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Blended CBT versus face-to-face CBT: a randomised non-inferiority trial.

ABSTRACT: 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.

SUBMITTER: Mathiasen K

PROVIDER: S-EPMC5139089 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Blended CBT versus face-to-face CBT: a randomised non-inferiority trial.

Mathiasen Kim K Andersen Tonny E TE Riper Heleen H Kleiboer Annet A M AA Roessler Kirsten K KK

BMC psychiatry 20161205 1

<h4>Background</h4>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 ...[more]

PMID: 27919234

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Project description:Conventional face-to-face weight loss and weight control programs are very labor intensive for both the patient and the provider. It is unclear to what extent conventional programs can be (partially) completed by mobile health (mHealth) apps.The aim of this study was to compare the effectiveness of different weight loss programs using a combination of conventional and mobile programs among adults who are overweight (body mass index [BMI]>29 kg/m²).A single-blinded randomized controlled trial among obese adults was performed from September 2015 to March 2016. The study took place in Leuven, Belgium. Of the 102 eligible (BMI >29 kg/m²) adults, 81 (79%) completed the study. The three intervention groups consisted of a conventional face-to-face weight loss program, a weight loss app program (app group), and a partial face-to-face and partial app program (combi group). All intervention groups received the same advice from a dietician and a physical activity coach during a 12-week period. The control group did not receive any information during the same period. Primary outcomes were weight reduction (5% decrease of baseline weight in kg), BMI, metabolic risk factors, dietary pattern, and physical activity.Significant more participants in all three intervention groups lost at least 5% or more of their weight at baseline compared with the control group. No significant difference was found between the combi group and the conventional group. A trend was found that more participants in the combi group lost 5% or more compared with the app group (19%), P=.06. A significant time x group effect was found for BMI and metabolic risk factors, with the control group having the worst results and the combi group being significantly better with regard to BMI compared with the app group. No significant group x time effects were found for the intake of different food and drinks and moderate to vigorous physical activity (MVPA).The results of this study show that a conventional weight loss program could partially be completed with an mHealth program without affecting the effectiveness.Clinicaltrials.gov NCT02595671; https://clinicaltrials.gov/ct2/show/NCT02595671 (Archived by WebCite at http://www.webcitation.org/6w1H0x1Q6).

Project description:INTRODUCTION:Expert guidelines recommend cognitive-behavioural therapy (CBT) as a first-line treatment for obsessive-compulsive disorder (OCD), but the majority of patients with OCD do not have access to CBT. Internet-delivered CBT (ICBT) has the potential to make this evidence-based treatment more accessible while requiring less therapist time than traditional face-to-face (f2f) CBT. Data from six clinical trials suggest that ICBT for OCD is both efficacious and cost-effective, but whether ICBT is non-inferior to traditional f2f CBT for OCD is yet unknown. METHODS AND ANALYSIS:A single-blind, randomised, controlled, non-inferiority trial comparing therapist-guided ICBT, unguided ICBT and individual (f2f) CBT for adult OCD patients. The primary objective is to investigate whether ICBT is non-inferior to gold standard f2f CBT. Secondary objectives are to investigate if ICBT is equally effective when delivered unguided, to establish the cost-effectiveness of ICBT and to investigate if the treatment outcome differs between self-referred and clinically referred patients. Participants will be recruited at two specialist OCD clinics in Stockholm and also through online self-referral. Participants will be randomised to one of three treatment conditions: F2f CBT, ICBT with therapist support or unguided ICBT. The total number of participants will be 120, and masked assessments will be administered at baseline, biweekly during treatment, at post-treatment and at 3-month and 12-month follow-ups. The main outcome measure is the clinician-rated Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at 3-month follow-up. The margin of non-inferiority is set to 3 points on the Y-BOCS using a 90% CI. ETHICS AND DISSEMINATION:The study has been approved by the Regional Ethics Board of Stockholm (REPN 2015/1099-31/2) and registered at Clinicaltrials.gov (NCT02541968). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media. TRIAL REGISTRATION NUMBER:NCT02541968; Pre-results.

