Effectiveness of residential versus outpatient therapy for smoking cessation: The START randomized clinical trial.

BACKGROUND AND AIMS: Tobacco smoking represents a major cause for preventable death and morbidity. Results from non-randomized studies suggest that smoking cessation therapy in a residential setting might be a new viable way to facilitate smoking abstinence. We aimed to test the effects of residential multicomponent group therapy for smoking cessation compared with outpatient group therapy. DESIGN: Prospective parallel-group open-label randomized superiority trial, with assessments at baseline, 6 and 12 months. SETTING: Recruitment throughout Germany via media advertisements. PARTICIPANTS: Adult smokers (≥10 cigarettes/day) randomly assigned to residential (n = 157) or outpatient (n = 158) therapy. 51.8% female; mean age 53.2 years; mean years of smoking 34.4. INTERVENTION AND COMPARATOR: Residential 9-day smoking cessation group therapy comprising six daily therapy sessions and supportive interventions for cessation and daily structure embedded in the routines of a somatic rehabilitation center, compared with weekly outpatient smoking cessation group therapy (3-7 weeks) provided in routine care courses close to the participants' places of residence, both including at least 9 h of behavioral therapy. MEASUREMENTS: Co-primary outcomes were self-reported continuous 6- and 12-month abstinence (hierarchically ordered). Primary analyses were conducted in the therapy-uptake population including participants who started therapy with sensitivity analyses in the intention-to-treat population of all randomized participants. FINDINGS: Intervention uptake rates were 87.3% (n = 137) in the residential and 60.1% (n = 95) in the outpatient group. In the therapy-uptake population, abstinence rates were 46.7% in the residential versus 26.3% in the outpatient group at 6 months (odds ratio [OR] = 2.46, 95% confidence interval [CI] = 1.39-4.33, P = 0.0019) and 39.4% versus 24.2% at 12 months (OR = 2.04, 95% CI = 1.14-3.64, P = 0.017). Biochemically validated abstinence rates at 12 months were 33.1% in the residential versus 17.4% in the outpatient group (OR = 2.35, 95% CI = 1.22-4.51, P = 0.011). In the intention-to-treat population, self-reported and biochemically validated abstinence rates at 12 months were 34.4% in the residential versus 14.6% in the outpatient group (OR = 3.08, 95% CI = 1.77-5.34, P < 0.0001) and 28.6% versus 10.3% (OR = 3.48, 95% CI = 1.85-6.52, P = 0.0001), respectively. CONCLUSIONS: Residential therapy exclusively for smoking cessation is feasible and effective and could be a beneficial new treatment for smokers.

The association of early response with the outcome of psychosomatic rehabilitation in patients with mental disorders and its link to treatment and illness beliefs-A prospective longitudinal cohort study.

Early response is considered to be an important predictor for therapy outcomes; yet little is known about its relevance in psychosomatic rehabilitation. This paper aims to describe the association of early response in psychosomatic rehabilitation, as well as the associations of early response with pre-rehabilitative factors such as illness and treatment beliefs.A longitudinal study with three measurement points was applied. Early response was defined using the percent improvement method after two weeks of treatment. Its association with therapy outcome and with illness and treatment beliefs was analyzed using multiple regression analyses.A total of 264 participants took part. Early response was a significant predictor of psychosomatic rehabilitation outcome, explaining an incremental variance of 1-30% after controlling for initial symptom burden. Illness and treatment beliefs predicted 6-20% variance in early response. Important illness beliefs referred to perceived symptoms, consequences and comprehensibility of the illness. Important treatment beliefs referred to expectations about rehabilitation structure, processes and concerns.Early response is associated with the therapy outcome of psychosomatic rehabilitation, with illness and treatment beliefs found to be associated with early response. Further research on the predictors of early response in psychosomatic rehabilitation is needed.

Efficacy of Psychosocial Interventions for Survivors of Intimate Partner Violence: A Systematic Review and Meta-Analysis.

Survivors of intimate partner violence (IPV) face serious health-related, social and economic consequences. Prior meta-analyses indicate efficacy of psychosocial interventions for support of IPV survivors, but their results are affected by methodological limitations. Extensive subgroup analyses on the moderating effects of intervention and study characteristics are lacking. To address these limitations in an up-to-date and comprehensive meta-analytic review, four literature databases (PsycInfo, Medline, Embase, and CENTRAL, March 23, 2022) were searched for randomized-controlled trials examining the efficacy of psychosocial interventions compared to control groups in improving safety-related, mental health, and psychosocial outcomes in IPV survivors. Weighted effects on IPV, depression, posttraumatic stress disorder (PTSD), and psychosocial outcomes were calculated under random-effects assumption. Subgroup analyses were performed to investigate moderating effects of predefined intervention and study characteristics. Study quality was rated. In all, 80 studies were included in qualitative synthesis, and 40 studies in meta-analyses. Psychosocial interventions significantly reduced symptoms of depression (SMD: -0.15 [95% confidence interval, CI [-0.25, -0.04]; p = .006], I2 = 54%) and PTSD (SMD: -0.15 [95% CI [-0.29, -0.01]; p = .04], I2 = 52%), but not IPV reexperience (SMD: -0.02 [95% CI [ -0.09, 0.06]; p = .70], I2 = 21%) compared to control conditions at post. High-intensive and integrative interventions, combining advocacy-based and psychological components, were favorable subgroups. Yielded effects were modest and not maintained long term. The quality of evidence was low and potential harms remain unclear. Future research should adopt higher standards of research conduct and reporting and must account for the complexity and diversity of IPV experiences.

