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.

Absolute and relative outcomes of psychotherapies for eight mental disorders: a systematic review and meta-analysis.

Psychotherapies are first-line treatments for most mental disorders, but their absolute outcomes (i.e., response and remission rates) are not well studied, despite the relevance of such information for health care users, providers and policy makers. We aimed to examine absolute and relative outcomes of psychotherapies across eight mental disorders: major depressive disorder (MDD), social anxiety disorder, panic disorder, generalized anxiety disorder (GAD), specific phobia, post-traumatic stress disorder (PTSD), obsessive-compulsive disorder (OCD), and borderline personality disorder (BPD). We used a series of living systematic reviews included in the Metapsy initiative (www.metapsy.org), with a common strategy for literature search, inclusion of studies and extraction of data, and a common format for the analyses. Literature search was conducted in major bibliographical databases (PubMed, PsycINFO, Embase, and the Cochrane Register of Controlled Trials) up to January 1, 2023. We included randomized controlled trials comparing psychotherapies for any of the eight mental disorders, established by a diagnostic interview, with a control group (waitlist, care-as-usual, or pill placebo). We conducted random-effects model pairwise meta-analyses. The main outcome was the absolute rate of response (at least 50% symptom reduction between baseline and post-test) in the treatment and control conditions. Secondary outcomes included the relative risk (RR) of response, and the number needed to treat (NNT). Random-effects meta-analyses of the included 441 trials (33,881 patients) indicated modest response rates for psychotherapies: 0.42 (95% CI: 0.39-0.45) for MDD; 0.38 (95% CI: 0.33-0.43) for PTSD; 0.38 (95% CI: 0.30-0.47) for OCD; 0.38 (95% CI: 0.33-0.43) for panic disorder; 0.36 (95% CI: 0.30-0.42) for GAD; 0.32 (95% CI: 0.29-0.37) for social anxiety disorder; 0.32 (95% CI: 0.23-0.42) for specific phobia; and 0.24 (95% CI: 0.15-0.36) for BPD. Most sensitivity analyses broadly supported these findings. The RRs were significant for all disorders, except BPD. Our conclusion is that most psychotherapies for the eight mental disorders are effective compared with control conditions, but absolute response rates are modest. More effective treatments and interventions for those not responding to a first-line treatment are needed.

Insomnia and sleep characteristics in post COVID-19 fatigue: A cross-sectional case-controlled study.

OBJECTIVE: Following COVID-19 many patients report persistent fatigue and insomnia. Given the overlapping features, insomnia can be underdiagnosed in post-COVID-19 fatigue patients. This study aimed to determine insomnia severity, prevalence of clinical insomnia and sleep characteristics of post-COVID-19 fatigue patients. Data of post-COVID-19 fatigue patients were compared with those of patients with chronic fatigue syndrome (ME/CFS), a condition resembling post-COVID-19 fatigue. METHODS: In this cross-sectional case-controlled study, insomnia severity, assessed with the Insomnia Severity Index (ISI), and prevalence of clinical insomnia (ISI score ≥ 10), were determined in patients with post-COVID-19 fatigue (n = 114) and compared with ME/CFS (n = 59) using ANCOVA and logistic regression, respectively. Linear regression analyses were used to evaluate whether mood, concentration problems, pain, fatigue (assessed with questionnaires) and diagnosis were associated with insomnia. Sleep characteristics were determined with a sleep diary and accelerometer in post-COVID-19 fatigue and compared with ME/CFS using ANCOVA. RESULTS: In patients with post-COVID-19 fatigue mean (SD) insomnia severity was 11.46 (5.7) and 64% reported clinical insomnia. Insomnia severity was significantly associated with depressive symptoms (ß = 0.49, p = 0.006) and age (ß = 0.08, p = 0.04). The mean (SD) subjective sleep duration was 7.4 (1.0) hours with a sleep efficiency of 82 (11)%. Several subjective sleep characteristics of the post-COVID-19 fatigue patients differed from ME/CFS patients; only sleep duration, being significantly shorter in post-COVID-19 fatigue patients (p = 0.003), seemed clinically relevant (d = 0.58). CONCLUSION: Insomnia severity and prevalence of clinical insomnia are high in patients with post-COVID-19 fatigue. Insomnia should be assessed and if present treated with insomnia focused therapy.

