Investigating non-inferiority of internet-delivered versus face-to-face cognitive behavioural therapy for insomnia (CBT-I): a randomised controlled trial (iSleep well).

BACKGROUND: Insomnia is a highly prevalent disorder associated with numerous adverse health outcomes. Cognitive behavioural therapy for insomnia (CBT-I) is recommended as first-line treatment by clinical guidelines but is accessible to only a minority of patients suffering from insomnia. Internet-delivered CBT-I (iCBT-I) could contribute to the widespread dissemination of this first-line treatment. As there is insufficient evidence regarding non-inferiority, this study directly aims to compare therapist-guided internet-delivered versus face-to-face CBT-I in terms of insomnia severity post-treatment. Furthermore, a health-economic evaluation will be conducted, and potential benefits and disadvantages of therapist-guided iCBT-I will be examined. METHODS: This study protocol describes a randomised controlled two-arm parallel-group non-inferiority trial comparing therapist-guided iCBT-I with face-to-face CBT-I in routine clinical care. A total of 422 patients with insomnia disorder will be randomised and treated at 16 study centres throughout Germany. Outcomes will be assessed at baseline, 10 weeks after randomisation (post), and 6 months after randomisation (follow-up). The primary outcome is insomnia severity measured using the Insomnia Severity Index. Secondary outcomes include depression-related symptoms, quality of life, fatigue, physical activity, daylight exposure, adverse events related to treatment, and a health-economic evaluation. Finally, potential moderator variables and several descriptive and exploratory outcomes will be assessed (e.g. benefits and disadvantages of internet-delivered treatment). DISCUSSION: The widespread implementation of CBT-I is a significant healthcare challenge. The non-inferiority of therapist-guided iCBT-I versus face-to-face CBT-I will be investigated in an adequately powered sample in routine clinical care, with the same therapeutic content and same level of therapist qualifications provided with both interventions. If this trial demonstrates the non-inferiority of therapist-guided iCBT-I, healthcare providers may be more confident recommending this treatment to their patients, contributing to the wider dissemination of CBT-I. TRIAL REGISTRATION: Trial registration number in the German Clinical Trials Register: DRKS00028153 ( https://drks.de/search/de/trial/DRKS00028153 ). Registered on 16th May 2023.

'Leaving my comfort zone'. A qualitative study of physiotherapists' experiences blending an eHealth psychosocial intervention with face-to-face physiotherapy.

BACKGROUND: Many physiotherapists do not feel adequately equipped to address psychosocial risk factors in people with complex pain states. Hence, a biopsychosocial blended intervention (Back2Action) was developed to assist physiotherapists to manage people with persistent spinal pain and coexisting psychosocial risk factors associated with the development or maintenance of persistent pain. OBJECTIVE: This study aimed to gain insight into the experiences of physiotherapists with this blended psychosocial intervention. DESIGN: and methods: This was an interpretative qualitative study with a reflexive thematic analysis of semi-structured interviews with physiotherapists (N = 15) who delivered Back2Action. The interview started with the grand-tour question: "What was your experience in using Back2Action?" Physiotherapist were encouraged to provide examples, and follow-up questions were posed to ensure a deeper understanding could be reached. RESULTS: Four themes were constructed: Physiotherapists became increasingly aware of (1) their own implicit expectations, biases and skills, and underlying treatment paradigms, and (2) the implicit expectations from their patients towards them. This led to (3) creating a deeper and stronger therapeutic alliance with the patient, but also (4) an understanding that implementation of a true biopsychosocial intervention - even if offered in a blended form - requires more practice, confidence and resources. CONCLUSIONS: Back2Action is considered a valuable treatment to deliver a biopsychosocial intervention in primary care. Considering the high level of knowledge, skills and competency of the participating physiotherapists, the perceived barriers may be more difficult to overcome for more junior physiotherapists.

How people with persistent pain experience in-person physiotherapy blended with biopsychosocial digital health - A qualitative study on participants' experiences with Back2Action.

