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Lind, A., Cao, Y., Hesser, H., Hårdstedt, M., Jansson, S. P. O., Lernmark, Å., . . . Jendle, J. (2024). Anxiety, depression and quality of life in relation to SARS-CoV-2 antibodies in individuals living with diabetes during the second wave of COVID-19. Diabetes epidemiology and management, 13, Article ID 100194.
Open this publication in new window or tab >>Anxiety, depression and quality of life in relation to SARS-CoV-2 antibodies in individuals living with diabetes during the second wave of COVID-19
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2024 (English)In: Diabetes epidemiology and management, ISSN 2666-9706, Vol. 13, article id 100194Article in journal (Refereed) Published
Abstract [en]

Aims: The objective was to compare anxiety, depression, and quality of life (QoL) in individuals living with type 1 (T1D) and type 2 (T2D) diabetes with matched controls during the second wave of the COVID-19 pandemic.

Methods: Via randomization, individuals living with diabetes T1D (n = 203) and T2D (n = 413), were identified during February-July 2021 through health-care registers. Population controls (n = 282) were matched for age, gender, and residential area. Questionnaires included self-assessment of anxiety, depression, QoL, and demographics in relation to SARS-CoV-2 exposure. Blood was collected through home-capillary sampling, and SARS-CoV-2 Nucleocapsid (NCP) and Spike antibodies (SC2_S1) were determined by multiplex Antibody Detection by Agglutination-PCR (ADAP) assays.

Results: Younger age and health issues were related to anxiety, depression, and QoL, with no differences between the study groups. Female gender was associated with anxiety, while obesity was associated with lower QoL. The SARS-CoV-2 NCP seroprevalence was higher in T1D (8.9 %) compared to T2D (3.9 %) and controls (4.0 %), while the SARS-CoV-2 SC2_S1 seroprevalence was higher for controls (25.5 %) compared to T1D (16.8 %) and T2D (14.0 %).

Conclusions: A higher SARS-CoV-2 infection rate in T1D may be explained by younger age and higher employment rate, and the associated increased risk for viral exposure.

Place, publisher, year, edition, pages
Elsevier, 2024
Keywords
Diabetes, SARS-CoV-2, COVID-19, Anxiety, Depression, Quality of life, Virus antibodies
National Category
Endocrinology and Diabetes
Identifiers
urn:nbn:se:oru:diva-111559 (URN)10.1016/j.deman.2023.100194 (DOI)001154927400001 ()2-s2.0-85182889973 (Scopus ID)
Funder
Swedish Foundation for Strategic Research, IRC15-0067
Note

This work was supported by NIH SBIR 2R44DK110005-02, Strategic Research Area Exodiab Dnr 2009-1039, and the Swedish Foundation for Strategic Research Dnr IRC15-0067.

Available from: 2024-02-14 Created: 2024-02-14 Last updated: 2024-02-14Bibliographically approved
Molander, P., Novo, M., Ringqvist, Å., Hållstam, A., Hesser, H., Löfgren, M., . . . Gerdle, B. (2024). Interdisciplinary pain rehabilitation for patients with Ehlers-Danlos syndrome and hypermobility spectrum disorders. Journal of Rehabilitation Medicine, 56, Article ID jrm12431.
Open this publication in new window or tab >>Interdisciplinary pain rehabilitation for patients with Ehlers-Danlos syndrome and hypermobility spectrum disorders
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2024 (English)In: Journal of Rehabilitation Medicine, ISSN 1650-1977, E-ISSN 1651-2081, Vol. 56, article id jrm12431Article in journal (Refereed) Published
Abstract [en]

OBJECTIVE: Chronic pain is a common manifestation of Ehlers-Danlos syndrome and hypermobility spectrum disorders; thus it is often suggested that patients undergo generic interdisciplinary pain rehabilitation, despite there being little evidence to support this decision. The aim of this study is to examine the effectiveness of standard rehabilitation programmes for chronic pain on patients with Ehlers-Danlos syndrome and hypermobility spectrum disorders, compared with patients with other chronic pain disorders.

