Clinically representative therapy for Nordic adult outpatients with common mental health problems: A systematic review and meta-analysis.

There is a knowledge gap regarding clinically representative therapy given in routine settings, that is treatment as usual (TAU), for patients with common mental health problems (CMHP). This review and meta-analysis aimed to investigate what characterizes clinically representative therapy in Nordic routine clinics and meta-analyze the outcome of such treatment. Databases (PubMed, EMBASE, PsychINFO, and SveMed+) were searched for TAU, CMHP, and Nordic countries, together with backward and forward search in Scopus (7 November 2022). Studies were either randomized controlled trials (RCT) or open trials, using prospective study designs, examining heterogeneous outpatient groups in routine treatment. Within- and between-group effect sizes (ES), using random effects model, and moderator analyses were calculated. Eleven studies (n = 1,413), demonstrated a small to moderate within-group ES with high heterogeneity (g = 0.49, I2 = 90%). ESs in RCTs were significantly smaller than in open trials. TAU had a marginally smaller ES (g = -0.21; adjusted for publication bias g = -0.06) compared to a broad set of clinical interventions. Clinically representative therapy in the Nordic countries demonstrated a wide variety of characteristics and also a marginally lower ES compared to other interventions. The ESs were smaller than other meta-analyses examining evidence-based treatments in routine treatment.

The effect of structured psychoeducation on caregiver burden in carers of patients with schizophrenia in Nigeria: A 12-week follow-up investigation.

Background: Despite robust evidence of the huge burden of caregiving amongst caregivers of patients with schizophrenia, there is a paucity of data in Africa on the interventions to address this enormous burden of caregiving. Aim: This study aimed to determine the effect of structured psychoeducation intervention on the burden of caregiving in comparison with 'care as usual' in a Nigerian Psychiatric Hospital. Setting: This study was done at the out-patient and in-patient units of the Federal Neuropsychiatric Hospital, Enugu, Nigeria. Methods: Caregivers of inpatients who fulfilled the International Classification of Diseases (ICD-10) criteria for diagnosis of schizophrenia were recruited for the study. The caregivers were then allocated into two groups (Group A received structured psychoeducation intervention in addition to 'care as usual' whilst group B received only 'care as usual'). After the baseline assessment, the caregivers were followed up every 4 weeks for a period of 12 weeks. At each interval of follow-up, caregivers were assessed for caregivers' burden using the Zarit Burden Interview (ZBI). Repeated measures analysis of variance (mixed type) was used to determine the effects of the interventions on caregivers' burden in the two arms of the study across the intervals of follow-up. Results: The attrition rate at week 12 was 10.7%; leaving 130 for the assessment of outcome variable at the end of follow-up. Structured psychoeducation intervention was significantly better than 'care as usual' in ameliorating caregivers' burden [F (1, 123) = 21.75, p < 0.001, Partial Eta Squared = 0.39]. Conclusion: These findings seem to suggest that caregivers who received structured psychoeducation intervention experienced a greater reduction in caregiver burden than those who received 'care as usual'. Whilst the study addressed short-term effect, the findings of this study are in accord with other studies that have supported the impression that psychoeducational family-based intervention is useful with regard to caregiver burden.

Care-as-usual control groups across different settings in randomized trials on psychotherapy for adult depression: a meta-analysis.

BACKGROUND: Care-as-usual (CAU) is often used as a control condition in psychotherapy research, but it may vary considerably what that entails, ranging from no treatment, to routine treatment in primary care, general medical care, perinatal care, and specialized mental health care. METHODS: We conducted a meta-analysis of trials comparing psychotherapy for depression to CAU, with a focus on the different categories of CAU and countries where the studies were conducted. We used an existing database of randomized trials on psychotherapy for depression that is updated every year. RESULTS: A total of 140 studies with 15 419 patients were included. We found no significant differences in effects between categories of CAU (effect sizes ranging from g = 0.43 for CAU in primary care to g = 0.73 for no treatment), but heterogeneity was high in all CAU categories. After stratifying effects across specific countries (within CAU categories) we found that heterogeneity was considerably lower and there were several significant differences between countries. Overall, effects were larger in non-Western countries (g = 0.84 to 1.28) compared to those in Western countries (g = 0.52; p for difference = 0.002). Effects were smaller in studies with risk of bias (p = 0.01). CONCLUSIONS: There are no significant differences between major categories of CAU when compared to psychotherapy conditions in randomized trials. However, effects of psychotherapy differ considerably across CAU conditions in specific countries. CAU therefore is a heterogeneous control condition in psychotherapy research.