Background: A blended intervention consisting of in-person physiotherapy and psychologically-informed digital health, called Back2Action, was developed to optimise the management of people with persistent spinal pain who also have psychosocial risk factors associated with the development or maintenance of persistent pain. This study aimed to gain insights in how participants experienced this blended intervention. Methods: A qualitative study using semi-structured interviews was conducted. Eleven people with persistent non-specific spinal pain who received the blended intervention within a randomised clinical trial were included. All interviews were recorded, transcribed verbatim and analysed independently by two researchers. Data were analysed using a thematic analysis. Results: The analysis identified four themes: (1) Experiencing a better understanding of the relationship between own physical and mental health; (2) Importance of the physiotherapist's active involvement in biopsychosocial blended care, which describes the crucial role of physiotherapists in supporting participants in this; (3) Appreciation of digital health, to better understand persistent pain and make meaningful lifestyle changes; and (4) Trials and triumphs, revealing gains such as better coping, but also challenges with implementation of changes into long-term routines. Conclusion: Participants of the blended intervention experienced positive changes in thoughts and behaviours, which highlights the feasibility and acceptability of the blended intervention as a more holistic treatment within pain management. The differences in personal preferences for receiving psychologically-informed digital health poses challenges for implementation of blended biopsychosocial care in evidence-based practice.

E-Health intervention for subthreshold depression: Reach and two-year effects of a randomized controlled trial.

BACKGROUND: There is evidence for e-Health interventions for full-blown depression. Little is known regarding commonly untreated subthreshold depression in primary care. This randomized controlled multi-centre trial assessed reach and two-year-effects of a proactive e-Health intervention (ActiLife) for patients with subthreshold depression. METHODS: Primary care and hospital patients were screened for subthreshold depression. Over 6 months, ActiLife participants received three individualized feedback letters and weekly messages promoting self-help strategies against depression, e.g., dealing with unhelpful thoughts or behavioural activation. The primary outcome depressive symptom severity (Patient Health Questionnaire;PHQ-8) and secondary outcomes were assessed 6, 12 and 24 months. RESULTS: Of those invited, n = 618(49.2 %) agreed to participate. Of them, 456 completed the baseline interview and were randomized to ActiLife (n = 227) or assessment only (n = 226). Generalised estimation equation analyses adjusting for site, setting and baseline depression revealed that depressive symptom severity declined over time, with no significant group differences at 6 (mean difference = 0.47 points; d = 0.12) and 24 months (mean difference = -0.05 points; d = -0.01). Potential adverse effects were observed at 12 months, with higher depressive symptom severity for ActiLife than control participants (mean difference = 1.33 points; d = 0.35). No significant differences in rates of reliable deterioration or reliable improvement of depressive symptoms were observed. ActiLife increased applied self-help strategies at 6 (mean difference = 0.32; d = 0.27) and 24 months (mean difference = 0.22; d = 0.19), but not at 12 months (mean difference = 0.18; d = 0.15). LIMITATIONS: Self-report measures and lack of information on patients' mental health treatment. DISCUSSION: ActiLife yielded satisfactory reach and increased the use of self-help strategies. Data were inconclusive in terms of depressive symptom changes.

Remote mental health care interventions during the COVID-19 pandemic: An umbrella review.

Mitigating the COVID-19 related disruptions in mental health care services is crucial in a time of increased mental health disorders. Numerous reviews have been conducted on the process of implementing technology-based mental health care during the pandemic. The research question of this umbrella review was to examine what the impact of COVID-19 was on access and delivery of mental health services and how mental health services have changed during the pandemic. A systematic search for systematic reviews and meta-analyses was conducted up to August 12, 2022, and 38 systematic reviews were identified. Main disruptions during COVID-19 were reduced access to outpatient mental health care and reduced admissions and earlier discharge from inpatient care. In response, synchronous telemental health tools such as videoconferencing were used to provide remote care similar to pre-COVID care, and to a lesser extent asynchronous virtual mental health tools such as apps. Implementation of synchronous tools were facilitated by time-efficiency and flexibility during the pandemic but there was a lack of accessibility for specific vulnerable populations. Main barriers among practitioners and patients to use digital mental health tools were poor technological literacy, particularly when preexisting inequalities existed, and beliefs about reduced therapeutic alliance particularly in case of severe mental disorders. Absence of organizational support for technological implementation of digital mental health interventions due to inadequate IT infrastructure, lack of funding, as well as lack of privacy and safety, challenged implementation during COVID-19. Reviews were of low to moderate quality, covered heterogeneously designed primary studies and lacked findings of implementation in low- and middle-income countries. These gaps in the evidence were particularly prevalent in studies conducted early in the pandemic. This umbrella review shows that during the COVID-19 pandemic, practitioners and mental health care institutions mainly used synchronous telemental health tools, and to a lesser degree asynchronous tools to enable continued access to mental health care for patients. Numerous barriers to these tools were identified, and call for further improvements. In addition, more high quality research into comparative effectiveness and working mechanisms may improve scalability of mental health care in general and in future infectious disease outbreaks.