SUBJECTS: Data, collected between 2008 and 2016, were extracted from a Swedish national registry. The patient data comprised of 406 cases with Ehlers-Danlos syndrome or hypermobility spectrum disorders, 784 cases with a whiplash-related diagnosis, 3713 cases with diagnoses relating to spinal pain, and 2880 cases of fibromyalgia.

METHODS: The differences between groups on key outcome measures from pre- to 1-year follow-up after interdisciplinary pain rehabilitation were analysed using linear mixed effects models. Sensitivity analysis in the form of pattern-mixture modelling was conducted to discern the impact of missing data. RESULTS: No significant differences were found in improvements from pre- to 1-year follow-up for patients with Ehlers-Danlos syndrome or hypermobility spectrum disorder compared with other diagnostic groups regarding measures of health-related quality of life, mental health, or fatigue. At follow-up, differences in pain interference (d = -0.34 (95% confidence interval [95% CI] -0.5 to -0.18)), average pain (d = 0.22 (95% CI 0.11-0.62)) and physical functioning (d = 2.19 (95% CI 1.61-2.77)) were detected for the group with spinal-related diagnoses in relation to those with EDS/HSD, largely due to pre-treatment group differences. Sensitivity analysis found little evidence for missing data influencing the results.

CONCLUSION: This study suggests that patients with Ehlers-Danlos syndrome/hypermobility spectrum disorders may benefit from inclusion in an interdisciplinary pain rehabilitation programme.

Place, publisher, year, edition, pages
Foundation for Rehabilitation Information, 2024
National Category
General Practice
Identifiers
urn:nbn:se:oru:diva-111471 (URN)10.2340/jrm.v56.12431 (DOI)38323531 (PubMedID)
Funder
Region Östergötland
Available from: 2024-02-08 Created: 2024-02-08 Last updated: 2024-02-13Bibliographically approved
Larsson, J., Bjureberg, J., Zhao, X. & Hesser, H. (2024). The inner workings of anger: A network analysis of anger and emotion regulation. Journal of Clinical Psychology, 80(2), 437-455
Open this publication in new window or tab >>The inner workings of anger: A network analysis of anger and emotion regulation
2024 (English)In: Journal of Clinical Psychology, ISSN 0021-9762, E-ISSN 1097-4679, Vol. 80, no 2, p. 437-455Article in journal (Refereed) Published
Abstract [en]

OBJECTIVE: This study aimed to investigate the interrelations between emotion regulation strategies and different types of anger using network analysis.

METHOD: Data were drawn from a cross-sectional sample of 538 adults (55% females; mean age = 39.8 years, SD = 12.3) seeking treatment for anger. Data were collected between March and November 2019 in Sweden. Participants completed measures of anger problems (anger expression, anger suppression, angry reactions, anger rumination, trait anger, hostility, physical aggression, and verbal aggression) and emotion regulation (cognitive reappraisal, expressive suppression, anger relaxation, and five mindfulness strategies). To determine whether distinct clusters of anger nodes would emerge, exploratory graph analysis was employed. Based on clustering of nodes, we estimated separate networks including all measures of emotion regulation.

RESULTS: Two clusters emerged: one consisting primarily of cognitive components of anger, and another of behavioral. Across networks, anger nodes were strongly interconnected, and anger rumination and anger suppression were especially influential. Several direct links were found between specific emotion regulation strategies and cognitive components of anger, whereas most strategies were only indirectly related to angry behavior. Cognitive reappraisal showed no direct link with any of the anger nodes.

CONCLUSIONS: Our findings reveal potential pathways by which different emotion regulation strategies may influence different types of anger, which could serve as therapeutic targets.

