Periodic Reporting for period 1 - SPIN-MA (Schizophrenia Psychological Interventions Network Meta-Analysis of randomized evidence)
Periodo di rendicontazione: 2016-10-01 al 2018-09-30
Schizophrenia is a debilitating disorder that has a huge burden on patients, relatives and society in terms of loss of quality of life, loss of productivity and stigmatization.
Psychological interventions are currently regarded as necessary to be integrated in the care for schizophrenia.
In such a context, it is important to ascertain the efficacy and tolerability of psychological treatments, in order to provide patients and clinicians with information on the best treatment options and relieve the burden connected with this illness.
However all the available knowledge about psychological treatments for schizophrenia is limited to pairwise meta-analyses, which are able to compare only two treatments at a time and to pool results only when a comparison of two treatments was considered in existing studies. The comparative efficacy of psychological interventions all together has not been checked yet. As a result, it is still currently unclear which are the most efficacious, the most acceptable and the best tolerable psychological treatments for schizophrenia.
The aim of this project is to overcome this gap in the current knowledge applying a methodology called network meta-analysis. This novel approach allows to provide information on the comparison of two treatments even when they were not directly studied in a trial, and to have therefore a more comprehensive picture on the efficacy of the various psychological treatments.
This is a key information at different levels: for patients, to be aware of the different treatment options and their efficacy, and be therefore active in the decision making process; for clinicians, in order to inform the individual decision making process of the best treatment approach for the individual patient; for policy makers, for meaningful allocation of resources and offer of the best treatment options at a larger scale.
Psychological interventions are currently regarded as necessary to be integrated in the care for schizophrenia.
In such a context, it is important to ascertain the efficacy and tolerability of psychological treatments, in order to provide patients and clinicians with information on the best treatment options and relieve the burden connected with this illness.
However all the available knowledge about psychological treatments for schizophrenia is limited to pairwise meta-analyses, which are able to compare only two treatments at a time and to pool results only when a comparison of two treatments was considered in existing studies. The comparative efficacy of psychological interventions all together has not been checked yet. As a result, it is still currently unclear which are the most efficacious, the most acceptable and the best tolerable psychological treatments for schizophrenia.
The aim of this project is to overcome this gap in the current knowledge applying a methodology called network meta-analysis. This novel approach allows to provide information on the comparison of two treatments even when they were not directly studied in a trial, and to have therefore a more comprehensive picture on the efficacy of the various psychological treatments.
This is a key information at different levels: for patients, to be aware of the different treatment options and their efficacy, and be therefore active in the decision making process; for clinicians, in order to inform the individual decision making process of the best treatment approach for the individual patient; for policy makers, for meaningful allocation of resources and offer of the best treatment options at a larger scale.
We performed all the necessary steps that are part of a systematic review and network and meta-analysis:
- study protocol , in which all the methods are defined a priori, as a guarantee of methodological rigor (available here: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=67795 and published here: https://bmjopen.bmj.com/content/8/3/e019280);
- systematic searches in the main relevant databases, in order to identify studies comparing psychological interventions with each other or with a non-pharmacological control condition in people with schizophrenia who presented active positive symptoms;
- screening of the 21772 records search results by titles and abstracts, and then by reading 2754 articles in full;
- data extraction from the 53 included studies on an Access database specifically prepared for this project (Figure 1);
- data analysis with the software R;
- writing, submitting and publishing scientific reports;
- oral presentations in international conferences;
- organization of other dissemination and outreach activities (see below).
Treatments included are shown in Figure 2. The greater amount of information was available for the comparison between cognitive behavioral therapy (CBT) and treatment as usual (TAU). The results showed that CBT was associated with a higher reduction of positive symptoms compared to TAU (Figure 3). CBT showed a benefit in comparison to TAU also for other outcomes that we measured, i.e. reduction of overall and negative symptoms of schizophrenia (Figure 4), number of patients who benefitted from the therapy, quality of life and functioning, but it was also associated with a higher number of patients leaving the study before the end of the treatment (Figure 3).
The results are reported in full and discussed in details in our publication (https://onlinelibrary.wiley.com/doi/epdf/10.1002/wps.20577). In synthesis, our interpretation is that CBT can be challenging and requires a substantial investment of energies from the person, and for this reason it might be not suitable for every patient and was associated with high dropout rates. These results may contribute to the decision process of the best treatment for the individual patient, which should be discussed individually with the therapist.
The following activities were carried out for exploitation and dissemination of results to different target audiences:
1) 2 scientific publications, available open access on international peer-reviewed journals (BMC Psychiatry, World Psychiatry);
2) oral presentations and posters at 5 international conferences and at a national one, “10th Psychoedukations-Kongress an der TU München. Psychoeducation für Patienten und Angehörige: ein starkes Trio!”, specifically addressing patients and relatives;
3) lectures and seminars (for professionals at the Department of Psychiatry and Psychotherapy at TUM, workshop with staff at University of Bern during the secondment period there, lecture for medical students of the course “Evidence based medicine”);
4) affiliation and collaboration with the patient organization “BASTA – Bündnis für psychisch erkrankte Menschen”, involving patients, relatives and professionals. In this context, three meeting in schools with high schools students classes;
5) preparation of a lay version of the project, understandable by non-professionals, prepared in collaboration with the patients organization BASTA and disseminated through their newsblog;
6) author’s websites and profiles on Google Scholar and Researchgate;
7) creation of a project webpage (https://www.psykl.mri.tum.de/node/69) including additional analyses and data, and the lay version of the project;
8) participation with a talk at the event “Munich 15x4”, aiming at disseminate research results to the general public and organized for February 2019.
