Happy Ending and Balance

1. Happy Ending and Balance two internet behavior change interventions for smoking cessation and alcohol reduction, respectively • Håvar Brendryen • Affiliation: • The Workplace Advisory Center for issues related to alcohol, drugs and addictive gambling in the workplace. • Alcohol and Drug Research Western Norway, Stavanger university hospital. • Norwegian Centre for Addiction research, Univ. of Oslo.

2. My PhD-thesis:Digital Behavior Change Interventions and Smoking Cessation Testing the Efficacy and Describing the Rationale of a Fully Automated Smoking Cessation Intervention (Happy Ending), delivered by means of the Internet, Computers and Cell-phones. (Submitted June 2009) • Brendryen, H., & Kraft, P. (2008). Happy Ending: a randomized controlled trial of a digital multi-media smoking cessation intervention. Addiction, 103, 478-484. • Brendryen, H., Drozd, F., & Kraft, P. (2008). A Digital Smoking Cessation Program Delivered Through Internet and Cell Phone Without Nicotine Replacement (Happy Ending): Randomized Controlled Trial. Journal of Medical Internet Research, 10, e51. • Brendryen, H., Kraft, P., & Schaalma, H. (submitted). Looking inside the black box: Using Intervention Mapping to describe the development of the automated smoking cessation intervention Happy Ending. Journal of Smoking Cessation.

3. Starting all over again: Evaluating the web-based alcohol-reduction intervention, Balance • Qualitative interviews (already initiated) • Testing the user acceptance (adoption rate) in three populations: employees, students, surgery inpatients • RCT – efficacy trial (this winter)

4. Happy Ending & Balance are similar • Internet & cell-phone • Multi-media: text, pictures, and audio content • Fully automated • Intended for the masses • Core idea: Clients need different help at different times – TUNNELLING! • New information every day • Email with link to a web-page, every day • Restricted access to information (time & person) • Allows tracking of “objective” treatment adherence

5. Happy Ending & Balance are similar • Supports the self-regulatory processes required for behavior change • Targeting mood, willpower, and motivation • Focus on lapse prevention (prior to lapses) and relapse prevention (after lapses) • The target behavior is monitored continuously • Efficacy trials (RCTs)

6. Challenges of running clinical trials on internet behavior change interventions • Designing and running such trials is not as easy as it seems – the perfect trial is illusive – and I guess that’s why you are here? • In the following, I will outline a selection of challenges/questions/tradeoffs • Feel free to contribute/discuss

7. Choosing the control ”treatment” • Should there be treatment at all? • Waiting list control • Nocebo effect? • When people sign up for a trial they expect “something” • We wanted something that “felt like” a realistic treatment without actual effect • Should the control treatment resemble the real treatment on important aspects (e.g. media channel)? • I.e. a web-based “mock-up” control intervention • Expensive & tradeoff: realism vs. no effect? • I did: Happy Ending vs booklet / booklet + NRT • Hope to do: Balance vs. screening only

8. Follow-up / data collection / timeline(Happy Ending and Smoking cessation) • ”Standard” long-term: 6 or 12 months • Multiple follow ups are common • Long follow up time = big noise • All other factors than treatment will have an increased effect over time and hence tend to level out group differences • I did: 1+3+6+12 months • A mistake? Four questionnaires might be considered an intervention in itself (particularly among people that were motivated to quit anyway) • I will show you some data on that afterwards • Taking the intervention into consideration • Happy Ending: 2 weeks + 1 months + 11 months (1 contact a week) • Better to have one short term (1m) and one long term follow-up (6m/13m) instead? (Will do that with Balance)

9. Choosing the main outcome Continuous abstinence Prolonged abstinence (initial grace period) Point prevalence abstinence Quit attempt 12 m. post Repeated point prevalence abstinence

10. Response rate and Repeated Point Prevalence Abstinence (RPPA) • “Recycling” • we wanted to capture only the recycling due to the treatment (relapse prevention) and leave out the recycling due to multiple and “clearly separated” cessation attempts • RPPA defines abstinence as abstinence on all (four) follow-ups • PPA = 7 days with no smoking • We applied ITT – i.e. 4 x ITT • Generally low response rate in web-research • RPPA+ITT was a gamble i did not immediately realize …

11. Response rate Trial 1 Trial 2 ——————— ——————— Treatment Control Treatment Control —————————————————————— 1 month 98.5 97.0 96.5 87.0 3 months 93.4 91.0 93.8 89.7 6 months 95.4 94.0 86.1 82.2 12 months 95.9 91.5 91.0 83.3 —————————————————————— • How did it happen? • Web-questionnaires + phone • Cell phone (not ground line) • Time of day/week • (a long) baseline questionnaire completed (before randomization) • Motivated quitters • Adults

12. Point abstinence (PA) vs Repeated PA – trial 1

13. Point abstinence (PA) vs Repeated PA – trial 2

14. Mediation and timeline 2 week preparation phase Smoke as usual Abstinence measured Active quit phase Predefined quit day when do we measure the potential mediators? Baseline & randomization

15. Mediation • How to select potential mediators? • For what purpose? • When do we measure the mediators, relative to the main outcome and the other measures? • Can the target behavior (main outcome) confound the mediation analysis? • Say you find a partial mediation of treatment effect over self-efficacy; self-efficacy measured at one month post and smoking cessation at six months post • Is there a trade-off between process evaluation and efficacy testing? • Might require several additional follow-ups • Measuring every thinkable mediator would require a massive questionnaire