Adherence With Online Therapy vs Face-to-Face Therapy and With Online Therapy vs Care as Usual: Secondary Analysis of Two Randomized Controlled Trials.

BACKGROUND: Adherence to internet-delivered interventions targeting mental health such as online psychotherapeutic aftercare is important for the intervention's impact. High dropout rates limit the impact and generalizability of findings. Baseline differences may be putting patients at risk for dropping out, making comparisons between online with face-to-face (F2F) therapy and care as usual (CAU) necessary to examine. OBJECTIVE: This study investigated adherence to online, F2F, and CAU interventions as well as study dropout among these groups and the subjective evaluation of the therapeutic relationship. Sociodemographic, social-cognitive, and health-related variables were considered. METHODS: In a randomized controlled trial, 6023 patients were recruited, and 300 completed the baseline measures (T1), 144 completed T2 (retention 44%-52%), and 95 completed T3 (retention 24%-36%). Sociodemographic variables (eg, age, gender, marital status, educational level), social-cognitive determinants (eg, self-efficacy, social support), health-related variables (eg, depressiveness), and expectation towards the treatment for patients assigned to online or F2F were measured at T1. RESULTS: There were no significant differences between the groups regarding dropout rates (χ21=0.02-1.06, P≥.30). Regarding adherence to the treatment condition, the online group outperformed the F2F and CAU conditions (P≤.01), indicating that patients randomized into the F2F and CAU control groups were much more likely to show nonadherent behavior in comparison with the online therapy groups. Within study groups, gender differences were significant only in the CAU group at T2, with women being more likely to drop out. At T3, age and marital status were also only significant in the CAU group. Patients in the online therapy group were significantly more satisfied with their treatment than patients in the F2F group (P=.02; Eta²=.09). Relationship satisfaction and success satisfaction were equally high (P>.30; Eta²=.02). Combining all study groups, patients who reported lower depressiveness scores at T1 (T2: odds ratio [OR] 0.55, 95% CI 0.35-0.87; T3: OR 0.56, 95% CI 0.37-0.92) were more likely to be retained, and patients who had higher self-efficacy (T2: OR 0.57, 95% CI 0.37-0.89; T3: OR 0.52, 95% CI 0.32-0.85) were more likely to drop out at T2 and T3. Additionally, at T3, the lower social support that patients reported was related to a higher likelihood of remaining in the study (OR 0.68, 95% CI 0.48-0.96). Comparing the 3 intervention groups, positive expectation was significantly related with questionnaire completion at T2 and T3 after controlling for other variables (T2: OR 1.64, 95% CI 1.08-2.50; T3: OR 1.59, 95% CI 1.01-2.51). CONCLUSIONS: While online interventions have many advantages over F2F variants such as saving time and effort to commute to F2F therapy, they also create difficulties for therapists and hinder their ability to adequately react to patients' challenges. Accordingly, patient characteristics that might put them at risk for dropping out or not adhering to the treatment plan should be considered in future research and practice. Online aftercare, as described in this research, should be provided more often to medical rehabilitation patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04989842; https://clinicaltrials.gov/ct2/show/NCT04989842.

Detection and management of hyperactive and hypoactive delirium in older patients during hospitalization: a retrospective cohort study evaluating daily practice.