Screening for depression: Psychometric properties of the German version of the Glasgow depression scale for people with a learning disability (individual and carer version).

BACKGROUND: Adults with intellectual disabilities should participate in the diagnostics of their mental health. The Glasgow Depression Scale for people with a Learning Disability (GDS-LD) and its Carer Supplement (GDS-CS) were translated into German and tested. METHODS: Internal consistency, criterion validity and inter-test reliability were tested in 64 adults with borderline, mild or moderate intellectual disabilities and their carers. Convergent validity was analysed in 57 adults without intellectual disabilities. RESULTS: Internal consistency was good (α = 0.81) for GDS-LD and acceptable (α = 0.72) for GDS-CS. The GDS-LD did not differentiate between groups with and without depression. The GDS-CS significantly differentiated between these groups. Convergent validity of the GDS-LD was high. The correlation of GDS-LD and GDS-CS was non-significant. CONCLUSIONS: In its present form the German version of the GDS-LD does not meet the psychometric properties to be used in clinical practice. This leads to the broader question, how to measure depression in people with learning disabilities with the knowledge of the fallibility of existing measures when utilised with this clinical cohort. Also, future studies need to investigate the role of self-rating.

Effects of a Web-Based Behavioral Activation Intervention on Depressive Symptoms, Activation, Motivation, and Volition: Results of a Randomized Controlled Trial.

INTRODUCTION: Behavioral activation (BA) is effective for the treatment of depression. The Health Action Process Approach (HAPA), which is derived from health psychology, can provide a motivational-volitional framework of BA. OBJECTIVE: This study investigated the efficacy of a HAPA-based internet-delivered BA intervention (iBA; called InterAKTIV) in individuals with depression, also assessing HAPA-based motivational and volitional outcomes. METHODS: In a two-arm randomized controlled efficacy trial with a parallel design, 128 participants with a major depressive episode were randomly allocated to the intervention group (IG; TAU + immediate access to iBA) or control group (CG; TAU + access to iBA after follow-up). The primary outcome of clinician-rated depressive symptoms and secondary outcomes were assessed at baseline (T1), 8 weeks (T2), 6-month after randomization (T3). Data were analyzed on an intention-to-treat basis. RESULTS: Linear mixed model analyses revealed a significant group*time interaction effect on clinician-rated depressive symptoms favoring the IG (F2, 156.0 = 7.40; p < 0.001, d = 0.79 at T2, d = 0.25 at T3). The IG was also superior regarding self-rated depressive symptoms, BA, most motivational, and all volitional outcomes. CONCLUSION: This study shows that HAPA-based iBA can significantly improve clinician-rated depressive symptoms, as well as outcomes used in the HAPA model in people with depression. Building on these efficacy results, in the next step, the relationship between BA interventions and activity levels should be investigated, taking into account motivation and volition as potential mediators.

Local, collaborative, stepped, and personalized care management for older people with chronic diseases - results from the randomized controlled LoChro-trial.

