Alcoholism Treatment Matching: Methodological and Clinical Issues

Dennis M. Donovan, Ph.D.

Alcohol & Drug Abuse Instituteand

Department of Psychiatry & Behavioral Sciences

University of Washington

CONJ 556:  Addiction: Mechanisms, Prevention, Treatment

The World's Largest 6-Pack:

“Honestly, Officer, I only had one can….”

NoNo ProblemsProblems

Primary PreventionPrimary Prevention

Brief InterventionBrief Intervention

TreatmentTreatment

Mild Mild ProblemsProblems

Moderate Moderate ProblemsProblems

Severe Severe ProblemsProblems

Thresholds for ActionThresholds for Action

Spectrum of Intervention Response

http://www.recoveryjonescartoons.com/cartoons.htm

The CURE for addiction as a brain disease

Selection of Level of Intensity of Intervention

No Intervention Needed

Brief Intervention

Self-Help Groups

Outpatient Treatment

Intensive Day or Night Treatment

Residential Treatment

Severity of Dependence

Miller, 1989

Institute of Medicine Report: Broadening the

Base of Treatment for Alcohol Problems (1990)

• It may no longer be appropriate to ask if treatment works, which is the best available treatment, or which treatment is more effective than another.

• The question needs to be reframed:

“Which kinds of individuals, with what kinds of alcohol problems, are likely to respond to what kind of treatments by achieving what kinds of goals when delivered by which kinds of practitioners?”

What Is Treatment Matching?

“Deliberate and consistent attempt to select a specific candidate for a specific method of intervention in order to achieve specific goals.”

Glaser & Skinner, 1982

“I utilize the best from Freud, the best from Jung, and the best from my Uncle Marty, a very smart fellow.”

The “Science” of Treatment Selection and Matching

Key Conceptual and Methodological Issues in Patient-Treatment Matching Conceptual issues: • Selecting effective matching variables

• Specifying the end result that matching is to enhance

• Determining the stage(s) in the treatment process at which matching decisions are to be made

Methodological issues deal with the type of patient-treatment match or interaction effect and include:

• Nonlinear interaction effects

• Higher-order interaction effects

• Multilevel interaction effects

Finney & Moos, 1986

Conditions Enhancing Probability of Identifying Interaction Effects Testing the Treatment Matching Hypothesis

• Large clinical sample, allowing subject heterogeneity for meaningful subtypes

• Controlled trial with random assignment to treatment conditions

• Use of reliable and valid instruments to assess prognostic characteristics

• Well-defined treatments that are clearly differentiable

• Use of a multidimensional assessment approach

• Inclusion of psychological variables (including degree of alcohol dependence) and demographic characteristics

• Use of data analytic strategies that are appropriate for the detection of complex interactions while also controlling for prognostic indicators1992

Methods of Treatment Matching

• Client preference/self-selection

• Client attribute by type of treatment (e.g., Project MATCH)

• Identified problem by services provided (e.g., McLellan / ASI)

• Severity of substance abuse problems / consequences by treatment intensity or setting (e.g., ASAM Criteria)

Degree of Empirical Evaluation Relative to Implementation of Matching Approaches

Em

pirical Evaluation

Implementation

Severity- Setting

Client-Treatment

Problem-Services

Client Preference

Low High

Low

High

Methods of Treatment Matching:

Client Preference/Self-Selection

Role of Client Choice in the Therapy Process

• A common clinical process following assessment is that the client is advised of the “appropriate” form of therapy.

• This is seen as undermining the client’s sense of responsibility with regard to the therapeutic process and may lead to dissatisfaction, reduced compliance and dropout.

Van Audenhove & Vertommen, 2000

Role of Client Choice in the Therapy Process

Treatment goals and approaches that have been chosen by the client, either independently or through negotiation with the clinician, are likely to capitalize on the client’s motivation and to increase compliance.

Miller, 1989

“try to make me go to rehab, i won't go, no, no, no…!”

Does Self-Selection of Treatments Lead to Better Outcomes than Random Assignment?

• Receiving treatment of preference had no measurable impact on treatment outcome, either for drinking behavior or general functioning.

• Receiving treatment of preference had no measurable impact on treatment process, utilizing client-rated (satisfaction and effectiveness), clinician rated (rapport and engagement) and objective (number of sessions attended) measures.