OBJECTIVES: The objectives of the study are to study daily hospital practice regarding detection and management and to study hyperactive and hypoactive delirium of older patients during their hospitalization. METHODS: A retrospective cohort study evaluating care as usual for older hospitalized patients with delirium at Maastricht University Medical Center+, a university hospital in the Netherlands, was performed. Inclusion criteria were older hospitalized patients (65+ years), diagnosed with delirium between 1 January and 31 December 2014. Data were retrieved from the patients' medical files. Delirium was categorized as hyperactive or hypoactive. Primary outcome measures were prevalence and management (pharmacological, reorientation, screening for delirium and delirium consultations, and physical restraints). Secondary outcomes were short-term adverse outcomes. RESULTS: Prevalence of delirium was 5% (N = 401), of which 77% (n = 307) was hyperactive and 23% (n = 94) was hypoactive. Significantly, more patients with a hyperactive delirium received medication to manage the delirium than patients with a hypoactive delirium (89% vs. 77%, respectively, p = 0.004). No other significant differences between the subtypes were found. CONCLUSION: There was probably a strong under-recognition of delirium. Drugs were the main intervention of choice, especially for patients with hyperactive delirium. The two subtypes did not differ on non-pharmacological management. The retrospective nature of this study sheds light on the status quo of recognition, management, and care as usual for the different delirium subtypes in daily hospital practice, which may help in forming new guidelines and protocols for the detection and treatment of delirium for older patients in hospitals.

Clinical effectiveness of internet-based cognitive behavioral therapy for insomnia in routine secondary care: results of a randomized controlled trial.

Introduction: Delivering cognitive behavioral therapy for insomnia over the internet bears the advantage of accessibility and uptake to many patients suffering from chronic insomnia. In the current study, we aimed to investigate the effectiveness of internet-based cognitive behavioral therapy for insomnia (iCBT-I) in routine care. Materials and methods: We conducted a two-arm non-blinded randomized controlled trial with care as usual (CAU) as a control condition. Participants were recruited in a specialized outpatient sleep medicine department. Both arms had access to other healthcare resources, and the intervention group had access to the iCBT-I program for 2 months. The primary outcome was insomnia severity, measured by the Insomnia Severity Index (ISI). Secondary outcomes were fatigue severity, daytime sleepiness, affective symptoms, dysfunctional beliefs and attitudes about sleep, sleep locus of control, sleep hygiene, sleep efficiency (SE), sleep onset latency, wake time after sleep onset (WASO), and total sleep time (TST). Linear mixed models for repeated measures were used to analyze the longitudinal data at baseline, post-treatment, and after 3 months of follow-up. The trial was registered at www.clinicaltrials.gov (NCT04300218 21.04.2020). Results: The results showed a significant time*group interaction effect (p = 0.001) at post-treatment with between-group effect size (d = 0.51), indicating that the ISI decreased by a score of 3.8-fold in the iCBT-I group than in the CAU group. There was no significant difference in ISI between groups at follow-up. Regarding secondary outcomes, dysfunctional beliefs about sleep, SE, and WASO decreased significantly during treatment in the intervention group with between-group effect sizes d = 0.35, d = -0.51, and d = 0.47, respectively. At the follow-up, between-group effects on DBAS and SE remained significant: d = 0.36 and d = -0.63, respectively. For TST, we observed a significant time*group effect of d = -0.38 only after follow-up. Conclusion: Our findings suggest that iCBT-I has a significant effect on insomnia severity at post-treatment compared to CAU. iCBT-I further improved dysfunctional beliefs about sleep and improved subjective sleep characteristics, such as SE, WASO, and TST during 3 months after treatment. Clinical trial registration: www.clinicaltrials.gov, identifier (NCT04300218).

The effect of cognitive behavioral therapy for insomnia on sleep and glycemic outcomes in people with type 2 diabetes: A randomized controlled trial.

