Working Alliance in Blended Versus Face-to-Face Cognitive Behavioral Treatment for Patients with Depression in Specialized Mental Health Care.

This study investigates working alliance in blended cognitive behavioral therapy (bCBT) for depressed adults in specialized mental health care. Patients were randomly allocated to bCBT (n = 47) or face-to-face CBT (n = 45). After 10 weeks of treatment, both patients and therapists in the two groups rated the therapeutic alliance on the Working Alliance Inventory Short-Form Revised (WAI-SR; Task, Bond, Goal, and composite scores). No between-group differences were found in relation to either patient or therapist alliance ratings, which were high in both groups. In the full sample, a moderate positive association was found between patient and therapist ratings on Task (ρ = 0.41, 95% CI 0.20; 0.59), but no significant associations emerged on other components or composite scores. At 30 weeks, within-and between-group associations between alliance and changes in depression severity (QIDS, Quick Inventory of Depressive Symptomatology) were analyzed with linear mixed models. The analyses revealed an association between depression over time, patient-rated alliance, and group (p < 0.001). In face-to-face CBT, but not in bCBT, lower depression scores were associated with higher alliance ratings. The online component in bCBT may have led patients to evaluate the working alliance differently from patients receiving face-to-face CBT only.

Cost and Effectiveness of Blended Versus Standard Cognitive Behavioral Therapy for Outpatients With Depression in Routine Specialized Mental Health Care: Pilot Randomized Controlled Trial.

BACKGROUND: Cognitive behavioral therapy (CBT) is an effective treatment, but access is often restricted due to costs and limited availability of trained therapists. Blending online and face-to-face CBT for depression might improve cost-effectiveness and treatment availability. OBJECTIVE: This pilot study aimed to examine the costs and effectiveness of blended CBT compared with standard CBT for depressed patients in specialized mental health care to guide further research and development of blended CBT. METHODS: Patients were randomly allocated to blended CBT (n=53) or standard CBT (n=49). Blended CBT consisted of 10 weekly face-to-face sessions and 9 Web-based sessions. Standard CBT consisted of 15 to 20 weekly face-to-face sessions. At baseline and 10, 20, and 30 weeks after start of treatment, self-assessed depression severity, quality-adjusted life-years (QALYs), and costs were measured. Clinicians, blinded to treatment allocation, assessed psychopathology at all time points. Data were analyzed using linear mixed models. Uncertainty intervals around cost and effect estimates were estimated with 5000 Monte Carlo simulations. RESULTS: Blended CBT treatment duration was mean 19.0 (SD 12.6) weeks versus mean 33.2 (SD 23.0) weeks in standard CBT (P<.001). No significant differences were found between groups for depressive episodes (risk difference [RD] 0.06, 95% CI -0.05 to 0.19), response to treatment (RD 0.03, 95% CI -0.10 to 0.15), and QALYs (mean difference 0.01, 95% CI -0.03 to 0.04). Mean societal costs for blended CBT were €1183 higher than standard CBT. This difference was not significant (95% CI -399 to 2765). Blended CBT had a probability of being cost-effective compared with standard CBT of 0.02 per extra QALY and 0.37 for an additional treatment response, at a ceiling ratio of €25,000. For health care providers, mean costs for blended CBT were €176 lower than standard CBT. This difference was not significant (95% CI -659 to 343). At €0 per additional unit of effect, the probability of blended CBT being cost-effective compared with standard CBT was 0.75. The probability increased to 0.88 at a ceiling ratio of €5000 for an added treatment response, and to 0.85 at €10,000 per QALY gained. For avoiding new depressive episodes, blended CBT was deemed not cost-effective compared with standard CBT because the increase in costs was associated with negative effects. CONCLUSIONS: This pilot study shows that blended CBT might be a promising way to engage depressed patients in specialized mental health care. Compared with standard CBT, blended CBT was not considered cost-effective from a societal perspective but had an acceptable probability of being cost-effective from the health care provider perspective. Results should be carefully interpreted due to the small sample size. Further research in larger replication studies focused on optimizing the clinical effects of blended CBT and its budget impact is warranted. TRIAL REGISTRATION: Netherlands Trial Register NTR4650; https://www.trialregister.nl/trial/4408. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-014-0290-z.

Development and initial evaluation of blended cognitive behavioural treatment for major depression in routine specialized mental health care.