Effectiveness of a scalable, remotely delivered stepped-care intervention to reduce symptoms of psychological distress among Polish migrant workers in the Netherlands: study protocol for the RESPOND randomised controlled trial.

BACKGROUND: The COVID-19 pandemic has negatively affected the mental health of international migrant workers (IMWs). IMWs experience multiple barriers to accessing mental health care. Two scalable interventions developed by the World Health Organization (WHO) were adapted to address some of these barriers: Doing What Matters in times of stress (DWM), a guided self-help web application, and Problem Management Plus (PM +), a brief facilitator-led program to enhance coping skills. This study examines whether DWM and PM + remotely delivered as a stepped-care programme (DWM/PM +) is effective and cost-effective in reducing psychological distress, among Polish migrant workers with psychological distress living in the Netherlands. METHODS: The stepped-care DWM/PM + intervention will be tested in a two-arm, parallel-group, randomized controlled trial (RCT) among adult Polish migrant workers with self-reported psychological distress (Kessler Psychological Distress Scale; K10 > 15.9). Participants (n = 212) will be randomized into either the intervention group that receives DWM/PM + with psychological first aid (PFA) and care-as-usual (enhanced care-as-usual or eCAU), or into the control group that receives PFA and eCAU-only (1:1 allocation ratio). Baseline, 1-week post-DWM (week 7), 1-week post-PM + (week 13), and follow-up (week 21) self-reported assessments will be conducted. The primary outcome is psychological distress, assessed with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). Secondary outcomes are self-reported symptoms of depression, anxiety, posttraumatic stress disorder (PTSD), resilience, quality of life, and cost-effectiveness. In a process evaluation, stakeholders' views on barriers and facilitators to the implementation of DWM/PM + will be evaluated. DISCUSSION: To our knowledge, this is one of the first RCTs that combines two scalable, psychosocial WHO interventions into a stepped-care programme for migrant populations. If proven to be effective, this may bridge the mental health treatment gap IMWs experience. TRIAL REGISTRATION: Dutch trial register NL9630, 20/07/2021, https://www.onderzoekmetmensen.nl/en/trial/27052.

The European Insomnia Guideline: An update on the diagnosis and treatment of insomnia 2023.

Progress in the field of insomnia since 2017 necessitated this update of the European Insomnia Guideline. Recommendations for the diagnostic procedure for insomnia and its comorbidities are: clinical interview (encompassing sleep and medical history); the use of sleep questionnaires and diaries (and physical examination and additional measures where indicated) (A). Actigraphy is not recommended for the routine evaluation of insomnia (C), but may be useful for differential-diagnostic purposes (A). Polysomnography should be used to evaluate other sleep disorders if suspected (i.e. periodic limb movement disorder, sleep-related breathing disorders, etc.), treatment-resistant insomnia (A) and for other indications (B). Cognitive-behavioural therapy for insomnia is recommended as the first-line treatment for chronic insomnia in adults of any age (including patients with comorbidities), either applied in-person or digitally (A). When cognitive-behavioural therapy for insomnia is not sufficiently effective, a pharmacological intervention can be offered (A). Benzodiazepines (A), benzodiazepine receptor agonists (A), daridorexant (A) and low-dose sedating antidepressants (B) can be used for the short-term treatment of insomnia (≤ 4 weeks). Longer-term treatment with these substances may be initiated in some cases, considering advantages and disadvantages (B). Orexin receptor antagonists can be used for periods of up to 3 months or longer in some cases (A). Prolonged-release melatonin can be used for up to 3 months in patients ≥ 55 years (B). Antihistaminergic drugs, antipsychotics, fast-release melatonin, ramelteon and phytotherapeutics are not recommended for insomnia treatment (A). Light therapy and exercise interventions may be useful as adjunct therapies to cognitive-behavioural therapy for insomnia (B).

