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Efficacy and cost-effectiveness of a blended cognitive behavioral therapy for depression in Spanish primary health care: study protocol for a randomised non-inferiority trial.

ABSTRACT: BACKGROUND:Data from primary health care in Spain show a high prevalence of the major depressive disorder. Blended treatment (combination of face-to-face and online components) seems to be a very promising tool for the optimization and dissemination of psychological treatments in a cost-effective form. Although there is growing data that confirm the advantages of blended therapies, few studies have analyzed their application in regular clinical practice. The objective of the present paper is to describe the protocol for a clinical study aimed at exploring the clinical and cost-effectiveness of a blended cognitive behavioral therapy (b-CBT) for depression, compared to treatment as usual (TAU) in a primary health care setting. METHODS:A two-arm randomised controlled non-inferiority trial will be carried out, with repeated measures (baseline, 3 months, 6 months, and 12 months) under two conditions: b-CBT and TAU. The b-CBT program will consist in three face-to-face sessions and eight online sessions. The TAU is defined as the routine care delivered by the general practitioner for the treatment of depression in primary care. The primary outcome is a symptomatic change of depressive symptoms on the patient-health questionnaire (PHQ-9). Other secondary outcomes will be considered (e.g., quality of life, treatment preference). All participants must be 18 years of age or older and meet the diagnostic criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental disorders 4th edition. 156 participants will be recruited (78 per arm). DISCUSSION:It is expected that b-CBT is clinically non-inferior when compared to TAU. This is the first study in Spain to use a b-CBT format in primary and specialized care, and this format could be an efficacious and cost-effective therapeutic strategy for the treatment of depression. TRIAL REGISTRATION:ClinicalTrials.gov NCT02361684. Registered on 8 January 2015. Currently recruiting participants.

SUBMITTER: Vara MD

PROVIDER: S-EPMC5865366 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Efficacy and cost-effectiveness of a blended cognitive behavioral therapy for depression in Spanish primary health care: study protocol for a randomised non-inferiority trial.

Vara Mª Dolores MD Herrero Rocío R Etchemendy Ernestina E Espinoza Macarena M Baños Rosa Mª RM García-Palacios Azucena A Lera Guillem G Folch Blanca B Palop-Larrea Vicente V Vázquez Pilar P Franco-Martín Manuel M Kleiboer Annet A Riper Heleen H Botella Cristina C

BMC psychiatry 20180323 1

<h4>Background</h4>Data from primary health care in Spain show a high prevalence of the major depressive disorder. Blended treatment (combination of face-to-face and online components) seems to be a very promising tool for the optimization and dissemination of psychological treatments in a cost-effective form. Although there is growing data that confirm the advantages of blended therapies, few studies have analyzed their application in regular clinical practice. The objective of the present pape ...[more]

PMID: 29566656

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Project description:BackgroundMajor depressive disorder is a chronic condition; its prevalence is expected to grow with the aging trend of high-income countries. Internet-based cognitive-behavioral therapy has proven efficacy in treating major depressive disorder.ObjectiveThe objective of this study was to assess the cost-effectiveness of implementing a community internet-based cognitive behavioral therapy intervention (Super@, the Spanish program for the MasterMind project) for treating major depressive disorder.MethodsThe cost-effectiveness of the Super@ program was assessed with the Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing tool, using a 3-state Markov model. Data from the cost and effectiveness of the intervention were prospectively collected from the implementation of the program by a health care provider in Badalona, Spain; the corresponding data for usual care were gathered from the literature. The health states, transition probabilities, and utilities were computed using Patient Health Questionnaire-9 scores.ResultsThe analysis was performed using data from 229 participants using the Super@ program. Results showed that the intervention was more costly than usual care; the discounted (3%) and nondiscounted incremental cost-effectiveness ratios were €29,367 and €26,484 per quality-adjusted life-year, respectively (approximately US $35,299 and $31,833, respectively). The intervention was cost-effective based on the €30,000 willingness-to-pay threshold typically applied in Spain (equivalent to approximately $36,060). According to the deterministic sensitivity analyses, the potential reduction of costs associated with intervention scale-up would reduce the incremental cost-effectiveness ratio of the intervention, although it remained more costly than usual care. A discount in the incremental effects up to 5% exceeded the willingness-to-pay threshold of €30,000.ConclusionsThe Super@ program, an internet-based cognitive behavioral therapy intervention for treating major depressive disorder, cost more than treatment as usual. Nevertheless, its implementation in Spain would be cost-effective from health care and societal perspectives, given the willingness-to-pay threshold of €30,000 compared with treatment as usual.

