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.

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 .

Reducing psychotropic pharmacotherapy in patients with severe mental illness: a cluster-randomized controlled intervention study.

BACKGROUND: Many patients with mental illness receive psychotropic medicine in high dosages and from more than one drug. One of the consequences of this practice is obesity, which is a contributing factor to increased physical morbidity and premature death. METHODS: Our study was a cluster-randomized intervention study involving 6 facilities and 174 patients diagnosed with severe mental illnesses (73% schizophrenia). The intervention period was 12 months and consisted of teaching sessions with the staff and evaluating the patients' intake of psychotropic medication. At index, 44% met criteria for obesity and 76% met criteria for overweight. Waist circumferences were 108 cm for men and 108 cm for women. Olanzapine, clozapine and quetiapine were the most common prescribed antipsychotics. Mean values of daily doses of antipsychotic were 2.5. RESULTS: The intervention showed no significant differences between the intervention and control group regarding psychotropic treatment. At follow up, independent of intervention, patients receiving antipsychotic polypharmacy had a larger waist circumference compared with patients receiving antipsychotic monotherapy of 9.8 cm (1.5-18.1) (p = 0.028). DISCUSSION AND CONCLUSION: We found both a high prevalence of obesity and that the patients received treatment with antipsychotic polypharmaceutics in high dosages. Active awareness did not change practice and we must think of other ways to restrict treatment with psychotropics in this group of patients.

Content and implementation of clinical decisions in the routine care of people with severe mental illness.

BACKGROUND: Clinical decision making (CDM) in the treatment of people with severe mental illness relates to a wide range of life domains. AIMS: To examine content of CDM in mental health care from the perspectives of service users and staff and to investigate variation in implementation of decisions for differing content. METHOD: As part of the European multicenter study clinical decision making and outcome in routine care for people with severe mental illness (ISRCTN75841675), 588 service users and their clinicians were asked to identify the decisions made during their last meeting. Decisions were then coded into content categories. Two months later, both parties reported if these decisions had been implemented. RESULTS: Agreement between patients and staff regarding decision making was moderate (k = 0.21­0.49; p < 0.001). Decisions relating to medication and social issues were most frequently identified. Overall reported level of implementation was 73.5% for patients and 74.7% for staff, and implementation varied by decision content. CONCLUSIONS: A variety of relevant decision topics were shown for mental health care.Implementation rates varied in relation to topic and may need different consideration within the therapeutic dyad.

The development and evaluation of a five-language multi-perspective standardised measure: clinical decision-making involvement and satisfaction (CDIS).

BACKGROUND: The aim of this study was to develop and evaluate a brief quantitative five-language measure of involvement and satisfaction in clinical decision-making (CDIS) - with versions for patients (CDIS-P) and staff (CDIS-S) - for use in mental health services. METHODS: An English CDIS was developed by reviewing existing measures, focus groups, semistructured interviews and piloting. Translations into Danish, German, Hungarian and Italian followed the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Task Force principles of good practice for translation and cultural adaptation. Psychometricevaluation involved testing the measure in secondary mental health services in Aalborg, Debrecen, London, Naples, Ulm and Zurich. RESULTS: After appraising 14 measures, the Control Preference Scale and Satisfaction With Decision-making English-language scales were modified and evaluated in interviews (n = 9), focus groups (n = 22) and piloting (n = 16). Translations were validated through focus groups (n = 38) and piloting (n = 61). A total of 443 service users and 403 paired staff completed CDIS. The Satisfaction sub-scale had internal consistency of 0.89 (0.86-0.89 after item-level deletion) for staff and 0.90 (0.87-0.90) for service users, both continuous and categorical (utility) versions were associated with symptomatology and both staff-rated and service userrated therapeutic alliance (showing convergent validity), and not with social disability (showing divergent validity), and satisfaction predicted staff-rated (OR 2.43, 95%CI 1.54- 3.83 continuous, OR 5.77, 95%CI 1.90-17.53 utility) and service user-rated (OR 2.21, 95%CI 1.51-3.23 continuous, OR 3.13, 95%CI 1.10-8.94 utility) decision implementation two months later. The Involvement sub-scale had appropriate distribution and no floor or ceiling effects, was associated with stage of recovery, functioning and quality of life (staff only) (showing convergent validity), and not with symptomatology or social disability (showing divergent validity), and staff-rated passive involvement by the service user predicted implementation (OR 3.55, 95%CI 1.53-8.24). Relationships remained after adjusting for clustering by staff. CONCLUSIONS: CDIS demonstrates adequate internal consistency, no evidence of item redundancy, appropriate distribution, and face, content, convergent, divergent and predictive validity. It can be recommended for research and clinical use. CDIS-P and CDIS-S in all 3 five languages can be downloaded at http://www.cedar-net.eu/instruments. TRIAL REGISTRATION: ISRCTN75841675.

Development and psychometric properties of a five-language multiperspective instrument to assess clinical decision making style in the treatment of people with severe mental illness (CDMS).

BACKGROUND: The aim of this study was to develop and evaluate psychometric properties of the Clinical Decision Making Style (CDMS) scale which measures general preferences for decision making as well as preferences regarding the provision of information to the patient from the perspectives of people with severe mental illness and staff. METHODS: A participatory approach was chosen for instrument development which followed 10 sequential steps proposed in a current guideline of good practice for the translation and cultural adaptation of measures. Following item analysis, reliability, validity, and long-term stability of the CDMS were examined using Spearman correlations in a sample of 588 people with severe mental illness and 213 mental health professionals in 6 European countries (Germany, UK, Italy, Denmark, Hungary, and Switzerland). RESULTS: In both patient and staff versions, the two CDMS subscales "Participation in Decision Making" and "Information" reliably measure distinct characteristics of decision making. Validity could be demonstrated to some extent, but needs further investigation. CONCLUSIONS: Together with two other five-language patient- and staff-rated measures developed in the CEDAR study (ISRCTN75841675) - "Clinical Decision Making in Routine Care" and "Clinical Decision Making Involvement and Satisfaction" - the CDMS allows empirical investigation of the complex relation between clinical decision making and outcome in the treatment of people with severe mental illness across Europe.