STUDY OBJECTIVES: Investigate whether aiding sleep by online cognitive behavioral therapy for insomnia (CBT-I) can improve glycemic and metabolic control, mood, quality of life (QoL) and insomnia symptoms in people with type 2 diabetes and assess the mediating role of lifestyle factors. METHODS: Adults with type 2 diabetes and insomnia symptoms were randomly assigned to CBT-I or care as usual. At baseline, three and six months we assessed HbA1c as primary outcome and glycemic control, metabolic outcomes, sleep, mood and QoL as secondary outcomes. Mixed models were used to determine within-person and between-persons differences in outcomes and mediation analysis for lifestyle factors. RESULTS: We randomized 29 participants to CBT-I and 28 to care as usual. Intention-to-treat analysis showed no significant differences in glycemic control, metabolic outcomes, anger, distress or QoL, but showed a significantly larger decrease in insomnia (-1.37(2.65: 0.09)) and depressive symptoms (-0.92(-1.77: 0.06)) and increase in BMI (0.29 kg/m2(0.00:0.57)) in the intervention compared to the control group. Only half of the intervention participants completed the CBT-I. Per protocol analysis showed a not statistically significant decrease in HbA1c (-2.10 mmol/l(-4.83:0.63)) and glucose (-0.39 mmol/l(-1.19:0.42)), metabolic outcomes and increase in QoL. Furthermore, the intervention group showed a significant decrease in insomnia (-2.22(-3.65: 0.78)) and depressive symptoms (-1.18(-2.17: 0.19)) compared to the control group. Lifestyle factors partially mediated the effect of the intervention. CONCLUSIONS: CBT-I might improve insomnia symptoms and mood, and perhaps improves glycemic control, albeit not significant, in people with type 2 diabetes and insomnia symptoms, compared to care as usual.

A protocol for a type 1 effectiveness-implementation randomized controlled trial of the WHO digital mental health intervention Step-by-Step to address depression among Chinese young adults in Macao (SAR), China.

Background: Among Chinese college students, the burden of depression is considerably high, affecting up to 30 % of the population. Despite this burden, few Chinese students seek mental health treatment. In addition, depression is highly comorbid with other mental health disorders, such as anxiety. Scalable, transdiagnostic, evidence-based interventions are needed for this population. Objective: The study will evaluate the effectiveness of a World Health Organization transdiagnostic digital mental health intervention, Step-by-Step, to reduce depressive and anxiety symptoms and improve well-being compared with enhanced care as usual and its implementation in a Chinese university community. Methods: A type 1 effectiveness-implementation two-arm, parallel, randomized controlled trial will be conducted. The two conditions are 1) the 5-session Step-by-Step program with minimal guidance by trained peer-helpers and 2) psychoeducational information on depression and anxiety and referrals to local community services. A total of 334 Chinese university students will be randomized with a 1:1 ratio to either of the two groups. Depression, anxiety, wellbeing, and client defined problems will be assessed at pre-intervention, post-intervention, and 3-month follow-up. Endline qualitative interviews and focus group discussions will be conducted to explore SbS implementation among service users, university staff, and stakeholders. Data will be analysed based on the intent-to-treat principle. Discussion: Step-by-Step is an innovative approach to address common mental health problems in populations with sufficient digital literacy. It is a promising intervention that can be embedded to scale mental health services within a university setting. It is anticipated that after successful evaluation of the program and its implementation in the type 1 hybrid design RCT study, Step-by-Step can be scaled and maintained as a low-intensity treatment in universities, and potentially extended to other populations within the Chinese community. Trial registration: ChiCTR2100050214.

Psychotherapies for depression in low- and middle-income countries: a meta-analysis.

Most psychotherapies for depression have been developed in high-income Western countries of North America, Europe and Australia. A growing number of randomized trials have examined the effects of these treatments in non-Western countries. We conducted a meta-analysis of these studies to examine whether these psychotherapies are effective and to compare their effects between studies from Western and non-Western countries. We conducted systematic searches in bibliographical databases and included 253 randomized controlled trials, of which 32 were conducted in non-Western countries. The effects of psychotherapies in non-Western countries were large (g=1.10; 95% CI: 0.91-1.30), with high heterogeneity (I2 =90; 95% CI: 87-92). After adjustment for publication bias, the effect size dropped to g=0.73 (95% CI: 0.51-0.96). Subgroup analyses did not indicate that adaptation to the local situation was associated with the effect size. Comparisons with the studies in Western countries showed that the effects of the therapies were significantly larger in non-Western countries, also after adjusting for characteristics of the participants, the treatments and the studies. These larger effect sizes in non-Western countries may reflect true differences indicating that therapies are indeed more effective; or may be explained by the care-as-usual control conditions in non-Western countries, often indicating that no care was available; or may be the result of the relative low quality of many trials in the field. This study suggests that psychotherapies that were developed in Western countries may or may not be more effective in non-Western countries, but they are probably no less effective and can therefore also be used in these latter countries.

