Antidepressants or running therapy: Comparing effects on mental and physical health in patients with depression and anxiety disorders.

BACKGROUND: Antidepressant medication and running therapy are both effective treatments for patients with depressive and anxiety disorders. However, they may work through different pathophysiological mechanisms and could differ in their impact on physical health. This study examined effects of antidepressants versus running therapy on both mental and physical health. METHODS: According to a partially randomized patient preference design, 141 patients with depression and/or anxiety disorder were randomized or offered preferred 16-week treatment: antidepressant medication (escitalopram or sertraline) or group-based running therapy ≥2 per week. Baseline (T0) and post-treatment assessment at week 16 (T16) included mental (diagnosis status and symptom severity) and physical health indicators (metabolic and immune indicators, heart rate (variability), weight, lung function, hand grip strength, fitness). RESULTS: Of the 141 participants (mean age 38.2 years; 58.2 % female), 45 participants received antidepressant medication and 96 underwent running therapy. Intention-to-treat analyses showed that remission rates at T16 were comparable (antidepressants: 44.8 %; running: 43.3 %; p = .881). However, the groups differed significantly on various changes in physical health: weight (d = 0.57; p = .001), waist circumference (d = 0.44; p = .011), systolic (d = 0.45; p = .011) and diastolic (d = 0.53; p = .002) blood pressure, heart rate (d = 0.36; p = .033) and heart rate variability (d = 0.48; p = .006). LIMITATIONS: A minority of the participants was willing to be randomized; the running therapy was larger due to greater preference for this intervention. CONCLUSIONS: While the interventions had comparable effects on mental health, running therapy outperformed antidepressants on physical health, due to both larger improvements in the running therapy group as well as larger deterioration in the antidepressant group. TRIAL REGISTRATION: Trialregister.nl Number of identification: NTR3460.

Pilot Study of Blended-Format Interpersonal Psychotherapy for Major Depressive Disorder.

OBJECTIVE: Blended-format interpersonal psychotherapy (IPT) is an integrated approach consisting of alternating face-to-face (in person or videoconferencing) and online sessions, and this format may increase access to care, empower patients, and improve quality and cost-effectiveness of care. This study, conducted in the Netherlands, was one of the first to investigate the feasibility of blended-format IPT in specialized mental health care. METHODS: Participants (ages 18-64, N=21) with a unipolar depressive episode were recruited at an outpatient mood disorder clinic. In this pre-post nonrandomized pilot study, the blended IPT consisted of six online sessions alternated with six to 10 in-person or videoconferencing sessions. Feasibility (defined as >60% of the participants having completed >50% of the online sessions), usability (via the System Usability Scale [SUS]), satisfaction (via the Client Satisfaction Questionnaire-8 [CSQ-8] and qualitative interviewing), and symptom reduction (via the nine-item Patient Health Questionnaire [PHQ-9]) were assessed. RESULTS: Of the participants, 90% (95% CI=70%-99%) completed all online sessions. Mean±SD scores were 25.12±3.55 (of 32) on the CSQ-8 and 66.0±12.4 (of 100) on the SUS. PHQ-9 scores (N=21) decreased significantly, from 17.48±5.41 at baseline to 11.90±6.45 postintervention, indicating improvement (t=4.86, df=20, p=0.001). Hedges' g was 0.90 (95% CI=0.44-1.41), indicating a large effect size. The treatment response rate was 33% (95% CI=15%-57%); the remission rate was 19% (95% CI=6%-42%). CONCLUSIONS: Blended-format IPT was feasible, and patients were satisfied with the intervention. The therapy described here may serve as a starting point for cost-effectiveness research on this promising format.

Patient preferences for a guided self-help programme to prevent relapse in anxiety or depression: A discrete choice experiment.