Adamson, Sellman, & Dore, 2005

Self-Directed Care

• A system that is “intended to allow informed consumers to assess their own needs . . . determine how and by whom these needs should be met, and monitor the quality of services they receive” (Dougherty, 2003).

• A system “in which funds that would ordinarily be paid to service provider agencies are transferred to consumers, using various formulas to account for direct, administrative, and other costs.” (Cook et al., 2004).

SAMHSA, 2004

Patient-Centered Care

“Patient-centered care” is care that is “respectful of and responsive to individual patient preferences, needs, and values and ensures that patient values guide all clinical decisions.”

• Patient access to and receipt of information that permits informed health care decisions

• Supporting the client through disagreements about treatment decisions

• Asking the patient’s goals for recovery

• Factoring these into shared decision making for the recovery process

• Assessing and supplementing education/information

Source: Institute of Medicine (2006), Improving the Quality of Health Care for Mental and Substance-Use Conditions.

Methods of Treatment Matching:

Client Attribute by Type of Treatment

(e.g., Project MATCH)

Matching Alcoholism Treatment to Client Heterogeneity

Purpose of Project MATCH

To determine if various types of alcoholics respond differentially to

different treatment approaches

Why a Multi-Site Matching Trial?

• There is considerable heterogeneity among alcoholics

• No single treatment helps all alcoholics

• Promising results in small-scale matching studies

• Matching is a dominant question on the research agenda

Clinical Research UnitsProject MATCH

SeattleVAMC

Albuquerque

HoustonVAMC

CharlestonVAMC

Milwaukee

Buffalo

Providence

WHaven VAMC*

**

* ***

**

Farmington

Two Parallel Study Arms

To test the generalizability of matching in different client populations and

treatment settings

Outpatient Aftercare

Project MATCH Therapy Manuals

To evaluate matching clients to distinct, manual-driven, theoretically-based treatments that are widely applicable

to a range of settings and providers

Research Design: Outpatient Study

M o tiva tio n a lE n ha n ce m e nt

T h e ra py

C o gn it iveB e h av io ra l

T ra in ing

T w e lveS tep

F a c ilita tion

R a nd omA ss ig nm e nt

R e c ru itm e nt fromC o m m u n ity a t 5 s ites

Assessment and Follow-up Protocol

• Baseline Pre-Treatment

• End of Treatment (Month 3)

• Post-Treatment Follow-up: Mos 6, 9, 12, 15

• All contacts were in person except month 12

• Self reports corroborated by blood/urine samples and collateral reports

Client Attributes Examined in Project MATCH

• Gender

• Alcohol involvement

• Cognitive impairment

• Meaning seeking (spirituality)

• Motivation

• Sociopathy

• Social network support for drinking

• Alcohol dependence

• Level of anger

• Interpersonal dependency

• Prior AA involvement

• Self-efficacy

• Social functioning

• Antisocial personality disorder

• Type and severity of psychiatric disorder

• Religiosity

• Alcoholism type

• Readiness to change.

Outcome Variables

Primary Measures• Percent of Days Abstinent (frequency)• Drinks per Drinking Day (intensity)

Secondary Measures (Partial list)• Other measures of drinking• Negative consequences of drinking• Other substance use• Social functioning• Psychological functioning

Compliance in Project MATCH:Treatment Attendance

Percent of Prescribed Sessions

0102030405060708090

100

Outpatient Aftercare

CB

MET

TS

The Crushing Weight of the Data

Mean Percent Days Abstinent as a Function of Time (Outpatient)

0102030405060708090

100

-2 -1 0 4 5 6 7 8 9 10 11 12 13 14 15

CBT

MET

TSF

Project MATCH Research Group, 1997

Proportion of Patients Maintaining Total Abstinence as a Function of Time (Outpatient)

0

0.2

0.4

0.6

0.8

1

1.2

1 3 7 14 30 60 90 120 150 180 240 300 360

Time in Days

Pro

po

rtio

n o

f C

lien

ts

CBT

MET

TSF

Mean Drinks per Drinking Day as a Function of Time (Outpatient)

0

2

4

6

8

10

12

14

-2 -1 0 4 5 6 7 8 9 10 11 12 13 14 15

Time in Months

Mean N

um

ber of D

rinks

CBTMETTSF

Project MATCH Research Group, 1997

Proportion of Outpatients Avoiding a Heavy Drinking Day as a Function of Time

0

0.2

0.4

0.6

0.8

1

1.2

1 3 7 14 30 60 90 120 150 180 240 300 360

Time in Days

Pro

po

rtio

n o

f C

lien

ts

CBT

MET

TSF

Project MATCH Research Group, 1997

Only 4 of 21Possible Treatment - Attribute Matches Found in Project MATCH

Alcohol Dependence: In the aftercare group, individuals with high levels of alcohol dependence benefited more from TSF than from CBT, whereas the reverse was true for patients low in dependence.

