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Individual Placement and Support supplemented with cognitive remediation and work-related social skills training in Denmark: study protocol for a randomized controlled trial.

ABSTRACT: Individual Placement and Support (IPS) appears to be an effective vocational intervention for obtaining competitive employment for people with severe mental illness. However, no IPS studies or trials have been conducted in Denmark, a country characterized by a specialized labor market with a higher minimum wage and fewer entry-level jobs in comparison with other countries such as the US. Furthermore, long-term job retention and economic self-sufficiency have not been clearly demonstrated. Integrating methods such as cognitive remediation and work-related social skills training may be ways to address these issues.The trial design is an investigator-initiated, randomized, assessor-blinded, multi-center trial. A total of 750 patients with severe mental illness will be randomly assigned into three groups: (1) IPS, (2) IPS enhanced with cognitive remediation and work-related social skills training, and (3) service as usual. The primary outcome is number of hours in competitive employment or education at 18-month follow-up. Secondary and exploratory outcomes are money earned, days to first employment, symptoms, functional level, self-esteem, and self-efficacy at 18-month follow-up. Thirty- and 60-month follow-ups will be register-based.This will be one of the largest randomized trials investigating IPS to date. The trial will be conducted with high methodological quality in order to reduce the risk of bias. If the results of this trial show that IPS, or IPS enhanced with cognitive remediation and work-related social skills training, is superior to service as usual, this will support preliminary evidence. Furthermore, it will show that the method is generalizable to a variety of labor markets and welfare systems and provide important knowledge about the effect of adding cognitive remediation and social skills training to the IPS intervention.ClinicalTrials registration number: NCT01722344 (registered 2 Nov. 2012).

SUBMITTER: Christensen TN

PROVIDER: S-EPMC4479316 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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Project description:ImportanceIndividual placement and support (IPS) seems to be an effective vocational intervention for people with severe mental illness, but its effects have not yet been shown in the Danish welfare model. Also, effects may be enhanced by adding cognitive remediation and work-focused social skills training (IPS with enhancements [IPSE]).ObjectivesTo investigate the effects of IPS vs IPSE vs service as usual (SAU) on a population of individuals with severe mental illness in Denmark.Design, setting, and participantsThis was an investigator-initiated, 3-group, parallel, assessor-blinded randomized clinical trial that used early-intervention teams or community mental health services in 3 Danish cities to recruit participants with severe mental illness. Participants were randomly assigned to receive IPS, IPSE, or SAU from November 2012 to February 2016, and follow-up continued until August 2017.InterventionsParticipants allocated to the IPS intervention received vocational support per the principles of the IPS model. Participants in the IPSE arm received cognitive remediation and social skills training in addition to IPS. The group receiving SAU received vocational rehabilitation at the Danish job centers.Main outcomes and measuresThe primary outcome was the number of hours in competitive employment or education during the 18-month follow-up. Secondary outcomes included intergroup differences in employment or education at any point during follow-up; time to employment or education; and cognitive and social functioning, self-esteem, and self-efficacy.ResultsOf the 720 included participants (mean [SD] age, 32.8 [9.9] years; 276 [38.3%] women), 243 received IPS, 238 received IPSE, and 239 received SAU. Most participants (551 [76.5%]) were diagnosed with a schizophrenia spectrum disorder. During the 18-month follow-up, the IPSE group worked or studied a mean (SD) of 488.1 (735.6) hours, compared with 340.8 (573.8) hours in the group receiving SAU (success-rate difference [SRD], 0.151 [95% CI, 0.01-0.295]; P = .016). The mean (SD) in the IPS group was 411 (656.9) (SRD, 0.127 [95% CI, -0.017 to 0.276]; P = .004). There was no difference between IPS and IPSE in any vocational outcomes, and the 3 groups showed no differences in any nonvocational outcomes, except that the IPS and IPSE groups were more satisfied with the services received than the group receiving SAU (IPS vs SAU: SRD, 0.310 [95% CI, 0.167-0.445]); IPSE vs SAU: SRD, 0.341 [95% CI, 0.187-0.478]).Conclusions and relevanceCompared with SAU, IPS and IPSE seem to be viable routes to increase employment and education rates in people with severe mental illness in Denmark, but no additional effects were observed by enhancing IPS.Trial registrationClinicalTrials.gov identifier: NCT01722344.