BACKGROUND: In the aging population of Western societies, an increasing number of older adults have multiple chronic diseases. As multifaceted health problems imply the involvement of several healthcare professionals, multimorbid older people frequently face a fragmentation of health care. Addressing these challenges, we developed a local, collaborative, stepped, and personalized care management approach (LoChro-Care) and evaluated its effectiveness. METHODS: A two-group, parallel randomized controlled trial was conducted comparing LoChro-Care recipients (IG) to participants with usual care (CG). Patients aged 65 + with chronic conditions were recruited at inpatient and outpatient departments of the Medical Center, University of Freiburg. Participants were allocated using block randomization (nIG = 261, nCG = 263). LoChro-Care comprised individualized care provided by chronic care managers with 7 to 13 contacts over 12 months. Questionnaires were given at 3 time points (T0: baseline, T1: after 12 months, T2: after 18 months). The primary outcome was the physical, psychological, and social health status represented by a composite score of functional health and depressive symptoms. Secondary outcomes were the participants' evaluation of their health care situation, health-related quality of life (HRQL), and life-satisfaction (LS). The data were analyzed using linear mixed modelling. RESULTS: We analyzed N = 491 participants (nIG = 244, nCG = 247), aged M = 76.78 years (SD = 6.35). For the composite endpoint, neither a significant difference between IG and CG (p = .88) nor a group-time interaction (p = .52; p = .88) could be observed. Participants in both groups showed a significant decline on the primary outcome between T0 and T2 (p < .001). Post hoc analyses revealed a decline in both functional health (p < .001) and depressive symptoms (p = .02). Both groups did not differ in their evaluation of their health care situation (p = .93), HRQL (p = .44) or LS (p = .32). Relevant confounding variables were female gender and multimorbidity. CONCLUSION: Supporting patients' self-management in coordinating their individual care network through LoChro-Care did not result in any significant effect on the primary and secondary outcomes. A decline of functional health and depressive symptoms was observed among all participants. Potential future intervention adaptations are discussed, such as a more active case management through direct referral to (in-)formal support, an earlier treatment initiation, and the consideration of specific sociodemographic factors in care management planning. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00013904 (02.02.2018), https://drks.de/search/de/trial/DRKS00013904.

Psychometric properties of the rehabilitation treatment beliefs questionnaire for psychosomatic rehabilitation.

PURPOSE: Treatment beliefs play a crucial role for patient satisfaction and the treatment outcome in psychosomatic rehabilitation. The aim of this study was the development and the psychometric evaluation of an indication-specific questionnaire of beliefs about psychosomatic rehabilitation. MATERIALS AND METHODS: The study was conducted at a psychosomatic rehabilitation clinic. The primary item list comprised k = 125 items. After a descriptive item analysis, we conducted an exploratory factor analysis. Furthermore, we tested reliability via McDonald's Omega and construct validity by analyzing correlations of the scales with related constructs. RESULTS: Of the N = 264 participants, 50% were female and the mean age was 50.4 (SD = 9.8) years. K = 85 items were suitable for factor analysis, which resulted in k = 30 items constituting six scales, explaining of 57% the overall variance. The corrected item-total correlations were between r = 0.48 and r = 0.83. Internal consistency ranged from ω = 0.81 to ω = 0.86. CONCLUSION: The newly developed questionnaire assesses specific treatment beliefs about inpatient psychosomatic rehabilitation. The psychometric properties of the six scales are acceptable. Further studies should confirm the psychometric results, such as the factorial structure of the questionnaire.IMPLICATIONS FOR REHABILITATIONTreatment beliefs are known to play an important role for the adherence, therapy outcome and satisfaction in psychosomatic rehabilitation.We developed and tested a indication-specific questionnaire assessing treatment beliefs in psychosomatic rehabilitation.The questionnaire can be used to explore patient's rehabilitation-related treatment beliefs, predict treatment outcomes, and to develop interventions attempting to modify these.

Illness Beliefs, Treatment Beliefs, and Fulfilled Treatment Expectations in Psychosomatic Rehabilitation: Associations with Patient Satisfaction.

Purpose: Patients' illness and treatment beliefs have been shown to predict health outcomes in many health care settings. However, information about their impact on patient satisfaction is scarce. The aim of this study was to investigate illness- and rehabilitation-related treatment beliefs and met rehabilitation-related treatment expectations and their relationship with patient satisfaction in psychosomatic rehabilitation. Methods: In a repeated measures study design, patients filled out questionnaires 2 to 3 weeks before the start of rehabilitation and at the end of an inpatient rehabilitation 6 to 7 weeks later. The predictive value of illness beliefs, treatment beliefs, and fulfilled treatment expectations regarding patient satisfaction was analyzed with multiple hierarchical regression analyses controlling for sociodemographic and clinical variables. Results: Two hundred sixty-four patients participated. The sample was composed of equal numbers of men and women (n = 129 each). The mean age was 50.4 years. Most patients had diagnoses from the ICD-10 diagnostic group F3 (affective disorders; n = 145) or F4 (neurotic, stress-related and somatoform disorders; n = 94). Sociodemographic and clinical variables were not associated with patient satisfaction. The explained variance of patient satisfaction increased to 10% by adding illness beliefs (namely personal control and coherence) (p = 0.006), to 5% by adding rehabilitation-related treatment beliefs (namely concerns) (p = 0.063), and to 49% by adding fulfilled expectations (namely a positive discrepancy between expectations and experiences related to outcome expectations and related to participation and treatment structure, and a negative discrepancy between expectations and experiences related to concerns) (p < 0.001) as predictor variables. Conclusion: This study highlights the relationship of fulfilled (rehabilitation-related) treatment expectations with patient satisfaction in psychosomatic rehabilitation. Given the evidence underlining the importance of patients' illness and treatment beliefs and expectations, it is vital that these constructs are addressed in corresponding interventions.