- study protocol , in which all the methods are defined a priori, as a guarantee of methodological rigor (available here: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=67795 and published here: https://bmjopen.bmj.com/content/8/3/e019280);
- systematic searches in the main relevant databases, in order to identify studies comparing psychological interventions with each other or with a non-pharmacological control condition in people with schizophrenia who presented active positive symptoms;
- screening of the 21772 records search results by titles and abstracts, and then by reading 2754 articles in full;
- data extraction from the 53 included studies on an Access database specifically prepared for this project (Figure 1);
- data analysis with the software R;
- writing, submitting and publishing scientific reports;
- oral presentations in international conferences;
- organization of other dissemination and outreach activities (see below).
Treatments included are shown in Figure 2. The greater amount of information was available for the comparison between cognitive behavioral therapy (CBT) and treatment as usual (TAU). The results showed that CBT was associated with a higher reduction of positive symptoms compared to TAU (Figure 3). CBT showed a benefit in comparison to TAU also for other outcomes that we measured, i.e. reduction of overall and negative symptoms of schizophrenia (Figure 4), number of patients who benefitted from the therapy, quality of life and functioning, but it was also associated with a higher number of patients leaving the study before the end of the treatment (Figure 3).
The results are reported in full and discussed in details in our publication (https://onlinelibrary.wiley.com/doi/epdf/10.1002/wps.20577). In synthesis, our interpretation is that CBT can be challenging and requires a substantial investment of energies from the person, and for this reason it might be not suitable for every patient and was associated with high dropout rates. These results may contribute to the decision process of the best treatment for the individual patient, which should be discussed individually with the therapist.
The following activities were carried out for exploitation and dissemination of results to different target audiences:
1) 2 scientific publications, available open access on international peer-reviewed journals (BMC Psychiatry, World Psychiatry);
2) oral presentations and posters at 5 international conferences and at a national one, “10th Psychoedukations-Kongress an der TU München. Psychoeducation für Patienten und Angehörige: ein starkes Trio!”, specifically addressing patients and relatives;
3) lectures and seminars (for professionals at the Department of Psychiatry and Psychotherapy at TUM, workshop with staff at University of Bern during the secondment period there, lecture for medical students of the course “Evidence based medicine”);
4) affiliation and collaboration with the patient organization “BASTA – Bündnis für psychisch erkrankte Menschen”, involving patients, relatives and professionals. In this context, three meeting in schools with high schools students classes;
5) preparation of a lay version of the project, understandable by non-professionals, prepared in collaboration with the patients organization BASTA and disseminated through their newsblog;
6) author’s websites and profiles on Google Scholar and Researchgate;
7) creation of a project webpage (https://www.psykl.mri.tum.de/node/69) including additional analyses and data, and the lay version of the project;
8) participation with a talk at the event “Munich 15x4”, aiming at disseminate research results to the general public and organized for February 2019.
This project represents a significant step forward in the field of interventions for schizophrenia.
The results produced had so far an impact:
- on the scientific community, contributing to the debate of psychological treatments for schizophrenia. We were contacted by other authors of the field who read our publications, and with whom we discussed and commented our results, starting a fruitful exchange. We are also following the debate about the topic in Twitter (our work was mentioned 121 times so far);
- on patients and families, who were interested in knowing which psychological treatment options are available and what are their results in the studies;
- on lay public (lay summary version; BASTA newsletter, Psychoeducation congress);
- on high school students: the students had the opportunity to come into contact with the reality of mental health problems, in a constructive context that prevents prejudice and stigmatization;
- on medical undergraduate students, who were sensitized on issues about research on mental health topics;
- on staff members (medical doctors, psychiatrists, psychotherapists, psychiatrists and psychologists in training, nurses and other staff of the psychiatric clinic), who were updated with these brand new evidence;
- on policy makers: the supervisor of the project, Professor Stefan Leucht, is a member of the board of the German national institution responsible for guideline production (DGPPN). In this context the need for a better evidence base about psychological treatments for schizophrenia has been highlighted several times, and our results will cover this gap, contributing to the final goal of providing the best possible treatment for people suffering from schizophrenia.
The results produced had so far an impact:
- on the scientific community, contributing to the debate of psychological treatments for schizophrenia. We were contacted by other authors of the field who read our publications, and with whom we discussed and commented our results, starting a fruitful exchange. We are also following the debate about the topic in Twitter (our work was mentioned 121 times so far);
- on patients and families, who were interested in knowing which psychological treatment options are available and what are their results in the studies;
- on lay public (lay summary version; BASTA newsletter, Psychoeducation congress);
- on high school students: the students had the opportunity to come into contact with the reality of mental health problems, in a constructive context that prevents prejudice and stigmatization;
- on medical undergraduate students, who were sensitized on issues about research on mental health topics;
- on staff members (medical doctors, psychiatrists, psychotherapists, psychiatrists and psychologists in training, nurses and other staff of the psychiatric clinic), who were updated with these brand new evidence;
- on policy makers: the supervisor of the project, Professor Stefan Leucht, is a member of the board of the German national institution responsible for guideline production (DGPPN). In this context the need for a better evidence base about psychological treatments for schizophrenia has been highlighted several times, and our results will cover this gap, contributing to the final goal of providing the best possible treatment for people suffering from schizophrenia.