Psychopathology: In the outpatient group, those without psychopathology were found to benefit more from TSF than from CBT.

Anger: Also in the outpatient arm of the trial, patients high in anger had more successful outcomes with the MET than with the other two approaches.

Social Network Support for Abstinence: Patients whose social networks offered less support for abstinence had better outcomes in TSF than in MET.

Project MATCH Findings

• Treatment attendance was high across all three treatments

• Excellent overall outcomes, with substantial reductions in frequency and intensity of drinking following treatment

• Few differences among treatments

• Outcomes similar for MET vs. CBT+TSF

• Observed main effects generally favored TSF

• Outcomes are not substantially improved by client-treatment matching.

“In sum, Project MATCH’s findings challenged the notion that patient-treatment matching is a prerequisite for optimal alcoholism treatment. Other than the four relationships, the findings did not show that matches between patient characteristics and treatments produced substantially better outcomes.”

NIAAA's 10th Report to Congress

Was Project MATCH Right After All?

Witkiewitz: J Abnorm Psychol, 116(2). 2007.378–394

Interaction between self-efficacy and treatment assignment on percentage of drinking days for infrequent drinking class (top) and frequent drinking class (bottom)

Original Project MATCH Hypothesis: Individuals lower in baseline self-efficacy would have better outcomes if they were randomly assigned to CBT rather than to MET.

Original Project MATCH Finding:No interaction effect obtained.

Witkiewitz, et al., Finding:Provided support for the original self-efficacy matching hypotheses. Baseline self-efficacy was related to different outcomes depending on whether individual was randomly assigned to CBT or to MET, and this relationship was moderated by levels of drinking frequency.

Witkiewitz: J Abnorm Psychol, 116(2). 2007.378–394

Subsequent Therapy Component by Client Attribute Interactions

• A focus on emotional material in therapy was associated with more frequent alcohol consumption among patients high in depressive symptoms

• Therapist use of confrontation was associated with more frequent alcohol consumption among patients at medium and high levels of trait anger while it was associated with less frequent alcohol consumption among patients low in anger

• Confrontation was associated with more frequent alcohol consumption among patients high in interpersonal reactance (extent to which an individual generally resists being influenced by others)

• Therapy structure was associated with more frequent alcohol consumption among patients at medium or high levels of reactance

Karno & Longabaugh, Addiction, 102, 587–596, 2007

Effects of Match between Patient Depressive Symptoms and Therapy Emotion Focus

0

1020

3040

5060

7080

90100

Matched Unmatched Mismatched Matched Unmatched Mismatched

PDA % Recovered

Karno & Longabaugh, Addiction, 102, 587–596, 2007

Do Client Attribute / Treatment Matches Matter?

• Mismatches between patient attributes and treatment appear to have serious consequences, and this effect is magnified with multiple mismatches.

• Matches, on the other hand, while beneficial, may not be necessary to achieve good outcomes

Karno & Longabaugh, Addiction, 102, 587–596, 2007

Still left with variable response…..

• Even when treatment delivery is standardized and high adherence to manual is achieved, some patients do well and others do not.

• Very hard to predict who will do well in a particular treatment

• Nonresponse is often blamed on the patient, but that is likely not the whole story.

Another Possible Approach?

Adaptive Treatment

In Adaptive Treatment Protocols…

• One of the conceptual issues identified by Finney & Moos (1986): Determining the stage(s) in the treatment process at which matching decisions are to be made

• Treatment is tailored or modified on the basis of measures of response (e.g., symptoms, status, or functioning) obtained at regular intervals during treatment

• Goal is to deliver the least burdensome treatment that is effective, to promote better compliance over time

• Rules for changing treatment are clearly operationalized and described…..