Kontextfaktoren der patient*innenseitigen Selbstregulation in der psychosomatischen Rehabilitation ­ eine Querschnittsanalyse vor Rehabilitationsbeginn.

BACKGROUND: Contextual factors are a central element of the ICF and important factors for therapy planning in psychosomatic rehabilitation. At the same time, little is known about the relationship between contextual factors and patient self-regulation, an important goal of rehabilitation.The aim of this study is therefore to investigate the relationship between contextual factors and illness belies. Illness beliefs are a core element of self-regulation in psychosomatic rehabilitation and part of the common sense model of self-regulation. METHODS: Between April 2019 and January 2020, a cross-sectional questionnaire study was conducted in a psychosomatic rehabilitation clinic, in which registered rehabilitation patients were questioned about their illness beliefs using the Illness Perception Questionnaire (IPQ-R). Contextual factors were divided into clinically modifiable and non-clinically modifiable and included gender, age, duration of illness, subjective social status, main diagnosis (dichotomised: F3/F4), occupational stress, depressive stress as well as activity and participation (operationalised by the Health-49). Multiple regressions were used for the analysis, in which the scales of the IPQ-R served as dependent variables. RESULTS: N=264 rehabilitants took part in the survey, 50% of them were female. The average age was 50 years. With regard to the non-clinically modifiable contextual factors, it was shown that a younger age was associated with higher control assumptions, but that younger rehabilitation patients simultaneously perceived more symptoms due to their illness (identity). A longer duration of illness showed a connection with the chronic timeline assumptions. A lower social status showed correlations with lower control assumptions and more assumptions about the cyclical timeline. Regarding clinically modifiable contextual factors, an F3 diagnosis was associated with more expected consequence, but also with a higher perceived personal control than an F4 diagnosis. A higher occupational burden was associated with the assumption of a more chronic course of the disease. Reduced activity and participation were associated with more expected consequences and more perceived symptoms (identity). Depressive stress showed associations with six out of eight domains of illness beliefs. CONCLUSION: The study supports the relevance of contextual factors, which in majority can be discussed as person-related factors, for patient self-regulation in psychosomatic rehabilitation. Interventions to increase self-regulation, e. g. by taking illness beliefs into account, have already achieved promising results, also in the context of rehabilitation. The patient-oriented approach of these interventions could be further strengthened by a stronger inclusion of contextual factors.

Illness and treatment beliefs as predictors of rehabilitation outcome in patients with mental disorders.

OBJECTIVE: Illness and treatment beliefs are important predictors of health outcomes. However, little is known about their impact on outcomes in psychosomatic rehabilitation. Thus, the aim of this study was to investigate the impact of illness and rehabilitation-related treatment beliefs in patients with mental disorders attending psychosomatic rehabilitation. METHODS: We applied a longitudinal study with two measurement points (before rehabilitation; end of rehabilitation) in a psychosomatic rehabilitation clinic. Patients with mood disorders, anxiety or fear-related disorders, stress associated disorders or bodily distress disorders were included. Using regression models, we analysed whether illness and rehabilitation-related treatment beliefs predicted the rehabilitation outcome (operationalised through "Health-49"). Illness beliefs were assessed using the IPQ-R, while treatment beliefs were assessed using the RTBQ-Psych. Analyses were conducted separately for patients with a F3 and F4 diagnosis in accordance with the ICD-10. RESULTS: N = 239 patients were included, sample size per regression model ranged between n = 48 and n = 85. Mean age was 50.8 years, and n = 120 were female. Initial symptom burden was the strongest predictor in all models with 12% to 64% explained variance. Concerning illness beliefs, perceived consequences, treatment control, and cyclic timeline were negatively linked to the outcome, whereas coherence and emotional representations were shown to be positive predictors. Regarding treatment beliefs, expectations towards treatment results were positively and concerns were negatively associated predictors. CONCLUSION: Illness and treatment beliefs are predictors of the rehabilitation outcome. Patients´ beliefs might therefore be good starting points for interventions in the context of rehabilitation.

Effectiveness of a web-based behavioural activation intervention for individuals with depression based on the Health Action Process Approach: protocol for a randomised controlled trial with a 6-month follow-up.

