Music to improve sleep quality in adults with depression-related insomnia (MUSTAFI): randomized controlled trial.

BACKGROUND: Insomnia in depression is common and difficult to resolve. Unresolved depression-related sleep disturbances increase risk of relapse at high costs for individuals and society. Trials have suggested music for insomnia in various populations, but there is little research on the effectiveness of music for depression-related insomnia. METHODS: We examined the efficacy of a music intervention on insomnia, depression symptoms and quality of life in adults with depression-related insomnia. A two-armed randomized controlled trial was conducted, including depression outpatients with insomnia (n = 112) in a 1:1 ratio to music intervention and waitlist control group. The intervention group listened to music at bedtime for 4 weeks. Participants received treatment as usual during 8 weeks with assessments at baseline, at 4 and 8 weeks. The primary outcome measure was Pittsburgh Sleep Quality Index (PSQI), secondary outcomes comprised Actigraphy, the Hamilton Depression Rating Scale (HAMD-17) and World Health Organisation well-being questionnaires (WHO-5, WHOQOL-BREF). RESULTS: The music intervention group experienced significant improvements in sleep quality and well-being at 4 weeks according to global PSQI scores (effect size = -2.1, 95%CI -3.3; -0.9) and WHO-5 scores (effect size 8.4, 95%CI 2.7;14.0). At 8 weeks, i.e. 4 weeks after termination of the music intervention, the improvement in global PSQI scores had decreased (effect size = -0.1, 95%CI -1.3; 1.1). Actigraphy sleep assessments showed no changes and there was no detection of change in depression symptoms. CONCLUSIONS: Music intervention is suggested as a safe and moderately effective sleep aid in depression-related insomnia. Trial registration: Clinicaltrials.gov. ID NCT03676491.

Music to improve sleep quality in adults with depression-related insomnia (MUSTAFI): study protocol for a randomized controlled trial.

BACKGROUND: Insomnia is a common sleep disorder for adults with depression, with major impact on their quality of life. Previous trials suggest that listening to music may be helpful in the treatment of sleep disturbances in healthy populations, including students and elderly. In addition, small studies with clinical populations of traumatized refugees, adults with chronic insomnia and adults with depression insomnia add to the evidence base. However, the impact of music listening in the treatment of depression related insomnia is not well documented. OBJECTIVE: To examine the efficacy of music listening on sleep quality, symptoms of depression, and quality of life in adults with depression-related insomnia. METHOD: A single-center randomized controlled trial (RCT) in a two-arm parallel-group design is conducted and reported according to the CONSORT guidelines. The trial consists of an experimental group and a standard care control group. Both groups receive standard treatment for depression following Danish clinical guidelines in an outpatient psychiatry unit. The experimental group listens to music for a minimum of 30 minutes at bedtime for 4 weeks. DISCUSSION: This trial will provide information on the efficacy of music intervention as a non-pharmacological intervention in the treatment of depression-related insomnia. This study will provide novel knowledge concerning music medicine as an evidence-based treatment for depression. TRIAL REGISTRATION: Clinicaltrials.gov. ID NCT03676491, registered on 19 September 2018.

An outreach collaborative model for early identification and treatment of mental disorder in Danish workplaces.

BACKGROUND: Depression and anxiety are prevalent mental disorders among the working population with potentially high personal and financial cost. The overall aim of this study was to test the applicability of an outreach collaborative model for early identification and treatment of clinical and sub-clinical mental disorders among Danish employees. This applicability was examined by I) investigating the fractions of identified and treated clinical and subclinical cases, II) describing the distribution and characteristics of cases identified and III) investigating the effect of allocated treatment. METHODS: A longitudinal study design with four assessments (T0-T3) over 16 months was applied. Self-reporting questionnaires probing for psychopathology were distributed to all employees in six consecutively enrolled companies at the four time points. Employees meeting the screening criteria at T1 were assessed diagnostically. Subjects diagnosed with a clinical mental disorder were allocated to outpatient psychiatric treatment, and subjects with subclinical conditions were allocated to preventive cognitive behavioural therapy. Follow-up was conducted 6 and 12 months after initiation of treatment. We used chi-squared test and F-test to compare the different groups on baseline characteristics and mixed effects linear regression to analyse the treatment effects. RESULTS: Forty (6.8%) of the 586 responders at T1 were diagnosed with a clinical mental disorder and referred to outpatient psychiatric treatment. Thirty-three (5.6%) were affected by a subclinical condition and referred to preventive treatment. Nearly two-thirds (63%) of the employees diagnosed with a clinical condition had never received treatment before. Symptom severity decreased significantly for both treated groups until follow-up. When compared to a composed control group, subclinical cases displayed a more rapid initial significant symptomatic decrease on the global symptom scale (coefs = - 0.914, 95% CI [- 1.754, - 0,075]) and anxiety sub-scale (coefs = - 1.043, 95% CI [- 2.021, - 0.066]). This did not apply to the clinical cases as no significant difference in change were identified. CONCLUSIONS: The outreach collaborative model demonstrated an applicability to identify both clinical and subclinical cases, among these a high number of employees with an unmet need for treatment. We found evidence of a positive initial effect on symptomatology from the allocated preventive treatment among the subclinical cases, but not for clinical cases. TRIAL REGISTRATION: Retrospectively registered at December 18, 2018 at clinicaltrials.gov, identifier: NCT03786328 .