BACKGROUND: Anxiety and depressive disorders are increasingly being viewed as chronic conditions with fluctuating symptom levels. Relapse prevention programmes are needed to increase self-management and prevent relapse. Fine-tuning relapse prevention programmes to the needs of patients may increase uptake and effectiveness. MATERIALS AND METHODS: A discrete choice experiment (DCE) was conducted amongst patients with a partially or fully remitted anxiety or depressive disorder. Patients were presented 20 choice tasks with two hypothetical treatment scenarios for relapse prevention, plus a "no treatment" option. Each treatment scenario was based on seven attributes of a hypothetical but realistic relapse prevention programme. Attributes considered professional contact frequency, treatment type, delivery mode, programme flexibility, a personal relapse prevention plan, time investment and effectiveness. Choice models were estimated to analyse the data. RESULTS: A total of 109 patients with a partially or fully remitted anxiety or depressive disorder completed the DCE. Attributes with the strongest impact on choice were high effectiveness, regular contact with a professional, low time investment and the inclusion of a personal prevention plan. A high heterogeneity in preferences was observed, related to both clinical and demographic characteristics: for example, a higher number of previous treatment episodes was related to a preference for a higher frequency of contact with a professional, while younger age was related to a stronger preference for high effectiveness. CONCLUSIONS: This study using a DCE provides insights into preferences for a relapse prevention programme for anxiety and depressive disorders that can be used to guide the development of such a programme.

The decision tool unipolar depression (DTUD): a new measure to facilitate the early identification of patients with major depressive disorder in need of highly specialized care.

BACKGROUND: Selection of the optimal initial treatment in patients with major depressive disorder (MDD) in need of highly specialized care has the potential to benefit treatment outcomes and cost-effectiveness of treatment strategies. However, to date, there is a paucity of measures that could guide the selection of the initial treatment, in particular to indicate which patients with MDD are in need of highly specialized care. Recognizing this gap, this paper reports on the development and psychometric evaluation of the Decision Tool Unipolar Depression (DTUD), aimed to facilitate the early identification of patients with MDD in need of highly specialized care. METHODS: The DTUD was developed using a mixed-methods approach, consisting of a systematic review and a concept mapping study. To evaluate the psychometric features of the DTUD, a cross-sectional multicenter study was conducted. A total of 243 patients with MDD were evaluated with the DTUD. Feasibility was operationalized as the time required to complete the DTUD and the content clarity of the DTUD. Inter-rater reliability was evaluated using Krippendorf's alpha. The Maudsley Staging Method (MSM) and the Dutch Measure for quantification of Treatment Resistance in Depression (DM-TRD) were administered to assess the convergent validity. A receiver operator characteristic curve was generated to evaluate the criterion validity and establish the optimal cut-off value. RESULTS: The mean administration time was 4.49 min (SD = 2.71), and the content of the total DTUD was judged as clear in 94.7% of the evaluations. Inter-rater reliability values ranged from 0.69 to 0.91. Higher scores on the DTUD were associated with higher scores on the MSM (rs = 0.47) and DM-TRD (rs = 0.53). Based on the maximum Youden index (0.494), maximum discrimination was reached at a cut-off score of ≥5 (sensitivity 67%, specificity 83%). CONCLUSION: The DTUD demonstrated to be a tool with solid psychometric properties and, therefore, is a promising measure for the early identification of patients with MDD in need of highly specialized care. Use of the DTUD has the potential to facilitate the selection and initiation of the optimal initial treatment in patients with MDD, which in turn may improve the clinical effectiveness and cost-effectiveness of treatment strategies.

Preventive cognitive therapy versus care as usual in cognitive behavioral therapy responders: A randomized controlled trial.

OBJECTIVE: The optimization of long-term outcomes is an important goal in the treatment of major depressive disorder. Offering subsequent preventive cognitive therapy (PCT) to patients who responded to acute cognitive behavioral therapy (CBT) may reduce the risk of relapse/recurrence. METHOD: Therefore, a multicenter randomized controlled trial was conducted comparing the addition of eight weekly sessions of PCT to care as usual (CAU) versus CAU alone in patients with a history of depression in remission following treatment with CBT. A total of 214 recurrently depressed patients who remitted following treatment with CBT were randomized to PCT (n = 107) or CAU (n = 107). Primary outcome was time to relapse/recurrence over 15 months and was assessed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I). Secondary outcomes were depressive symptoms measured by the Inventory of Depressive Symptomatology-Self Report and number and severity of relapses/recurrences measured by the SCID-I. RESULTS: Over the 15-month follow-up, the addition of PCT significantly delayed time to relapse/recurrence relative to CAU alone, hazard ratio = 1.807 (number needed to treat = 8.1), p = .02, 95% CI [1.029, 3.174]. No significant differences were found between the conditions on number or severity of relapses/recurrences and residual symptoms. CONCLUSION: Adding PCT was significantly more effective than CAU alone in delaying time to relapse/recurrence of depression over a period of 15 months among CBT responders. After response on CBT, therapists should consider providing PCT to recurrently depressed patients. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Linking childhood emotional abuse and depressive symptoms: The role of emotion dysregulation and interpersonal problems.

