Internet-based emotion regulation training aimed at reducing violent revictimization and depressive symptoms in victimized depressed patients: Results of a randomized controlled trial.

BACKGROUND: Depressed patients who have become victim of violence are prone to revictimization. However, no evidence-based interventions aimed at reducing revictimization in this group exist. METHODS: This multicenter randomized controlled trial evaluated the effectiveness of an internet-based emotion regulation training (iERT) added to TAU in reducing revictimization, emotion dysregulation, and depressive symptoms in recently victimized, depressed patients compared to TAU alone. Adult outpatients (N = 153) with a depressive disorder who had experienced threat, physical assault, or sexual assault within the previous three years were randomly allocated to TAU+iERT (n = 74) or TAU (n = 79). TAU involved psychotherapy (mainly cognitive behavioral therapy [77.8 %]). iERT comprised six guided online sessions focused on the acquisition of adaptive emotion regulation skills. The primary outcome measure was the number of revictimization incidents at 12 months after baseline, measured with the Safety Monitor. Analyses were performed according to the intention-to-treat principle. RESULTS: Both groups showed a large decrease in victimization incidents. Mixed-model negative binomial regression analyses showed that TAU+iERT was not effective in reducing revictimization compared to TAU (IRR = 0.97; 95%CI = 0.64,1.46; p = .886). Linear mixed-model analyses demonstrated that TAU+iERT yielded a larger reduction of emotion dysregulation (B = -7.217; p = .046; Cohens d = 0.33), but not depressive symptoms (B = -1.041; p = .607) than TAU. LIMITATIONS: The study was underpowered to detect small treatment effects. Additionally, uptake of iERT was quite low. CONCLUSIONS: Although TAU+iERT resulted in a larger decrease of emotion dysregulation than TAU alone, it was not effective in reducing revictimization and depressive symptoms. Patients' revictimization risk substantially decreased during psychotherapy.

Internet-delivered cognitive behavioural therapy for insomnia disorder in depressed patients treated at an outpatient clinic for mood disorders: protocol of a randomised controlled trial.

BACKGROUND: Major depression is a highly prevalent disorder causing severe personal distress, and high societal costs. Patients with depression often have comorbid insomnia disorder (ID) leading to even worse personal distress and worse treatment outcomes. Recent results from a non-randomised pilot study with internet-delivered Cognitive Behavioural Therapy (CBTi) for Insomnia (I-Sleep) added to regular depression care were promising regarding feasibility and initial effects on insomnia complaints and depression. However, no randomised controlled trial (RCT) has been performed yet to access the (cost-) effectiveness of I-Sleep for depression. Therefore, this protocol article presents the design of an RCT aimed to assess the (cost-) effectiveness of I-Sleep in addition to usual care for depression compared to usual care alone in depressed patients with a comorbid Insomnia Disorder (ID) treated at outpatient clinics for mood disorders.  METHODS /DESIGN: This is a multi-centre RCT with measurements at baseline and at 3, 6, 9, and 12 months of follow-up. Patients with depression and an ID are randomised to either I-Sleep treatment followed by regular depression care or to regular depression care alone. Our aim is to recruit one hundred and seventy-five patients from multiple outpatient clinics for mood disorders. The primary outcome is the change in depressive symptoms over 12 months of follow-up measured with the Patient Health Questionnaire (PHQ-9). Secondary outcomes are recovery from depression (PHQ-9), insomnia severity (Insomnia Severity Index, ISI), daily functioning (Work and Social Adjustment Scale, WSAS), general quality of life (EuroQol 5-level version, EQ-5D-5L), and societal costs (Adapted versions of the iMTA Productivity Cost Questionnaire, iPCQ and iMTA Medical Cost Questionnaire, iMCQ). DISCUSSION: We hypothesize that the addition of I-Sleep to usual care will result in a significant improvement in depression treatment outcomes and quality of life as well as a decrease in healthcare and societal costs compared to usual care alone. This study is the first pragmatic RCT evaluating the effectiveness and cost-effectiveness of adding CBTi to usual care for depression. TRIAL REGISTRATION: Netherlands Trial Register (NL8955). Registered on October 6th2020. https://trialsearch.who.int/Trial2.aspx?TrialID=NL8955.