Place, publisher, year, edition, pages
John Wiley & Sons, 2024
Keywords
Aggression, anger, emotion regulation, network analysis
National Category
Applied Psychology
Identifiers
urn:nbn:se:oru:diva-109805 (URN)10.1002/jclp.23622 (DOI)001107050600001 ()37975317 (PubMedID)2-s2.0-85177070145 (Scopus ID)
Available from: 2023-11-20 Created: 2023-11-20 Last updated: 2024-02-06Bibliographically approved
Larsson, J., Bjureberg, J. & Hesser, H. (2023). Anger profiles among individuals seeking treatment for maladaptive anger: Associations with emotion regulation. Clinical Psychology and Psychotherapy, 30(3), 599-610
Open this publication in new window or tab >>Anger profiles among individuals seeking treatment for maladaptive anger: Associations with emotion regulation
2023 (English)In: Clinical Psychology and Psychotherapy, ISSN 1063-3995, E-ISSN 1099-0879, Vol. 30, no 3, p. 599-610Article in journal (Refereed) Published
Abstract [en]

Individuals who experience problems with anger represent a heterogeneous group. Identifying clinically relevant subtypes of anger may advance treatment research. In the current study, latent profile analysis (LPA) was conducted to explore if distinct subtypes of anger could be identified within a sample of individuals seeking treatment for maladaptive anger (N = 538; 55.4% females; mean age = 39.78, SD = 12.28). Furthermore, the utility of the empirical classification was examined based on differences in usage of emotion regulation strategies (cognitive reappraisal, expressive suppression, mindful emotion awareness and relaxation) across subtypes. Four anger profiles were identified in the best-fitted LPA model: Low Anger (n = 153, 28.4%), Anger In (n = 91, 16.9%), Moderate Anger (n = 193, 35.9%) and High Anger (n = 101, 35.5%). Results from the multinominal regression revealed that the use of emotion regulation differed across all profiles. Participants from the High Anger and Anger In profiles exhibited distinct patterns of dysfunctional emotion regulation. The results add to the increasing amount of evidence demonstrating a link between emotion regulation strategies and maladaptive anger. Clinical implications on how to tailor treatments for individuals with maladaptive anger are discussed.

Place, publisher, year, edition, pages
John Wiley & Sons, 2023
Keywords
Anger, anger subtypes, emotion regulation, latent profile analysis, maladaptive anger
National Category
Psychiatry
Identifiers
urn:nbn:se:oru:diva-103173 (URN)10.1002/cpp.2821 (DOI)000915785200001 ()36607221 (PubMedID)2-s2.0-85146347041 (Scopus ID)
Available from: 2023-01-23 Created: 2023-01-23 Last updated: 2023-12-08Bibliographically approved
Fors, M., Öberg, B., Enthoven, P., Schröder, K., Hesser, H., Hedevik, H. & Abbott, A. (2023). Are illness perceptions and patient self-care enablement mediators of treatment effect in best practice physiotherapy low back pain care? Secondary mediation analyses in the BetterBack trial. Physiotherapy Theory and Practice, 1-14
Open this publication in new window or tab >>Are illness perceptions and patient self-care enablement mediators of treatment effect in best practice physiotherapy low back pain care? Secondary mediation analyses in the BetterBack trial
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2023 (English)In: Physiotherapy Theory and Practice, ISSN 0959-3985, E-ISSN 1532-5040, p. 1-14Article in journal (Refereed) Epub ahead of print
Abstract [en]

INTRODUCTION: A best practice physiotherapy model of care (BetterBack MoC) for low back pain (LBP) aimed to improve patients' illness perceptions and self-care enablement, according to the Common-Sense Model of Self-Regulation (CSM).

OBJECTIVE: To confirm if illness perceptions and patient self-care enablement, in line with the CSM, are mediators of treatment effects on disability and pain of the BetterBack MoC for patients with LBP compared to routine primary care. A secondary aim was to explore if illness perceptions and patient self-care enablement are mediators of guideline adherent care.

METHODS: Pre-planned single mediation analyses tested whether hypothesized mediators at 3 months mediated the treatment effect of the MoC (n = 264) compared to routine care (n = 203) on disability and pain at 6 months. Secondary mediation analyses compared guideline adherent care with non-adherent care.

RESULTS: No indirect effects were identified. The BetterBack intervention did not have superior effects over routine care on the hypothesized mediators. Illness perceptions and self-care enablement were significantly associated with disability and pain at 6 months. Secondary analyses showed significant indirect effects of guideline adherent care through tested mediators.

