response where TC had in-house
  researcher.

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Economic evaluations

• Dolan 1996, Henderson, n29
• Davies 1999, FDL, n56
• Chiesa 1996, Cassel, n26
• Other evaluations
• Chiesa 2006, geographical randomisation,
  comparison to N Devon TAU group, n111

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Problems of not implementing an RCT of TC
treatment

• Alternative treatment approaches produce higher
  quality evidence
• Uncertainty over effectiveness persists
• NNT
• Selection bias
• ?Future (NHS) funding at risk

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National Institute for Health and Clinical
Excellence (NICE)

• None of TC research had significant influence on
  outcomes for BPD or ASPD guidelines (2008 draft)
• Drug misuse (2007)
• psychosocial residential treatment should
  normally include contingency management,
  behavioural couples therapy and cognitive
  behavioural therapy. Services should encourage
  and facilitate participation in self-help groups.
  
• People in prison who have significant drug
  misuse problems may be considered for a
  therapeutic community developed for the specific
  purpose of treating drug misuse within the prison
  environment.
• http//www.nice.org.uk/Guidance/CG51/NiceGuidance/
  pdf/English

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Consensus statement

• RCTs of therapeutic communities are an essential
  aspect of the enquiry with policy makers,
  funders and clinicians for proper development
  of treatment programmes for PD, addictions and
  psychosis.
• Other approaches are required to explore the
  active ingredients.
• Different research designs could be equally valid
  at this stage of development of the field
• Econometric research
• Service user research
• Qualitative research
• Action research

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An exploratory randomised trial of a
day-therapeutic community intervention for
people with PDTaCIT

• Steve Pearce Mike Crawford
• Oxfordshire Complex Needs Service Imperial
  College London
• Thames Valley Initiative

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Residential and community based TCs

• Take on less than 30 of those who are referred
  (Rutter Tyrer, 2003)
• Costs are substantial
• Step-down model as or more effective than
  residential alone (Chiesa Fonagy, 2000)
• Concerns about quality of service provision in
  England (NIMHE, 2002)
• Eleven new dedicated community-based PD services

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Managed clinical network Day TC in
Cumbria in Leeds Day care and outreach in
Cambridge Peterborough
Coventry Specialist teams and user
support workers Day TC and support
Expansion of network in voluntary
sector Nottinghamshire support services
in Essex Thames Valley -
Expansion of day TC
DDART OP DBT for psychotherapy
people with dual diagnosis
Primary care workers
central London Youth workers providing
SUN (Service user network) Early
intervention in Plymouth in South
West London
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Managed clinical network Day TC in
Cumbria in Leeds Day care and outreach in
Cambridge Peterborough
Coventry Specialist teams and user
support workers Day TC and support
Expansion of network in voluntary
sector Nottinghamshire support services
in Essex Thames Valley -
Expansion of day TC DDART OP DBT
for psychotherapy people with dual
diagnosis
Primary care workers central
London Youth workers providing SUN
(Service user network) early intervention in
Plymouth in South West London
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Qualitative findings

• Hardest to use (role of staff, use of medication)
• you know, we need some kind of response and, if
  it was made clear initially that those responses
  dont exist, it would be easier to deal with. But
  it is not and it is so frustrating. (FGSU29)
• I am just not happy about the medication thing
  I mean, I am living alone. I cant not have
  meds What if I start getting aggressive,
  drinking, all sorts of things that some of the
  medication might just dampen down and I have got
  to go home on my own. (SU49)
• Greatest benefits
• I did feel quite low on Monday and then left
  quite cheerful because the one thing that I am
  feeling is a belonging with some of the others.
  (SU49)
• I know it sounds strange, but we are like one
  big family, like when were all together
  everybody helps everybody else. (SU5)

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Service developments

• Community rather than residential
• Less intensive rather than more intensive
• Needs based rather than buildings-based
• Evidence-based DBT CBT CAT MBT
• All the same..
• DIY Bateman and Fonagy

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Aims

• To examine whether treatment in a therapeutic
  community among people with personality disorder
  leads to reductions in the use of other
  healthcare resources
• To determine whether treatment in a therapeutic
  community among people with personality disorder
  leads to improved mental health, increased social
  functioning and improved quality of life

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Methods

• Design Two-arm, parallel, randomised controlled
  trial
• Population people aged 16 to 65 who are
  registered with a GP and have a personality
  disorder (assessed by SCID-II).
• Recruitment From people in contact with mental
  health services and living in Oxfordshire.
• Exclusion criteria
• i) A primary diagnosis of a psychotic disorder,
  alcohol or drug dependence
• ii) A degree of learning disability, or
  intellectual impairment which prevents use of DTC
  services
• iii) Unwilling or unable to provide written
  informed consent to participate in the trial.

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Active treatment

• Active treatment Day-DTC
  Groups provided by
  Oxfordshire service
• - weekly options group and individual sessions
• visitors slot at the TC
• - 4.5 day TC (for up to18 months) or 1.5 day TC
  creative
  group, psychodrama, small groups, objectives
  groups and large groups. Cooking, shopping,
  eating, working and playing together PLUS out of
  hours telephone support
• access to weekly peer support group
• 6 months post therapy support

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Interventions and follow-up

• Control group Treatment as usual (TAU)
  
• Crisis plan (SUN) and follow-up
  review
• Follow-up interviews at
  6 and 12 and 24 months and 5 years

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Randomisation

• Independent telephone randomisation.
• Randomisation ratio of 11 with a minimisation
  scheme in order to balance potential confounding
  variables (age, sex and baseline service
  utilisation) across intervention groups.

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Outcome measures

• As used in an ongoing cohort study among 5 day
  TCs
• Primary outcome healthcare utilisation
  (inpatient, outpatient, AE)
• Health GHQ-12
• Social function SFQ-12
• Self harm modified Davidson measure (2000)
• Quality of Life EQ-5HD
• Medication use, aggression, CSQ, use of benefits

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Sample size

• Previous studies have shown that patients
  treated in DTCs have a mean number of 45 (SD
  71) days of inpatient psychiatric treatment in
  the year prior to referral and 12 (SD 22) days
  in the year following referral. A sample of 76
  patients (38 DTC and 38 TAU) would be required to
  have 80 power and 5 level of statistical
  significance to demonstrate a reduction in the
  mean number of inpatient days of this magnitude.
• As our primary outcome is based on examination
  of routine records we estimate that the
  proportion lost to follow-up will be small (10).
  
• We aim to randomise 85 participants over the
  course of 24 months.
• Davies S, Campling P. (2003) Therapeutic
  community treatment of personality disorder.
  Br.J.Psych. 44, S24-S27.

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Data analysis

• All primary statistical analysis will use the
  intention-to-treat principle.
• Cost and cost-effectiveness analyses will be
  undertaken. The number of patients dropping out
  before the assessments at 12 months will be
  compared between the arms of the trial, and
  sensitivity analyses undertaken to consider their
  potential effect on the overall results of the
  trial.

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How have we addressed the problems?
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end

• steve.pearce_at_obmh.nhs.uk