Background: In the last decades, shared decision-making (SDM) models have been developed to increase patient involvement in treatment decisions. The purpose of this study was to evaluate a SDM intervention (SDMI) for patients dependent on psychoactive substances in addiction health care programs. The intervention consisted of a structured procedure to reach a treatment agreement and comprised 5 sessions. Methods: Clinicians in 3 treatment centres in the Netherlands were randomly assigned to the SDMI or a standard procedure to reach a treatment agreement. Results: A total of 220 substance-dependent patients receiving inpatient treatment were randomised either to the intervention (n = 111) or control (n = 109) conditions. Reductions in primary substance use (F(1, 124) = 248.38, p < 0.01) and addiction severity (F(8) = 27.76, p < 0.01) were found in the total population. Significant change was found in the total population regarding patients’ quality of life measured at baseline, exit and follow-up (F(2, 146) = 5.66, p < 0.01). On the European Addiction Severity Index, SDMI showed significantly better improvements than standard decision-making regarding drug use (F(1, 164) = 7.40, p < 0.01) and psychiatric problems (F(1, 164) = 5.91, p = 0.02) at 3-month follow-up. Conclusion: SDMI showed a significant add-on effect on top of a well-established 3-month inpatient intervention. SDMI offers an effective, structured, frequent and well-balanced intervention to carry out and evaluate a treatment agreement.

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