Comparison of the Working Alliance in Blended Cognitive Behavioral Therapy and Treatment as Usual for Depression in Europe: Secondary Data Analysis of the E-COMPARED Randomized Controlled Trial.

BACKGROUND: Increasing interest has centered on the psychotherapeutic working alliance as a means of understanding clinical change in digital mental health interventions in recent years. However, little is understood about how and to what extent a digital mental health program can have an impact on the working alliance and clinical outcomes in a blended (therapist plus digital program) cognitive behavioral therapy (bCBT) intervention for depression. OBJECTIVE: This study aimed to test the difference in working alliance scores between bCBT and treatment as usual (TAU), examine the association between working alliance and depression severity scores in both arms, and test for an interaction between system usability and working alliance with regard to the association between working alliance and depression scores in bCBT at 3-month assessments. METHODS: We conducted a secondary data analysis of the E-COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment versus Treatment-as-usual) trial, which compared bCBT with TAU across 9 European countries. Data were collected in primary care and specialized services between April 2015 and December 2017. Eligible participants aged 18 years or older and diagnosed with major depressive disorder were randomized to either bCBT (n=476) or TAU (n=467). bCBT consisted of 6-20 sessions of bCBT (involving face-to-face sessions with a therapist and an internet-based program). TAU consisted of usual care for depression. The main outcomes were scores of the working alliance (Working Alliance Inventory-Short Revised-Client [WAI-SR-C]) and depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]) at 3 months after randomization. Other variables included system usability scores (System Usability Scale-Client [SUS-C]) at 3 months and baseline demographic information. Data from baseline and 3-month assessments were analyzed using linear regression models that adjusted for a set of baseline variables. RESULTS: Of the 945 included participants, 644 (68.2%) were female, and the mean age was 38.96 years (IQR 38). bCBT was associated with higher composite WAI-SR-C scores compared to TAU (B=5.67, 95% CI 4.48-6.86). There was an inverse association between WAI-SR-C and PHQ-9 in bCBT (B=-0.12, 95% CI -0.17 to -0.06) and TAU (B=-0.06, 95% CI -0.11 to -0.02), in which as WAI-SR-C scores increased, PHQ-9 scores decreased. Finally, there was a significant interaction between SUS-C and WAI-SR-C with regard to an inverse association between higher WAI-SR-C scores and lower PHQ-9 scores in bCBT (b=-0.030, 95% CI -0.05 to -0.01; P=.005). CONCLUSIONS: To our knowledge, this is the first study to show that bCBT may enhance the client working alliance when compared to evidence-based routine care for depression that services reported offering. The working alliance in bCBT was also associated with clinical improvements that appear to be enhanced by good program usability. Our findings add further weight to the view that the addition of internet-delivered CBT to face-to-face CBT may positively augment experiences of the working alliance. TRIAL REGISTRATION: ClinicalTrials.gov NCT02542891, https://clinicaltrials.gov/study/NCT02542891; German Clinical Trials Register DRKS00006866, https://drks.de/search/en/trial/DRKS00006866; Netherlands Trials Register NTR4962, https://www.onderzoekmetmensen.nl/en/trial/25452; ClinicalTrials.Gov NCT02389660, https://clinicaltrials.gov/study/NCT02389660; ClinicalTrials.gov NCT02361684, https://clinicaltrials.gov/study/NCT02361684; ClinicalTrials.gov NCT02449447, https://clinicaltrials.gov/study/NCT02449447; ClinicalTrials.gov NCT02410616, https://clinicaltrials.gov/study/NCT02410616; ISRCTN Registry ISRCTN12388725, https://www.isrctn.com/ISRCTN12388725?q=ISRCTN12388725&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10; ClinicalTrials.gov NCT02796573, https://classic.clinicaltrials.gov/ct2/show/NCT02796573. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-016-1511-1.

Guided Internet-Based Cognitive Behavioral Therapy for Insomnia: Prognostic and Treatment-Predictive Factors.

