brief intervention for heavy drinking

Brief Intervention for Heavy Drinking

PhD defence

Anders Blædel Gottlieb Hansen

Om ph.d.-projekt

Ph.d.-afhandlingen:

…blev vurderet og godkendt til forsvar af:

• Research associate Per Nielsen, Department of Medical and Health Sciences, Linköping University

• Professor Paul Wallace, University College London

• Professor Bent Nielsen, Psykiatri, Klinisk Institut, SDU

…blev forsvaret den 16/4 2012 på SIF

…bestod af en sammenfatning, samt 3 studier, publiceret som videnskabelige artikler i internationale peer review tidsskrifter

…har sin baggrund i SUSY-undersøgelsen 2005 og KRAM-undersøgelsen 2007-2008

Study 1

Alkohol indtag I Danmark: kategorier og diagnoser

The number of persons with alcohol problems in the Danish population. Hansen AB, et al. Scandinavian Journal of Public Health. 2011

Diagnoser i ICD-10: Alkoholafhængighed: en kombination af fysiologiske, holdningsmæssige og kognitive forstyrrelser associeret med et alkoholforbrug, hvor alkohol indtager en dominerende plads i dagligdagen -Storforbrug af alkohol Forbrug over Sundhedsstyrelsens genstandsgrænser (14 / 21)

Skadeligt alkoholforbrug: -et forbrug, der har medført helbredsskade (fysisk eller mentalt), og hvor patienten ikke opfylder de diagnostiske kriterier for alkohol-afhængighed

O'Connor PG. J Gen Intern Med 2005.

Background: Heavy drinking as a risk factor for…

• Alcohol-related diseases and conditions (e.g. liver cirrhosis, chronic pancreatitis, cancers, dependence)

• injuries and accidents

• People around the drinker Harms to other

Rehm et al. 2010 Giesbrecht et al. 2010

But, alcohol is also an ambiguous risk factor…

• And many people’s everyday practices of drinking is

associated with pleasure and relaxation

• Many heavy drinkers are:

- unaware of the harmful consequences

- not motivated to decrease consumption

- never identified as heavy drinkers

• Estimated as many as 80% of problem drinkers are not receiving help missed screening opportunities and stigma associated with alcohol treatment

Gusfield JR. 1996 Cunningham et al. 2004 Drummond et al. 2011

Fremtidens alkoholpolitik ifølge danskerne. Mandag Morgen, 2009.

• Evidens:

• Små effektstørrelser

• Nedsættelse af forbruget med 12% -15%

• Gennemsnitlig forskel i alkoholforbrug:

• -38 g/uge

• Ca. 3-4 genstande

• Kaner et al. 2007; Bertholet N et al. 2005

Korte interventioner / kort rådgivning

Karakteristika:

• Definition: konsultationer/samtaler af kort varighed (1 – 4 sessioner)

• Formål: Har ofte nedsættelse af forbrug som mål / drikke under genstandsgrænserne

• Setting: Bliver ofte gennemført af læger / sundhedspersonale etc.

• Målgruppe: Er oftest rettet imod folk der ikke er afhængige, men har et (potentielt) skadeligt forbrug, ’ikke-behandlingssøgende individer’

• Teoretisk baggrund: Bygger på en motiverende tilgang / empatisk samtale teknik

Moyer A, et al. Addiction 2002

Baggrund for begge studier: KRAM-undersøgelsen

Blev gennemført i 13 kommuner i løbet af 2007 og 2008

Undersøgelsen foregik over en måned i hver

kommune

Undersøgelsen omfattede:

• Internet-baseret spørgeskema undersøgelse (alle voksne, n=76.484, deltagelses-procent=13,5)

• Helbreds-undersøgelse ved KRAM-

bussen (n=18.065, deltagelsesprocent=10)

• Lokale sundheds-fremme aktiviteter i

KRAM-perioden

Eriksen et al. 2011

Study 2

• To investigate the efficacy of an

opportunistic brief motivational intervention (BMI) (approximately 10 minutes) in conjunction with a telephone booster session (approximately 5 minutes)

• To determine whether a BMI resulted in a decrease in alcohol use in a non-treatment seeking population of adult heavy drinkers compared with subjects in a control group with a minimal intervention