CONCLUSION: Despite no indirect effects, patients' illness perceptions and self-care enablement were associated with disability and back pain intensity outcomes and are potentially relevant treatment targets.

Place, publisher, year, edition, pages
Taylor & Francis, 2023
Keywords
Physiotherapy, illness perception, low back pain, mediation analysis, self-management
National Category
Physiotherapy
Identifiers
urn:nbn:se:oru:diva-105988 (URN)10.1080/09593985.2023.2210676 (DOI)000992675300001 ()37204261 (PubMedID)2-s2.0-85159687254 (Scopus ID)
Funder
Region Östergötland, RO-938179 RO-921021
Note

Funding agency:

Research Council in Southeast Sweden FORSSx?660371 FORSS?x?757721 FORSS?x?931966

Available from: 2023-05-22 Created: 2023-05-22 Last updated: 2023-12-08Bibliographically approved
Bjureberg, J., Ojala, O., Hesser, H., Häbel, H., Sahlin, H., Gratz, K. L., . . . Hellner, C. (2023). Effect of Internet-Delivered Emotion Regulation Individual Therapy for Adolescents With Nonsuicidal Self-Injury Disorder: A Randomized Clinical Trial. JAMA Network Open, 6(7), Article ID e2322069.
Open this publication in new window or tab >>Effect of Internet-Delivered Emotion Regulation Individual Therapy for Adolescents With Nonsuicidal Self-Injury Disorder: A Randomized Clinical Trial
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2023 (English)In: JAMA Network Open, E-ISSN 2574-3805, Vol. 6, no 7, article id e2322069Article in journal (Refereed) Published
Abstract [en]

IMPORTANCE: Nonsuicidal self-injury is prevalent in adolescence and associated with adverse clinical outcomes. Effective interventions that are brief, transportable, and scalable are lacking.

OBJECTIVE: To test the hypotheses that an internet-delivered emotion regulation individual therapy for adolescents delivered adjunctive to treatment as usual is superior to treatment as usual only in reducing nonsuicidal self-injury and that improvements in emotion regulation mediate these treatment effects.

DESIGN, SETTING, AND PARTICIPANTS: This 3-site, single-masked, randomized superiority trial enrolled participants from November 20, 2017, to April 9, 2020. Eligible participants were aged between 13 and 17 years and met diagnostic criteria for nonsuicidal self-injury disorder; they were enrolled as a mixed cohort of consecutive patients and volunteers. Parents participated in parallel to their children. The primary end point was at 1 month after treatment. Participants were followed up at 3 months posttreatment. Data collection ended in January 2021.

INTERVENTIONS: Twelve weeks of therapist-guided, internet-delivered emotion regulation individual therapy delivered adjunctive to treatment as usual vs treatment as usual only.

MAIN OUTCOMES AND MEASURES: Primary outcome was the youth version of the Deliberate Self-harm Inventory, both self-reported by participants prior to treatment, once every week during treatment, and for 4 weeks posttreatment, and clinician-rated by masked assessors prior to treatment and at 1 and 3 months posttreatment.

RESULTS: A total of 166 adolescents (mean [SD] age, 15.0 [1.2] years; 154 [92.8%] female) were randomized to internet-delivered emotion regulation therapy plus treatment as usual (84 participants) or treatment as usual only (82 participants). The experimental intervention was superior to the control condition in reducing clinician-rated nonsuicidal self-injury (82% vs 47% reduction; incidence rate ratio, 0.34; 95% CI, 0.20-0.57) from pretreatment to 1-month posttreatment. These results were maintained at 3-month posttreatment. Improvements in emotion dysregulation mediated improvements in self-injury during treatment.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, a 12-week, therapist-guided, internet-delivered emotion regulation therapy delivered adjunctive to treatment as usual was efficacious in reducing self-injury, and mediation analysis supported the theorized role of emotion regulation as the mechanism of change in this treatment. This treatment may increase availability of evidence-based psychological treatments for adolescents with nonsuicidal self-injury.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03353961.