Project description:ObjectiveImpaired cognition is a hallmark of schizophrenia spectrum disorders, including schizotypal personality disorder, and it is the best predictor of functional outcome. Cognitive remediation therapy has demonstrated efficacy for improving cognition, augmenting other rehabilitation efforts in schizophrenia, and effecting gains in real-world functioning. Pharmacological augmentation of cognitive remediation has been attempted, but the effects of augmentation on combined therapies, such as cognitive remediation and social skills training, have not been studied.MethodsTwenty-eight participants with schizotypal personality disorder enrolled in an 8-week, randomized, double-blind, placebo-controlled trial of guanfacine plus cognitive remediation and social skills training (15 guanfacine, 13 placebo). Cognition was assessed with the MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) Consensus Cognitive Battery (MCCB), social cognition with the Movie for the Assessment of Social Cognition (MASC), and functional capacity with the University of California San Diego Performance-Based Skills Assessment (UPSA).ResultsA statistically significant pre- versus posttreatment effect was observed for MCCB speed of processing, verbal learning, and visual learning and UPSA total score. A significant time-by-medication (guanfacine, placebo) interaction was observed for MCCB reasoning and problem solving and UPSA total score; the time-by-treatment interaction approached significance for MASC hypomentalizing errors.ConclusionsBoth guanfacine and cognitive remediation plus social skills training were well tolerated, with no side effects or dropouts. Participants treated with cognitive remediation, social skills training, and guanfacine demonstrated statistically significant improvements in reasoning and problem solving, as well as in functional capacity and possibly social cognition, compared with those treated with cognitive remediation, social skills training, and placebo. Cognitive remediation plus social skills training may be an appropriate intervention for individuals with schizotypal personality disorder, and guanfacine appears to be a promising pharmaceutical augmentation to this psychosocial intervention.

Project description:AimsIndividual placement and support (IPS) is an evidence-based service model to support people with mental disorders in obtaining and sustaining competitive employment. IPS is increasingly offered to a broad variety of service users. In this meta-analysis we analysed the relative effectiveness of IPS for different subgroups of service users both based on the diagnosis and defined by a range of clinical, functional and personal characteristics.MethodsWe included randomised controlled trials that evaluated IPS for service users diagnosed with any mental disorder. We examined effect sizes for the between-group differences at follow-up for three outcome measures (employment rate, job duration and wages), controlling for methodological confounders (type of control group, follow-up duration and geographic region). Using sensitivity analyses of subgroup differences, we analysed moderating effects of the following diagnostic, clinical, functional and personal characteristics: severe mental illness (SMI), common mental disorders (CMD), schizophrenia spectrum disorders, mood disorders, duration of illness, the severity of symptoms, level of functioning, age, comorbid alcohol and substance use, education level and employment history.ResultsIPS is effective in improving employment outcomes compared to the control group in all subgroups, regardless of any methodological confounder. However, IPS was relatively more effective for service users with SMIs, schizophrenia spectrum disorders and a low symptom severity. Although IPS was still effective for people with CMD and with major depressive disorder, it was relatively less effective for these subgroups. IPS was equally effective after both a short and a long follow-up period. However, we found small, but clinically not meaningful, differences in effectiveness of IPS between active and passive control groups. Finally, IPS was relatively less effective in European studies compared to non-European studies, which could be explained by a potential benefits trap in high welfare countries.ConclusionsIPS is effective for all different subgroups, regardless of diagnostic, clinical, functional and personal characteristics. However, there might be a risk of false-positive subgroup outcomes and results should be handled with caution. Future research should focus on whether, and if so, how the IPS model should be adapted to better meet the vocational needs of people with CMD and higher symptom severity.

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Individual Placement and Support supplemented with cognitive remediation and work-related social skills training in Denmark: study protocol for a randomized controlled trial.

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