Evaluation of randomized controlled trials: a primer and tutorial for mental health researchers.

BACKGROUND: Considered one of the highest levels of evidence, results of randomized controlled trials (RCTs) remain an essential building block in mental health research. They are frequently used to confirm that an intervention "works" and to guide treatment decisions. Given their importance in the field, it is concerning that the quality of many RCT evaluations in mental health research remains poor. Common errors range from inadequate missing data handling and inappropriate analyses (e.g., baseline randomization tests or analyses of within-group changes) to unduly interpretations of trial results and insufficient reporting. These deficiencies pose a threat to the robustness of mental health research and its impact on patient care. Many of these issues may be avoided in the future if mental health researchers are provided with a better understanding of what constitutes a high-quality RCT evaluation. METHODS: In this primer article, we give an introduction to core concepts and caveats of clinical trial evaluations in mental health research. We also show how to implement current best practices using open-source statistical software. RESULTS: Drawing on Rubin's potential outcome framework, we describe that RCTs put us in a privileged position to study causality by ensuring that the potential outcomes of the randomized groups become exchangeable. We discuss how missing data can threaten the validity of our results if dropouts systematically differ from non-dropouts, introduce trial estimands as a way to co-align analyses with the goals of the evaluation, and explain how to set up an appropriate analysis model to test the treatment effect at one or several assessment points. A novice-friendly tutorial is provided alongside this primer. It lays out concepts in greater detail and showcases how to implement techniques using the statistical software R, based on a real-world RCT dataset. DISCUSSION: Many problems of RCTs already arise at the design stage, and we examine some avoidable and unavoidable "weak spots" of this design in mental health research. For instance, we discuss how lack of prospective registration can give way to issues like outcome switching and selective reporting, how allegiance biases can inflate effect estimates, review recommendations and challenges in blinding patients in mental health RCTs, and describe problems arising from underpowered trials. Lastly, we discuss why not all randomized trials necessarily have a limited external validity and examine how RCTs relate to ongoing efforts to personalize mental health care.

Psychological treatment of adult depression in primary care compared with outpatient mental health care: A meta-analysis.

BACKGROUND: It is not yet known whether psychological treatments of depression in primary care have comparable effects to treatments in specialized mental health care. We conducted a meta-analysis comparing randomized controlled trials in primary and specialized care. METHODS: We selected studies from an existing database of randomized trials of psychological treatments of depression in adults, which was built through searches in PubMed, PsychINFO, Embase and the Cochrane Library. Random effects meta-analyses were conducted to examine the effects of therapies and mixed effects subgroup analyses were used to compare the effects in primary and specialized care. RESULTS: We included 52 trials (7984 patients) in primary care and compared them with 50 trials (3685 patients) in specialized care. The main effect of therapies in primary care was g = 0.43 (95 % CI: 0.32; 0.53; PI: -0.18; 1.03). The overall effects were significantly smaller than those in specialized care (p = 0.006), but this was no longer significant after adjustment for differences between the two settings. The proportion of patients responding to treatment was comparable in primary (0.38; 95 % CI: 0.33; 0.43) and specialized care (0.34; 95 % CI: 0.28; 0.41; p = 0.41), but higher in control conditions in primary care (0.25; 95 % CI: 0.22; 0.28) compared to specialized care (0.16; 95 % CI: 0.12; 0.20; p < 0.001). DISCUSSION: Psychological treatments are effective in primary care, but somewhat less than in specialized care. Response rates in control conditions in primary care are higher than in specialized care, which may point at a transient nature of depression in primary care.

