Treatment of psychosis and Treatment of psychosis and substance misusesubstance misuse:development :development of the of the trialtrial

Christine BarrowcloughSchool of Psychological SciencesUniversity of Manchester, UK

christine.barrowclough@manchester.ac.uk

2004 -20092004 -2009

MMotivationalotivational

IInterventionntervention

forfor DDrug rug

and and AAlcohol lcohol useuse

in in SSchizophreniachizophrenia

Medical Research Council/Department of Health funded

University of ManchesterUniversity of London

Local NHS trusts

Content of PresentationContent of Presentation

•Briefly review background and treatment literature

•Describe Manchester study

•Describe development of treatment model

•Outline MIDAS trial

AcknowledgementsAcknowledgementsMIDAS grant holders: Christine BarrowcloughGillian Haddock Nick TarrierTil Wykes Jan Moring Graham Dunn Linda Davies Tom Craig John Strang

Collaborators Patricia ConradIan Lowens

MIIDAS TherapistsRory AllotRichard CravenPaul EarnshawSarah NothardMike Fitzsimmons

MIIDAS Research teamRuth JohnsonGwen Alvey

Sarah Jones Charlotte HartleyLaura Foster Anna RuddleKaren OwensAlicia Picken

Substance use in psychosisSubstance use in psychosis Prevalence : 30 - 60% past -year problem drug or harmful alcohol use in UK/US samples

Correlates:Adverse impact on social functioning, mental health, treatment outcomes

Clinical implications:Patient group presenting many challenges to clinical teams

Treatment approaches & evaluation Treatment approaches & evaluation 1. Service evaluation research1. Service evaluation research

IntegratingIntegrating mental health and substance mental health and substance use treatment delivered concurrentlyuse treatment delivered concurrently

Focus on models of delivery of multiple Focus on models of delivery of multiple

treatments in a specialist servicetreatments in a specialist service

Ingredients usually include: Ingredients usually include: motivational motivational interventions, assertive outreach, case interventions, assertive outreach, case management, group/individual therapymanagement, group/individual therapy

Mainly US studies but promising examples Mainly US studies but promising examples in UK eg COMPASS in UK eg COMPASS

Treatment approaches & evaluation Treatment approaches & evaluation 1. Service evaluation research cont’d1. Service evaluation research cont’d

Evaluation methodologically difficult: no Evaluation methodologically difficult: no evidence evidence that any treatment programme is that any treatment programme is better than treatment as usual (reviews better than treatment as usual (reviews Drake et al 1998, Cochrane review)Drake et al 1998, Cochrane review)

KEY ISSUES HIGHLIGHTED:KEY ISSUES HIGHLIGHTED:

Emphasise importance of Emphasise importance of INTEGRATION INTEGRATION of of mental health & substance use treatmentsmental health & substance use treatments

And highlighted need for interventions to And highlighted need for interventions to MATCH STAGE OF CHANGEMATCH STAGE OF CHANGE

Relapse

Thinking about change

(Contemplation)

Getting ready for change

(Determination)

Change

(Action)

Maintenance

Not thinking about it(Pre-contemplation)

STAGES OF CHANGE (Prochaska & DiClimente)

Motivational Interviewing Motivational Interviewing (Miller & Rollnick 2002)(Miller & Rollnick 2002)

non judgemental, quiet, reflective, eliciting stylenon judgemental, quiet, reflective, eliciting style

ambivalence is a normal central phenomenon.ambivalence is a normal central phenomenon.

it is important to understand the costs and it is important to understand the costs and benefits - assume they are unique to each benefits - assume they are unique to each individual.individual.

the working through of ambivalence is a central the working through of ambivalence is a central goal of Motivational Interviewinggoal of Motivational Interviewing

Treatment approaches & evaluation: Treatment approaches & evaluation: 2. Specific treatments :Brief interventions2. Specific treatments :Brief interventions

Focus on delivering a specific treatment package Focus on delivering a specific treatment package as an addition to existing service - easier to as an addition to existing service - easier to evaluateevaluate

Treatments evaluated - brief Motivational Treatments evaluated - brief Motivational Interviewing / MI and Cognitive Behaviour Interviewing / MI and Cognitive Behaviour Therapy Therapy