Project description:BackgroundInternet-based cognitive behavioral therapy (iCBT) has been demonstrated to be cost- and clinically effective. There is a need, however, for increased therapist contact for some patient groups. Combining iCBT with traditional face-to-face (FtF) consultations in a blended format may produce a new treatment format (B-CBT) with multiple benefits from both traditional CBT and iCBT, such as individual adaptation, lower costs than traditional therapy, wide geographical and temporal availability, and possibly lower threshold to implementation.ObjectiveThe primary aim of this study is to compare directly the clinical effectiveness of B-CBT with FtF-CBT for adult major depressive disorder.MethodsA 2-arm randomized controlled noninferiority trial compared B-CBT for adult depression with treatment as usual (TAU). The trial was researcher blinded (unblinded for participants and clinicians). B-CBT comprised 6 sessions of FtF-CBT alternated with 6-8 web-based CBT self-help modules. TAU comprised 12 sessions of FtF-CBT. All participants were aged 18 or older and met the diagnostic criteria for major depressive disorder and were recruited via a national iCBT clinic. The primary outcome was change in depression severity on the 9-item Patient Health Questionnaire (PHQ-9). Secondary analyses included client satisfaction (8-item Client Satisfaction Questionnaire [CSQ-8]), patient expectancy (Credibility and Expectancy Questionnaire [CEQ]), and working (Working Alliance Inventory [WAI] and Technical Alliance Inventory [TAI]). The primary outcome was analyzed by a mixed effects model including all available data from baseline, weekly measures, 3-, 6, and 12-month follow-up.ResultsA total of 76 individuals were randomized, with 38 allocated to each treatment group. Age ranged from 18 to 71 years (SD 13.96) with 56 (74%) females. Attrition rate was 20% (n=15), which was less in the FtF-CBT group (n=6, 16%) than in the B-CBT group (n=9, 24%). As many as 53 (70%) completed 9 or more sessions almost equally distributed between the groups (nFtF-CBT=27, 71%; nB-CBT=26, 68%). PHQ-9 reduced 11.38 points in the FtF-CBT group and 8.10 in the B-CBT group. At 6 months, the mean difference was a mere 0.17 points. The primary analyses confirmed large and significant within-group reductions in both groups (FtF-CBT: β=-.03; standard error [SE] 0.00; P<.001 and B-CBT: β=-.02; SE 0.00; P<.001). A small but significant interaction effect was observed between groups (β=.01; SE 0.00; P=.03). Employment status influenced the outcome differently between groups, where the B-CBT group was seen to profit more from not being full-time employed than the FtF group.ConclusionsWith large within-group effects in both treatment arms, the study demonstrated feasibility of B-CBT in Denmark. At 6 months' follow-up, there appeared to be no difference between the 2 treatment formats, with a small but nonsignificant difference at 12 months. The study seems to demonstrate that B-CBT is capable of producing treatment effects that are close to FtF-CBT and that completion rates and satisfaction rates were comparable between groups. However, the study was limited by small sample size and should be interpreted with caution.Trial registrationClinicalTrials.gov NCT02796573; https://clinicaltrials.gov/ct2/show/NCT02796573.International registered report identifier (irrid)RR2-10.1186/s12888-016-1140-y.