Effectiveness of family-based therapy for depressive symptoms in children and adolescents: A systematic review and meta-analysis.

Early-onset depression contributes significantly to the global health burden and has long-term negative effects. This meta-analysis collates and examines the effectiveness of family-based interventions, where family members are involved in the treatment of depression in children and adolescents. A literature search was performed up to 8th March 2023. Randomised controlled trials of family-based interventions were included for participants aged 3-18 years with a diagnosis of major depressive disorder or dysthymia, according to the Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5; American Psychiatric Association, 2013) or with a score above a cut-off on a standardised self-report depression measure. The overall effect size for treatment versus active control was g = 0.22 (95% confidence interval [CI]: -0.05-0.50) (nine studies; 659 participants), and for treatment versus non-active control it was g = 0.46 (95% CI: -0.09-1.01) (four studies; 385 participants). Effect sizes were not statistically significant, and heterogeneity was high, ranging between I2 = 64.3-81.1%. Subgroup analysis comparing attachment-based family therapy with family therapy using other theoretical frameworks did not yield a significant difference between the two. The effects of family-based therapies were larger than those in the comparison groups, but family-based therapy did not demonstrate a significant treatment benefit compared to the controls. More randomised controlled trials are warranted, considering that evidence for other psychotherapies for depression in children and adolescents, indicates modest effects. Family-based therapy may be an alternative for children and adolescents whose needs are not addressed by these treatments.

Psychological treatment of depression with other comorbid mental disorders: systematic review and meta-analysis.

Most people with a mental disorder meet criteria for multiple disorders. We conducted a systematic review and meta-analysis of randomized trials comparing psychotherapies for people with depression and comorbid other mental disorders with non-active control conditions. We identified studies through an existing database of randomized trials on psychotherapies for depression. Thirty-five trials (3,157 patients) met inclusion criteria. Twenty-seven of the 41 interventions in the 35 trials (66%) were based on CBT. The overall effect on depression was large (g = 0.65; 95% CI: 0.40 ~ 0.90), with high heterogeneity (I2 = 78%; 95% CI: 70 ~ 83). The ten studies in comorbid anxiety showed large effects on depression (g = 0.90; 95% CI: 0.30 ~ 1.51) and anxiety (g = 1.01; 95% CI: 0.28 ~ 1.74). For comorbid insomnia (11 comparisons) a large and significant effect on depression (g = 0.99; 95% CI: 0.16 ~ 1.82) and insomnia (g = 1.38; 95% CI: 0.38 ~ 2.38) were found. For comorbid substance use problems (12 comparisons) effects on depression (g = 0.25; 95% CI: 0.06 ~ 0.43) and on substance use problems (g = 0.25; 95% CI: 0.01 ~ 0.50) were significant. Most effects were no longer significant after adjustment for publication bias and when limited to studies with low risk of bias. Therapies are probably effective in the treatment of depression with comorbid anxiety, insomnia, and substance use problems.

Integrating technology to increase the reach of CBT-I: state of the science and challenges ahead.

In this Round Table Discussion, an international panel of experts discuss issues related to the use of technology in the delivery of cognitive behavioral therapy for insomnia (CBT-I), in order to increase its reach. Panelists were, in alphabetical order, Carmela Alcántara, PhD, an Associate Professor at Columbia University School of Social Work in New York, USA, Bei Bei, PhD., an Associate Professor at Monash University in Melbourne, Australia, Charles M. Morin, PhD., a Professor of Psychology at Laval University in Quebec City, Canada, and Annemieke A. van Straten, PhD., a Professor of Clinical Psychology at the Vrije Universiteit in Amsterdam, the Netherlands. The session was chaired by Rachel Manber, PhD., a Professor of Psychiatry and Behavioral Sciences at Stanford University, in Palo Alto, California, USA. In their introductions each panelist discussed the use of technology in their respective country. All indicated that the most common way technology is used in the treatment of insomnia is through the use of video calls (telemedicine) to deliver individual CBT-I, and that this is mostly covered by publicly funded health insurance programs such as Medicare, especially since the COVID-19 pandemic. There are also some fully automated insomnia treatment programs, but they're often not covered by Medicare or other health insurance programs.