Treatment approaches & evaluation: Treatment approaches & evaluation: 2. Specific treatments :Brief 2. Specific treatments :Brief

motivational/MI plus CBT interventionsmotivational/MI plus CBT interventions

Kavanagh et al 2002 n = 25 psychosis inpatients - Kavanagh et al 2002 n = 25 psychosis inpatients - MI significant reduction substancesMI significant reduction substances

But Kavenagh et al 2004 n = 86 MI/CBT 6 sessions But Kavenagh et al 2004 n = 86 MI/CBT 6 sessions - No impact on substances or symptoms- No impact on substances or symptoms

Baker et al, 2002 n = 160 psychiatric inpatients - Baker et al, 2002 n = 160 psychiatric inpatients - One session of MI - Little impactOne session of MI - Little impact

Baker et al (in press) N = 130 community Baker et al (in press) N = 130 community psychosis sample 10 sessions MI plus CBT- No psychosis sample 10 sessions MI plus CBT- No impact substances or symptomsimpact substances or symptoms

Manchester studyManchester studyBarrowclough et al, 2001, Haddock et al, 2004Barrowclough et al, 2001, Haddock et al, 2004

Will an intensive combined individual (MI Will an intensive combined individual (MI plus CBT) and family treatment plus CBT) and family treatment delivered over 9 months be efficacious delivered over 9 months be efficacious for dually diagnosed schizophrenia for dually diagnosed schizophrenia patients?patients?

Target sampleTarget sample

People with diagnosis of schizophrenia in touch People with diagnosis of schizophrenia in touch with mental health serviceswith mental health services

Diagnosis of DSM IV substance misuse or Diagnosis of DSM IV substance misuse or dependencedependence

At least 10 hours contact with family or significant At least 10 hours contact with family or significant carercarer

Random allocation N= 36

Integrated treatment9 months

Treatment asusual

TreatmentTreatment

Treatment consisted ofTreatment consisted of : :- Motivational interviewing (first 5 sessions and then - Motivational interviewing (first 5 sessions and then

integrated)integrated)- Individual CBT (20-24 sessions)- Individual CBT (20-24 sessions)- Family CBT (Between 10-16 sessions)- Family CBT (Between 10-16 sessions)- All delivered over 9 months- All delivered over 9 months

Context:Context:- Mental health service treatment as usual- Mental health service treatment as usual

- Family support worker- Family support worker

General functioningGeneral functioningGlobal assessment functioning (GAF) Global assessment functioning (GAF)

at 0, 9, 12 and 18m (p = 0.001)at 0, 9, 12 and 18m (p = 0.001)

46

48

50

52

54

56

58

60

62

0m 9m 12m 18m

CBT N=15

Control N=14

Positive psychotic symptomsPositive psychotic symptomsMean PANSS positive score at 0, 9, 12 Mean PANSS positive score at 0, 9, 12

and 18m (ns) and 18m (ns)

12

13

14

15

16

17

18

0m 9m 12m 18m

CBT N=15

Control N=14

Negative symptomsNegative symptomsMean PANSS negative score at 0, 9, Mean PANSS negative score at 0, 9,

12 & 18 (p = 0.028)12 & 18 (p = 0.028)

10

11

12

13

14

15

16

17

0m 9m 12m 18m

CBT N=15

Control N=14

Relapses*Relapses*(No. of people relapsed by group(No. of people relapsed by group))

9 months

12 months

18 months

CBT 5 6 7

Control 11 12 12

Relapse = symptom exacerbation lasting > 2 weeks

resulting in either hospitalisation or change in management eg increase medication

Results: drugs and alcohol Results: drugs and alcohol (Time line follow back scores)(Time line follow back scores)

The experimental group had more % days The experimental group had more % days abstinent from all substances over first 12 abstinent from all substances over first 12 months months (p =0.03)(p =0.03)

No differences in abstinence rates overall No differences in abstinence rates overall between the groups at 18 monthsbetween the groups at 18 months

*19 drug(s) + alcohol 11 alcohol only 6 drug(s) only

*Drug use: Cannabis (n = 22); Amphetamines (n = 10); Cocaine (n = 4); heroin (n = 4)