Project description:BackgroundCognitive 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.ObjectiveThis 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.MethodsPatients 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.ResultsBlended 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.ConclusionsThis 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 registrationNetherlands Trial Register NTR4650; https://www.trialregister.nl/trial/4408.International registered report identifier (irrid)RR2-10.1186/s12888-014-0290-z.

Project description:BackgroundCognitive behavioral therapy (CBT) is an effective intervention to treat depressive disorders in youth. However, 50% of adolescents still have depressive symptoms after treatment, and 57% drop out during treatment. Online CBT interventions have proven to be effective in reducing depressive symptoms and seem promising as a treatment for depressed adolescents. However, combining online programs with face-to-face sessions seems necessary to increase their effectiveness and monitor for suicide risk.ObjectiveIn this study, we examine the effectiveness and cost-effectiveness of a blended CBT treatment protocol, a mixture of online and face-to-face CBT, as a treatment for clinically depressed adolescents.MethodsA pragmatic quasi-experimental controlled trial will be conducted to study the effectiveness of a blended CBT treatment protocol, in which blended CBT is compared with face-to-face CBT (n=44) and treatment as usual (n=44); the latter two were collected in a previous randomized controlled trial. The same inclusion and exclusion criteria will be used: adolescents aged between 12 and 21 years, with a clinical diagnosis of a depressive disorder, and referred to one of the participating mental health institutions. Assessments will be conducted at the same time points: before the start of the intervention, during the intervention (after 5 and 10 weeks), postintervention, and at 6- and 12-month follow-ups.ResultsThe primary outcome is the presence of a depression diagnosis at 12-month follow-up. Several secondary outcomes will be measured, such as depressive symptoms, quality of life, and suicide risk. Costs and effects in both conditions will be compared to analyze cost-effectiveness. Further, moderating (age, gender, alcohol and drug use, parental depression, and other psychopathology) and mediating effects (negative automatic thoughts, cognitive emotion regulation, attributional style) will be analyzed. Also, treatment characteristics will be studied, such as characteristics of the therapists, treatment expectancy, and therapeutic alliance. Dropout rates and treatment characteristics will be measured to study the feasibility of blended CBT.ConclusionsThis study will examine the effectiveness and cost-effectiveness of a blended CBT program in which depressed adolescents are treated in mental health care. Results of blended CBT will be compared with face-to-face CBT and treatment as usual, and implications for implementation will be reviewed.Trial registrationDutch Trial Register (NTR6759); http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6759.International registered report identifier (irrid)DERR1-10.2196/13434 RR1-10.2196/12654.