Response Shift After Cognitive Behavioral Therapy Targeting Severe Fatigue: Explorative Analysis of Three Randomized Controlled Trials.

BACKGROUND: Cognitive behavioral therapy (CBT) is an evidence-based intervention for severe fatigue. Changes in patients' fatigue scores following CBT might reflect not only the intended relief in fatigue but also response shift, a change in the meaning of patients' self-evaluation. Objectives were to (1) identify the occurrence of response shift in patients undergoing CBT, (2) determine the impact of response shift on the intervention effect, and (3) investigate whether changes in fatigue-related cognitions and perceptions, targeted during CBT, are associated with response shift. METHODS: Data of three randomized controlled trials testing the efficacy of CBT in individuals with chronic fatigue syndrome (CFS, n = 222), cancer (n = 123), and diabetes (n = 107) were re-analyzed. Fatigue severity was measured with 8 items from the Checklist Individual Strength, a valid and widely used self-report questionnaire. Structural equation modelling was applied to assess lack of longitudinal measurement invariance, as indication of response shift. RESULTS: As expected, in all three trials, response shift was indicated in the CBT groups, not the control groups. Response shift through reprioritization was indicated for the items "Physically, I feel exhausted" (CFS) and "I tire easily" (cancer, diabetes), which became less vs. more important to the measurement of fatigue, respectively. However, this did not affect the intervention effects. Some changes in cognitions and perceptions were associated with the response shifts. CONCLUSIONS: CBT seems to induce response shift through reprioritization across patient groups, but its occurrence does not affect the intervention effect. Future research should corroborate these findings and investigate whether patients indeed change their understanding of fatigue.

Psychoneurological Symptoms and Biomarkers of Stress and Inflammation in Newly Diagnosed Head and Neck Cancer Patients: A Network Analysis.

Psychoneurological symptoms are commonly reported by newly diagnosed head and neck cancer (HNC) patients, yet there is limited research on the associations of these symptoms with biomarkers of stress and inflammation. In this article, pre-treatment data of a multi-center cohort of HNC patients were analyzed using a network analysis to examine connections between symptoms (poor sleep quality, anxiety, depression, fatigue, and oral pain), biomarkers of stress (diurnal cortisol slope), inflammation markers (c-reactive protein [CRP], interleukin [IL]-6, IL-10, and tumor necrosis factor alpha [TNF-α]), and covariates (age and body mass index [BMI]). Three centrality indices were calculated: degree (number of connections), closeness (proximity of a variable to other variables), and betweenness (based on the number of times a variable is located on the shortest path between any pair of other variables). In a sample of 264 patients, poor sleep quality and fatigue had the highest degree index; fatigue and CRP had the highest closeness index; and IL-6 had the highest betweenness index. The model yielded two clusters: a symptoms-cortisol slope-CRP cluster and a IL-6-IL-10-TNF-α-age-BMI cluster. Both clusters were connected most prominently via IL-6. Our findings provide evidence that poor sleep quality, fatigue, CRP, and IL-6 play an important role in the interconnections between psychoneurological symptoms and biomarkers of stress and inflammation in newly diagnosed HNC patients.

Psychological interventions to prevent relapse in anxiety and depression: A systematic review and meta-analysis.

