Evaluation of Very Integrated Program (VIP): Health promotion for patients with alcohol and drug addiction — A Randomized Trial

BACKGROUND: Compared to the general population, patients with alcohol and drug addiction have an increased risk of additional hazardous lifestyles and suffer from more chronic diseases, adding to their already significantly higher morbidity and mortality. The objective of this study was to test the efficacy of the Very Integrated Program (VIP) on treatment and health outcomes for patients diagnosed with alcohol and drug addiction. METHODS: Parallel randomized clinical trial with intervention as add-on to addiction care as usual. A total of 322 patients aged 18 years or older were identified, and the study requirements were fulfilled by 219 patients, 7 of whom participated in a pilot. The intervention was a 6-week intensive, tailored, educational program that included motivational interviewing, a smoking cessation program, dietary and physical activity counseling, and patient education. The main outcome measures were substance-free days, time to relapse and treatment adherence assessed after 6 weeks and 12 months. Secondary outcomes were lifestyle factors, symptoms of comorbidity, and quality of life. Missing data were imputed conservatively by using data closest to the follow-up date and baseline values in patients with no follow-up. RESULTS: The 212 patients (intervention, n=113; control, n=99) were randomized, and 202 had complete data for primary outcomes. After 6 weeks, there were no significant differences between the groups regarding primary or secondary outcomes. At the 12-month follow-up, the patients in the control group had significantly more total substance-free days (139 days; ranging 0-365 vs. 265; 0-366, p=0.021) - specifically among the patients with drug addiction - and higher physical and mental quality of life (45 vs 58, p= 0.049 and 54 vs. 66, p=0.037), but not in the per-protocol analysis (60 vs. 46, p=0.52 and 70 vs. 66, p=0.74). The sensitivity analyses did not support significant differences between the groups. CONCLUSION: Overall, adding VIP intervention did not improve outcome of the alcohol or drug addiction care or the lifestyle compared to the addiction care alone. This patient group is still in need of effective programs and new intervention research is required to develop that.