INTRODUCTION: Behavioural activation is a highly effective treatment for depression. However, there is considerable heterogeneity of interventions grouped under the term 'behavioural activation'. A main reason for the heterogeneity is the lack of a unified theory in the intervention development: few of the established intervention manuals give a theoretical rationale for their intervention techniques. For the first time, this study will examine the effectiveness of a theory-based behavioural activation intervention (InterAKTIV) based on the Health Action Process Approach. The intervention is implemented online to ensure broad dissemination and standardisation. METHODS AND ANALYSIS: In a two-arm randomised controlled trial, the effectiveness of a guided web-based behavioural activation intervention for people with depression will be evaluated. Participants are recruited via the print and online media of a large German healthcare insurance company. Individuals (age 18-65), who meet criteria for major depressive episode in a clinical interview and no exclusion criteria are eligible for inclusion. A target sample of 128 participants is randomly allocated to either the intervention group (immediate access to InterAKTIV) or treatment as usual (access after follow-up assessment). The primary outcome of depressive symptom severity (Quick Inventory of Depressive Symptomatology Clinician Rating) and secondary outcomes, including behavioural activation, physical activity and motivational and volitional outcomes are assessed at baseline, post treatment and 6-month follow-up. Data will be analysed on an intention-to-treat basis with additional per-protocol analyses. ETHICS AND DISSEMINATION: This trial is approved by the ethics committee of the Albert-Ludwigs-University of Freiburg (no.: 20-1045). All participants are required to submit their informed consent online before study inclusion. The results will be submitted for publication in a peer-reviewed journal and presented at conferences. TRIAL REGISTRATION NUMBER: This trial was registered in the German Clinical Trials Register (DRKS): DRKS00024349 (date of registration: 29 January 2021).

Decreased mental health, quality of life, and utilization of professional help in cancer patients with unexpressed needs: A longitudinal analysis.

BACKGROUND: Cancer patients' mental health and quality of life can be improved through professional support according to their needs. In previous analyses of the UNSAID study, we showed that a relevant proportion of cancer patients did not express their needs during the admission interview of inpatient rehabilitation. We now examine trajectories of mental health, quality of life, and utilization of professional help in cancer patients with unexpressed needs. METHODS: We enrolled 449 patients with breast, prostate, and colon cancer at beginning (T0) and end (T1) of a 3-week inpatient rehabilitation and 3 (T2) and 9 (T3) months after discharge. We explored depression (PHQ-2), anxiety (GAD-2), emotional functioning (EORTC QLQ-C30), fear of progression (FoP-Q-SF), and global quality of life (EORTC QLQ-C30) using structuring equation models. Furthermore, we evaluated self-reports about expressing needs and utilization of professional help at follow-up. RESULTS: Patients with unexpressed needs (24.3%, n = 107) showed decreased mental health compared to other patients (e.g., depression: d T0 = 0.32, d T1-T3 = 0.39). They showed a significant decline in global quality of life at discharge and follow-up (d = 0.28). Furthermore, they had a higher need for support (Cramer's V T2 = 0.10, T3 = 0.15), talked less about their needs (Cramer's V T2 = 0.18), and made less use of different health care services at follow-up. CONCLUSION: Unexpressed needs in cancer patients may be a risk factor for decreased mental health, quality of life, and non-utilization of professional help in the long term. Further research should clarify causal relationships and focus on this specific group of patients to improve cancer care.

Psychological and pharmacological interventions for depression in patients with coronary artery disease.