Health economy outcomesHealth economy outcomes

No significant cost differences between No significant cost differences between experimental and control groups even when dose experimental and control groups even when dose of therapy accounted forof therapy accounted for

Controls had more inpatient daysControls had more inpatient days Experimentals used more outpatient resourcesExperimentals used more outpatient resources Support for ‘cost-effectiveness’ Support for ‘cost-effectiveness’ (i.e. cost small for significant (i.e. cost small for significant

gains)gains)

ConclusionsConclusions

Positive: Positive: Intensive sustained treatment produced Intensive sustained treatment produced

encouraging outcomes from a encouraging outcomes from a methodologically rigorous trial methodologically rigorous trial

Low attrition in a group defined by Low attrition in a group defined by noncompliance (3 deaths; 1 drop out from noncompliance (3 deaths; 1 drop out from TAU)TAU)

Limitations:Limitations: Small sample / low powerSmall sample / low power Family status restricted sampleFamily status restricted sample Moderate impact on substance misuseModerate impact on substance misuse

Stages of ChangeStages of Change

Relapse

Maintenance

Action

Determination

Contemplation

Pre-contemplation

patients with low motivation* to change at start of study:

• 78% (n = 36) (Barrowclough et al, 2001)

•70- 49% (n = 106) (lower motivation, less use) (Baker et al, 2002)

*precontemplative/contemplative

Many psychosis patients are unmotivated to change their substance use

Problems for the therapistProblems for the therapist

Substance use may not appear on the problem list

Patient may be very ambivalent about “problem” status of substance use

“…a failure to agree on a problem list dooms the treatment”

Jacqueline Persons, p. 24

Challenges for the therapistChallenges for the therapist •Chaotic lifestyles and dissatisfaction with services can make engagement problematic

•Aspects of psychosis make substance use very functional eg -ameliorating negative affects -accessing pleasure in context of restricted life style

•Personal disadvantages less salient given have multiple complex problems and level of substances may be culturally “normal”

•Low self esteem/self efficacy for change

Model of maintenance of substance use in Model of maintenance of substance use in psychosispsychosis

psychosisNegative

AffectsBeliefs

Experiences

Substance misuse

Limited range of

alternativestrategies

+

Learned expectancies

of positive effects/Coping functions

Availability&Endorsement

By peers +

Internal stressors

ExternalstressorsMedication

non- adherence

Integrated Motivational Interviewing Integrated Motivational Interviewing /Cognitive Behaviour Therapy/Cognitive Behaviour Therapy

Many patients won’t identify substance use as Many patients won’t identify substance use as

problematicproblematic

Aims to facilitate them making links between key Aims to facilitate them making links between key concerns & substance use concerns & substance use

Assumes this may often be a slow process with Assumes this may often be a slow process with initial focus on engagement initial focus on engagement

RP needs to take account function of substances RP needs to take account function of substances (eg CBT for symptom management) (eg CBT for symptom management)

Intervention needs to be sufficiently flexible to Intervention needs to be sufficiently flexible to focus on other client led issues where initial focus on other client led issues where initial attempts to increase motivation for substance attempts to increase motivation for substance reduction unsuccessfulreduction unsuccessful

Phases of integrated MI/CBTPhases of integrated MI/CBT

1. 1. Motivation building phaseMotivation building phase

1. Engagement1. Engagement

2. Elicit talk about concerns and life satisfactions2. Elicit talk about concerns and life satisfactions

3 Elicit how substance use fits into life 3 Elicit how substance use fits into life

4 Identify of how the psychosis fits into this picture4 Identify of how the psychosis fits into this picture

5 Share formulation of life concerns with the client5 Share formulation of life concerns with the client fitting together concerns/illness/substance use fitting together concerns/illness/substance use

6 Help motivate/consolidate motivation for the 6 Help motivate/consolidate motivation for the client to reach an action stage of planned substance reduction client to reach an action stage of planned substance reduction

CommittedTo change

Ambivalent Precontemplative

Identify & develop strategies for substance reduction based on the a shared formulation - change plan and CBT for RP including symptom related problems where appropriate

Work on any aspect of the formulation acceptable to the client & continue to use motivational strategies to highlight/link the substance use to the problem focus