Place, publisher, year, edition, pages
American Medical Association (AMA), 2023
National Category
Psychiatry
Identifiers
urn:nbn:se:oru:diva-107468 (URN)10.1001/jamanetworkopen.2023.22069 (DOI)001059367900001 ()37440232 (PubMedID)2-s2.0-85164844339 (Scopus ID)
Funder
Swedish Research Council, 2014.1008 2017-01506Fredrik och Ingrid Thurings StiftelseKnut and Alice Wallenberg Foundation, 2018.0426The Royal Swedish Academy of Letters, History and Antiquities (KVHAA)
Note

Funding agencies:

Clas Groschinsky's Foundation SF18121

Sven Jerring Foundation

Kempe-Carlgrenska Foundation

Bror Gadelius Foundation

Stiftelsen Natur Kultur

National Self Injury Project in Sweden

Markus and Amelia Wallenberg Foundation MAW2014.0021

 

Available from: 2023-08-09 Created: 2023-08-09 Last updated: 2024-01-11Bibliographically approved
Zhao, X., Boersma, K., Gerdle, B., Molander, P. & Hesser, H. (2023). Fear network and pain extent: Interplays among psychological constructs related to the fear-avoidance model. Journal of Psychosomatic Research, 167, Article ID 111176.
Open this publication in new window or tab >>Fear network and pain extent: Interplays among psychological constructs related to the fear-avoidance model
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2023 (English)In: Journal of Psychosomatic Research, ISSN 0022-3999, E-ISSN 1879-1360, Vol. 167, article id 111176Article in journal (Refereed) Published
Abstract [en]

Objective: Psychological constructs related to the fear-avoidance model such as fear of movement, pain catastrophizing, and affective distress have been found to be inter-related among patients with chronic pain. However, relationships of these constructs have mostly been examined using regression-based analyses. This cross-sectional study employs a novel analytical approach, network analysis, to illustrate the complex interplays among these variables as well as pain intensity and pain interference.

Methods: This study utilized the Swedish Quality Registry for Pain Rehabilitation, including data from 10,436 participants (76.0% women; Mage = 45.0 years). Networks were analyzed separately for patients with different pain extents (i.e., numbers of pain locations) as the interplays may differ qualitatively depending on pain extent.

Results: We found that patients with a larger pain extent showed a worse clinical presentation (i.e., more depression and anxiety, increased fear of movement and pain interference), and their network differed from the patients with a smaller number of pain extent in terms of how strongly key variables were interconnected. In all network models, pain interference and catastrophizing showed consistently influential roles.

Conclusion: Our findings highlight the interactive nature of psychological aspects of pain and how interrelated associations differ depending on pain extent. Findings are discussed based on ideas on how both fear and pain become overgeneralized.

Place, publisher, year, edition, pages
Elsevier, 2023
Keywords
Catastrophizing, Pain extent, Network analysis, Moderated network, Fear-avoidance
National Category
Psychology
Research subject
Psychology
Identifiers
urn:nbn:se:oru:diva-104117 (URN)10.1016/j.jpsychores.2023.111176 (DOI)000944533000001 ()36773415 (PubMedID)2-s2.0-85147663952 (Scopus ID)
Funder
Afa Trygghetsförsäkringsaktiebolag, DNR 190054Swedish Research Council, 2015-02512Forte, Swedish Research Council for Health, Working Life and Welfare, 2017-00177
Available from: 2023-02-09 Created: 2023-02-09 Last updated: 2023-03-30Bibliographically approved
Frick, M. A., Hesser, H. & Sonuga-Barke, E. (2023). Pervasive versus situational childhood ADHD: latent classes and their clinical characteristics, based on parent and teacher ratings in a large longitudinal population sample. European Child and Adolescent Psychiatry
Open this publication in new window or tab >>Pervasive versus situational childhood ADHD: latent classes and their clinical characteristics, based on parent and teacher ratings in a large longitudinal population sample
2023 (English)In: European Child and Adolescent Psychiatry, ISSN 1018-8827, E-ISSN 1435-165XArticle in journal (Refereed) Epub ahead of print
Abstract [en]