Project description:Background and aimsMost people with alcohol use disorder (AUD) are never treated. Internet-based interventions are effective in reducing alcohol consumption and could help to overcome some of the barriers to people not seeking or receiving treatment. The aim of the current study was to compare internet-delivered and face-to-face treatment among adult users with AUD.DesignRandomized controlled non-inferiority trial with a parallel design, comparing internet-delivered cognitive-behavioural therapy (ICBT) (n = 150) with face-to-face CBT (n = 151), at 3- and 6-month follow-ups.SettingA specialized clinic for people with AUD in Stockholm, Sweden. Participants were recruited between 8 December 2015 and 5 January 2018.ParticipantsA total of 301 patients [mean age 50 years, standard deviation (SD) = 12.3] with AUD, of whom 115 (38%) were female and 186 (62%) were male.Intervention and comparatorParticipants were randomized in blocks of 20 at a ratio of 1 : 1 to five modules of therapist-guided ICBT or to five modules of face-to-face CBT, delivered over a 3-month period. The same treatment material and the same therapists were used in both groups.MeasurementsThe primary outcome was standard drinks of alcohol consumed during the previous week at 6-month follow-up, analysed according to intention-to-treat. The pre-specified non-inferiority limit was five standard drinks of alcohol and d = 0.32 for secondary outcomes.ResultsThe difference in alcohol consumption between the internet and the face-to-face group was non-inferior in the intention-to-treat analysis of data from the 6-month follow-up [internet = 12.33 and face-to-face = 11.43, difference = 0.89, 95% confidence interval (CI) = -1.10 to 2.88]. The secondary outcome, Alcohol Use Disorder Identification Test score, failed to show non-inferiority of internet compared with face-to-face in the intention-to-treat analysis at 6-month follow-up (internet = 12.26 and face-to-face = 11.57, d = 0.11, 95% CI = -0.11 to 0.34).ConclusionsInternet-delivered treatment was non-inferior to face-to-face treatment in reducing alcohol consumption among help-seeking patients with alcohol use disorder but failed to show non-inferiority on some secondary outcomes.

Project description:BackgroundAnxiety disorders are highly prevalent and cause substantial economic burden. Blended cognitive-behavioural therapy (bCBT), which integrates Internet-based CBT and face-to-face CBT (ftfCBT), is an attractive and potentially cost-saving treatment alternative to conventional CBT for patients with anxiety disorders in specialised mental health care. However, little is known about the effectiveness of bCBT in routine care. We examined the acceptability, effectiveness and cost-effectiveness of bCBT versus ftfCBT in outpatient specialised care to patients with panic disorder, social anxiety disorder and generalised anxiety disorder.Methods and findingsPatients with anxiety disorders were randomised to bCBT (n = 52) or ftfCBT (n = 62). Acceptability of bCBT and ftfCBT were evaluated by assessing treatment preference, adherence, satisfaction and therapeutic alliance. Costs and effects were assessed at post-treatment and one-year follow-up. Primary outcome measure was the Beck Anxiety Inventory (BAI). Secondary outcomes were depressive symptoms, general psychopathology, work and social adjustment, quality of life and mastery. Incremental cost-effectiveness ratios (ICERs) were computed from societal and healthcare perspectives by calculating the incremental costs per incremental quality-adjusted life year (QALY). No significant differences between bCBT and ftfCBT were found on acceptability or effectiveness measures at post-treatment (Cohen's d between-group effect size on BAI = 0.15, 95% CI -0.30 to 0.60) or at one-year follow-up (d = -0.38, 95% CI -0.84 to 0.09). The modelled point estimates of societal costs (bCBT €10945, ftfCBT €10937) were higher and modelled point estimates of direct medical costs (bCBT €3748, ftfCBT €3841) were lower in bCBT. The acceptability curves showed that bCBT was expected to be a cost-effective intervention. Results should be carefully interpreted due to the small sample size.ConclusionsbCBT appears an acceptable, clinically effective and potentially cost-saving alternative option for treating patients with anxiety disorders. Trials with larger samples are needed to further investigate cost-effectiveness.Trial registrationNetherlands Trial Register: NTR4912.

Project description:IntroductionSpecific phobias (intense, enduring fears of an object or situation that lead to avoidance and severe distress) are highly prevalent among children and young people. Cognitive-behavioural therapy (CBT) is a well-established, effective intervention, but it can be time consuming and costly because it is routinely delivered over multiple sessions during several months. Alternative methods of treating severe and debilitating phobias in children are needed, like one-session treatment (OST), to reduce time and cost, and to prevent therapeutic drift and help children recover quickly. Our study explores whether (1) outcomes with OST are 'no worse' than outcomes with multisession CBT, (2) OST is acceptable to children, their parents and the practitioners who use it and (3) OST offers good value for money to the National Health Service (NHS) and to society.MethodA pragmatic, non-inferiority, randomised controlled trial will compare OST with multisession CBT-based therapy on their clinical and cost-effectiveness. The primary clinical outcome is a standardised behavioural task of approaching the feared stimulus at 6 months postrandomisation. The outcomes for the within-trial cost-effectiveness analysis are quality-adjusted life years based on EQ-5D-Y, and individual-level costs based of the intervention and use of health and social service care. A nested qualitative evaluation will explore children's, parents' and practitioners' perceptions and experiences of OST. A total of 286 children, 7-16 years old, with DSM-IV diagnoses of specific phobia will be recruited via gatekeepers in the NHS, schools and voluntary youth services, and via public adverts.Ethics and disseminationThe trial received ethical approval from North East and York Research Ethics Committee (Reference: 17/NE/0012). Dissemination plans include publications in peer-reviewed journals, presentations in relevant research conferences, local research symposia and seminars for children and their families, and for professionals and service managers.Trial registration numberISRCTN19883421;Pre-results.