BACKGROUND: Blended care combines face-to-face treatment with web-based components in mental health care settings. Blended treatment could potentially improve active patient participation, by letting patients work though part of the protocol autonomously. Further, blended treatment might lower the costs of mental health care, by reducing treatment duration and/or therapist contact. However, knowledge on blended care for depression is still limited. OBJECTIVES: To develop a blended cognitive behavioural treatment (bCBT) for depressed patients in an outpatient specialized mental health care centre and to conduct a preliminary evaluation of this bCBT protocol. METHOD: A bCBT protocol was developed, taking recommendations into account from depressed patients (n = 3) and therapists and experts in the field of e-health (n = 18). Next, an initial evaluation of integrated high-intensive bCBT was conducted with depressed patients (n = 9) in specialized mental health care. Patients' clinical profiles were established based on pre-treatment diagnostic information and patient self-reports on clinical measures. Patient treatment adherence rates were explored, together with patient ratings of credibility and expectancy (CEQ) before treatment, and system usability (SUS) and treatment satisfaction after treatment (CSQ-8). During and after treatment, the blended treatment protocol was evaluated in supervision sessions with the participating therapists (n = 7). RESULTS: Seven out of nine patients started bCBT, of whom five completed ≥ 90% of treatment. System usability was evaluated as being above average (range 63 to 85), and patients were mostly to very satisfied with bCBT (range 16 to 32). Patients reported improvements in depression, health-related quality of life and anxiety. We observed that therapists evaluated the highly structured blended treatment as a helpful tool in providing evidence-based treatment to this complex patient group. DISCUSSION: Although no conclusions can be drawn based on the current study, our observations suggest that a blended CBT approach might shorten treatment duration and has the potential to be a valuable treatment option for patients with severe depression in specialized mental health care settings. Further exploration of the effectiveness of our bCBT protocol by means of a randomized controlled trial is warranted.

Cost-effectiveness of blended vs. face-to-face cognitive behavioural therapy for severe anxiety disorders: study protocol of a randomized controlled trial.

BACKGROUND: Anxiety disorders are among the most prevalent psychiatric conditions, and are associated with poor quality of life and substantial economic burden. Cognitive behavioural therapy is an effective treatment to reduce anxiety symptoms, but is also costly and labour intensive. Cost-effectiveness could possibly be improved by delivering cognitive behavioural therapy in a blended format, where face-to-face sessions are partially replaced by online sessions. The aim of this trial is to determine the cost-effectiveness of blended cognitive behavioural therapy for adults with anxiety disorders, i.e. panic disorder, social phobia or generalized anxiety disorder, in specialized mental health care settings compared to face-to-face cognitive behavioural therapy. In this paper, we present the study protocol. It is hypothesized that blended cognitive behavioural therapy for anxiety disorders is clinically as effective as face-to-face cognitive behavioural therapy, but that intervention costs may be reduced. We thus hypothesize that blended cognitive behavioural therapy is more cost-effective than face-to-face cognitive behavioural therapy. METHODS/DESIGN: In a randomised controlled equivalence trial 156 patients will be included (n = 78 in blended cognitive behavioural therapy, n = 78 in face-to-face cognitive behavioural therapy) based on a power of 0.80, calculated by using a formula to estimate the power of a cost-effectiveness analysis: [Formula: see text]. Measurements will take place at baseline, midway treatment (7 weeks), immediately after treatment (15 weeks) and 12-month follow-up. At baseline a diagnostic interview will be administered. Primary clinical outcomes are changes in anxiety symptom severity as measured with the Beck Anxiety Inventory. An incremental cost-effectiveness ratio will be calculated to obtain the costs per quality-adjusted life years (QALYs) measured by the EQ-5D (5-level version). Health-economic outcomes will be explored from a societal and health care perspective. DISCUSSION: This trial will be one of the first to provide information on the cost-effectiveness of blended cognitive behavioural therapy for anxiety disorders in routine specialized mental health care settings, both from a societal and a health care perspective. TRIAL REGISTRATION: Netherlands Trial Register NTR4912. Registered 13 November 2014.

Blending online therapy into regular face-to-face therapy for depression: content, ratio and preconditions according to patients and therapists using a Delphi study.