Clinical and psychometric validation of the psychotic depression assessment scale.

BACKGROUND: Recent studies have indicated that the 11-item Psychotic Depression Assessment Scale (PDAS), consisting of the 6-item melancholia subscale (HAM-D6) of the Hamilton Depression Rating Scale and 5 psychosis items from the Brief Psychiatric Rating Scale (BPRS), is a valid measure for the severity of psychotic depression. The aim of this study was to subject the PDAS, and its depression (HAM-D6) and psychosis (BPRS5) subscales to further validation. METHODS: Patients diagnosed with psychotic depression at Danish psychiatric hospitals participated in semi-structured interviews. Video recordings of these interviews were assessed by two experienced psychiatrists (global severity rating of psychotic depression, depressive symptoms and psychotic symptoms) and by two young physicians (rating on 27 symptom items, including the 11 PDAS items). The clinical validity and responsiveness of the PDAS and its subscales was investigated by Spearman correlation analysis of the global severity ratings and the PDAS, HAM-D6, and BPRS5 total scores. The unidimensionality of the scales was tested by item response theory analysis (Mokken). RESULTS: Ratings from 39 participants with unipolar psychotic depression and nine participants with bipolar psychotic depression were included in the analysis. The Spearman correlation analysis indicated that the PDAS, HAM-D6 and BPRS5 were clinically valid (correlation coefficients from 0.78 to 0.85, p<0.001) and responsive (correlation coefficients from 0.72 to 0.86, p<0.001) measures of psychotic depression. According to the Mokken analysis, all three scales were unidimensional. CONCLUSIONS: The clinical validity, responsiveness and unidimensionality of the PDAS and its subscales were confirmed in an independent sample of patients with psychotic depression.

Where are patients who have co-occurring mental and physical diseases located?

BACKGROUND: Patients with a psychiatric illness have a higher prevalence of physical diseases and thus a higher morbidity and mortality. AIM: The main aim was to investigate where patients with co-occurring physical diseases and mental disorders (psychotic spectrum or mood) in the health and social service system are identified most frequently before admission into psychiatry. The second aim was to compare the differences in the treatment routes taken by the patients before entry into psychiatric services in all the participating countries (Denmark, Germany, Japan, Nigeria and Switzerland). METHODOLOGY: On admission to a psychiatric service, patients diagnosed with schizophrenia, schizotypal or delusional disorders (International Classification of Diseases-10 (ICD-10) group F2) or mood (affective) disorders (ICD-10 group F3) and a co-morbid physical condition (cardiovascular disease, diabetes mellitus and overweight) were asked with which institutions or persons they had been in contact with in the previous 6 months. RESULTS: Patients from Denmark, Germany and Switzerland with mental disorders had almost the same contact pattern. Their primary contact was to public or private psychiatry, with a contact percentage of 46%-91%; in addition, general practice was a common contact, with a margin of 41%-93%. Similar tendencies are seen in Japan despite the small sample size. With regard to general practice, this is also the case with Nigerian patients. However, religious guidance or healing was rarely sought by patients in Europe and Japan, while in Nigeria about 80% of patients with mental disorders had contacted this type of service. CONCLUSION: Promoting prophylactic work between psychiatry and the general practice sector may be beneficial in diminishing physical conditions such as cardiovascular disease, diabetes mellitus and overweight in patients with mental disorders in European countries and Japan. In Nigeria (a low-to-middle-income country), religious guides or healers, along with general practitioners, are the most frequently contacted, and they therefore seem to be the most obvious partner to collaborate with.

Physical illness in psychiatric inpatients: comparison of patients with and without substance use disorders.