OBJECTIVES: The aim of this review is to establish the effectiveness of psychological relapse prevention interventions, as stand-alone interventions and in combination with maintenance antidepressant treatment (M-ADM) or antidepressant medication (ADM) discontinuation for patients with remitted anxiety disorders or major depressive disorders (MDD). METHODS: A systematic review and a meta-analysis were conducted. A literature search was conducted in PubMed, PsycINFO and Embase for randomised controlled trials (RCTs) comparing psychological relapse prevention interventions to treatment as usual (TAU), with the proportion of relapse/recurrence and/or time to relapse/recurrence as outcome measure. RESULTS: Thirty-six RCTs were included. During a 24-month period, psychological interventions significantly reduced risk of relapse/recurrence for patients with remitted MDD (RR 0.76, 95% CI: 0.68-0.86, p<0.001). This effect persisted with longer follow-up periods, although these results were less robust. Also, psychological interventions combined with M-ADM significantly reduced relapse during a 24-month period (RR 0.76, 95% CI: 0.62-0.94, p = 0.010), but this effect was not significant for longer follow-up periods. No meta-analysis could be performed on relapse prevention in anxiety disorders, as only two studies focused on relapse prevention in anxiety disorders. CONCLUSIONS: In patients with remitted MDD, psychological relapse prevention interventions substantially reduce risk of relapse/recurrence. It is recommended to offer these interventions to remitted MDD patients. Studies on anxiety disorders are needed. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO 2018: CRD42018103142.

Insomnia Symptoms and Daytime Fatigue Co-Occurrence in Adolescent and Young Adult Childhood Cancer Patients in Follow-Up after Treatment: Prevalence and Associated Risk Factors.

Insomnia symptoms and daytime fatigue commonly occur in pediatric oncology, which significantly impact physical and psychosocial health. This study evaluated the prevalence of insomnia only, daytime fatigue only, the co-occurrence of insomnia−daytime fatigue symptoms, and associated risk factors. Childhood cancer patients (n = 565, 12−26 years old, ≥6 months after treatment) participated in a national, cross-sectional questionnaire study, measuring insomnia symptoms (ISI; Insomnia Severity Index) and daytime fatigue (single item). Prevalence rates of insomnia and/or daytime fatigue subgroups and ISI severity ranges were calculated. Multinomial regression models were applied to assess risk factors. Most patients reported no insomnia symptoms or daytime fatigue (61.8%). In the 38.2% of patients who had symptoms, 48.1% reported insomnia and daytime fatigue, 34.7% insomnia only, and 17.1% daytime fatigue only. Insomnia scores were higher in patients with insomnia−daytime fatigue compared to insomnia only (p < 0.001). Risk factors that emerged were: female sex and co-morbidities (all), shorter time after treatment and bedtime gaming (insomnia only), young adulthood (insomnia−fatigue/fatigue only), needing someone else to fall asleep and inconsistent wake times (both insomnia groups), lower educational level and consistent bedtimes (insomnia−fatigue). Insomnia symptoms and daytime fatigue are common and often co-occur. While current fatigue guidelines do not include insomnia symptoms, healthcare providers should inquire about insomnia as this potentially provides additional options for treatment and prevention.

Automated app-based augmented reality cognitive behavioral therapy for spider phobia: Study protocol for a randomized controlled trial.

BACKGROUND: Fear of spiders, or Arachnophobia, is one of the most common specific phobias. The gold standard treatment, in vivo exposure therapy, is effective, but comes with significant limitations, including restricted availability, high costs, and high refusal rates. Novel technologies, such as augmented reality, may help to overcome these limitations and make Exposure Therapy more accessible by using mobile devices. OBJECTIVE: This study will use a Randomized Controlled Trial design to investigate whether ZeroPhobia: Arachnophobia, a 6-week Augmented Reality Exposure Therapy smartphone self-help application, can effectively reduce spider phobia symptoms. Additionally, we will examine user-friendliness of the application and the effect of usage intensity and presence on treatment outcome. METHODS: This study is registered in the Netherlands Trial Registry under NL70238.029.19 (Trial NL9221). Ethical approval was received on October 11, 2019. One-hundred-twelve participants (age 18-64, score ≥ 59) on the Fear of Spiders Questionnaire [FSQ] will be recruited from the general Dutch population and randomly assigned to a treatment or waitlist control group. The ZeroPhobia application can be accessed on users' smartphone. Baseline, post-test (i.e., at six weeks), 3- and 12-month follow-up assessments will be done, each including the Fear of Spiders Questionnaire as the main outcome measure as well as additional measures of anxiety, depression, user-friendliness, and presence as secondary measures and covariates. RESULTS: The study was funded on September 25, 2018. Data collection started in September 2021 and the study is expected to run until September 2022. CONCLUSIONS: Our study will improve our understanding of the efficacy and feasibility of providing Exposure Therapy for spider phobia using an Augmented Reality self-help application, with the intention of making mental health care more accessible.