Understanding which factors predict the outcome of internet-based cognitive behavioral therapy for insomnia (iCBT-I) may help to tailor this intervention to the patient's needs. We have conducted a secondary analysis of a randomized, controlled trial comparing a multicomponent iCBT-I (MCT) and an online sleep restriction therapy (SRT) for 83 chronic insomnia patients. The difference in the Insomnia Severity Index from pre- to post-treatment and from pre-treatment to follow-up at 6 months after treatment was the dependent variable. Prognostic and treatment-predictive factors assessed at baseline were analyzed with multiple linear regression. The shorter duration of insomnia, female gender, high health-related quality of life, and the higher total number of clicks had prognostic value for a better outcome. Other factors were found to be prognostic for outcome at the follow-up assessment: treatment with benzodiazepines, sleep quality, and personal significance of sleep problems. A high level of dysfunctional beliefs and attitudes about sleep (DBAS) was a moderator for better effects in the MCT at post-treatment assessment. Various prognostic factors (e.g., duration of insomnia, gender, or quality of life) may influence the success of treatment. The DBAS scale may be recommended to select patients for MCT rather than SRT.

Examining the Theoretical Framework of Behavioral Activation for Major Depressive Disorder: Smartphone-Based Ecological Momentary Assessment Study.

BACKGROUND: Behavioral activation (BA), either as a stand-alone treatment or as part of cognitive behavioral therapy, has been shown to be effective for treating depression. The theoretical underpinnings of BA derive from Lewinsohn et al's theory of depression. The central premise of BA is that having patients engage in more pleasant activities leads to them experiencing more pleasure and elevates their mood, which, in turn, leads to further (behavioral) activation. However, there is a dearth of empirical evidence about the theoretical framework of BA. OBJECTIVE: This study aims to examine the assumed (temporal) associations of the 3 constructs in the theoretical framework of BA. METHODS: Data were collected as part of the "European Comparative Effectiveness Research on Internet-based Depression Treatment versus treatment-as-usual" trial among patients who were randomly assigned to receive blended cognitive behavioral therapy (bCBT). As part of bCBT, patients completed weekly assessments of their level of engagement in pleasant activities, the pleasure they experienced as a result of these activities, and their mood over the course of the treatment using a smartphone-based ecological momentary assessment (EMA) application. Longitudinal cross-lagged and cross-sectional associations of 240 patients were examined using random intercept cross-lagged panel models. RESULTS: The analyses did not reveal any statistically significant cross-lagged coefficients (all P>.05). Statistically significant cross-sectional positive associations between activities, pleasure, and mood levels were identified. Moreover, the levels of engagement in activities, pleasure, and mood slightly increased over the duration of the treatment. In addition, mood seemed to carry over, over time, while both levels of engagement in activities and pleasurable experiences did not. CONCLUSIONS: The results were partially in accordance with the theoretical framework of BA, insofar as the analyses revealed cross-sectional relationships between levels of engagement in activities, pleasurable experiences deriving from these activities, and enhanced mood. However, given that no statistically significant temporal relationships were revealed, no conclusions could be drawn about potential causality. A shorter measurement interval (eg, daily rather than weekly EMA reports) might be more attuned to detecting potential underlying temporal pathways. Future research should use an EMA methodology to further investigate temporal associations, based on theory and how treatments are presented to patients. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02542891, https://clinicaltrials.gov/ct2/show/NCT02542891; German Clinical Trials Register, DRKS00006866, https://tinyurl.com/ybja3xz7; Netherlands Trials Register, NTR4962, https://www.trialregister.nl/trial/4838; ClinicalTrials.Gov, NCT02389660, https://clinicaltrials.gov/ct2/show/NCT02389660; ClinicalTrials.gov, NCT02361684, https://clinicaltrials.gov/ct2/show/NCT02361684; ClinicalTrials.gov, NCT02449447, https://clinicaltrials.gov/ct2/show/NCT02449447; ClinicalTrials.gov, NCT02410616, https://clinicaltrials.gov/ct2/show/NCT02410616; ISRCTN registry, ISRCTN12388725, https://www.isrctn.com/ISRCTN12388725.

Differential Effects of Psychological Interventions in Online and Face-to-Face Settings on DSM-5 and ICD-11 Maladaptive Trait Domains: An Exploratory Pilot Study.

While mental health treatments have proven to be effective for a range of mental health problems, there is comparably little research on its effects on personality disorders or difficulty (PD). New dimensional conceptualizations of PD such as the ICD-11 PD model enable the cost- and time-effective dimensional assessment of severity and style of PD. Furthermore, they constitute a promising tool to investigate PD, not only as a treatment endpoint but also as a predictive or influencing factor for mental health treatments. In this study, we investigated the effects in two different mental health treatment settings [online (N = 38); face-to-face and blended [FTF/blended] (N = 35)] on the reduction of maladaptive personality traits as well as the interaction between maladaptive personality patterns and the response on primary endpoints (i.e., mental distress). Results indicate that both treatment settings have comparable within-group effects on the reduction of distress symptoms, while the treatment in the FTF/blended setting seems to have a stronger impact on the reduction of maladaptive traits. Further, reduction of maladaptive trait expressions was a reliable predictor of treatment response in the FTF/blended setting while explaining less variance in the online setting. Beyond the promising findings on the utility of maladaptive trait change as an outcome measure, we discuss possible applications as an information source for treatment decisions.