BACKGROUND: Depression occurs frequently in individuals with coronary artery disease (CAD) and is associated with a poor prognosis. OBJECTIVES: To determine the effects of psychological and pharmacological interventions for depression in CAD patients with comorbid depression. SEARCH METHODS: We searched the CENTRAL, MEDLINE, Embase, PsycINFO, and CINAHL databases up to August 2020. We also searched three clinical trials registers in September 2021. We examined reference lists of included randomised controlled trials (RCTs) and contacted primary authors. We applied no language restrictions. SELECTION CRITERIA: We included RCTs investigating psychological and pharmacological interventions for depression in adults with CAD and comorbid depression. Our primary outcomes included depression, mortality, and cardiac events. Secondary outcomes were healthcare costs and utilisation, health-related quality of life, cardiovascular vital signs, biomarkers of platelet activation, electrocardiogram wave parameters, non-cardiac adverse events, and pharmacological side effects. DATA COLLECTION AND ANALYSIS: Two review authors independently examined the identified papers for inclusion and extracted data from the included studies. We performed random-effects model meta-analyses to compute overall estimates of treatment outcomes. MAIN RESULTS: Thirty-seven trials fulfilled our inclusion criteria. Psychological interventions may result in a reduction in end-of-treatment depression symptoms compared to controls (standardised mean difference (SMD) -0.55, 95% confidence interval (CI) -0.92 to -0.19, I2 = 88%; low certainty evidence; 10 trials; n = 1226). No effect was evident on medium-term depression symptoms one to six months after the end of treatment (SMD -0.20, 95% CI -0.42 to 0.01, I2 = 69%; 7 trials; n = 2654). The evidence for long-term depression symptoms and depression response was sparse for this comparison. There is low certainty evidence that psychological interventions may result in little to no difference in end-of-treatment depression remission (odds ratio (OR) 2.02, 95% CI 0.78 to 5.19, I2 = 87%; low certainty evidence; 3 trials; n = 862). Based on one to two trials per outcome, no beneficial effects on mortality and cardiac events of psychological interventions versus control were consistently found. The evidence was very uncertain for end-of-treatment effects on all-cause mortality, and data were not reported for end-of-treatment cardiovascular mortality and occurrence of myocardial infarction for this comparison. In the trials examining a head-to-head comparison of varying psychological interventions or clinical management, the evidence regarding the effect on end-of-treatment depression symptoms is very uncertain for: cognitive behavioural therapy compared to supportive stress management; behaviour therapy compared to person-centred therapy; cognitive behavioural therapy and well-being therapy compared to clinical management. There is low certainty evidence from one trial that cognitive behavioural therapy may result in little to no difference in end-of-treatment depression remission compared to supportive stress management (OR 1.81, 95% CI 0.73 to 4.50; low certainty evidence; n = 83). Based on one to two trials per outcome, no beneficial effects on depression remission, depression response, mortality rates, and cardiac events were consistently found in head-to-head comparisons between psychological interventions or clinical management. The review suggests that pharmacological intervention may have a large effect on end-of-treatment depression symptoms (SMD -0.83, 95% CI -1.33 to -0.32, I2 = 90%; low certainty evidence; 8 trials; n = 750). Pharmacological interventions probably result in a moderate to large increase in depression remission (OR 2.06, 95% CI 1.47 to 2.89, I2 = 0%; moderate certainty evidence; 4 trials; n = 646). We found an effect favouring pharmacological intervention versus placebo on depression response at the end of treatment, though strength of evidence was not rated (OR 2.73, 95% CI 1.65 to 4.54, I2 = 62%; 5 trials; n = 891). Based on one to four trials per outcome, no beneficial effects regarding mortality and cardiac events were consistently found for pharmacological versus placebo trials, and the evidence was very uncertain for end-of-treatment effects on all-cause mortality and myocardial infarction. In the trials examining a head-to-head comparison of varying pharmacological agents, the evidence was very uncertain for end-of-treatment effects on depression symptoms. The evidence regarding the effects of different pharmacological agents on depression symptoms at end of treatment is very uncertain for: simvastatin versus atorvastatin; paroxetine versus fluoxetine; and escitalopram versus Bu Xin Qi. No trials were eligible for the comparison of a psychological intervention with a pharmacological intervention. AUTHORS' CONCLUSIONS: In individuals with CAD and depression, there is low certainty evidence that psychological intervention may result in a reduction in depression symptoms at the end of treatment. There was also low certainty evidence that pharmacological interventions may result in a large reduction of depression symptoms at the end of treatment. Moderate certainty evidence suggests that pharmacological intervention probably results in a moderate to large increase in depression remission at the end of treatment. Evidence on maintenance effects and the durability of these short-term findings is still missing. The evidence for our primary and secondary outcomes, apart from depression symptoms at end of treatment, is still sparse due to the low number of trials per outcome and the heterogeneity of examined populations and interventions. As psychological and pharmacological interventions can seemingly have a large to only a small or no effect on depression, there is a need for research focusing on extracting those approaches able to substantially improve depression in individuals with CAD and depression.

"Help in a Heartbeat?": A Systematic Evaluation of Mobile Health Applications (Apps) for Coronary Heart Disease.

For patients with coronary heart disease (CHD) lifestyle changes and disease management are key aspects of treatment that could be facilitated by mobile health applications (MHA). However, the quality and functions of MHA for CHD are largely unknown, since reviews are missing. Therefore, this study assessed the general characteristics, quality, and functions of MHA for CHD. Hereby, the Google Play and Apple App stores were systematically searched using a web crawler. The general characteristics and quality of MHA were rated with the Mobile Application Rating Scale (MARS) by two independent raters. From 3078 identified MHA, 38 met the pre-defined criteria and were included in the assessment. Most MHA were affiliated with commercial companies (52.63%) and lacked an evidence-base. An overall average quality of MHA (M = 3.38, SD = 0.36) was found with deficiencies in information quality and engagement. The most common functions were provision of information and CHD risk score calculators. Further functions included reminders (e.g., for medication or exercises), feedback, and health management support. Most MHA (81.58%) had one or two functions and MHA with more features had mostly higher MARS ratings. In summary, this review demonstrated that a number of potentially helpful MHA for patients with CHD are commercially available. However, there is a lack of scientific evidence documenting their usability and clinical potential. Since it is difficult for patients and healthcare providers to find suitable and high-quality MHA, databases with professionally reviewed MHA are required.

Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial.

BACKGROUND: Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. METHODS: A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare ( www.studicare.com ). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. DISCUSSION: This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. TRIAL REGISTRATION: The German clinical trials register (DRKS) DRKS00016889 . Registered on 28 February 2019.