Patient-reported outcomes of lifestyle interventions in patients with severe mental illness: a systematic review and meta-analysis.

BACKGROUND: Lifestyle interventions for severe mental illness (SMI) are known to have small to modest effect on physical health outcomes. Little attention has been given to patient-reported outcomes (PROs). AIM: To systematically review the use of PROs and their measures, and quantify the effects of lifestyle interventions in patients with SMI on these PROs. METHODS: Five electronic databases were searched (PubMed/Medline, Embase, PsycINFO, CINAHL, and Web of Science) from inception until 12 November 2020 (PROSPERO: CRD42020212135). Randomised controlled trials (RCTs) evaluating the efficacy of lifestyle interventions focusing on healthy diet, physical activity, or both for patients with SMI were included. Outcomes of interest were PROs. RESULTS: A total of 11.267 unique records were identified from the database search, 66 full-text articles were assessed, and 36 RCTs were included, of which 21 were suitable for meta-analyses. In total, 5.907 participants were included across studies. Lifestyle interventions had no significant effect on quality of life (g = 0.13; 95% CI = - 0.02 to 0.27), with high heterogeneity (I2 = 68.7%). We found a small effect on depression severity (g = 0.30, 95% CI = 0.00 to 0.58, I2 = 65.2%) and a moderate effect on anxiety severity (g = 0.56, 95% CI = 0.16 to 0.95, I2 = 0%). DISCUSSION: This meta-analysis quantifies the effects of lifestyle interventions on PROs. Lifestyle interventions have no significant effect on quality of life, yet they could improve mental health outcomes such as depression and anxiety symptoms. Further use of patient-reported outcome measures in lifestyle research is recommended to fully capture the impact of lifestyle interventions.

Effect of Sleep Disturbance Symptoms on Treatment Outcome in Blended Cognitive Behavioral Therapy for Depression (E-COMPARED Study): Secondary Analysis.

