G-estimation of causal pathways in vocational rehabilitation for adults with psychotic disorders – a secondary analysis of a randomized trial

Background Vocational rehabilitation (VR) has increasingly become an important intervention targeting poor occupational functioning in schizophrenia. The Norwegian Job Management Program (JUMP), sought to enhance occupational outcomes by augmenting VR with either cognitive behavioral therapy (CBT) techniques aiming to improve psychotic symptoms or cognitive remediation (CR) aiming to improve cognition. CBT is standard treatment in schizophrenia, but recent meta-analyses question the effect of CBT on negative psychotic symptoms. It is of interest to study the causal role of psychotic symptoms and cognitive functioning on occupational functioning. Methods Data from the JUMP VR – program, was reanalyzed with a causal inference method to assess the causal effects of reduced symptoms / improved neurocognitive functioning on occupational functioning measured by number of working hours per week. Participants (N = 131) had been randomized to either VR + CBT (N = 68) or VR + CR (N = 63). Large improvements in number of working hours were demonstrated in both intervention groups (nonsignificant group difference). G-estimation was used to assess the strength and nature of the causal effects, adjusted for time-varying confounding and selection – bias from loss to follow-up. Results Significant causal effects of reduction in each of four dimensions of symptoms and improved neurocognition respectively, on number of working hours were found (separate models). The effect of negative symptoms was the strongest and increased in magnitude during the whole observation period, while the effect of two other symptoms and neurocognition was constant. Adjusted for confounding (including potential feedback), the causal effect of a hypothetical change in negative symptoms equal to the average improvement in the CBT group corresponded to an increase in working hours of 3.2 h per week (95% CI: 1.11, 5.35). Conclusion High performance of g-estimation in a small psychiatric data set with few repeated measures and time-varying confounding and effects, was demonstrated. Augmented vocational rehabilitation showed causal effects of intervention targets with the strongest and increasing effect from negative symptoms on number of working hours. Combination of therapy and activation (indirect and direct approach) might explain improvement in both cognition and negative symptoms, and shed some light on effective ingredients for improved treatment of negative symptoms

Exploring the potential cost-effectiveness of a vocational rehabilitation program for individuals with schizophrenia in a high-income welfare society

Background Over the past decades research has shown that employment has a positive impact on quality of life, global functioning and recovery in individuals with schizophrenia. However, access to vocational rehabilitation services for this group is limited and unemployment rates remain high. In this study we explore the potential cost-effectiveness of a novel vocational rehabilitation program (The Job Management Program – JUMP) earmarked for individuals with schizophrenia in Norway. Methods The JUMP study was a vocational rehabilitation program augmented with either cognitive behaviour therapy or cognitive remediation. In addition to the JUMP protocol, we extracted treatment cost data from comprehensive and mandatory health and welfare registers. The costs over a two-year follow-up period were compared with the costs over the two-year period prior to inclusion in the study. We also compared the cost-effectiveness of JUMP with a treatment as usual group (TAU). Results We identified significant reductions in inpatient services in the JUMP group, both for those who obtained employment and those who did not. Significant reductions were also found in the TAU group, but adjusted for baseline differences the total cost for JUMP participants were € 10,621 lower than in the TAU group during the follow-up period. Conclusion In addition to supporting individuals with schizophrenia obtain employment, JUMP appears to have reduced the reliance on mental health services, which should be of interest to stakeholders. Trial registration ClinicalTrials.gov Identifier: NCT01139502 . Retrospectively registered on 6 February 2010

The effect evaluation of Individual Placement and Support (IPS) for patients with substance use disorders: study protocol for a randomized controlled trial of IPS versus enhanced self-help

Background Employment is associated with better outcomes of substance use treatment and protects against relapse after treatment completion. Unemployment rates are high for people with substance use disorders (SUD) who undergo treatment, with Norwegian estimates ranging from 81 to 91%. Evidence-based vocational models are lacking for patients in SUD treatment but exist for patients with psychosis in terms of Individual Placement and Support (IPS). The aim of the IPS for substance use disorders (IPS-SUD) trial is to investigate the effect of IPS in a SUD population. Methods/design The IPS-SUD trial is a randomized controlled trial (RCT) comparing IPS to an enhanced control intervention. The study is a seven-site, two-arm, pragmatic, parallel-group, superiority RCT. Participants are randomly assigned (1:1) to receive either IPS plus treatment as usual (TAU) or to receive a self-help guide book and 12-h workshop plus 1-h individual vocational guidance plus TAU. Aiming to recruit 200 participants, we will be able to detect a 20% difference in the main outcome of employment with 90% power. We will make assessments at inclusion and at 6- and 12-month follow-ups and obtain outcome data on employment from national mandatory registries. The primary outcome will be at least 1 day of competitive employment during the 18-month follow-up period. Secondary employment outcomes will capture the pattern and extent of employment in terms of total time worked (days/hours), time to first employment, number of different jobs, duration of the longest employment, and sustained employment. Secondary non-employment outcomes will be substance use, mental distress, and quality of life measured by validated instruments at 6, 12, and 18 months follow-up assessments. To be eligible, participants must be between 18 and 65 years, currently unemployed and in treatment for SUD. Discussion The IPS-SUD trial will provide evidence for the use of IPS in a SUD population. Findings from the study will have implications for service delivery. Trial registration ClinicalTrials.gov NCT04289415 . Registered on February 28, 202