Attention-deficit/hyperactivity disorder (ADHD) diagnoses require symptoms to be present in two settings. Low levels of concordance between symptoms rated at home and school raise questions regarding this approach. The aim was to examine whether there are sub-groups with context-specific expressions of ADHD symptoms (i.e., at home or school only) with clinically significant problems sufficient to support a new diagnostic formulation. We applied latent class transition analysis to parent and teacher data (N = 10,476) from the Avon Longitudinal Study of Parents and Children (ALSPAC), collected at ages 8, 10, and 20 years. We examined the short-term stability of emergent classes and their childhood and adult-associated risk profiles. In addition to an Unaffected class (~ 45%), there was a Pervasive Combined class with elevated inattentive and hyperactive/impulsive symptoms at both home and school (~ 11%) and three classes with situational expressions; School Combined (~ 9%), Home Combined (~ 18%), and School Inattentive (~ 16%). Stability ranged from 0.27 to 0.78. The Pervasive Combined class was most symptomatic and impaired. School inattentive also displayed clinical symptom levels, whereas the School and Home Combined classes displayed subclinical levels. Different profiles regarding sex, cognition, conduct problems, and substance use emerged for the three situational classes. Distinct groupings of pervasive and situational ADHD expressions are identifiable in the general population. The isolation of a stable and burdensome Pervasive Combined class lends support to the current diagnostic approach. However, there are indications of situational expressions of ADHD with clinical symptom levels and associated difficulties.

Place, publisher, year, edition, pages
Springer, 2023
Keywords
ALSPAC, Latent class analysis, Longitudinal, Pervasive and situational ADHD
National Category
Psychiatry
Identifiers
urn:nbn:se:oru:diva-109012 (URN)10.1007/s00787-023-02308-3 (DOI)001084812900001 ()37845375 (PubMedID)2-s2.0-85174207073 (Scopus ID)
Available from: 2023-10-17 Created: 2023-10-17 Last updated: 2023-12-08Bibliographically approved
Axelsson, E., Kern, D., Hedman-Lagerlöf, E., Lindfors, P., Palmgren, J., Hesser, H., . . . Ljótsson, B. (2023). Psychological treatments for irritable bowel syndrome: a comprehensive systematic review and meta-analysis. Cognitive Behaviour Therapy, 52(6), 565-584
Open this publication in new window or tab >>Psychological treatments for irritable bowel syndrome: a comprehensive systematic review and meta-analysis
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2023 (English)In: Cognitive Behaviour Therapy, ISSN 1650-6073, E-ISSN 1651-2316, Vol. 52, no 6, p. 565-584Article, review/survey (Refereed) Published
Abstract [en]

A wide range of psychological treatments have been found to reduce the symptoms of irritable bowel syndrome (IBS) but their relative effects are unclear. In this systematic review and meta-analysis, we determined the effects of psychological treatments for IBS, including subtypes of cognitive behavior therapy, versus attention controls. We searched 11 databases (March 2022) for studies of psychological treatments for IBS, reported in journal articles, books, dissertations, and conference abstracts. The resulting database comprised 9 outcome domains from 118 studies published in 1983-2022. Using data from 62 studies and 6496 participants, we estimated the effect of treatment type on improvement in composite IBS severity using random-effects meta-regression. In comparison with the attention controls, there was a significant added effect of exposure therapy (g = 0.52, 95% CI = 0.17-0.88) and hypnotherapy (g = 0.36, 95% CI = 0.06-0.67) when controlling for the pre- to post-assessment duration. When additional potential confounders were included, exposure therapy but not hypnotherapy retained a significant added effect. Effects were also larger with a longer duration, individual treatment, questionnaire (non-diary) outcomes, and recruitment outside of routine care. Heterogeneity was substantial. Tentatively, exposure therapy appears to be a particularly promising treatment for IBS. More direct comparisons in randomized controlled trials are needed. OSF.io identifier: 5yh9a.