An Integrative Neuro-Psychotherapy Treatment to Foster the Adjustment in Acquired Brain Injury Patients-A Randomized Controlled Study.

Adjustment disorders (AjD) with depressive symptoms following an acquired brain injury (ABI) is a common phenomenon. Although brain injuries are increasing more and more, research on psychological therapies is comparably scarce. The present study compared, by means of a randomized controlled trial (RCT), a newly developed integrative treatment (Standard PLUS) to a standard neuropsychological treatment (Standard). Primary outcomes were depressive symptoms assessed with the Beck Depression Inventory (BDI-II) at post-treatment and 6-month follow-up assessment. In total, 25 patients (80% after a stroke) were randomized to one of the two conditions. Intention-to-treat analyses showed that the two groups did not significantly differ either at post-treatment nor at follow-up assessment regarding depressive symptoms. Both treatments showed large within-group effect sizes on depressive symptoms. Regarding secondary outcomes, patients in the Standard PLUS condition reported more emotion regulation skills at post-assessment than in the control condition. However, this difference was not present anymore at follow-up assessment. Both treatments showed medium to large within-group effects sizes on most measures for patients suffering from an AjD after ABI. More research with larger samples is needed to investigate who profits from which intervention.

Using the Personalized Advantage Index for Individual Treatment Allocation to Blended Treatment or Treatment as Usual for Depression in Secondary Care.

A variety of effective psychotherapies for depression are available, but patients who suffer from depression vary in their treatment response. Combining face-to-face therapies with internet-based elements in the sense of blended treatment is a new approach to treatment for depression. The goal of this study was to answer the following research questions: (1) What are the most important predictors determining optimal treatment allocation to treatment as usual or blended treatment? and (2) Would model-determined treatment allocation using this predictive information and the personalized advantage index (PAI)-approach result in better treatment outcomes? Bayesian model averaging (BMA) was applied to the data of a randomized controlled trial (RCT) comparing the efficacy of treatment as usual and blended treatment in depressive outpatients. Pre-treatment symptomatology and treatment expectancy predicted outcomes irrespective of treatment condition, whereas different prescriptive predictors were found. A PAI of 2.33 PHQ-9 points was found, meaning that patients who would have received the treatment that is optimal for them would have had a post-treatment PHQ-9 score that is two points lower than if they had received the treatment that is suboptimal for them. For 29% of the sample, the PAI was five or greater, which means that a substantial difference between the two treatments was predicted. The use of the PAI approach for clinical practice must be further confirmed in prospective research; the current study supports the identification of specific interventions favorable for specific patients.

A randomized controlled trial comparing guided internet-based multi-component treatment and internet-based guided sleep restriction treatment to care as usual in insomnia.

BACKGROUND: Internet-based cognitive behavioral treatment (iCBT-I) for insomnia comprising different sleep-related cognitive and behavioral interventional components has shown some promise. However, it is not known which components are necessary for a good treatment outcome. METHOD: People suffering from insomnia (N = 104) without any other comorbid psychiatric disorders were randomized (2:2:1) to two guided internet-based self-help interventions for insomnia [multi-component cognitive behavioral self-help intervention (MCT); sleep restriction intervention for insomnia (SRT)], and care as usual [CAU]. In all three conditions, additional care or treatment was allowed. The primary outcome was insomnia severity measured with the insomnia severity index (ISI) at eight weeks. Furthermore, the two active conditions were compared regarding sleep efficacy from daily diary data over the eight weeks, and other measures from the daily protocols. Secondary outcomes included sleep quality, depressive symptoms, dysfunctional beliefs, and quality of life at post-treatment (eight weeks) and follow-up (six months after randomization). RESULTS: Both conditions were more effective than CAU at post-treatment, with medium to large between-group effect sizes on the primary outcome (ISI; MCT: Cohen's d = -1.15; SRT: d = -0.68) and small to medium between-group effect sizes for secondary outcomes. Treatment gains were maintained at six-month follow-up. Active conditions did not differ from each other on all measures from pre to post, except for dysfunctional beliefs about sleep, and sleep protocol data throughout the intervention. Participants in MCT were significantly more satisfied with the intervention than participants in SRT. CONCLUSIONS: Results of the present study indicate that CAU + MCT and CAU + SRT are both effective compared to CAU. There were no statistical differences regarding efficacy between the two active conditions, but participants in MCT reported to be more satisfied with the intervention.