2 Action Phase

JackJack

Aged 30, 6 year history of schizophrenia, Aged 30, 6 year history of schizophrenia, lives alone (previously married, has weekly lives alone (previously married, has weekly access for 2 small children), repeated access for 2 small children), repeated admissions and two serious suicide attemptsadmissions and two serious suicide attempts

Has been using alcohol regularly (over 80 Has been using alcohol regularly (over 80 units per week) for several yearsunits per week) for several years

Regular cannabis use (12-20 cigs per week)Regular cannabis use (12-20 cigs per week)

KEY SYMPTOMSKEY SYMPTOMS

Believes that the police are after him Believes that the police are after him because he committed a murder.because he committed a murder.

Hears voices telling him he will be Hears voices telling him he will be punished.punished.

Very distressed by voices and fears of Very distressed by voices and fears of police. Fearful to go out, spends most police. Fearful to go out, spends most time alone although does attempt to time alone although does attempt to spend access time with his children. spend access time with his children.

INITIAL CONCERNS (PROBLEM) LISTINITIAL CONCERNS (PROBLEM) LIST

(Things that (Things that JackJack sees as a problem) sees as a problem)

Difficulty going out / lack of social activityDifficulty going out / lack of social activity Would like to do more with childrenWould like to do more with children Arguments with ex wife and his motherArguments with ex wife and his mother Fear of police / paranoiaFear of police / paranoia Keeping out of hospitalKeeping out of hospital Depression Depression

Initial Motivational Interviewing> Initial Motivational Interviewing> contemplativecontemplative

Links alcohol to some bad consequences - makes Links alcohol to some bad consequences - makes him depressed the next day and going to bed him depressed the next day and going to bed makes him feel useless.makes him feel useless.

Very ambivalent about cannabis - bad effects Very ambivalent about cannabis - bad effects (paranoia, fear of police attention) outweigh the (paranoia, fear of police attention) outweigh the good (initial feelings of well-being, sharing with good (initial feelings of well-being, sharing with friends) but friends) but lacks self efficacylacks self efficacy for change. for change.

Fears that giving up drink will leave him with Fears that giving up drink will leave him with no no ways to copeways to cope with intense fears with intense fears

Some willingness (discrepancy) , very low self Some willingness (discrepancy) , very low self efficacy, substance reduction not the efficacy, substance reduction not the highest priorityhighest priority

Highest priority - Going out /seeing children -Highest priority - Going out /seeing children -

Primary Intervention focusPrimary Intervention focus

Analysis of problems when out identified his fears Analysis of problems when out identified his fears (paranoid delusions) as central(paranoid delusions) as central

Monitoring of fears highlighted relationship of fear Monitoring of fears highlighted relationship of fear intensity to cannabis useintensity to cannabis use

Substance reduction linked to the highest priority Substance reduction linked to the highest priority

Jack elected on a change plan for reduction in useJack elected on a change plan for reduction in use

Going out /seeing children - next Going out /seeing children - next stepssteps

Challenging of paranoid beliefsChallenging of paranoid beliefs

Graded exposure in a hierarchy of public situations Graded exposure in a hierarchy of public situations

Behavioural “experiments” (eg distraction to Behavioural “experiments” (eg distraction to prevent hyper-vigilance)prevent hyper-vigilance)

With reduction in distress & increased confidence, With reduction in distress & increased confidence, planned reduction in alcoholplanned reduction in alcohol

InterventionIntervention

Integrated motivational interviewing & CBTIntegrated motivational interviewing & CBT

(lack of family not exclusion)(lack of family not exclusion)

26 sessions over 1year (anticipate variable 26 sessions over 1year (anticipate variable takeup > analyses of “dose” effects)takeup > analyses of “dose” effects)

Assertive outreach approach to appointment Assertive outreach approach to appointment scheduling – home based therapy scheduling – home based therapy

DesignDesignSimple, two arm trial, random allocation of Simple, two arm trial, random allocation of

400 patients :400 patients :

Experimental interventionPlus TAU

Treatment as usual

Participants meeting Inclusion criteria

End of treatment Assessment (12 months)

Follow up Assessment (24 months)

6 monthly Substance useassessment

6 monthly Substance useassessment

To date 160 patients randomised (Nov 05)

Results…………………………..2009