Childhood abuse is a major public health problem that has been linked to depression in adulthood. Although different types of childhood abuse often co-occur, few studies have examined their unique impact on negative mental health outcomes. Most studies have focused solely on the consequences of childhood physical or sexual abuse; however, it has been suggested that childhood emotional abuse is more strongly related to depression. It remains unclear which underlying psychological processes mediate the effect of childhood emotional abuse on depressive symptoms. In a cross-sectional study in 276 female college students, multiple linear regression analyses were used to determine whether childhood emotional abuse, physical abuse, and sexual abuse were independently associated with depressive symptoms, emotion dysregulation, and interpersonal problems. Subsequently, OLS regression analyses were used to determine whether emotion dysregulation and interpersonal problems mediate the relationship between childhood emotional abuse and depressive symptoms. Of all types of abuse, only emotional abuse was independently associated with depressive symptoms, emotion dysregulation, and interpersonal problems. The effect of childhood emotional abuse on depressive symptoms was mediated by emotion dysregulation and the following domains of interpersonal problems: cold/distant and domineering/controlling. The results of the current study indicate that detection and prevention of childhood emotional abuse deserves attention from Child Protective Services. Finally, interventions that target emotion regulation skills and interpersonal skills may be beneficial in prevention of depression.

Why Uptake of Blended Internet-Based Interventions for Depression Is Challenging: A Qualitative Study on Therapists' Perspectives.

(1) Background: Blended cognitive behavioral therapy (bCBT; online and face-to-face sessions) seems a promising alternative alongside regular face-to-face CBT depression treatment in specialized mental health care organizations. Therapists are key in the uptake of bCBT. This study focuses on therapists' perspectives on usability, satisfaction, and factors that promote or hinder the use of bCBT in routine practice; (2) Methods: Three focus groups (n = 8, n = 7, n = 6) and semi-structured in-depth interviews (n = 15) were held throughout the Netherlands. Beforehand, the participating therapists (n = 36) completed online questionnaires on usability and satisfaction. Interviews were analyzed by thematic analysis; (3) Results: Therapists found the usability sufficient and were generally satisfied with providing bCBT. The thematic analysis showed three main themes on promoting and hindering factors: (1) therapists' needs regarding bCBT uptake, (2) therapists' role in motivating patients for bCBT, and (3) therapists' experiences with bCBT; (4) Conclusions: Overall, therapists were positive; bCBT can be offered by all CBT-trained therapists and future higher uptake is expected. Especially the pre-set structure of bCBT was found beneficial for both therapists and patients. Nevertheless, therapists did not experience promised time-savings-rather, the opposite. Besides, there are still teething problems and therapeutic shortcomings that need improvement in order to motivate therapists to use bCBT.

The impact of depression and anxiety treatment on biological aging and metabolic stress: study protocol of the MOod treatment with antidepressants or running (MOTAR) study.