An Internet-Based Compassion-Focused Intervention for Increased Self-Criticism: A Randomized Controlled Trial.

Increased levels of self-criticism and a lack of self-compassion have been associated with the development and maintenance of a range of psychological disorders. In the current study, we tested the efficacy of an online version of a compassion-focused intervention, mindfulness-based compassionate living (MBCL), with guidance on request. A total of 122 self-referred participants with increased levels of self-criticism were randomly assigned to care as usual (CAU) or the intervention group (CAU + online intervention). Primary endpoints were self-reported depressive, anxiety and distress symptoms (DASS-21) and self-compassion (SCS) at 8 weeks. Secondary endpoints were self-criticism, mindfulness, satisfaction with life, fear of self-compassion, self-esteem, and existential shame. At posttreatment, the intervention group showed significant changes with medium to large effect sizes compared to the control group regarding primary outcomes (Cohen's d: 0.79 [DASS] and -1.21 [SCS]) and secondary outcomes (Cohen's ds: between 0.40 and 0.94 in favor of the intervention group). The effects in the intervention group were maintained at 6-months postrandomization. Adherence measures (number of completed modules, self-reported number of completed exercises per week) predicted postintervention scores for self-compassion but not for depressive, anxiety, and distress symptoms in the intervention group. The current study shows the efficacy of an online intervention with a transdiagnostic intervention target on a broad range of measures, including depressive and anxiety symptoms and self-compassion.

A patient post hoc perspective on advantages and disadvantages of blended cognitive behaviour therapy for depression: A qualitative content analysis.

Background: Blended cognitive behavioural therapy (bCBT), which combines face-to-face (FtF), and internet-based cognitive behavioural therapy (iCBT), may be a particularly promising approach, but little is known about the effectiveness and patients' subjective evaluations of the bCBT format. The aim of this qualitative study is to explore perceived advantages and disadvantages of bCBT from the patients' perspective in specialized mental health care. Methods: Semi-structured interviews were conducted with 15 patients suffering from major depression who underwent treatment in a bCBT format. The interview data were processed by means of a qualitative content analysis. Results: The content analysis generated 18 advantages and 15 disadvantages which were grouped into 6 main topics. In general, bCBT was perceived as purposive and effective for treating depression. The patients perceived the combined treatment as complementary and emphasized the advantage of the constant availability of the online programme. Furthermore, a segment analysis revealed that patients reported different advantages and disadvantages of bCBT as a function of the severity of their depressive episode. Conclusion: The findings of the present study reveal advantages and disadvantages of bCBT, which should be taken into account in the further implementation of this new treatment format. Clinical or methodological significance of this article: Blended treatment seems to balance missing aspects of stand-alone internet-based and face-to-face treatment for depression. Patients suffering from major depression perceived the blended format as purposive and effective after 18 weeks. Patients with different levels of depression severity may perceive different advantages and disadvantages of blended treatment for depression.

A mobile app for social anxiety disorder: A three-arm randomized controlled trial comparing mobile and PC-based guided self-help interventions.

OBJECTIVE: Internet-based cognitive-behavioral treatments (ICBT) have shown promise for various mental disorders, including social anxiety disorder (SAD). Most of these treatments have been delivered on desktop computers. However, the use of smartphones is becoming ubiquitous and could extend the reach of ICBT into users' everyday life. Only a few studies have empirically examined the efficacy of ICBT delivered through a smartphone app and there is no published study on mobile app delivered ICBT for SAD. This three-arm randomized-controlled trial (RCT) is the first to compare the efficacy of guided ICBT for smartphones (app) and conventional computers (PC) with a wait list control group (WL). METHOD: A total of 150 individuals meeting the diagnostic criteria for SAD were randomly assigned to one of the three conditions. Primary endpoints were self-report measures and diagnostic status of SAD. RESULTS: After 12 weeks of treatment, both active conditions showed superior outcome on the composite of all SAD measures (PC vs. WL: d = 0.74; App vs. WL: d = 0.89) and promising diagnostic response rates (NNTPC = 3.33; NNTApp = 6.00) compared to the WL. No significant between-groups effects were found between the two active conditions on the composite score (Cohen's d = 0.07). Treatment gains were maintained at 3-month follow-up. Program use was more evenly spread throughout the day in the mobile condition, indicating an integration of the program into daily routines. CONCLUSIONS: ICBT can be delivered effectively using smartphones. (PsycINFO Database Record

Attitudes towards digital treatment for depression: A European stakeholder survey.