Aim

• Two-arm non-blinded randomized controlled trial

• Randomization after consent

• Outcome measure: reduction in weekly alcohol consumption

Methods

Participants

Intervention group: - Brief motivational intervention (approx 10 min.) - Two leaflets about alcohol. - Telephone booster session (approximately 5 minutes, 4 weeks later)

Control: -Two leaflets about alcohol

12 month follow up

Baseline 6 month follow up

Followed-up 80%

Followed-up 87%

Participants of the Danish

Health Examination

Survey 2008

(n=12,364)

Not meeting inclusion criteria

(n=11,338)

6 month follow-

up (n=342)

BMI (n=391)

6 month

follow-up

(n=328)

Control (n=381)

Randomized

(n=772)

Refused to participate (n= 214)

Other reasons (n=40)

Lost to follow-up

(n=49)

Lost follow-up

(n=75)

12 month

follow-up

(n=316)

Lost to follow-up

(n=53)

Lost follow-up

(n=81)

12 month

follow-up

(n=300)

Heavy drinkers

(n=1026)

Booster 4

weeks after

BMI (n=366)

Telephone

booster

session (94%).

Did not receive

booster (n=25)

Flow-chart

78% accepted participation

Description of the brief motivational intervention

– The interventionists had received 2 days of training in MI and BMI

– They had been instructed to ask three pre-defined open questions during the intervention:

– ‘What do you know about the association between heavy drinking and health?’

– ‘What are you already doing to restrain your drinking?’

– ‘What can you do more?’

– to use scale questions (assessing importance of changing drinking and assessing confidence to change drinking habits)

How brief can you get? •Average intervention duration 11 min. •Based on the principles of motivational interviewing (MI), i.e. guiding style, designed to enhance motivation for change Miller, W & Rollnick S, 2009

Rollnick S. , 1998

Results for women based on the intention-to-treat principle (drinks/week)*

* Mean number of standard drinks in a typical week. Error bars indicate 95% confidence interval.

19.9

14.1 14.6

21.3

15.1

15.0

0

5

10

15

20

25

30

35

Baseline 6 month 12 month

Dri

nk

s/w

eek

Brief motivational intervention Control

Results for men based on the intention-to-treat principle (drinks/week)*

* Mean number of standard drinks in a typical week. Error bars indicate 95% confidence interval.

32.6

23.9

23.3

0

5

10

15

20

25

30

35

Baseline 6 months 12 months

Dri

nk

s/w

eek

Brief motivational intervention Control

31.1

23.1

23.1

How to document whether the staff carried out the intervention as planned?

How can we investigate whether the interventionists actually did adhere to the MI style prescribed?

This is important as research has shown that the use of MI-inconsistent skills in BMI are related to poorer drinking outcomes

Gaume J, et al. 2009 Allsop S,. 2007 McCambridge et al. 2011

MITI-analysis

• Motivational Interviewing Treatment Integrity 3.0 code (MITI)

• Tool for the evaluation of treatment integrity in clinical trials using MI

• 39 BMI was recorded and analyzed using MITI

Moyers TB, et al. 2005

Results of the MITI-analysis

Coder 1 Coder 2 ICC

Evocation

Collaboration Global spirit rating Average of 3.5 3.6 (0.7) 3.8 (0.5) 0.43

Autonomy/Support

Direction

Empathy

Behavior Counts

Giving information

MI adherent

MI non adherent

Closed questions

Open questions

Simple reflections Reflection/questions ratio 1 0.8 (0.5) 0.6 (0.4) 0.62

Complex reflections % Complex reflections 40% - - -

Global ratings Summary measures

48% (23) 0.69

69% (43) 50% (51) 0.66

Recommended

standard

% Open questions

% MI adherent 90%

Study mean scores (SD)

50% 53% (22)

The three open questions: Only 21% phrased the questions correctly, i.e. as open questions. However 44% of the interventionists did ask about the same themes as in the open questions, but phrased as closed questions. 87% used the scale questions correctly.

Study 2: Conclusion

• No evidence that a brief motivational intervention (BMI) as conducted by our interventionists, was effective.