BACKGROUND: Depressive and anxiety disorders have shown to be associated to premature or advanced biological aging and consequently to adversely impact somatic health. Treatments with antidepressant medication or running therapy are both found to be effective for many but not all patients with mood and anxiety disorders. These interventions may, however, work through different pathophysiological mechanisms and could differ in their impact on biological aging and somatic health. This study protocol describes the design of an unique intervention study that examines whether both treatments are similarly effective in reducing or reversing biological aging (primary outcome), psychiatric status, metabolic stress and neurobiological indicators (secondary outcomes). METHODS: The MOod Treatment with Antidepressants or Running (MOTAR) study will recruit a total of 160 patients with a current major depressive and/or anxiety disorder in a mental health care setting. Patients will receive a 16-week treatment with either antidepressant medication or running therapy (3 times/week). Patients will undergo the treatment of their preference and a subsample will be randomized (1:1) to overcome preference bias. An additional no-disease-no-treatment group of 60 healthy controls without lifetime psychopathology, will be included as comparison group for primary and secondary outcomes at baseline. Assessments are done at week 0 for patients and controls, and at week 16 and week 52 for patients only, including written questionnaires, a psychiatric and medical examination, blood, urine and saliva collection and a cycle ergometer test, to gather information about biological aging (telomere length and telomerase activity), mental health (depression and anxiety disorder characteristics), general fitness, metabolic stress-related biomarkers (inflammation, metabolic syndrome, cortisol) and genetic determinants. In addition, neurobiological alterations in brain processes will be assessed using structural and functional Magnetic Resonance Imaging (MRI) in a subsample of at least 25 patients per treatment arm and in all controls. DISCUSSION: This intervention study aims to provide a better understanding of the impact of antidepressant medication and running therapy on biological aging, metabolic stress and neurobiological indicators in patients with depressive and anxiety disorders in order to guide a more personalized medicine treatment. TRIAL REGISTRATION: Trialregister.nl Number of identification: NTR3460, May 2012.

A supported self-help for recurrent depression in primary care; An economic evaluation alongside a multi-center randomised controlled trial.

BACKGROUND: Major depression is a prevalent mental disorder with a high risk of relapse or recurrence. Only few studies have focused on the cost-effectiveness of interventions aimed at the prevention of relapse or recurrence of depression in primary care. AIM: To evaluate the cost-effectiveness of a supported Self-help Preventive Cognitive Therapy (S-PCT) added to treatment-as-usual (TAU) compared with TAU alone for patients with a history of depression, currently in remission. METHODS: An economic evaluation alongside a multi-center randomised controlled trial was performed (n = 248) over a 12-month follow-up. Outcomes included relapse or recurrence of depression and quality-adjusted-life-years (QALYs) based on the EuroQol-5D. Analyses were performed from both a societal and healthcare perspective. Missing data were imputed using multiple imputations. Uncertainty was estimated using bootstrapping and presented using the cost-effectiveness plane and the Cost-Effectiveness Acceptability Curve (CEAC). Cost estimates were adjusted for baseline costs. RESULTS: S-PCT statistically significantly decreased relapse or recurrence by 15% (95%CI 3;28) compared to TAU. Mean total societal costs were €2,114 higher (95%CI -112;4261). From a societal perspective, the ICER for relapse or recurrence was 13,515. At a Willingness To Pay (WTP) of 22,000 €/recurrence prevented, the probability that S-PCT is cost-effective, in comparison with TAU, is 80%. The ICER for QALYs was 63,051. The CEA curve indicated that at a WTP of 30,000 €/QALY gained, the probability that S-PCT is cost-effective compared to TAU is 21%. CONCLUSIONS: Though ultimately depending on the WTP of decision makers, we expect that for both relapse or recurrence and QALYs, S-PCT cannot be considered cost-effective compared to TAU.

Prevention of violent revictimization in depressed patients with an add-on internet-based emotion regulation training (iERT): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Psychiatric patients are at high risk of becoming victim of a violent crime compared to the general population. Although most research has focused on patients with severe mental illness, depressed patients have been demonstrated to be prone to victimization as well. Victimization is associated with more severe symptomatology, decreased quality of life, and high risk of revictimization. Hence, there is a strong need for interventions that focus on preventing violent revictimization. Since emotion dysregulation is associated with both victimization and depression, we developed an internet-based Emotion Regulation Training (iERT) to reduce revictimization in depressed patients. This study aims to evaluate the clinical and cost-effectiveness of iERT added to Treatment As Usual (TAU) in reducing incidents of violent revictimization among depressed patients with a recent history of victimization. Furthermore, this study aims to examine secondary clinical outcomes, and moderators and mediators that may be associated with treatment outcomes. METHODS: In a multicenter randomized controlled trial with parallel group design, patients with a major depressive disorder and a history of violent victimization over the past three years (N = 200) will be allocated to either TAU + iERT (N = 100) or TAU only (N = 100), based on computer-generated stratified block randomization. Assessments will take place at baseline, 8 weeks, 14 weeks, and 6 months after start of treatment, and 12, 24, and 36 months after baseline. The primary outcome measure is the total number of violent victimization incidents at 12 months after baseline, measured with the Safety Monitor: an adequate self-report questionnaire that assesses victimization over the preceding 12 months. Secondary outcome measures and mediators include emotion dysregulation and depressive symptomatology. An economic evaluation with the societal perspective will be performed alongside the trial. DISCUSSION: This study is the first to examine the effectiveness of an intervention aimed at reducing violent revictimization in depressed patients. If effective, iERT can be implemented in mental health care, and contribute to the well-being of depressed patients. Furthermore, the results will provide insight into underlying mechanisms of revictimization. TRIAL REGISTRATION: The study is registered at the Netherlands Trial Register ( NTR5822 ). Date of registration: 4 April 2016.