Place, publisher, year, edition, pages
Routledge, 2023
Keywords
Functional gastrointestinal disorders, gut–brain interaction, psychotherapy, systematic review
National Category
Gastroenterology and Hepatology
Identifiers
urn:nbn:se:oru:diva-106576 (URN)10.1080/16506073.2023.2225745 (DOI)001013937400001 ()37341454 (PubMedID)2-s2.0-85162683468 (Scopus ID)
Funder
Region StockholmSwedish Research Council, 521-2013-2846Jane and Dan Olsson Foundation, 4-1559/2013Forte, Swedish Research Council for Health, Working Life and Welfare, 2014-4052
Available from: 2023-06-27 Created: 2023-06-27 Last updated: 2023-11-16Bibliographically approved
Bejerot, S., Eklund, D., Hesser, H., Hietala, M. A., Kariis, T., Lange, N., . . . Humble, M. B. (2023). Study protocol for a randomized controlled trial with rituximab for psychotic disorder in adults (RCT-Rits). BMC Psychiatry, 23(1), Article ID 771.
Open this publication in new window or tab >>Study protocol for a randomized controlled trial with rituximab for psychotic disorder in adults (RCT-Rits)
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2023 (English)In: BMC Psychiatry, E-ISSN 1471-244X, Vol. 23, no 1, article id 771Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: The role of inflammation in the aetiology of schizophrenia has gained wide attention and research on the association shows an exponential growth in the last 15 years. Autoimmune diseases and severe infections are risk factors for the later development of schizophrenia, elevated inflammatory markers in childhood or adolescence are associated with a greater risk of schizophrenia in adulthood, individuals with schizophrenia have increased levels of pro-inflammatory cytokines compared to healthy controls, and autoimmune diseases are overrepresented in schizophrenia. However, treatments with anti-inflammatory agents are so far of doubtful clinical relevance. The primary objective of this study is to test whether the monoclonal antibody rituximab, directed against the B-cell antigen CD20 ameliorates psychotic symptoms in adults with schizophrenia or schizoaffective disorder and to examine potential mechanisms. A secondary objective is to examine characteristics of inflammation-associated psychosis and to identify pre-treatment biochemical characteristics of rituximab responders. A third objective is to interview a subset of patients and informants on their experiences of the trial to obtain insights that rating scales may not capture.

METHODS: A proof-of-concept study employing a randomised, parallel-group, double-blind, placebo-controlled design testing the effect of B-cell depletion in patients with psychosis. 120 participants with a diagnosis of schizophrenia spectrum disorders (SSD) (ICD-10 codes F20, F25) will receive either one intravenous infusion of rituximab (1000 mg) or saline. Psychiatric measures and blood samples will be collected at baseline, week 12, and week 24 post-infusion. Brief assessments will also be made in weeks 2 and 7. Neuroimaging and lumbar puncture, both optional, will be performed at baseline and endpoints. Approximately 40 of the patients and their informants will be interviewed for qualitative analyses on the perceived changes in well-being and emotional qualities, in addition to their views on the research.

DISCUSSION: This is the first RCT investigating add-on treatment with rituximab in unselected SSD patients. If the treatment is helpful, it may transform the treatment of patients with psychotic disorders. It may also heighten the awareness of immune-psychiatric disorders and reduce stigma.

TRIAL REGISTRATION: NCT05622201, EudraCT-nr 2022-000220-37 version 2.1. registered 14th of October 2022.

Place, publisher, year, edition, pages
BioMed Central (BMC), 2023
Keywords
Clinical trials, Immunology, Inflammation, Magnetic resonance imaging, Monoclonal antibodies, Schizophrenia & psychotic disorders
National Category
Psychiatry
Identifiers
urn:nbn:se:oru:diva-109377 (URN)10.1186/s12888-023-05250-5 (DOI)001095789000002 ()37872497 (PubMedID)2-s2.0-85174826025 (Scopus ID)
Funder
Örebro UniversitySwedish Research Council, 2022-00288The Swedish Brain Foundation, FO2022-0073Torsten Söderbergs stiftelse, MT4/22
Available from: 2023-10-24 Created: 2023-10-24 Last updated: 2024-01-17Bibliographically approved
Organisations
Identifiers
ORCID iD: ORCID iD iconorcid.org/0000-0002-9736-8228

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