When Research Meets Reality–-Lessons Learned from a Pragmatic Multisite Group-Randomized Clinical Trial on Psychosocial Interventions in the Psychiatric and Addiction Field

Abstract

Research on treatments for patients with co-occurring psychiatric and substance use disorders is of core importance and at the same time highly challenging as it includes patients that are normally excluded from clinical studies. Such research may require methodological adaptations which in turn create new challenges. However, the challenges that arise in such studies are insufficiently discussed in the literature. The aim of this methodology paper is, firstly, to discuss the methodological adaptations that may be required in such research; secondly, to describe how such adaptations created new challenges in a group-randomized clinical trial on Integrated Treatment amongst patients with co-occurring psychiatric and substance use disorders. We also discuss how these challenges might be understood and highlight lessons for future research in this field.Trial registrationNCT00447733.

The effectiveness of integrated treatment in patients with substance use disorders co-occurring with anxiety and/or depression - a group randomized trial

“…This was a difficult study to conduct and the challenges we encountered are described in detail in a previous article [ 30 ]. Thirty-five CMHCs from 3 out of 5 Regional Health Trusts were invited to participate in the trial but only 9 CMHCs accepted.…”

“…Eighteen per cent of the screened patients scored above the cut-off level of the screening instruments, and only 31% of these patients were referred to the local trial administrator for the baseline evaluation (Figure 1 ). All these challenges delayed the project and are thoroughly discussed in a previous paper [ 30 ].…”

“… Flowchart of participants. Flowchart of patients in the Intervention Group (IG) and the Control Group (CG) [ 54 ]. …”

“…Five CMHCs were drawn to the intervention group and four CMHCs to the control group. For more details see a previous paper [ 30 ].…”

Lessons learned from two clinical trials on nutritional supplements to reduce aggressive behaviour

“…Although it is often hard to recruit participants in regular trials, it can be just as hard (or even harder) to recruit sites. 17 First, most sites had no research infrastructure. Thus, some personnel were somewhat reluctant to participate because of the anticipated extra workload.…”