Adverse childhood experiences and global mental health: avenues to reduce the burden of child and adolescent mental disorders.

Mental disorders are one of the largest contributors to the burden of disease globally, this holds also for children and adolescents, especially in low- and middle-income countries. The prevalence and severity of these disorders are influenced by social determinants, including exposure to adversity. When occurring early in life, these latter events are referred to as adverse childhood experiences (ACEs).In this editorial, we provide an overview of the literature on the role of ACEs as social determinants of mental health through the lenses of global mental health. While the relation between ACEs and mental health has been extensively explored, most research was centred in higher income contexts. We argue that findings from the realm of global mental health should be integrated into that of ACEs, e.g. through preventative and responsive psychosocial interventions for children, adolescents and their caregivers. The field of global mental health should also undertake active efforts to better address ACEs in its initiatives, all with the goal of reducing the burden of mental disorders among children and adolescents globally.

Long-term effectiveness of Self-Help Plus in refugees and asylum seekers resettled in Western Europe: 12-month outcomes of a randomised controlled trial.

AIMS: As refugees and asylum seekers are at high risk of developing mental disorders, we assessed the effectiveness of Self-Help Plus (SH + ), a psychological intervention developed by the World Health Organization, in reducing the risk of developing any mental disorders at 12-month follow-up in refugees and asylum seekers resettled in Western Europe. METHODS: Refugees and asylum seekers with psychological distress (General Health Questionnaire-12 ⩾ 3) but without a mental disorder according to the Mini International Neuropsychiatric Interview (M.I.N.I.) were randomised to either SH + or enhanced treatment as usual (ETAU). The frequency of mental disorders at 12 months was measured with the M.I.N.I., while secondary outcomes included self-identified problems, psychological symptoms and other outcomes. RESULTS: Of 459 participants randomly assigned to SH + or ETAU, 246 accepted to be interviewed at 12 months. No difference in the frequency of any mental disorders was found (relative risk [RR] = 0.841; 95% confidence interval [CI] 0.389-1.819; p-value = 0.659). In the per protocol (PP) population, that is in participants attending at least three group-based sessions, SH + almost halved the frequency of mental disorders at 12 months compared to ETAU, however so few participants and events contributed to this analysis that it yielded a non-significant result (RR = 0.528; 95% CI 0.180-1.544; p-value = 0.230). SH + was associated with improvements at 12 months in psychological distress (p-value = 0.004), depressive symptoms (p-value = 0.011) and wellbeing (p-value = 0.001). CONCLUSIONS: The present study failed to show any long-term preventative effect of SH + in refugees and asylum seekers resettled in Western European countries. Analysis of the PP population and of secondary outcomes provided signals of a potential effect of SH + in the long-term, which would suggest the value of exploring the effects of booster sessions and strategies to increase SH + adherence.

Group problem management plus (PM+) to decrease psychological distress among Syrian refugees in Turkey: a pilot randomised controlled trial.