Effectiveness of Supported Self-Help in Recurrent Depression: A Randomized Controlled Trial in Primary Care.

BACKGROUND: The burden and economic consequences of depression are high, mostly due to its recurrent nature. Due to current budget and time restraints, a preventive, low- cost, accessible minimal intervention is much needed. In this study, we evaluated the effectiveness of a supported self-help preventive cognitive therapy (S-PCT) added to treatment as usual (TAU) in primary care, compared to TAU alone. METHODS: We conducted a randomized controlled trial among 248 patients with a history of depression, currently in full or partial remission or recovery. Participants were randomized to TAU augmented with S-PCT (n = 124) or TAU alone (n = 124). S-PCT consisted of an 8-week self-help intervention, supported by weekly telephone guidance by a counselor. The intervention included a self-help book that could be read at home. The primary outcome was the incidence of relapse or recurrence and was assessed over the telephone by the Structured Clinical Interview for DSM-IV axis 1 disorders. Participants were observed for 12 months. Secondary outcomes were depressive symptoms, quality of life (EQ-5D and SF-12), comorbid psychopathology, and self-efficacy. These secondary outcomes were assessed by digital questionnaires. RESULTS: In the S-PCT group, 44 participants (35.5%) experienced a relapse or recurrence, compared to 62 participants (50.0%) in the TAU group (incidence rate ratio = 0.71, 95% CI 0.52-0.97; risk difference = 14, 95% CI 2-24, number needed to treat = 7). Compared to the TAU group, the S-PCT group showed a significant reduction in depressive symptoms over 12 months (mean difference -2.18; 95% CI -3.09 to -1.27) and a significant increase in quality of life (EQ-5D) (mean difference 0.04; 95% CI 0.004-0.08). S-PCT had no effect on comorbid psychopathology, self-efficacy, and quality of life based on the SF-12. CONCLUSIONS: A supported self-help preventive cognitive therapy, guided by a counselor in primary care, proved to be effective in reducing the burden of recurrent depression.

The therapist's role in the implementation of internet-based cognitive behavioural therapy for patients with depression: study protocol.

BACKGROUND: Internet-based Cognitive Behavioural Therapy (iCBT) for the treatment of depressive disorders is innovative and promising. Various studies have demonstrated large effect sizes up to 2.27, but implementation in routine practice lags behind. Mental health therapists play a significant role in the uptake of internet-based interventions. Therefore, it is interesting to study factors that influence the therapists in whether they apply internet-based therapy or not. This study, as part of the European implementation project MasterMind, aims to identity the factors that promote or hinder therapists in the use of iCBT in depression care. METHODS/DESIGN: The uptake of iCBT by therapists in routine mental health care practice for the treatment of depression will be evaluated by a mixed method approach, to provide an understanding of the implementation factors (quantitative), and to ascertain the facilitating and hindering factors in the involvement of therapists in the implementation of iCBT (qualitative). The involvement of therapists in the implementation of iCBT is analysed following the RE-AIM framework on the five dimensions Reach, Efficacy/Effectiveness, Adoption, Implementation, and Maintenance. This enables us to evaluate the reach of therapists, the impact of iCBT on depression care, the extent to which therapists adopt iCBT, the extent to which iCBT is delivered as intended, and how iCBT can be maintained over time. DISCUSSION: The results will provide valuable insight into the role of therapists in the implementation of iCBT for depression in secondary mental health care settings. They will result in concrete recommendations for how therapists can be facilitated in implementing and up-scaling iCBT for depression.

