Dataset Information

Music Therapy as Treatment of Negative Symptoms for Adult Patients Diagnosed with Schizophrenia-Study Protocol for a Randomized, Controlled and Blinded Study.

ABSTRACT: Background: Three Cochrane reviews show that music therapy has a positive effect on schizophrenia concerning general functioning and positive/negative symptoms. This study aims to replicate these results in the Danish health system, a requirement for recommendation in guidelines from the Danish National Board of Health. Methods: The study is a randomized, controlled multi-site study, with a blinded design, aiming to include 90 participants who are 18?65 years in age, diagnosed according to ICD-10 with a schizophrenia diagnosis. The participants are randomized to one of two different music therapy activities for 25 weekly sessions. The study interventions are added to standard care. Outcome measures are rated at baseline, after 15 sessions and post therapy. A qualitative interview is performed as a one month follow up at the end of study. The primary intended outcome is a reduction in negative symptoms. The secondary intended outcome is progression in quality of life, alliance and psychosocial functioning. Results: As this study is still running, the results are not yet available. Conclusion: The study will investigate the direct effects of music therapy on negative symptoms as part of schizophrenia in a blinded, randomized trial. If proven effective, music therapy can be added to the small treatment armamentarium of effective therapies for negative symptoms in patients with schizophrenia.

SUBMITTER: Pedersen IN

PROVIDER: S-EPMC6631001 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Music Therapy as Treatment of Negative Symptoms for Adult Patients Diagnosed with Schizophrenia-Study Protocol for a Randomized, Controlled and Blinded Study.

Pedersen Inge Nygaard IN Bonde Lars Ole LO Hannibal Niels Jørgensen NJ Nielsen Jimmy J Aagaard Jørgen J Bertelsen Lars Rye LR Jensen Silvia Beatriz SB Nielsen René Ernst RE

Medicines (Basel, Switzerland) 20190401 2

<b>Background:</b> Three Cochrane reviews show that music therapy has a positive effect on schizophrenia concerning general functioning and positive/negative symptoms. This study aims to replicate these results in the Danish health system, a requirement for recommendation in guidelines from the Danish National Board of Health. <b>Methods:</b> The study is a randomized, controlled multi-site study, with a blinded design, aiming to include 90 participants who are 18⁻65 years in age, diagnosed acco ...[more]

PMID: 30939778

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Project description:BackgroundMeta-analyses of studies on psychological treatment of refugees describe highly varying outcomes, and research on multi-facetted and personalized treatment of refugees with post-traumatic stress disorder (PTSD) is needed. Music therapy has been found to affect arousal regulation and emotional processing, and a pilot study on the music therapy method Trauma-focused Music and Imagery (TMI) with traumatized refugees resulted in significant changes of trauma symptoms, well-being and sleep quality. The aim of the trial is to test the efficacy of TMI compared to verbal psychotherapy.MethodsA randomized controlled study with a non-inferiority design is carried out in three locations of a regional outpatient psychiatric clinic for refugees. Seventy Arabic-, English- or Danish-speaking adult refugees (aged 18-67 years) diagnosed with PTSD are randomized to 16 sessions of either music therapy or verbal therapy (standard treatment). All participants are offered medical treatment, psychoeducation by nurses, physiotherapy or body therapy and social counseling as needed. Outcome measures are performed at baseline, post therapy and at 6 months' follow-up. A blind assessor measures outcomes post treatment and at follow-up. Questionnaires measuring trauma symptoms (HTQ), quality of life (WHO-5), dissociative symptoms (SDQ-20, DSS-20) and adult attachment (RAAS) are applied, as well as physiological measures (salivary oxytocin, beta-endorphin and substance P) and participant evaluation of each session.DiscussionThe effect of music therapy can be explained by theories on affect regulation and social engagement, and the impact of music on brain regions affected by PTSD. The study will shed light on the role of therapy for the attainment of a safe attachment style, which recently has been shown to be impaired in traumatized refugees. The inclusion of music and imagery in the treatment of traumatized refugees hopefully will inform the choice of treatment method and expand the possibilities for improving refugee health and integration.Trial registrationClinicalTrials.gov ID number NCT03574228, registered retrospectively on 28 June 2016.

Project description:ImportanceNegative symptoms are associated with a range of poor clinical outcomes, and currently available treatments generally do not produce a clinically meaningful response. Limited treatment progress may be owing in part to poor clarity regarding latent structure. Prior studies have inferred latent structure using exploratory factor analysis, which has led to the conclusion that there are 2 dimensions reflecting motivation and pleasure (MAP) and diminished expressivity (EXP) factors. However, whether these conclusions are statistically justified remains unclear because exploratory factor analysis does not test latent structure. Confirmatory factor analysis (CFA) is needed to test competing models regarding the latent structure of a construct.ObjectiveTo evaluate the fit of 4 models of the latent structure of negative symptoms in schizophrenia using CFA.Design, setting, and participantsThree cross-sectional studies were conducted on outpatients with schizophrenia who were rated on the 3 most conceptually contemporary measures: Scale for the Assessment of Negative Symptoms (SANS), Brief Negative Symptom Scale (BNSS), and Clinical Assessment Interview for Negative Symptoms (CAINS). Confirmatory factor analysis evaluated the following 4 models: (1) a 1-factor model; (2) a 2-factor model with EXP and MAP factors; (3) a 5-factor model with separate factors for the 5 domains of the National Institute of Mental Health consensus development conference (blunted affect, alogia, anhedonia, avolition, and asociality); and (4) a hierarchical model with 2 second-order factors reflecting EXP and MAP and 5 first-order factors reflecting the 5 consensus domains.Main outcomes and measuresOutcomes included CFA model fit statistics derived from symptom severity scores on the SANS, BNSS, and CAINS.ResultsThe study population included 860 outpatients with schizophrenia (68.0% male; mean [SD] age, 43.0 [11.4] years). Confirmatory factor analysis was conducted on each scale, including 268 patients for the SANS, 192 for the BNSS, and 400 for the CAINS. The 1- and 2-factor models provided poor fit for the SANS, BNSS, and CAINS as indicated by comparative fit indexes (CFIs) and Tucker Lewis indexes (TLIs) less than 0.950, RMSEAs that exceeded the 0.080 threshold, and WRMRs greater than 1.00. The 5-factor and hierarchical models provided excellent fit, with the 5-factor model being more parsimonious. The CFIs and TLIs met the 0.95 threshold and the 1.00 threshold for both factor models with all 3 measures. Interestingly, the RMSEAs for the 5-factor model and the hierarchical model fell under the 0.08 threshold for the BNSS and the CAINS but not the SANS.Conclusions and relevanceThese findings suggest that the recent trend toward conceptualizing the latent structure of negative symptoms as 2 distinct dimensions does not adequately capture the complexity of the construct. The latent structure of negative symptoms is best conceptualized in relation to the 5 consensus domains. Implications for identifying pathophysiological mechanisms and targeted treatments are discussed.

Dataset Information

Music Therapy as Treatment of Negative Symptoms for Adult Patients Diagnosed with Schizophrenia-Study Protocol for a Randomized, Controlled and Blinded Study.

Publications

Music Therapy as Treatment of Negative Symptoms for Adult Patients Diagnosed with Schizophrenia-Study Protocol for a Randomized, Controlled and Blinded Study.

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