Project description:BackgroundDepression is a common, debilitating, and costly disorder. Many patients request psychological therapy, but the best-evidenced therapy-cognitive behavioural therapy (CBT)-is complex and costly. A simpler therapy-behavioural activation (BA)-might be as effective and cheaper than is CBT. We aimed to establish the clinical efficacy and cost-effectiveness of BA compared with CBT for adults with depression.MethodsIn this randomised, controlled, non-inferiority trial, we recruited adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder from primary care and psychological therapy services in Devon, Durham, and Leeds (UK). We excluded people who were receiving psychological therapy, were alcohol or drug dependent, were acutely suicidal or had attempted suicide in the previous 2 months, or were cognitively impaired, or who had bipolar disorder or psychosis or psychotic symptoms. We randomly assigned participants (1:1) remotely using computer-generated allocation (minimisation used; stratified by depression severity [Patient Health Questionnaire 9 (PHQ-9) score of <19 vs ≥19], antidepressant use, and recruitment site) to BA from junior mental health workers or CBT from psychological therapists. Randomisation done at the Peninsula Clinical Trials Unit was concealed from investigators. Treatment was given open label, but outcome assessors were masked. The primary outcome was depression symptoms according to the PHQ-9 at 12 months. We analysed all those who were randomly allocated and had complete data (modified intention to treat [mITT]) and also all those who were randomly allocated, had complete data, and received at least eight treatment sessions (per protocol [PP]). We analysed safety in the mITT population. The non-inferiority margin was 1·9 PHQ-9 points. This trial is registered with the ISCRTN registry, number ISRCTN27473954.FindingsBetween Sept 26, 2012, and April 3, 2014, we randomly allocated 221 (50%) participants to BA and 219 (50%) to CBT. 175 (79%) participants were assessable for the primary outcome in the mITT population in the BA group compared with 189 (86%) in the CBT group, whereas 135 (61%) were assessable in the PP population in the BA group compared with 151 (69%) in the CBT group. BA was non-inferior to CBT (mITT: CBT 8·4 PHQ-9 points [SD 7·5], BA 8·4 PHQ-9 points [7·0], mean difference 0·1 PHQ-9 points [95% CI -1·3 to 1·5], p=0·89; PP: CBT 7·9 PHQ-9 points [7·3]; BA 7·8 [6·5], mean difference 0·0 PHQ-9 points [-1·5 to 1·6], p=0·99). Two (1%) non-trial-related deaths (one [1%] multidrug toxicity in the BA group and one [1%] cancer in the CBT group) and 15 depression-related, but not treatment-related, serious adverse events (three in the BA group and 12 in the CBT group) occurred in three [2%] participants in the BA group (two [1%] patients who overdosed and one [1%] who self-harmed) and eight (4%) participants in the CBT group (seven [4%] who overdosed and one [1%] who self-harmed).InterpretationWe found that BA, a simpler psychological treatment than CBT, can be delivered by junior mental health workers with less intensive and costly training, with no lesser effect than CBT. Effective psychological therapy for depression can be delivered without the need for costly and highly trained professionals.FundingNational Institute for Health Research.

Project description:BACKGROUND:Depression is a common and serious problem among adolescents, but few seek or have access to therapy. Internet-delivered cognitive behavioral therapies (ICBTs), developed to increase treatment access, show promise in reducing depression. The inclusion of coach support in treatment is desired and may be needed. OBJECTIVE:The aim of this study was to determine the efficacy of an ICBT protocol blended with weekly real-time therapist sessions via chat; blended treatment, for adolescent depression, including major depressive episode (MDE). The protocol has previously been evaluated in a controlled study. METHODS:In a two-arm randomized controlled trial, adolescents 15 to 19 years of age were recruited through a community setting at the national level in Sweden (n=70) and allocated to either 8 weeks of treatment or to minimal attention control. Depression was assessed at baseline, at posttreatment, and at 12 months following treatment (in the intervention group). The primary outcome was self-reported depression level as measured with the Beck Depression Inventory II at posttreatment. The intervention was offered without the need for parental consent. RESULTS:Over two weeks, 162 adolescents registered and completed the baseline screening. Eligible participants (n=70) were on average 17.5 years of age (SD 1.15), female (96%, 67/70), suffered from MDE (76%, 53/70), had no previous treatment experience (64%, 45/70), and reported guardian(s) to be aware about their depression state (71%, 50/70). The average intervention completion was 74% (11.8 of 16 modules and sessions). Following the treatment, ICBT participants demonstrated a significant decrease in depression symptoms compared with controls (P<.001), corresponding to a large between-group effect (intention-to-treat analysis: d=0.86, 95% CI 0.37-1.35; of completer analysis: d=0.99, 95% CI 0.48-1.51). A significant between-group effect was observed in the secondary depression outcome (P=.003); clinically significant improvement was found in 46% (16/35) of ICBT participants compared with 11% (4/35) in the control group (P=.001). CONCLUSIONS:The results are in line with our previous study, further demonstrating that adolescents with depression can successfully be engaged in and experience significant improvement following ICBT blended with therapist chat sessions. Findings on participants' age and baseline depression severity are of interest in relation to used study methods. TRIAL REGISTRATION:ClinicalTrials.gov NCT02363205; https://clinicaltrials.gov/ct2/show/NCT02363205.