Project description:ObjectiveTo assess whether secondary prevention, which preemptively treats women with above-average postpartum bleeding, is non-inferior to universal prophylaxis.DesignA cluster-randomised non-inferiority community trial.SettingHealth sub-centres and home deliveries in the Bijapur district of Karnataka, India.PopulationWomen with low-risk pregnancies who were eligible for delivery with an Auxiliary Nurse Midwife at home or sub-centre and who consented to be part of the study.MethodsAuxiliary Nurse Midwifes were randomised to secondary prevention using 800 mcg sublingual misoprostol administered to women with postpartum blood loss ≥350 ml or to universal prophylaxis using 600 mcg oral misoprostol administered to all women during the third stage of labour.Main outcome measuresPostpartum haemoglobin ≤7.8 g/dl, mean postpartum blood loss and postpartum haemoglobin, postpartum haemorrhage rate, transfer to higher-level facilities, acceptability and feasibility of the intervention.ResultsMisoprostol was administered to 99.7% of women as primary prevention. In secondary prevention, 92 (4.7%) women had postpartum bleeding ≥350 ml, of which 90 (97.8%) received misoprostol. The proportion of women with postpartum haemoglobin ≤7.8 g/dl was 5.9 and 8.8% in secondary and primary prevention clusters, respectively [difference -2.9%, one-sided 95% confidence interval (CI) <1.3%]. Postpartum transfer and haemorrhage rates were low (<1%) in both groups. Shivering was more common in primary prevention clusters (P = 0.013).ConclusionSecondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis based on the primary outcome of postpartum haemoglobin. Secondary prevention could be a good alternative to universal prophylaxis as it medicates fewer women and is an acceptable and feasible strategy at the community level.Tweetable abstractSecondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis.

Project description:IntroductionEmotional disorders (anxiety and depressive disorders) are a relevant public health concern associated with high prevalence, high costs, and important disability. Therefore, research priorities include designing and testing cost-effective interventions to reach everyone in need. Internet-delivered interventions for emotional disorders are effective and can help to disseminate and implement evidence-based treatments. However, although these treatments are generally effective, not all patients benefit from this treatment format equally. Blended treatments are a new form of intervention that combines the strengths of face-to-face and Internet approaches. Nevertheless, research on blended interventions has focused primarily on individual therapy, and less attention has been paid to the potential of using this format in group psychotherapy. This study aims to analyze the feasibility of blended transdiagnostic group CBT for emotional disorders. The current article describes the study protocol for this trial.Method and analysisA one-armed pilot trial will be conducted. Participants will be 30 adults suffering from DSM-5 anxiety and/or depressive disorders. The treatment consists of a blended transdiagnostic group intervention delivered during a period of 24 weeks. Groups of 6 to 10 patients will attend a total of eight 2-hour, face-to-face sessions, alternated with the use of an online platform where they will find the contents of the treatment protocol. The intervention has four core components: present-focused awareness, cognitive flexibility, identification and modification of behavioral and cognitive patterns of emotional avoidance, and interoceptive and situational exposure. These components are delivered in 16 modules. Assessments will be performed at baseline, during the treatment, at post-treatment, and at 3-month follow-up. Clinical and treatment acceptability outcomes will be included. Quantitative and qualitative data (participants' views about blended group psychotherapy) will be analyzed.Ethics and disseminationThe trial has received ethical approval from the Ethics Committee of Universitat Jaume I (September 2019) and will be conducted in accordance with the study protocol, the Declaration of Helsinki, and good clinical practice. The results of this study will be disseminated by presentation at conferences and will be submitted for publication in a peer-reviewed journal.Trial registrationClinicalTrials.gov Identifier: NCT04008576. Registered 05 July 2019, https://clinicaltrials.gov/ct2/show/NCT04008576.

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Blended CBT versus face-to-face CBT: a randomised non-inferiority trial.

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Blended CBT versus face-to-face CBT: a randomised non-inferiority trial.

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