• No significant difference was found between the BMI and simple information

on alcohol by means of two leaflets.

• The intervention effect of the BMI was −1.0 drinks/week, but the effect was not significant.

• From baseline to 6 and 12 month follow-up, alcohol consumption declined significantly in both the BMI and the control group with approximately 7 drinks per week.

• Motivational Interviewing Treatment Integrity 3.0 code was used as a quality

control of the interventions delivered. We found that the quality of the BMI delivered was suboptimal, as only one of four aspects was above the recommended level for beginning proficiency.

Some reflections on feasibility

• 78 % accepted to participate

• Many of the participants did not see themselves as drinking too excessively and stressed that they did not have a problem with alcohol

• The majority did not mind discussing their alcohol use, when it was done in an empathic, respectful and collaborative manner

• The opening question and the attitude of the staff, was of vital importance for the willingness of participants to participate

Hansen, ABG et al. 2009

Study 3

Population: • Participants from the DANHES who had

completed an Internet-based questionnaire (n=54.157)

• To determine whether an Internet-based

brief personalized feedback intervention and an Internet-based personalized brief advice intervention, results in a decrease in alcohol use in a non-treatment seeking population of adult heavy drinkers

Aim

Evidence: • Small effect sizes

• Decreased consumption

by approx. 10%

• Mean differences in alcohol use between intervention and control groups at follow-up after typically 12 months:

• 26g/week,corresponding to 2-3 standard drinks

Why use Internet-based brief interventions?

• Has the opportunity of reaching large numbers of individuals who are otherwise unwilling, not ready or not motivated to seek help

• Involves no clinical contact

• Can be accessed without limitations of distance

• Advantage of using personalized feedback on alcohol consumption, based upon the initial screening

• Automated data collection

Khadjesari Z, et al. 2011 Riper H et al. 2009 Murray et al. 2009

• Three-arm non-blinded randomized controlled trial

• Randomization after consent • Participants were allocated to either:

- An intervention group receiving Internet-based brief personalized feedback (normative feedback)

- An intervention group receiving Internet-based personalized brief advice

- A control group receiving nothing • Outcome measure: reduction in weekly

alcohol consumption

Methods

Participants

Brief personalized feedback

Control

12 month follow up

Baseline 6 month follow up

Persona-lized brief advice intervention

1. People received an invitation letter inviting them to participate in a National Health Examination Survey (DANHES)

2. Participants completed an Internet-based questionnaire

3. An automated screening process identified heavy drinkers

4. Heavy drinkers received an e-mail inviting them to participate in an intervention study

5. By clicking on a link in the e-mail invitees were directed to a web page explaining them about the intervention study

6. When joining the study participants were automatically randomized and immediately directed to a web page presenting them to the interventions or control

How did it work?

Core features of the Internet-based personalized normative feedback intervention

– Information about health consequences of heavy drinking

– A graph comparing weekly alcohol consumption with that of the average population

• Norms are important!

- People compare their own habits to that of people around them

- If no discrepancy change is unlikely to occur

• Change is triggered by a perceived discrepancy between present and desired states

• By a comparison between one´s own drinking and other peoples actual drinking discrepancy becomes explicit

• Normative feedback is assumed to be more effective than standardized feedback

Why Personalized Normative Feedback?

Riper H, et al. 2009 Miller. 2006 Neighbors et al. 2006

Flow-chart

Participants of the

Danish Health

Examination Survey

2008

(n=54,157)

Not meeting inclusion criteria

(n=50,739)

Heavy drinkers

(n=3418) Refused to participate (n=785)

Did not respond to invitation

mail (n=1215)

Other reasons (n=38) Randomized

(n=1380)

Lost to

follow-up

(n=96)

12 month

follow-up

(n=358)

Lost to

follow-up

(n=109)

12 month

follow-up

(n=341)

Lost to

follow-up

(n=111)

12 month

follow-upe

(n= 365)

Lost to

follow-up

(n=170)

Lost to

follow-up

(n=151)

Lost to

follow-up

(n=188)

6 month

follow-

up

(n=303)

Control (n=454)

6 month

follow-

up

(n=288)

6 month

follow-

up

(n=280)

PBAb

(n=450)

PFIa

(n=476)

41% accepted participation

63% followed-up

77% followed-up

a PFI: Internet-based brief personalized feedback intervention. b PBA: Internet-based personalized brief advice intervention.