Effectiveness of a Guided Web-Based Intervention to Reduce Depressive Symptoms before Outpatient Psychotherapy: A Pragmatic Randomized Controlled Trial.

INTRODUCTION: Psychotherapy is a first-line treatment for depression. However, capacities are limited, leading to long waiting times for outpatient psychotherapy in health care systems. Web-based interventions (WBI) could help to bridge this treatment gap. OBJECTIVE: This study investigates the effectiveness of a guided cognitive-behavioral WBI in depressive patients seeking face-to-face psychotherapy. METHODS: A 2-arm randomized controlled trial was conducted. Depressive patients (n = 136) recruited from the waiting lists of outpatient clinics were randomly assigned to an intervention group (IG; treatment as usual [TAU] + immediate access to WBI) or a control group (CG; TAU + access to WBI after follow-up). Depressive symptoms and secondary outcomes were assessed at baseline, 7 weeks, and 5 months after randomization. RESULTS: Mixed-model analyses revealed a significant group × time interaction effect on depressive symptoms (F2, 121.5 = 3.91; p < 0.05). Between-group effect sizes were d = 0.55 at 7 weeks and d = 0.52 at 5 months. The IG was superior regarding psychological symptoms and mental health quality of life but not on physical health quality of life, attitudes, motivation for psychotherapy, or subjective need and uptake of psychotherapy. CONCLUSIONS: Patients waiting for face-to-face psychotherapy can benefit from a WBI when compared to TAU. Despite the reduction of depressive symptoms in the IG, the uptake of subsequent psychotherapy was still high in both groups. The effects remained stable at the 5-month follow-up. However, this study could not determine the proportion of specific intervention effects vs. nonspecific effects, such as positive outcome expectations or attention. Future research should focus on the long-term effects and cost-effectiveness of WBI before psychotherapy.

Prevention of depression in adults with long-term physical conditions.