BACKGROUND: Syrian refugees resettled in Turkey show a high prevalence of symptoms of mental disorders. Problem Management Plus (PM+) is an effective psychological intervention delivered by non-specialist health care providers which has shown to decrease psychological distress among people exposed to adversity. In this single-blind pilot randomised controlled trial, we examined the methodological trial procedures of Group PM+ (gPM+) among Syrian refugees with psychological distress in Istanbul, Turkey, and assessed feasibility, acceptability, perceived impact and the potential cost-effectiveness of the intervention. METHODS: Refugees with psychological distress (Kessler Psychological Distress Scale, K10 > 15) and impaired psychosocial functioning (World Health Organization Disability Assessment Schedule, WHODAS 2.0 > 16) were recruited from the community and randomised to either gPM+ and enhanced care as usual (E-CAU) (n = 24) or E-CAU only (n = 22). gPM+ comprised of five weekly group sessions with eight to ten participants per group. Acceptability and feasibility of the intervention were assessed through semi-structured interviews. The primary outcome at 3-month follow-up was symptoms of depression and anxiety (Hopkins Symptoms Checklist-25). Psychosocial functioning (WHODAS 2.0), symptoms of posttraumatic stress disorder and self-identified problems (Psychological Outcomes Profiles, PSYCHLOPS) were included as secondary outcomes. A modified version of the Client Service Receipt Inventory was used to document changes in the costs of health service utilisation as well as productivity losses. RESULTS: There were no barriers experienced in recruiting study participants and in randomising them into the respective study arms. Retention in gPM+ was high (75%). Qualitative analyses of the interviews with the participants showed that Syrian refugees had a positive view on the content, implementation and format of gPM+. No adverse events were reported during the implementation. The study was not powered to detect an effect. No significant difference between gPM+ and E-CAU group on primary and secondary outcome measures, or in economic impacts were found. CONCLUSIONS: gPM+ delivered by non-specialist peer providers seemed to be an acceptable, feasible and safe intervention for Syrian refugees in Turkey with elevated levels of psychological distress. This pilot RCT sets the stage for a fully powered RCT. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03567083 ; date: 25/06/2018.

A risk algorithm that predicts alcohol use disorders among college students.

The first year of college may carry especially high risk for onset of alcohol use disorders. We assessed the one-year incidence of alcohol use disorders (AUD) among incoming first-year students, predictors of AUD-incidence, prediction accuracy and population impact. A prospective cohort study of first-year college students (baseline: N = 5843; response rate = 51.8%; 1-year follow-up: n = 1959; conditional response rate = 41.6%) at a large university in Belgium was conducted. AUD were evaluated with the AUDIT and baseline predictors with the Composite International Diagnostic Interview Screening Scales (CIDI-SC). The one-year incidence of AUD was 3.9% (SE = 0.4). The most important individual-level baseline predictors of AUD incidence were being male (OR = 1.53; 95% CI = 1.12-2.10), a break-up with a romantic partner (OR = 1.67; 95% CI = 1.08-2.59), hazardous drinking (OR = 3.36; 95% CI = 1.31-8.63), and alcohol use characteristics at baseline (ORs between 1.29 and 1.38). Multivariate cross-validated prediction (cross-validated AUC = 0.887) shows that 55.5% of incident AUD cases occurred among the 10% of students at highest predicted risk (20.1% predicted incidence in this highest-risk subgroup). Four out of five students with incident AUD would hypothetically be preventable if baseline hazardous drinking was to be eliminated along with a reduction of one standard deviation in alcohol use characteristics scores, and another 15.0% would potentially be preventable if all 12-month stressful events were eliminated. Screening at college entrance is a promising strategy to identify students at risk of transitioning to more problematic drinking and AUD, thus improving the development and deployment of targeted preventive interventions.

Comparing machine learning to a rule-based approach for predicting suicidal behavior among adolescents: Results from a longitudinal population-based survey.

INTRODUCTION: Suicidal thoughts and suicide attempts are one of the most prominent public health concerns in adolescents and therefore early detection is important to initiate preventive interventions and closer monitoring. METHOD: We examined whether the Machine Learning models Random Forest and Lasso Regression better predict future suicidal behavior than a simple decision rule that classifies every adolescent with history of suicide ideation at baseline as at risk (current practice). We used data from a general population of students in second and fourth year of secondary education in Amsterdam, the Netherlands. RESULTS: Both the Random Forest and the Lasso Regression resulted in slightly better prediction. The AUC of the Random Forest (0.79) and Lasso regression (0.76) were both higher than the AUC of the decision rule (0.64). The Random Forest achieved slightly (but non-significantly) higher sensitivity than the decision rule (0.37 versus 0.34), with the same specificity (0.94). With Lasso Regression the sensitivity increased significantly (0.52), but at the expense of the specificity (0.85). LIMITATIONS: The loss of cases after merging the data, the use of self-reported data, confidential data collection and the use of only four questions to measure suicidal behavior. CONCLUSIONS: This is the first study applying Machine Learning techniques to predict future suicidal behavior on survey data collected in a general population of adolescents. Our study showed that integrating machine learning techniques in screening practice will result in a small improvement in the ability to predict suicide. The models need to be further optimized to improve accuracy.