BACKGROUND: Sleep disturbance symptoms are common in major depressive disorder (MDD) and have been found to hamper the treatment effect of conventional face-to-face psychological treatments such as cognitive behavioral therapy. To increase the dissemination of evidence-based treatment, blended cognitive behavioral therapy (bCBT) consisting of web-based and face-to-face treatment is on the rise for patients with MDD. To date, no study has examined whether sleep disturbance symptoms have an impact on bCBT treatment outcomes and whether it affects bCBT and treatment-as-usual (TAU) equally. OBJECTIVE: The objectives of this study are to investigate whether baseline sleep disturbance symptoms have an impact on treatment outcomes independent of treatment modality and whether sleep disturbance symptoms impact bCBT and TAU in routine care equally. METHODS: The study was based on data from the E-COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment Versus Treatment-as-Usual) study, a 2-arm, multisite, parallel randomized controlled, noninferiority trial. A total of 943 outpatients with MDD were randomized to either bCBT (476/943, 50.5%) or TAU consisting of routine clinical MDD treatment (467/943, 49.5%). The primary outcome of this study was the change in depression symptom severity at the 12-month follow-up. The secondary outcomes were the change in depression symptom severity at the 3- and 6-month follow-up and MDD diagnoses at the 12-month follow-up, assessed using the Patient Health Questionnaire-9 and Mini-International Neuropsychiatric Interview, respectively. Mixed effects models were used to examine the association of sleep disturbance symptoms with treatment outcome and treatment modality over time. RESULTS: Of the 943 patients recruited for the study, 558 (59.2%) completed the 12-month follow-up assessment. In the total sample, baseline sleep disturbance symptoms did not significantly affect change in depressive symptom severity at the 12-month follow-up (ß=.16, 95% CI -0.04 to 0.36). However, baseline sleep disturbance symptoms were negatively associated with treatment outcome for bCBT (ß=.49, 95% CI 0.22-0.76) but not for TAU (ß=-.23, 95% CI -0.50 to 0.05) at the 12-month follow-up, even when adjusting for baseline depression symptom severity. The same result was seen for the effect of sleep disturbance symptoms on the presence of depression measured with Mini-International Neuropsychiatric Interview at the 12-month follow-up. However, for both treatment formats, baseline sleep disturbance symptoms were not associated with depression symptom severity at either the 3- (ß=.06, 95% CI -0.11 to 0.23) or 6-month (ß=.09, 95% CI -0.10 to 0.28) follow-up. CONCLUSIONS: Baseline sleep disturbance symptoms may have a negative impact on long-term treatment outcomes in bCBT for MDD. This effect was not observed for TAU. These findings suggest that special attention to sleep disturbance symptoms might be warranted when MDD is treated with bCBT. Future studies should investigate the effect of implementing modules specifically targeting sleep disturbance symptoms in bCBT for MDD to improve long-term prognosis.

Usage Intensity of a Relapse Prevention Program and Its Relation to Symptom Severity in Remitted Patients With Anxiety and Depression: Pre-Post Study.

BACKGROUND: Given that relapse is common in patients in remission from anxiety and depressive disorders, relapse prevention is needed in the maintenance phase. Although existing psychological relapse prevention interventions have proven to be effective, they are not explicitly based on patients' preferences. Hence, we developed a blended relapse prevention program based on patients' preferences, which was delivered in primary care practices by mental health professionals (MHPs). This program comprises contact with MHPs, completion of core and optional online modules (including a relapse prevention plan), and keeping a mood and anxiety diary in which patients can monitor their symptoms. OBJECTIVE: The aims of this study were to provide insight into (1) usage intensity of the program (over time), (2) the course of symptoms during the 9 months of the study, and (3) the association between usage intensity and the course of symptoms. METHODS: The Guided E-healTh for RElapse prevention in Anxiety and Depression (GET READY) program was guided by 54 MHPs working in primary care practices. Patients in remission from anxiety and depressive disorders were included. Demographic and clinical characteristics, including anxiety and depressive symptoms, were collected via questionnaires at baseline and after 3, 6, and 9 months. Log data were collected to assess the usage intensity of the program. RESULTS: A total of 113 patients participated in the study. Twenty-seven patients (23.9%) met the criteria for the minimal usage intensity measure. The core modules were used by ≥70% of the patients, while the optional modules were used by <40% of the patients. Usage decreased quickly over time. Anxiety and depressive symptoms remained stable across the total sample; a minority of 15% (12/79) of patients experienced a relapse in their anxiety symptoms, while 10% (8/79) experienced a relapse in their depressive symptoms. Generalized estimating equations analysis indicated a significant association between more frequent face-to-face contact with the MHPs and an increase in both anxiety symptoms (ß=.84, 95% CI .39-1.29) and depressive symptoms (ß=1.12, 95% CI 0.45-1.79). Diary entries and the number of completed modules were not significantly associated with the course of symptoms. CONCLUSIONS: Although the core modules of the GET READY program were used by most of the patients and all patients saw an MHP at least once, usage decreased quickly over time. Most patients remained stable while participating in the study. The significant association between the frequency of contact and the course of symptoms most likely indicates that those who received more support had more symptoms, and thus, it is questionable whether the support offered by the program was sufficient to prevent these patients from relapsing. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-019-2034-6.