“If……..Then”

Decision RulesDecision Rules

IfIf (tailoring variable)(tailoring variable) thenthen (decision option)(decision option)

If client does not complete web-based CBT assignments for 2 weeks

Provide telephone Motivational Interviewing

session

Example:

Operationalizing Clinical DecisionsOperationalizing Clinical Decisions

• Reduces inappropriate variance in treatment delivery

• Provides framework for improving outcomes

• Permits systematic research

An Example of an Adaptive Strategy for Aftercare for Patients Recently Treated for Substance Use Disorder

(SUD) and Depression

SUD AND depression in remission

Telephone contact with BS Staff1 per 7 days

Evaluate at 6 weeks on risk factors for

BOTH SUD and Depression

Risk Low for BOTH

Risk Moderate for ONE OR MORE

Decrease telephone contact to once per 14Days with BS level staff

Increase telephone contact once Per 5 days with therapist

Goal: minimize relapse for all treated within constraints of health care system

Sequential, Sequential, Multiple Multiple Assignment, Assignment, Randomized Randomized Trial Trial (SMART)(SMART)

Baseline

Treatment Control

Assessment

Randomization

Switch Treatment

ResponderNon- Responder

No Change

RandomizationRandomization

Final Outcome

Reduce Treatment

Burden

Assessment

ResponderNon- Responder

Final Outcome

Final Outcome

Final Outcome

Final Outcome

Final Outcome

No Change

Combined Pharmacological and Behavioral Interventions for Alcohol Dependence

Ways in Which Psychopharmacology Is Used to Treat Alcohol or Other Drug Dependencies

Purpose Treatment Goal Examples

Relapse Prevention

• Make drinking alcohol aversive

• Reduce alcohol craving

Disulfiram (Antabuse)

Naltrexone (ReVia, Vivitrol)

Acamprosate (Campral)

Three Medications Approved by the FDA for Use inthe Treatment of Alcohol Dependence

Rationale for Project COMBINE

• Recent advances have occurred in the development of pharmacological and behavioral treatments for alcohol dependence

• The hypothesis that pharmacological and behavioral treatments may enhance each other and yield optimal improvement rates requires investigation

• COMBINE will evaluate the efficacy of naltrexone, acamprosate, and psychotherapy individually and in combination

80

70

60

50

40

30

20

10

0

Baseline Month 1 Month 2 Month 3 Month 4

PercentHeavyDrinking Days

Lines: Top to Bottom at 4 monthsType A Placebo Type B Naltrexone Type B Placebo Type A Naltrexone

FIGURE 1.

Percent Heavy Drinking Days by Typology and Medication ConditionPercent Heavy Drinking Days by Typology and Medication ConditionBabor’s Type A Alcoholism

• Later age of alcoholism onset

• Weaker family history (i.e.,

• Fewer first-degree relatives who are alcoholics)

• Less severe dependence

• Fewer symptoms of co-occurring psychiatric disorders

• Less psychosocial impairment (i.e., negative familial, social, legal, or occupational consequences of drinking).

Effect of Alcoholism Typology on Response to Naltrexone in the COMBINE Study

Bogenschutz, Tonigan, Pettinati, under review

Among those receiving medication management without CBI, Type A alcoholics had better drinking outcomes with naltrexone than placebo, whereas medication conditiondid not influence outcomes significantly in the Type Bs. For those who received CBI, there were no significant effects of A/B typology.

Methods of Treatment Matching:

Identified Problem by Services Provided

(e.g., McLellan / ASI)

Drug Abuse Treatment Core Components and Comprehensive Services

Medical Services Mental

Health

Vocational

Legal Services

Educational

AIDS/HIV Services

Financial Services

Housing & Transportation

Child Care

Family Services

Substance Use Monitoring

Self-Help/Peer Support Groups

Continuing Care

Pharmaco-therapy

Intake Processing/ Assessment

Treatment Plan

Clinical and Case

Management

Behavioral Therapy and Counseling

CoreTreatment

An investigation that randomized 94 patients to problem–service matching versus standard services found that those who received three or more service sessions matched to mental health, family or employment problems had better treatment completion and post-treatment outcomes.

