nullHappy Ending and BalanceHappy Ending and Balancetwo internet behavior change interventions for smoking cessation
and alcohol reduction, respectively
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)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.http://www.tdzl.net/ 天津塔吊租赁 河北塔吊租赁 西安塔吊租赁 塔吊租赁 http://www.u51688.com/Starting all over again:
Evaluating the web-based alcohol-reduction intervention, BalanceStarting all over again:
Evaluating the web-based alcohol-reduction intervention, BalanceQualitative interviews (already initiated)
Testing the user acceptance (adoption rate) in three populations: employees, students, surgery inpatients
RCT – efficacy trial (this winter)Happy Ending & Balance are similar 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 adherenceHappy Ending & Balance are similarHappy Ending & Balance are similarSupports 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)Challenges of running clinical trials on internet behavior change interventionsChallenges of running clinical trials on internet behavior change interventionsDesigning 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/discussChoosing the control ”treatment”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
Follow-up / data collection / timeline
(Happy Ending and Smoking cessation)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)Choosing the main outcomeChoosing the main outcomeQuit
attempt12 m.
postRepeated point prevalence abstinenceContinuous abstinenceProlonged abstinence (initial grace period)Point prevalence abstinenceResponse rate and Repeated Point Prevalence Abstinence (RPPA) 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 …Response rateResponse 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
AdultsPoint abstinence (PA) vs Repeated PA – trial 1Point abstinence (PA) vs Repeated PA – trial 1Point abstinence (PA) vs Repeated PA – trial 2Point abstinence (PA) vs Repeated PA – trial 2Mediation and timelineMediation and timelineBaseline & randomizationPredefined
quit daywhen do we measure the potential mediators?Active quit phase2 week preparation phase
Smoke as usualAbstinence
measuredMediationMediationHow 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
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