The Long-Term Effects of the Youth Crime Prevention Program "New Perspectives" on Delinquency and Recidivism.

New Perspectives (NP) aims to prevent persistent criminal behavior. We examined the long-term effectiveness of NP and whether the effects were moderated by demographic and delinquency factors. At-risk youth aged 12 to 19 years were randomly assigned to the intervention group (NP, n = 47) or care as usual (CAU, n = 54). Official and self-report data were collected to assess recidivism. NP was not more effective in reducing delinquency levels and recidivism than CAU. Also, no moderator effects were found. The overall null effects are discussed, including further research and policy implications.

A multimodal day treatment program for multi-problem young adults: study protocol for a randomized controlled trial.

BACKGROUND: Effective interventions for young adults with severe, multiple problems - such as psychosocial and psychiatric problems, delinquency, unemployment and substance use - are scarce but urgently needed in order to support an adequate transition to adulthood. A multimodal day treatment program called "New Opportunities" (in Dutch: "De Nieuwe Kans"; DNK) was specifically developed to target multi-problem young adults in The Netherlands. The aim of this study protocol is to describe the design of a randomized controlled trial (RCT) in clinical practice to examine the effectiveness of DNK in comparison with care as usual (CAU). METHODS/DESIGN: Multi-problem young adults in Rotterdam, The Netherlands, will be assigned randomly to DNK (expected N = 150) and CAU (expected N = 150). Primary outcome measures are recidivism and self-sufficiency. Secondary outcome measures include quality of life, attending school/work, psychological functioning, cognitive distortions and substance use. Participant and program characteristics will be examined as potential moderators of effectiveness. Additionally, cost-effectiveness will be measured. During 14 months, data from multiple resources will be collected at four time points. DISCUSSION: This study is one of the first RCTs on the effectiveness of interventions developed for multi-problem young adults. The results will contribute to the currently scant knowledge about what works for various multi-problem young adults in their transition to adulthood. In addition, the study protocol will provide insight into implementing an RCT in a dynamic setting of clinical practice. TRIAL REGISTRATION: Dutch Trial Register, identifier: NTR5163 . Registered on 17 April 2015; retrospectively registered during the recruitment phase.

Increasing engagement with an occupational digital stress management program through the use of an online facilitated discussion group: Results of a pilot randomised controlled trial.

INTRODUCTION: Rates of work-related stress, depression and anxiety are high, resulting in reduced work performance and absenteeism. There is evidence that digital mental health interventions delivered in the workplace are an effective way of treating these conditions, but intervention engagement and adherence remain a challenge. Providing guidance can lead to greater engagement and adherence; an online facilitated discussion group may be one way of providing that guidance in a time efficient way. This study compares engagement with a minimally guided digital mental health program (WorkGuru) delivered in the workplace with a discussion group (DG) and without a discussion group (MSG), and with a wait list control (WLC); it was conducted as a pilot phase of a definitive trial. METHODS: Eighty four individuals with elevated levels of stress from six organisations were recruited to the study and randomised to one of two active conditions (DG or MSG) or a WLC. The program WorkGuru is a CBT based, eight-week stress management intervention that is delivered with minimal guidance from a coach. Data was collected at baseline, post-intervention and at 16-week follow-up via online questionnaires. The primary outcome measure was number of logins. Secondary measures included further engagement measures, and measures of depression, anxiety, stress, comfort and enthusiasm. Quality measures including satisfaction and system usability were also collected. RESULTS: A greater number of logins was observed for the DG compared with the MSG; this was a medium between group effect size (d = 0.51; 95% CI: - 0.04, 1.05). Small to medium effect size differences were found at T2 in favour of the active conditions compared with the control on the DASS subscales depression, anxiety and stress, and the IWP subscales enthusiasm and comfort. This was largely maintained at T3. Satisfaction with the intervention was high with individuals in the MSG reporting greater satisfaction than individuals in the DG. CONCLUSIONS: This study shows that access to an online facilitated discussion group increases engagement with a minimally supported occupational digital mental health intervention (as defined by the number of logins), but that this doesn't necessarily result in improved psychological outcomes or increased satisfaction when compared to access to the intervention without the group. Access to the web-based program was associated with lower levels of depression, anxiety and stress and an increase in comfort and enthusiasm post intervention; these changes were largely maintained at follow-up. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov on March the 18th 2016 NCT02729987 (website link https://clinicaltrials.gov/ct2/show/NCT02729987?term=NCT02729987&rank=1).