Patients with a preference for medication do equally well in mindfulness-based cognitive therapy for recurrent depression as those preferring mindfulness.

BACKGROUND: Previous studies have suggested that patients' treatment preferences may influence treatment outcome. The current study investigated whether preference for either mindfulness-based cognitive therapy (MBCT) or maintenance antidepressant medication (mADM) to prevent relapse in recurrent depression was associated with patients' characteristics, treatment adherence, or treatment outcome of MBCT. METHODS: The data originated from two parallel randomised controlled trials, the first comparing the combination of MBCT and mADM to MBCT in patients preferring MBCT (n=249), the second comparing the combination to mADM alone in patients preferring mADM (n=68). Patients' characteristics were compared across the trials (n=317). Subsequently, adherence and clinical outcomes were compared for patients who all received the combination (n=154). RESULTS: Patients with a preference for mADM reported more previous depressive episodes and higher levels of mindfulness at baseline. Preference did not affect adherence to either MBCT or mADM. With regard to treatment outcome of MBCT added to mADM, preference was not associated with relapse/recurrence (χ(2)=0.07; p=.80), severity of (residual) depressive symptoms during the 15-month follow-up period (ß=-0.08, p=.49), or quality of life. LIMITATIONS: The group preferring mADM was relatively small. The influence of preferences on outcome may have been limited in the current study because both preference groups received both interventions. CONCLUSIONS: The fact that patients with a preference for medication did equally well as those with a preference for mindfulness supports the applicability of MBCT for recurrent depression. Future studies of MBCT should include measures of preferences to increase knowledge in this area.

Discontinuation of antidepressant medication after mindfulness-based cognitive therapy for recurrent depression: randomised controlled non-inferiority trial.

BACKGROUND: Mindfulness-based cognitive therapy (MBCT) and maintenance antidepressant medication (mADM) both reduce the risk of relapse in recurrent depression, but their combination has not been studied. AIMS: To investigate whether MBCT with discontinuation of mADM is non-inferior to MBCT+mADM. METHOD: A multicentre randomised controlled non-inferiority trial (ClinicalTrials.gov:NCT00928980). Adults with recurrent depression in remission, using mADM for 6 months or longer (n= 249), were randomly allocated to either discontinue (n= 128) or continue (n= 121) mADM after MBCT. The primary outcome was depressive relapse/recurrence within 15 months. A confidence interval approach with a margin of 25% was used to test non-inferiority. Key secondary outcomes were time to relapse/recurrence and depression severity. RESULTS: The difference in relapse/recurrence rates exceeded the non-inferiority margin and time to relapse/recurrence was significantly shorter after discontinuation of mADM. There were only minor differences in depression severity. CONCLUSIONS: Our findings suggest an increased risk of relapse/recurrence in patients withdrawing from mADM after MBCT.

Adding mindfulness-based cognitive therapy to maintenance antidepressant medication for prevention of relapse/recurrence in major depressive disorder: Randomised controlled trial.

BACKGROUND: Mindfulness-based cognitive therapy (MBCT) and maintenance antidepressant medication (mADM) both reduce the risk of relapse in recurrent depression, but their combination has not been studied. Our aim was to investigate whether the addition of MBCT to mADM is a more effective prevention strategy than mADM alone. METHODS: This study is one of two multicenter randomised trials comparing the combination of MBCT and mADM to either intervention on its own. In the current trial, recurrently depressed patients in remission who had been using mADM for 6 months or longer (n=68), were randomly allocated to either MBCT+mADM (n=33) or mADM alone (n=35). Primary outcome was depressive relapse/recurrence within 15 months. Key secondary outcomes were time to relapse/recurrence and depression severity. Analyses were based on intention-to-treat. RESULTS: There were no significant differences between the groups on any of the outcome measures. LIMITATIONS: The current study included patients who had recovered from depression with mADM and who preferred the certainty of continuing medication to the possibility of participating in MBCT. Lower expectations of mindfulness in the current trial, compared with the parallel trial, may have caused selection bias. In addition, recruitment was hampered by the increasing availability of MBCT in the Netherlands, and even about a quarter of participants included in the trial who were allocated to the control group chose to get MBCT elsewhere. CONCLUSIONS: For this selection of recurrently depressed patients in remission and using mADM for 6 months or longer, MBCT did not further reduce their risk for relapse/recurrence or their (residual) depressive symptoms.