Reasons for not reaching or using web-based self-management applications, and the use and evaluation of Oncokompas among cancer survivors, in the context of a randomised controlled trial.

INTRODUCTION: The web-based self-management application Oncokompas was developed to support cancer survivors to monitor health-related quality of life and symptoms (Measure) and to provide tailored information (Learn) and supportive care options (Act). In a previously reported randomised controlled trial (RCT), 68% of 655 recruited survivors were eligible, and of those 45% participated in the RCT. Among participants of the RCT that were randomised to the intervention group, 52% used Oncokompas as intended. The aim of this study was to explore reasons for not participating in the RCT, and reasons for not using Oncokompas among non-users, and the use and evaluation of Oncokompas among users. METHODS: Reasons for not participating were assessed with a study-specific questionnaire among 243 survivors who declined participation. Usage was investigated among 320 participants randomised to the intervention group of the RCT via system data and a study-specific questionnaire that was assessed during the 1 week follow-up (T1) assessment. RESULTS: Main reasons for not participating were not interested in participation in scientific research (40%) and not interested in scientific research and Oncokompas (28%). Main reasons for not being interested in Oncokompas were wanting to leave the period of being ill behind (29%), no symptom burden (23%), or lacking internet skills (18%). Out of the 320 participants in the intervention group 167 (52%) used Oncokompas as intended. Among 72 non-users, main reasons for not using Oncokompas were no symptom burden (32%) or lack of time (26%). Among 248 survivors that activated their account, satisfaction and user-friendliness were rated with a 7 (scale 0-10). Within 3 (IQR 1-4) sessions, users selected 32 (IQR 6-37) topics. Main reasons for not using healthcare options in Act were that the information in Learn was already sufficient (44%) or no supportive care needs (32%). DISCUSSION: Main reasons for not reaching or using Oncokompas were no symptom burden, no supportive care needs, or lack of time. Users selected many cancer-generic and tumour-specific topics to address, indicating added value of the wide range of available topics.

Psychometric properties of the Dutch-Flemish PROMIS® pediatric item banks Anxiety and Depressive Symptoms in a general population.

PURPOSE: This study aims to validate the Dutch-Flemish PROMIS pediatric item banks v2.0 Anxiety and Depressive Symptoms, the short forms 8a, and computerized adaptive tests (CATs) in a general Dutch population and to provide reference data. METHODS: Participants (N = 2,893, aged 8-18), recruited by two internet survey providers, completed both item banks. These item banks were assessed on unidimensionality, local independence, monotonicity, Graded Response Model (GRM) item fit, and differential item functioning (DIF) for gender, age group, region, ethnicity, and language. The short forms and CATs were assessed on reliability and construct validity compared to the Revised Child Anxiety and Depression Scale short version (RCADS-22) subscales. Reference scores were calculated. RESULTS: Both item banks showed sufficient unidimensionality, local independence, monotonicity, and GRM item fit, except for three Depressive Symptoms items that showed insufficient GRM item fit. No DIF was found when using ordinal regression analyses, except for two Depressive Symptoms items that showed DIF for language; all items showed DIF for language when using IRT PRO, except for one Anxiety item. Both short forms and CATs revealed sufficient reliability for moderate and severe levels of anxiety and depression, as well as high positive correlations with corresponding RCADS-22 subscales and slightly lower correlations with non-corresponding RCADS-22 subscales. CONCLUSION: The Dutch-Flemish PROMIS pediatric item banks v2.0 Anxiety and Depressive Symptoms, the short forms 8a and CATs are useful to assess and monitor anxiety and depression in a general population. Reference data are presented.

[Major depressive episode in college freshmen: prevalence, academic functioning and receipt of treatment]. / Depressieve stoornis bij Belgische eerstejaarsstudenten: voorkomen, academische impact en zorggebruik.