Blended internet care for patients with severe mental illnesses: An open label prospective controlled cohort pilot study.

INTRODUCTION: This paper reports first experiences while providing blended (combined face-to-face and internet-based) flexible assertive community treatment (FACT) to outpatients with severe mental illnesses (SMI). The aim was to compare treatment satisfaction, clinical outcome and quality of life in the short term (3 months) of patients receiving blended FACT with those receiving conventional FACT. METHOD: This pilot study was designed as an open label prospective controlled cohort study. 47 SMI patients were found eligible and non-randomly allocated to Blended FACT (n = 25) or to conventional FACT (n = 22). Data were collected at baseline and at a 3-month follow-up. Measures included were the Dutch Mental Health Care Thermometer, Health of the Nation Outcome Scales (HONOS), Manchester Short Assessment of Quality of Life (MANSA), EuroQoL 5 dimensional (EQ5D) and the Mental Health Confidence Scale (MHCS). RESULTS: At a three months follow-up, patients reported slightly improved quality of life (EuroQoL 5 dimensional, Wald χ2(1) = 6.80, p = 0.01; MANSA, Wald χ2(1) = 4.02, p = 0.05) and self-efficacy beliefs regarding their mental health problems (MHCS, Wald χ2(1) = 3.71, p = 0.05). HONOS scores did not change over time, Wald χ2(1) = 2.34, p = 0.13. Satisfaction scores were on average between satisfactory - good (BI: M = 7.50, SD = 1.54; CAU: M = 7.53 SD = 0.96; on a 1-10 scale). These results did not differ between the two study groups. CONCLUSION: It appears acceptable to patients to provide blended FACT with SMI, with outcomes comparable to face-to-face FACT. A future high quality trial is warranted to establish (cost-)effectiveness of blended FACT.

The effects of the prevention program 'New Perspectives' (NP) on juvenile delinquency and other life domains: study protocol for a randomized controlled trial.

BACKGROUND: New Perspectives (NP) is a prevention program aiming to prevent that youth at onset of a criminal career will develop a persistent criminal behaviour pattern. The effects of NP on juvenile delinquency and other life domains are investigated, using a randomized controlled trial (RCT). METHOD/DESIGN: In the present study at-risk youth aged 12 to 23 years are assigned randomly to the intervention (N = 90, NP) or control condition consisting of care as usual (N = 90, CAU). After screening, random assignment, and consent to participate, adolescents and their parents are requested to complete questionnaires. Data are collected at four points in time: at baseline (before the start of the intervention), after 3 months, after 6 months (post-test) and 1 year after treatment (follow-up). Primary outcome measures include involvement in delinquent behaviour and recidivism. Secondary outcome measures include parenting behaviour, life events, prosocial behaviour, deviant and prosocial peers, externalizing behaviour, cognitive distortions, moral reasoning, self-worth, anxiety, depression, client satisfaction, therapeutic alliance and motivation. Standardized questionnaires and interviews are used to collect data. Moderator analyses will also be conducted in order to examine the influence of ethnic background, gender and age on the program effectiveness. DISCUSSION: The present study will provide new insights in the effects of a prevention program targeting youth at risk for the development of a persistent criminal career. TRIAL REGISTRATION: Dutch trial register number NTR4370. The study is financially supported by a grant from ZonMw, the Dutch Organization for Health research and Development, grant number 157004006. The study is approved by the Ethics Committee of the University of Amsterdam, approval number 2011-CDE-01.