Project description:BackgroundBlended cognitive behavioral therapy (bCBT)-the combination of digital elements and face-to-face psychotherapy-has been proposed to alleviate challenges that patients and therapists face in conventional cognitive behavioral therapy. There is growing evidence that adding digital elements to face-to-face psychotherapy can contribute to better treatment outcomes. However, bCBT programs still show considerable shortcomings, and knowledge on how to improve digital apps using a bCBT protocol is limited.ObjectiveThis study aimed to inductively identify functions and qualities that are expected from a bCBT treatment for depression in the eyes of patients and psychotherapists who were not currently receiving or practicing bCBT treatment.MethodsWe used a qualitative exploratory study design and conducted 3 focus group interviews (n=6 in each) and 5 semistructured in-depth interviews with therapists as well as 11 individual interviews with patients with a primary diagnosis of depression and currently undergoing cognitive behavioral therapy treatment in Germany. Themes and categories were established inductively from transcribed interview records based on a rigorous coding method.ResultsBoth therapists and patients expected a digital app to provide patients with the opportunity to track their mood, work on therapeutic homework activities, easily access an intervention set for harder moments, and efficiently facilitate administrative tasks. The desire to be able to customize bCBT protocols to individual patient circumstances was evident in both patient and therapist interviews. Patients differed with respect to what content and the amount of material the app should focus on as well as the method of recording experiences. Therapists viewed digital apps as potentially aiding in their documentation work outside of sessions. Different attitudes surfaced on the topic of data security, with patients not as concerned as therapists.ConclusionsBoth patients and therapists had substantially positive attitudes toward the option of an integrated bCBT treatment. Our study presents novel findings on the expectations and attitudes of patients and therapists.

Project description:BACKGROUND:Internet based cognitive behavioural therapy (iCBT) has been demonstrated to be cost- and clinically effective. There is a need, however, for increased therapist contact for some patient groups. Combining iCBT with traditional face-to-face (ftf) consultations in a blended format (B-CBT) may produce a new treatment format with multiple benefits from both traditional CBT and iCBT such as individual adaptation, lower costs than traditional therapy, wide geographical and temporal availability, and possibly lower threshold to implementation. The primary aim of the present study is to compare directly the clinical effectiveness of B-CBT with face-to-face CBT for adult major depressive disorder. METHODS/DESIGN:The study is designed as a two arm randomised controlled non-inferiority trial comparing blended CBT for adult depression with treatment as usual (TAU). In the blended condition six sessions of ftf CBT is alternated with six to eight online modules (NoDep). TAU is defined as 12 sessions of ftf CBT. The primary outcome is symptomatic change of depressive symptoms on the patient-health questionnaire (PHQ-9). Additionally, the study will include an economic evaluation. All participants must be 18 years of age or older and meet the diagnostic criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental disorders 4th edition. Participants are randomised on an individual level by a researcher not involved in the project. The primary outcome is analysed by regressing the three-month follow-up PHQ-9 data on the baseline PHQ-9 score and a treatment group indicator using ancova. A sample size of 130 in two balanced groups will yield a power of at least 80% to detect standardised mean differences above 0.5 on a normally distributed variable. DISCUSSION:This study design will compare B-CBT and ftf CBT in a concise and direct manner with only a minimal of the variance explained by differences in therapeutic content. On the other hand, while situated in routine care, ecological validity is somewhat compromised by the controlled manner in which the study is conducted. TRIAL REGISTRATION:ClinicalTrials.gov NCT02796573 . Registered June 1st 2016. Currently recruiting participants.

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Efficacy and cost-effectiveness of a blended cognitive behavioral therapy for depression in Spanish primary health care: study protocol for a randomised non-inferiority trial.

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Efficacy and cost-effectiveness of a blended cognitive behavioral therapy for depression in Spanish primary health care: study protocol for a randomised non-inferiority trial.

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