Background Little is known about the epidemiology of Major Depressive Episode (mde) in university students. Aim To investigate the prevalence of mde, psychiatric comorbidity, and the association with academic performance among first-year university students, and to investigate to what extent these students use professional mental health services. Method All first-year students at the ku Leuven (Leuven, Belgium) were invited to complete a computer-assisted survey with a weighted cross-sectional design (N=5,460; response rate corrected for drop-out=51.8%). mde was assessed using the Composite International Diagnostic Interview - Screening Scales (cidi-sc) with dsm-iv criteria. Results We found that 13.6% of first-year students met criteria for a cidi-sc mde in the past year. mde was associated with a wide range of other comorbid disorders (such as generalized anxiety disorder or hypo[mania]) and suicidal thoughts and behaviors. mde was associated with significantly lower academic year percentage (-3.6 to -6.4%) and elevated odds of academic year failure (ors=1.5-2.0). Professional service use was estimated at 21.5%. Conclusion mde is common among first-year university students and is associated with a high degree of psychiatric comorbidity and poor academic performance. It is therefore surprising that so few students actually receive treatment for their psychiatric and emotional problems. Tijdschrift voor Psychiatrie 63(2021)1, 24-31.

[Prevention of depression: State-of-the-art and new opportunities]. / Preventie van depressie: stand van zaken en nieuwe mogelijkheden.

background In the past 25 years, 50 randomised controlled trials have examined the effects of preventive interventions on preventing the onset of new depressive disorders. aim To describe the state of affairs in research into the prevention of depression. method Narrative review of the field. results These trials have shown that preventive interventies can indeed prevent the onset of depression in some cases. The absolute effects of the interventions are, however, modest and most trial participants don't develop a disorder, also not when they don't get an intervention. An important challenge for the future is to strengthen the effects of the interventions and to identify high-risk groups with higher absolute risk to develop a disorder. Another challenge is to increase participation rates. conclusion Innovations, such as new methods to identify high-risk groups, better and more efficient interventions and 'indirect' prevention offer new possibilities to improve the field of prevention. Tijdschrift voor Psychiatrie 63(2021)2, 129-132.

The eHealth self-management application 'Oncokompas' that supports cancer survivors to improve health-related quality of life and reduce symptoms: which groups benefit most?

BACKGROUND: Oncokompas is a web-based self-management application that supports cancer survivors to monitor their health-related quality of life (HRQOL) and symptoms, and to obtain personalised feedback and tailored options for supportive care. In a large randomised controlled trial among survivors of head and neck cancer, colorectal cancer, and breast cancer and (non-)Hodgkin lymphoma, Oncokompas proved to improve HRQOL, and to reduce several tumour-specific symptoms. Effect sizes were however small, and no effect was observed on the primary outcome patient activation. Therefore, this study aims to explore which subgroups of cancer survivors may especially benefit from Oncokompas. MATERIALS AND METHODS: Cancer survivors (n = 625) were randomly assigned to the intervention group (access to Oncokompas, n = 320) or control group (6 months waiting list, n = 305). Outcome measures were HRQOL, tumour-specific symptoms, and patient activation. Potential moderators included socio-demographic (sex, age, marital status, education, employment), clinical (tumour type, stage, time since diagnosis, treatment modality, comorbidities), and personal factors (self-efficacy, personal control, health literacy, Internet use), and patient activation, mental adjustment to cancer, HRQOL, symptoms, and need for supportive care, measured at baseline. Linear mixed models were performed to investigate potential moderators. RESULTS: The intervention effect on HRQOL was the largest among cancer survivors with low to moderate self-efficacy, and among those with high personal control and those with high health literacy scores. Cancer survivors with higher baseline symptom scores benefitted more on head and neck (pain in the mouth, social eating, swallowing, coughing, trismus), and colorectal cancer (weight) specific symptoms. DISCUSSION: Oncokompas seems most effective in reducing symptoms in head and neck cancer and colorectal cancer survivors who report a higher burden of tumour-specific symptoms. Oncokompas seems most effective in improving HRQOL in cancer survivors with lower self-efficacy, and in cancer survivors with higher personal control, and higher health literacy.

Body image distress in head and neck cancer patients: what are we looking at?