BACKGROUND: Physical comorbidities and substance use are commonly reported in patients with mental disorders. AIM: To examine somatic comorbidity in patients with substance use disorders (SUD) compared to patients with mental disorders but no SUD. METHODS: Lifetime prevalence data on mental and physical health status were collected from inpatients in 12 mental health care facilities in five different countries. Differences in somatic comorbidity were examined by means of logistic regression analysis controlling for age and gender. RESULTS: Of 2,338 patients, 447 (19%) had a primary or secondary SUD diagnosis. In comparison to patients with other mental disorders, patients with SUD had a higher prevalence of infectious and digestive diseases but a lower prevalence of endocrine, nutritional and metabolic disorders. Patterns of physical comorbidities differed according to type of substance used (alcohol use - cardiovascular; tobacco use - respiratory, neoplasms; cannabinoid use - injuries; opioid use - infectious, digestive; benzodiazepine use - endocrine, nutritional, metabolic; stimulants - urogenital). CONCLUSIONS: SUD are related to specific somatic health risks while some of our findings point to potentially protective effects. The widespread prescription of benzodiazepines requires research on physical health effects. Early detection of SUD and their integration into programmes targeting physical comorbidity should be a priority in organizing mental health care.

Clinical decision making and outcome in routine care for people with severe mental illness (CEDAR): study protocol.

BACKGROUND: A considerable amount of research has been conducted on clinical decision making (CDM) in short-term physical conditions. However, there is a lack of knowledge on CDM and its outcome in long-term illnesses, especially in care for people with severe mental illness. METHODS/DESIGN: The study entitled "Clinical decision making and outcome in routine care for people with severe mental illness" (CEDAR) is carried out in six European countries (Denmark, Germany, Hungary, Italy, Switzerland and UK). First, CEDAR establishes a methodology to assess CDM in people with severe mental illness. Specific instruments are developed (and psychometric properties established) to measure CDM style, key elements of CDM in routine care, as well as CDM involvement and satisfaction from patient and therapist perspectives. Second, these instruments are being put to use in a multi-national prospective observational study (bimonthly assessments during a one-year observation period; N = 560). This study investigates the immediate, short- and long-term effect of CDM on crucial dimensions of clinical outcome (symptom level, quality of life, needs) by taking into account significant variables moderating the relationship between CDM and outcome. DISCUSSION: The results of this study will make possible to delineate quality indicators of CDM, as well as to specify prime areas for further improvement. Ingredients of best practice in CDM in the routine care for people with severe mental illness will be extracted and recommendations formulated. With its explicit focus on the patient role in CDM, CEDAR will also contribute to strengthening the service user perspective. This project will substantially add to improving the practice of CDM in mental health care across Europe. TRIAL REGISTER: ISRCTN75841675.

European network for promoting the physical health of residents in psychiatric and social care facilities (HELPS): background, aims and methods.

BACKGROUND: People with mental disorders have a higher prevalence of physical illnesses and reduced life expectancy as compared with the general population. However, there is a lack of knowledge across Europe concerning interventions that aim at reducing somatic morbidity and excess mortality by promoting behaviour-based and/or environment-based interventions. METHODS AND DESIGN: HELPS is an interdisciplinary European network that aims at (i) gathering relevant knowledge on physical illness in people with mental illness, (ii) identifying health promotion initiatives in European countries that meet country-specific needs, and (iii) at identifying best practice across Europe. Criteria for best practice will include evidence on the efficacy of physical health interventions and of their effectiveness in routine care, cost implications and feasibility for adaptation and implementation of interventions across different settings in Europe. HELPS will develop and implement a "physical health promotion toolkit". The toolkit will provide information to empower residents and staff to identify the most relevant risk factors in their specific context and to select the most appropriate action out of a range of defined health promoting interventions. The key methods are (a) stakeholder analysis, (b) international literature reviews, (c) Delphi rounds with experts from participating centres, and (d) focus groups with staff and residents of mental health care facilities.Meanwhile a multi-disciplinary network consisting of 15 European countries has been established and took up the work. As one main result of the project they expect that a widespread use of the HELPS toolkit could have a significant positive effect on the physical health status of residents of mental health and social care facilities, as well as to hold resonance for community dwelling people with mental health problems. DISCUSSION: A general strategy on health promotion for people with mental disorders must take into account behavioural, environmental and iatrogenic health risks. A European health promotion toolkit needs to consider heterogeneity of mental disorders, the multitude of physical health problems, health-relevant behaviour, health-related attitudes, health-relevant living conditions, and resource levels in mental health and social care facilities.