Results for men based on the intention-to-treat principle (drinks/week)*

0

5

10

15

20

25

30

35


Dri

nks

/we

ek


Personalized brief advice

Control

*Mean number of standard drinks in a typical week. Error bars indicate 95% confidence interval.

Results for men based on completers analysis (drinks/week)*

0

5

10

15

20

25

30

35


Dri

nks

/we

ek



Control

*

P=.01


Results for women based on the intention-to-treat principle (drinks/week)*


0

5

10

15

20

25

30

35


Dri

nks

/we

ek



Control

• We found no evidence that an Internet-based brief personalized feedback intervention could be effective in reducing drinking in an adult population of heavy drinkers

• The intervention effect of the Internet-based brief personalized feedback intervention was approximately 2 drinks/week and non-significant

• The sensitivity analyses showed a significant intervention effect of approximately 3 drinks/week for the Internet-based brief personalized feedback intervention

• From baseline to 6 and 12 month follow-up, alcohol consumption declined significantly in both intervention groups and the control group by approximately 6 drinks per week.

Conclusion

Reflections on feasibility

• 41 % accepted to participate

• Many invitations did never reach their destination, due to spam filters, wrong e-mail adresses etc. (1181 did not respond to invitation)

• Some invitees reacted rather negatively to our intervention study

(non-treatment seeking population)

Study 2 and 3: Discussion

Why did it not work?

A. The interventions (and theoretical assumptions they were based on) did not work

B. The interventions did work due to poor implementation and design, we were not able to show an effect

Common for study 2 and 3: • Highly motivated participants i.e. selected

population

• Non-blinded nature of the study assessment effects (intervention effect of the research procedures) blurring of experimental contrast biased the results towards the null

• Regression to the mean / Social desirability bias

Beich, A. et al. 2003

Study 2: The issue of briefness: - Suboptimal implementation of the intervention too brief training in MI? - Too brief an intervention? Study 3: - Attrition - Too brief an intervention?

McCambridge & Kypri. 2011 Bernstein et al. 2010

• Potential impact of brief intervention?

• Small effect sizes aggregation of effects across a large portion of the population (‘preventive paradox’)

• Problems with implementation

• Brief intervention should not be seen as a ‘magic bullet’ towards heavy drinking, but should be seen in the broader context of alcohol policy (taxation that increases prices, restrictions on the physical availability, minimun age, etc.)

Brief intervention: Public Health Perspectives

Kypri, 2007 Saitz et al. 2006 Nilsen, 2010

Concluding Remarks • The high number of heavy drinkers in Denmark make the targeting of heavy

drinkers for the reduction of consumption and alcohol-related problems a high priority

• We did not find effect of two different models of brief interventions, but we did find good indications of feasibility, such as:

- the high number of persons who accepted to enrol in the trial (study 2)

- the many advantages related to conducting an Internet-based brief intervention trial (study 3)

• Conducting brief intervention in settings outside the primary healthcare system, such as the Danish healthcare centres, could expand the range of brief interventions, resulting in a larger number of heavy drinkers being reached

If we were to do it all over again (study 2 & 3)

I would:

– in the design phase be more clear about the efficacy/effectiveness aspects of the study

– incorporate user feedback on the interventions, and start out with a pilot test

– apply a different intervention design, e.g. Zelen or Solomon design (in order to minimise assesment effects)

– have more focus on the follow-up procedure (in order to decrease attrition)

– have more than just one outcome, maybee some Intermediate outcomes

1. Kommuner skal have en ”nattelivspolitik” 2. Væk med drikkepresset i ungdoms-uddannelserne 3. Aldersgrænser skal overholdes 4. Klare rammer om ungdomsfester 5. Lavere promillegrænse i de første år med kørekort 6. Kloge priser på alkohol 7. Ingen alkohol i markedsføring til unge 8. Kortere vej til behandling 9. Reform af alkoholbehandlingen 10. Aktiv EU-politik skal styrke danske handlemuligheder

23/11 2012

brief intervention for heavy drinking

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