Depression, anxiety and 6-year risk of cardiovascular disease.

OBJECTIVE: Depression and anxiety are considered etiological factors in cardiovascular disease (CVD), though their relative contribution and differentiation by clinical characteristics have not been studied intensively. We examined 6-year associations between depressive and anxiety disorders, clinical characteristics and newly-developed CVD. METHODS: DSM-IV diagnoses were established in 2510 CVD-free participants of the Netherlands Study of Depression and Anxiety. Data on subtype, severity, and psychoactive medication were collected. The 6-year incidence of CVD was assessed using Cox regression analyses adjusted for sociodemographic, health and lifestyle factors. RESULTS: One-hundred-six subjects (4.2%) developed CVD. Having both current depressive and anxiety disorders (HR=2.86, 95%CI 1.49-5.49) or current depression only (HR=2.30; 95%CI 1.10-4.80) was significantly associated with increased CVD incidence, whereas current anxiety only (HR=1.48; 95%CI 0.74-2.96) and remitted disorders (HR=1.48; 95%CI 0.80-2.75) were not associated. Symptom severity was associated with increased CVD onset (e.g., Inventory of Depressive Symptomatology per SD increase: HR=1.51; 95%CI 1.25-1.83). Benzodiazepine use was associated with additional CVD risk (HR=1.95; 95%CI 1.16-3.31). CONCLUSIONS: Current depressive (but not anxiety) disorder independently contributed to CVD in our sample of initially CVD-free participants. CVD incidence over 6years of follow-up was particularly increased in subjects with more symptoms, and in those using benzodiazepines.

The effectiveness of the cognitive behavioral analysis system of psychotherapy for chronic depression: a randomized controlled trial.

BACKGROUND: It is widely agreed that chronic depression is difficult to treat, knowledge about optimal treatment approaches is emerging. METHOD: A multisite randomized controlled trial was conducted comparing the cognitive behavioral analysis system of psychotherapy (CBASP), a psychotherapy model developed specifically to treat chronic depression (n = 67) with care as usual (CAU; evidence-based treatments, n = 72) over a period of 52 weeks, with 23 sessions on average, in 3 outpatient clinics in the Netherlands. In both arms algorithm-based pharmacotherapy was provided. Patients (aged 18-65) met criteria for a DSM-IV diagnosis of major depressive disorder with diagnostic specifiers (chronic, without interepisode recovery) or with co-occurring dysthymic disorder indicating a chronic course. The Inventory for Depressive Symptomatology (IDS) Self-Report was used as the primary outcome measure. Mixed-effects linear regression analysis was used to compare the changes on the IDS scores between CBASP and CAU. The IDS was administered before treatment, and after 8, 16, 32 and 52 weeks. RESULTS: At week 52, patients assigned to CBASP had a greater reduction of depressive symptoms compared to patients assigned to CAU (t = -2.00, p = 0.05). However, CBASP and CAU did not differ from each other on the IDS after 8 weeks (t = 0.49, p = 0.63), 16 weeks (t = -0.03, p = 0.98) and 32 weeks (t = -0.17, p = 0.86) of treatment. CONCLUSIONS: This trial shows that CBASP is at least as effective as standard evidence-based treatments for chronic depression. In the long run, CBASP appears to have an added effect.

Cost-effectiveness of a stepped care programme to prevent depression and anxiety in residents in homes for the older people: a randomised controlled trial.