[Guided discontinuation of antidepressants: approach and first results of a Dutch multidisciplinary outpatient clinic]. / Werkwijze en eerste resultaten van multidisciplinaire afbouwpoli anti-depressiva.

BACKGROUND: Discontinuation of antidepressant medication can be difficult due to withdrawal symptoms and relapse risk. Scientific evidence on the questions of who, when, and how to stop antidepressants is limited. In Amsterdam a multidisciplinary outpatient clinic was started to provide advice and guidance. AIM: To substantiate the design of the clinic. Central questions relate to knowing which patients are referred, the background of their request, and their experiences with the outpatient clinic. METHOD: The first 51 patients of the clinic were described on the basis of file research, in addition a survey was conducted into patient experiences. RESULTS: Half of the patients (55%) actually started discontinuation, 39% were advised not to do so (yet). Patients at the clinic had used antidepressants for an average of 10 years, and 76% had previously attempted to stop. 21% had now successfully stopped and 25% were satisfied with a lower dose. One patient relapsed during tapering. CONCLUSION: So far, patients with long-term antidepressant use and multiple quit attempts have been referred. Our experiences are aimed at helping individual patients but can also result in more knowledge about who can stop at what moment, and how this should be done.

[Guided web-based intervention for sleeping problems (I-Sleep) in depressed patients within outpatient specialist mental health care: a pilot study]. / Begeleide web-based interventie voor slaapproblemen (I-Sleep) bij patiënten met een depressie in de ambulante gespecialiseerde ggz: een pilotstudie.

BACKGROUND: Insomnia in depressed patients is usually targeted by medication, while cognitive behavioural treatment for insomnia (CBT-I) is the treatment of first choice. Effective online CBT-I is available but is not frequently offered in regular care.
AIM: To determine the feasibility and indications for effectiveness of I-Sleep, an online CBT-I module, for uni- and bipolar depressed patients in specialised mental health care settings.
METHOD: In a pilot study I-Sleep (5 sessions) was offered to all 31 patients. Patients who did not (yet) want to participate in the online intervention, and patients who were included after the intended sample size was reached, participated in the control-group. Feasibility was assessed by compliance rates and satisfaction of patients and therapists (CSQ). Effectiveness was assessed within and between groups by the Insomnia Severity Index (ISI) and the Patient Health Questionnaire (PHQ-9) at baseline and after 6 and 12 weeks.
RESULTS: In the intervention group 41% completed all treatment sessions and 77% completed 3 or more sessions. Patients rated the intervention positively (CSQ 23.6, range 4-32). Sleep improved in the intervention group (Cohen's d = 1.93), as well as depression (Cohen's d=1.05). In the control group there was no significant improvement. The difference between the two groups was high and significant for sleep problems (Cohen's d = 0.99) but not for depressive symptoms.
CONCLUSION: Online CBT-I is a feasible treatment option for depressed patients in mental health care settings. There are indications that CBT-I is also effective in reducing sleep problems in more severely depressed patients.

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.

[Screening for depression and anxiety in residential homes for the elderly]. / Problemen bij het opsporen van depressieve- en angststoornissen bij bewoners van verzorgingshuizen.

Elderly persons in residential homes in the Netherlands are at high risk for developing major depressive and anxiety disorders. A stepped-care protocol being used in a study for vulnerable elderly in the community may also be feasible and effective for this group. A pilot study in a residential home in Amsterdam showed more problems than expected in screening and motivating the inhabitants for this intervention protocol. This article describes the problems in our screening procedure. A personal approach, performed by familiar persons, directed at the more independent inhabitants is most likely to succeed. The need for research on effectiveness and feasibility of evidence based methods in residential care remains evident. However, the more vulnerable inhabitants need something else. For this group of inhabitants we need to look more closely to the needs and possibilities by conducting research using a qualitative design.