Effectiveness and Safety of a Self-Management Program for Substance Addiction Consequences: A Pilot Clinical Trial

Background: Harmful substance use affects millions of people, producing health and social consequences that require both professional support and effective self-management. This study piloted a self-management program targeting the consequences of substance addiction in adults enrolled in medication-based program. Methods: A parallel-group pilot trial compared the Self-Management Substance Addiction Consequences Program (ADS Program) with treatment as usual (TAU) to assess the program’s effectiveness and identify the need for adjustments to the intervention or the trial design. Seventy-two randomly selected adults enrolled for at least 5 weeks in medication-based program for alcohol or other drugs participated. Data were collected at baseline and after 8 to 21 weeks to assess effects on substance addiction consequences (SAC) and positive mental health (PMH). Results: Of the 236 patients screened, 72 were randomized: 38 to the ADS Program and 34 to TAU. Twenty-five participants completed the ADS Program (34.2% attrition), and 16 completed TAU (52% attrition). ADS participants attended more sessions (6 vs 2), although still fewer than planned. Participants in the ADS Program demonstrated significant reduction in SAC (paired t(24) = –5.718, P < .001, d = –1.169). Similar improvements were observed in the TAU group (paired t(15) = –6.357, P < .001, d = –1.580), with no significant differences between groups ( P > .05). PMH also improved in both groups. The ADS group showed a statistically significant increase (paired t(20) = –3.945, P < .001, d = –0.861), whereas the TAU group demonstrated marginally non-significant improvement (paired t(11) = –2.170, P = .053, d = –0.626). No significant between-group differences were identified ( P > .05). Conclusions: This pilot trial indicates that the ADS Program is feasible, safe, and potentially effective in supporting self-management of SAC. Findings suggest an adjusted duration of 6 to 18 weeks may be beneficial. Given the substantial dropout rate, further research with larger samples is needed to confirm effectiveness and improve retention.