BACKGROUND: Major depression is one of the world's leading causes of disability in adults with long-term physical conditions compared to those without physical illness. This co-morbidity is associated with a negative prognosis in terms of increased morbidity and mortality rates, increased healthcare costs, decreased adherence to treatment regimens, and a substantial decline in quality of life. Therefore, preventing the onset of depressive episodes in adults with long-term physical conditions should be a global healthcare aim. In this review, primary or tertiary (in cases of preventing recurrences in those with a history of depression) prevention are the focus. While primary prevention aims at preventing the onset of depression, tertiary prevention comprises both preventing recurrences and prohibiting relapses. Tertiary prevention aims to address a depressive episode that might still be present, is about to subside, or has recently resolved. We included tertiary prevention in the case where the focus was preventing the onset of depression in those with a history of depression (preventing recurrences) but excluded it if it specifically focused on maintaining an condition or implementing rehabilitation services (relapse prevention). Secondary prevention of depression seeks to prevent the progression of depressive symptoms by early detection and treatment and may therefore be considered a 'treatment,' rather than prevention. We therefore exclude the whole spectrum of secondary prevention. OBJECTIVES: To assess the effectiveness, acceptability and tolerability of psychological or pharmacological interventions, in comparison to control conditions, in preventing depression in adults with long-term physical conditions; either before first ever onset of depressive symptoms (i.e. primary prevention) or before first onset of depressive symptoms in patients with a history of depression (i.e. tertiary prevention). SEARCH METHODS: We searched the Cochrane Common Mental Disorders Controlled Trials Register, CENTRAL, MEDLINE, Embase, PsycINFO and two trials registries, up to 6 February 2020. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of preventive psychological or pharmacological interventions, specifically targeting incidence of depression in comparison to treatment as usual (TAU), waiting list, attention/psychological placebo, or placebo. Participants had to be age 18 years or older, with at least one long-term physical condition, and no diagnosis of major depression at baseline (primary prevention). In addition, we included studies comprising mixed samples of patients with and without a history of depression, which explored tertiary prevention of recurrent depression. We excluded other tertiary prevention studies. We also excluded secondary preventive interventions. Primary outcomes included incidence of depression, tolerability, and acceptability. Secondary outcomes included severity of depression, cost-effectiveness and cost-utility. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included 11 RCTs, with one trial on psychological interventions, and 10 trials on pharmacological interventions. Data analyses on the psychological intervention (problem-solving therapy compared to TAU) included 194 participants with age-related macular degeneration. Data analyses on pharmacological interventions included 837 participants comparing citalopram (one trial), escitalopram (three trials), a mixed sample of fluoxetine/nortriptyline (one trial), melatonin (one trial), milnacipran (one trial), and sertraline (three trials), each to placebo. Included types of long-term physical conditions were acute coronary syndrome (one trial), breast cancer (one trial), head and neck cancer (two trials), stroke (five trials), and traumatic brain injury (one trial). Psychological interventions Very low-certainty evidence of one study suggests that problem solving therapy may be slightly more effective than TAU in preventing the incidence of depression, immediately post-intervention (odds ratio (OR) 0.43, 95% confidence interval (CI) 0.20 to 0.95; 194 participants). However, there may be little to no difference between groups at six months follow-up (OR 0.71, 95% CI 0.36 to 1.38; 190 participants; one study; very low-certainty evidence). No data were available regarding incidence of depression after six months. Regarding acceptability (drop-outs due to any cause), slightly fewer drop-outs occurred in the TAU group immediately post-intervention (OR 5.21, 95% CI 1.11 to 24.40; 206 participants; low-certainty evidence). After six months, however, the groups did not differ (OR 1.67, 95% CI 0.58 to 4.77; 206 participants; low-certainty evidence). This study did not measure tolerability. Pharmacological interventions Post-intervention, compared to placebo, antidepressants may be beneficial in preventing depression in adults with different types of long-term physical conditions, but the evidence is very uncertain (OR 0.31, 95% CI 0.20 to 0.49; 814 participants; nine studies; I2 =0%; very low-certainty evidence). There may be little to no difference between groups both immediately and at six months follow-up (OR 0.44, 95% CI 0.08 to 2.46; 23 participants; one study; very low-certainty evidence) as well as at six to 12 months follow-up (OR 0.81, 95% CI 0.23 to 2.82; 233 participants; three studies; I2 = 49%; very low-certainty evidence). There was very low-certainty evidence from five studies regarding the tolerability of the pharmacological intervention. A total of 669 adverse events were observed in 316 participants from the pharmacological intervention group, and 610 adverse events from 311 participants in the placebo group. There was very low-certainty evidence that drop-outs due to adverse events may be less frequent in the placebo group (OR 2.05, 95% CI 1.07 to 3.89; 561 participants; five studies; I2 = 0%). There was also very low-certainty evidence that drop-outs due to any cause may not differ between groups either post-intervention (OR 1.13, 95% CI 0.73 to 1.73; 962 participants; nine studies; I2 = 28%), or at six to 12 months (OR 1.13, 95% CI 0.69 to 1.86; 327 participants; three studies; I2 = 0%). AUTHORS' CONCLUSIONS: Based on evidence of very low certainty, our results may indicate the benefit of pharmacological interventions, during or directly after preventive treatment. Few trials examined short-term outcomes up to six months, nor the follow-up effects at six to 12 months, with studies suffering from great numbers of drop-outs and inconclusive results. Generalisation of results is limited as study populations and treatment regimes were very heterogeneous. Based on the results of this review, we conclude that for adults with long-term physical conditions, there is only very uncertain evidence regarding the implementation of any primary preventive interventions (psychological/pharmacological) for depression.

Effectiveness of a Guided Internet- and Mobile-Based Intervention for Patients with Chronic Back Pain and Depression (WARD-BP): A Multicenter, Pragmatic Randomized Controlled Trial.

INTRODUCTION: There is neither strong evidence on effective treatments for patients with chronic back pain (CBP) and depressive disorder nor sufficiently available mental health care offers. OBJECTIVE: The aim is to assess the effectiveness of internet- and mobile-based interventions (IMI) as a scalable approach for treating depression in a routine care setting. METHODS: This is an observer-masked, multicenter, pragmatic randomized controlled trial with a randomization ratio of 1:1.Patients with CBP and diagnosed depressive disorder (mild to moderate severity) were recruited from 82 orthopedic rehabilitation clinics across Germany. The intervention group (IG) received a guided depression IMI tailored to CBP next to treatment-as-usual (TAU; including medication), while the control group (CG) received TAU. The primary outcome was observer-masked clinician-rated Hamilton depression severity (9-week follow-up). The secondary outcomes were: further depression outcomes, pain-related outcomes, health-related quality of life, and work capacity. Biostatistician blinded analyses using regression models were conducted by intention-to-treat and per protocol analysis. RESULTS: Between October 2015 and July 2017, we randomly assigned 210 participants (IG, n = 105; CG, n = 105), mostly with only a mild pain intensity but substantial pain disability. No statistically significant difference in depression severity between IG and CG was observed at the 9-week follow-up (ß = -0.19, 95% CI -0.43 to 0.05). Explorative secondary depression (4/9) and pain-related (4/6) outcomes were in part significant (p < 0.05). Health-related quality of life was significantly higher in the IG. No differences were found in work capacity. CONCLUSION: The results indicate that an IMI for patients with CBP and depression in a routine care setting has limited impact on depression. Benefits in pain and health-related outcomes suggest that an IMI might still be a useful measure to improve routine care.