BACKGROUND: Blending online modules into face-to-face therapy offers perspectives to enhance patient self-management and to increase the (cost-)effectiveness of therapy, while still providing the support patients need. The aim of this study was to outline optimal usage of blended care for depression, according to patients and therapists. METHODS: A Delphi method was used to find consensus on suitable blended protocols (content, sequence and ratio). Phase 1 was an explorative phase, conducted in two rounds of online questionnaires, in which patients' and therapists' preferences and opinions about online psychotherapy were surveyed. In phase 2, data from phase 1 was used in face-to-face interviews with therapists to investigate how blended therapy protocols could be set up and what essential preconditions would be. RESULTS: Twelve therapists and nine patients completed the surveys. Blended therapy was positively perceived among all respondents, especially to enhance the self-management of patients. According to most respondents, practical therapy components (assignments, diaries and psycho-education) may be provided via online modules, while process-related components (introduction, evaluation and discussing thoughts and feelings), should be supported face-to-face. The preferred blend of online and face-to-face sessions differs between therapists and patients; most therapists prefer 75% face-to-face sessions, most patients 50 to 60%. The interviews showed that tailoring treatment to individual patients is essential in secondary mental health care, due to the complexity of their problems. The amount and ratio of online modules needs to be adjusted according to the patient's problems, skills and characteristics. Therapists themselves should also develop skills to integrate online and face-to-face sessions. CONCLUSIONS: Blending online and face-to-face sessions in an integrated depression therapy is viewed as a positive innovation by patients and therapists. Following a standard blended protocol, however, would be difficult in secondary mental health care. A database of online modules could provide flexibility to tailor treatment to individual patients, which asks motivation and skills of both patients and therapists. Further research is necessary to determine the (cost-)effectiveness of blended care, but this study provides starting points and preconditions to blend online and face-to-face sessions and create a treatment combining the best of both worlds.

Blended vs. face-to-face cognitive behavioural treatment for major depression in specialized mental health care: study protocol of a randomized controlled cost-effectiveness trial.

BACKGROUND: Depression is a prevalent disorder, associated with a high disease burden and substantial societal, economic and personal costs. Cognitive behavioural treatment has been shown to provide adequate treatment for depression. By offering this treatment in a blended format, in which online and face-to-face treatment are combined, it might be possible to reduce the number of costly face-to-face sessions required to deliver the treatment protocol. This could improve the cost-effectiveness of treatment, while maintaining clinical effects. This protocol describes the design of a pilot study for the evaluation of the feasibility, acceptability and cost-effectiveness of blended cognitive behavioural therapy for patients with major depressive disorder in specialized outpatient mental health care. METHODS/DESIGN: In a randomized controlled trial design, adult patients with major depressive disorder are allocated to either blended cognitive behavioural treatment or traditional face-to-face cognitive behavioural treatment (treatment as usual). We aim to recruit one hundred and fifty patients. Blended treatment will consist of ten face-to-face and nine online sessions provided alternately on a weekly basis. Traditional cognitive behavioural treatment will consist of twenty weekly sessions. Costs and effects are measured at baseline and after 10, 20 and 30 weeks. Evaluations are directed at cost-effectiveness (with depression severity and diagnostic status as outcomes), and cost-utility (with costs per quality adjusted life year, QALY, as outcome). Costs will encompass health care uptake costs and productivity losses due to absence from work and lower levels of efficiency while at work. Other measures of interest are mastery, working alliance, treatment preference at baseline, depressive cognitions, treatment satisfaction and system usability. DISCUSSION: The results of this pilot study will provide an initial insight into the feasibility and acceptability of blended cognitive behavioural treatment in terms of clinical and economic outcomes (proof of concept) in routine specialized mental health care settings, and an indication as to whether a well-powered clinical trial of blended cognitive behavioural treatment for depression in routine practice would be advisable. This will be determined based on the perspective of various stakeholders including patients, mental health service providers and health insurers. Strengths and limitations of the study are discussed. TRIAL REGISTRATION: Netherlands Trial Register NTR4650 . Registered 18 June 2014.

Short-term effectiveness of an online behavioral training in migraine self-management: a randomized controlled trial.

Behavioral training (BT) is recommended as a supplementary preventive treatment for migraine. Online interventions have been successful in promoting health behavior change, the evidence for online BT in migraine is limited, however. This randomized controlled trial aimed to determine the post-treatment effectiveness of online BT (n = 195) compared to a waitlist control group (WLC; n = 173) on migraine attack frequency (primary outcome), headache self-efficacy and locus of control (secondary outcomes). BT aims to counteract attacks in the prodromal stage through early detection of prodromal features and self-management via physical relaxation and cognitive behavioral regulation, and was offered with minimal e-mail support in eight online lessons. Results showed that 120 (62%) participants completed BT. A decrease of 20-25% in migraine attack frequency was found in both conditions without a between-group difference (ES = 0.02, p = .71). BT participants improved more than WLC participants on migraine related self-efficacy (ES = 0.86, p < .001), developed more internal (ES = 0.57, p < .001), and less external control (ES = 0.78, p < .001). To conclude, results at post-training did not corroborate that improvements in migraine attack frequency were due to online BT, the waitlist control group improved accordingly. However, positive effects of BT on self-efficacy and locus of control were established. We have to await the long term effects to see if improvements in psychological variables translate to a reduction in migraine headache.