McLellan et al., 1997

Change in “Wrap-Around” Services 1980s (TOPS) vs. 1990s (DATOS)

77

50

60

1520

5

LTR ODF OMT

1980s 1990s

Percent of Sample Receiving 2 or More Services

Etheridge, Craddock, Dunteman, & Hubbard, 1995

Change in “Wrap-Around” Services 1980s (TOPS) vs. 1990s (DATOS)

26 23

68

10

43

10

21

10

MedicalServices

PsycholServices

FamilyServices

EducationalServices

1980s 1990s

Percent of Outpatient Psychosocial Treatment Sample

Etheridge, Hubbard, Anderson, Craddock, & Flynn, 1997

• Examined five areas of need: medical, mental, vocational, family, and housing

• Most participants indicated needing at least one service (an average of 3.22 services needed per person)

• Only about 1/3 of service needs were met/matched

– (1.11 met, 2.22 unmet)

• Overall, matching of needs with services was associated with significant reductions in drug use

• Of the five areas, only matching on mental health failed to be associated with improved drug use outcomes

• The effects of matching are greater for clients with high needs (having needs in 4-5 areas) than those with low needs

Effects of Comprehensive Matching of Service Needs on Drug Use Outcomes

Friedmann, et al., 2004

Computer-Assisted System for Patient Assessment and Referral: CASPAR

Compared to clients of counselors conducting standard assessments, those of counselors using CASPAR

• Had treatment plans that were better matched to their needs

• Received significantly more and better-matched services

• Were less likely to leave treatment against medical advice

• Were more likely to complete the full course of treatment than patients of counselors in the SA group.

Carise, et al, 2005

Methods of Treatment Matching:

Severity of Substance Abuse Problems

and Consequences

by Treatment Intensity or Setting

(e.g., ASAM Patient Placement Criteria)

• Degree of direct medical management provided

• Degree of structure, safety, and security provided

• Degree of treatment intensity provided

ASAM Criteria Describe Levels of Treatment Differentiated by Three Characteristics

ASAM PLACEMENT CRITERIA LEVELS OF I. OUTPT II. INTENSIVE III. MED IV. MED

OF CARE OUTPT MON INPT MGD INPT CRITERIA

Withdrawal no risk minimal some risk severe risk

Medical Complications no risk manageable

medical monitoring

required

24-hr acute med. care required

Psych/Behav Complications no risk mild severity moderate

24-hr psych. & addiction Tx required

Readiness For Change cooperative

cooperative but requires

structure

high resist., needs 24-hr motivating

Relapse Potential

maintains abstinence

more symptoms, needs close monitoring

unable to control use in

outpt care

Recovery Environment

supportive

less support, w/ structure

can cope

danger to recovery, logistical

incapacity for outpt

Finding from Research on ASAM Patient Placement Criteria

• Individuals who receive a less intensive level of care than recommended have poorer outcomes than those who receive the recommended level

• Receiving a more intensive level of care than recommended did not improve outcomes over those for appropriately matched level of care

• There is substantial disagreement between clinicians’ recommended level of care and that recommended by a computer algorithm (which recommended more intensive levels than did counselors)

Practical Barriers to Implementing Matching Procedures

• Lack of true alternative treatments either within a given program or across programs in a community

• Need to specify the treatments long a number of theoretically or therapeutically relevant dimensions

• Need to specify the individual client characteristics or problems at which the treatment is targeted

• Practical impact of the increased workload in order to provide the necessary assessments and treatments

Donovan & Mattson, 1994

Practical Barriers to Implementing Matching Procedures

• Need to account for influence of therapist characteristics either within or across treatment modalities

• Potential requirement of “staged” matching across different levels of motivation or readiness to change and phases of treatment and recovery

• Need to determine the best methods of and criteria for matching clients to treatment

Donovan & Mattson, 1994

Suggestions for Conceptual Changes in Allocation Research

• Extend the scope of relevant factors in change processes

– Clarify the relevance of social support for maintaining or reducing problematic substance use

– Study patient–therapist interactions

– Study site effects

• Clarify the relevance of patient decision making for treatment allocation

– Analyze the relevance of motivation/readiness for change

– Clarify the role of patients’ treatment choices

• Search for mediator and moderator effects

Bühringer, 2006

Suggestions for Conceptual Changes in Allocation Research

• Consider treatment ‘macro-level’ allocation needs in practice (setting, duration, intensity)– Determine the need for in-patient/residential

interventions– Improve the knowledge on duration versus

intensity of interventions– Determine the choice of relevant problem areas

for treatment

Bühringer, 2006

Suggestions for Methodological Changes

in Allocation Research

• Maximize patient heterogeneity, increasing external validity

• Maximize intervention heterogeneity– have a larger variation in the time and intensity of

treatment– intensify the exposure of specific intervention

techniques, in order to achieve larger between-treatment effects

• Implement more adequate research designs

Bühringer, 2006