BACKGROUND: Depression and anxiety are common in residents of elderly homes. Both disorders have negative effects on functioning, well-being and health-care utilisation. Besides treatment, prevention can be an option to reduce the burden of mental disorders. The objective of this study was to evaluate the cost-effectiveness of a stepped care programme to prevent the onset of depression and anxiety disorders in residents of elderly homes compared with usual care from a societal perspective. METHODS: Outcomes were incidence of depression and/or anxiety, severity of depressive and anxiety symptoms and quality-adjusted life years. Health-care utilisation was measured during interviews. Multiple imputation was used to impute missing cost and effect data. Uncertainty around cost differences and incremental cost-effectiveness ratios was estimated using bootstrapping. Cost-effectiveness planes and acceptability curves were created. RESULTS: The incidence of depression and anxiety combined in the intervention group was not reduced in comparison with the usual care group. There was also no effect on the other outcomes. Mean total costs in the intervention group were €838 higher than in the usual care group, but this difference was not statistically significant (95% confidence interval, -593 to 2420). Cost-effectiveness planes showed that there was considerable uncertainty. Cost-effectiveness acceptability curves showed that the maximum probability of the intervention being cost-effective in comparison with usual care was 0.46 for reducing the incidence of depression and anxiety combined. CONCLUSION: A stepped care programme to prevent depression and anxiety in older people living in elderly homes was not considered cost-effective in comparison with usual care.

Preventing depression in homes for older adults: are effects sustained over 2 years?

OBJECTIVES: The objective of this study was to evaluate the 2-year effects of a stepped-care programme to prevent the onset of a major depressive disorder (MDD) in older people living in residential homes. METHODS: A 2-year follow-up study of a pragmatic randomised controlled trial was conducted in 14 residential homes in the Netherlands. A total of 185 residents (Center for Epidemiologic Studies Depression Scale score >7), who did not meet the diagnostic criteria for MDD, were randomised to a stepped-care programme (n = 93) or to usual care (n = 92). Stepped-care participants sequentially underwent watchful waiting, a self-help intervention, life review and a consultation with the general practitioner. The primary outcome measure was the incidence of MDD during a period of 2 years, according to the Mini International Neuropsychiatric Interview. RESULTS: After 2 years, the incidence of MDD was not significantly reduced in the intervention group compared with the control group (incidence rate ratio: 0.98; 95% confidence interval (CI) [0.54, 1.81]). However, in the completer analysis, on the basis of 79 residents who completed the 2-year measurements, there was a significant difference in favour of the intervention group (incidence rate ratio: 0.53; 95% CI [0.32, 0.87]). Dropout percentages were high (44%), mostly accounted for by illness and death (68%). CONCLUSION: A minority of residents had benefit from the intervention that sustained after 2 years in the completer group. Yet, these findings cannot be generalised as the majority of the residents did not opt for participation in the project and many dropped out. Ways should be sought to motivate residents with depressive symptoms to engage in preventive interventions.

Preventing relapse in recurrent depression using mindfulness-based cognitive therapy, antidepressant medication or the combination: trial design and protocol of the MOMENT study.

BACKGROUND: Depression is a common psychiatric disorder characterized by a high rate of relapse and recurrence. The most commonly used strategy to prevent relapse/recurrence is maintenance treatment with antidepressant medication (mADM). Recently, it has been shown that Mindfulness-Based Cognitive Therapy (MBCT) is at least as effective as mADM in reducing the relapse/recurrence risk. However, it is not yet known whether combination treatment of MBCT and mADM is more effective than either of these treatments alone. Given the fact that most patients have a preference for either mADM or for MBCT, the aim of the present study is to answer the following questions. First, what is the effectiveness of MBCT in addition to mADM? Second, how large is the risk of relapse/recurrence in patients withdrawing from mADM after participating in MBCT, compared to those who continue to use mADM after MBCT? METHODS/DESIGN: Two parallel-group, multi-center randomized controlled trials are conducted. Adult patients with a history of depression (3 or more episodes), currently either in full or partial remission and currently treated with mADM (6 months or longer) are recruited. In the first trial, we compare mADM on its own with mADM plus MBCT. In the second trial, we compare MBCT on its own, including tapering of mADM, with mADM plus MBCT. Follow-up assessments are administered at 3-month intervals for 15 months. Primary outcome is relapse/recurrence. Secondary outcomes are time to, duration and severity of relapse/recurrence, quality of life, personality, several process variables, and incremental cost-effectiveness ratio. DISCUSSION: Taking into account patient preferences, this study will provide information about a) the clinical and cost-effectiveness of mADM only compared with mADM plus MBCT, in patients with a preference for mADM, and b) the clinical and cost-effectiveness of withdrawing from mADM after MBCT, compared with mADM plus MBCT, in patients with a preference for MBCT. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00928980.