BACKGROUND: The integration of digital treatments into national mental health services is on the agenda in the European Union. The E-COMPARED consortium conducted a survey aimed at exploring stakeholders' knowledge, acceptance and expectations of digital treatments for depression, and at identifying factors that might influence their opinions when considering the implementation of these approaches. METHOD: An online survey was conducted in eight European countries: France, Germany, Netherlands, Poland, Spain, Sweden, Switzerland and The United Kingdom. Organisations representing government bodies, care providers, service-users, funding/insurance bodies, technical developers and researchers were invited to participate in the survey. The participating countries and organisations reflect the diversity in health care infrastructures and e-health implementation across Europe. RESULTS: A total of 764 organisations were invited to the survey during the period March-June 2014, with 175 of these organisations participating in our survey. The participating stakeholders reported moderate knowledge of digital treatments and considered cost-effectiveness to be the primary incentive for integration into care services. Low feasibility of delivery within existing care services was considered to be a primary barrier. Digital treatments were regarded more suitable for milder forms of depression. Stakeholders showed greater acceptability towards blended treatment (the integration of face-to-face and internet sessions within the same treatment protocol) compared to standalone internet treatments. Organisations in countries with developed e-health solutions reported greater knowledge and acceptability of digital treatments. CONCLUSION: Mental health stakeholders in Europe are aware of the potential benefits of digital interventions. However, there are variations between countries and stakeholders in terms of level of knowledge about such interventions and their feasibility within routine care services. The high acceptance of blended treatments is an interesting finding that indicates a gradual integration of technology into clinical practice may fit the attitudes and needs of stakeholders. The potential of the blended treatment approach, in terms of enhancing acceptance of digital treatment while retaining the benefit of cost-effectiveness in delivery, should be further explored. FUNDING: The E-COMPARED project has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 603098.

Virtual Reality-Based Attention Bias Modification Training for Social Anxiety: A Feasibility and Proof of Concept Study.

Attention bias modification (ABM) programs have been considered as a promising new approach for the treatment of various disorders, including social anxiety disorder (SAD). However, previous studies yielded ambiguous results regarding the efficacy of ABM in SAD. The present proof-of-concept study investigates the feasibility of a newly developed virtual reality (VR)-based dot-probe training paradigm. It was designed to facilitate attentional disengagement from threatening stimuli in socially anxious individuals (N = 15). The following outcomes were examined: (a) self-reports of enjoyment, motivation, flow, and presence; (b) attentional bias for social stimuli; and (c) social anxiety symptoms. Results showed that ABM training is associated with high scores in enjoyment, motivation, flow, and presence. Furthermore, significant improvements in terms of attention bias and social anxiety symptoms were observed from pre- to follow-up assessment. The study suggests that VR is a feasible and presumably a promising new medium for ABM trainings. Controlled studies will need to be carried out.

Evaluating an e-mental health program ("deprexis") as adjunctive treatment tool in psychotherapy for depression: design of a pragmatic randomized controlled trial.

BACKGROUND: Major depressive disorder (MDD) places a significant disease burden on individuals as well as on societies. Several web-based interventions for MDD have shown to be effective in reducing depressive symptoms. However, it is not known whether web-based interventions, when used as adjunctive treatment tools to regular psychotherapy, have an additional effect compared to regular psychotherapy for depression. METHODS/DESIGN: This study is a currently recruiting pragmatic randomized controlled trial (RCT) that compares regular psychotherapy plus a web-based depression program ("deprexis") with a control condition exclusively receiving regular psychotherapy. Adults with a depressive disorder (N = 800) will be recruited in routine secondary care from therapists over the course of their initial sessions and will then be randomized within therapists to one of the two conditions. The primary outcome is depressive symptoms measured with the Beck Depression Inventory (BDI-II) at three months post randomization. Secondary outcomes include changes on various indicators such as anxiety, somatic symptoms and quality of life. All outcomes are again assessed at the secondary endpoint six months post randomization. In addition, the working alliance and feasibility/acceptability of the treatment condition will be explored. DISCUSSION: This is the first randomized controlled trial to examine the feasibility/acceptability and the effectiveness of a combination of traditional face-to-face psychotherapy and web-based depression program compared to regular psychotherapeutic treatment in depressed outpatients in routine care. TRIAL REGISTRATION: ISRCTN20165665.