PURPOSE: The aim of the present study is to investigate the prevalence of body image distress among head and neck cancer (HNC) patients after treatment and to examine its association with sociodemographic and clinical factors, health-related quality of life (HRQOL), HNC symptoms, sexuality, self-compassion, and psychological distress. Second, we aim to explore daily life experiences of HNC patients regarding body image. METHODS: A cross-sectional survey among HNC patients investigated the prevalence of body image distress based on the Body Image Scale. Multivariable logistic regression analysis was applied to study associations with sociodemographic and clinical factors, HRQOL (EORTC QLQ-C30), HNC symptoms (QLQ-HN43), sexuality (FSFI-6; IIEF-5), self-compassion (SCS-SF), and psychological distress (HADS). Qualitative data from a body image writing intervention was used to explore experiences in daily life related to body image. RESULTS: Body image distress was prevalent in 13-20% (depending on cut-off scores) of 233 HNC patients. Symptoms of depression (p < 0.001), younger age (p < 0.001), problems with social contact (p = 0.001), problems with wound healing (p = 0.013), and larger extent of surgery (p = 0.014) were associated with having body image distress. This model explained 67% of variance. Writing interventions of 40 HNC patients showed that negative body image experiences were related to appearance and function, with social functioning problems described most often. CONCLUSION: Prevalence of body image distress in HNC patients, using different cut-off scores, is 13-20%. Younger patients, patients after extensive surgery, and patients who had wound healing problems are most at risk. There is a significant association between body image distress and depressive symptoms and social functioning.

Cost-utility of an eHealth application 'Oncokompas' that supports cancer survivors in self-management: results of a randomised controlled trial.

PURPOSE: The eHealth self-management application 'Oncokompas' was developed to support cancer survivors in monitoring health-related quality of life (HRQOL) and symptoms, and obtaining personalized feedback and options for supportive care. The aim of this study was to assess the cost-utility of Oncokompas compared with care as usual (CAU) among cancer survivors. METHODS: Survivors were randomly allocated to the intervention or control group. Direct (non-)medical, indirect non-medical costs, and HRQOL were measured at 3- and 6-month follow-up, using iMTA Medical Consumption and Productivity Costs and the EuroQol-5D questionnaires. Mean cumulative costs and quality-adjusted life-years (QALYs) were compared between both groups. RESULTS: In total, 625 survivors were randomized into intervention (n = 320) or control group (n = 305). Base case analysis showed that incremental costs from a societal perspective were - €163 (95% CI, - 665 to 326), and incremental QALYs were 0.0017 (95% CI, - 0.0121 to 0.0155) in the intervention group compared with those in the control group. The probability that, compared with CAU, Oncokompas is more effective was 60%, less costly 73%, and both more effective and less costly 47%. Sensitivity analyses showed that incremental costs vary between - €40 and €69, and incremental QALYs vary between - 0.0023 and - 0.0057. CONCLUSION: Oncokompas is likely to be equally effective on utilities, and not more expensive than CAU, and will therefore contribute to sustainable cancer survivorship care in a (cost-)effective manner. IMPLICATIONS FOR CANCER SURVIVORS: Oncokompas seems to improve HRQOL and reduces the burden of several tumour-specific symptoms, while costs from a societal perspective are similar to CAU.

The effect of e-mental health interventions on academic performance in university and college students: A meta-analysis of randomized controlled trials.

BACKGROUND: Mental health symptoms are common among college and university students and these can affect their academic performance. E-mental health interventions have proven effective in addressing mental health complaints but their effect on academic performance has not been synthesized yet. OBJECTIVES: To synthesize the evidence from randomized controlled trials for the effectiveness of e-mental health interventions on academic performance in college and university students compared to inactive controls. DATA SOURCES AND ELIGIBILITY CRITERIA: We searched six databases (PubMed, Cochrane library, CINAHL, ERIC, PsycINFO, Web of Science) during the period January 2000 until September 2019 for randomized controlled trials that reported on e-mental health interventions (guided or unguided) for college and university students and measured academic performance (e.g. grade point average). STUDY APPRAISAL AND SYNTHESIS METHODS: Study and participant characteristics and the academic performance measures at post-intervention were extracted. The latter were pooled and Hedges' g was calculated as the effect size. Heterogeneity and publication bias were investigated. RESULTS: Six studies containing 2428 participants were included in the meta-analysis. These focussed on either mood and anxiety or alcohol and tobacco use. The pooling of data resulted in a small but non-significant effect of g = 0.26 (95% CI, -0.00, 0.52; p = .05) on academic performance, favouring e-mental health interventions over inactive controls. Interventions had positive effects on depression (g = -0.24) and anxiety (g = -0.2). Heterogeneity was high. DISCUSSION: Despite the small and non-significant effect, our meta-analysis points to a promising direction for the effectiveness of e-mental health interventions on academic performance. Yet, these results must be interpreted with caution, as heterogeneity was high and few studies on the effectiveness of e-mental health interventions for students reported academic performance measures.