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Study protocol for a single-blind, randomised controlled, non-inferiority trial of internet-based versus face-to-face cognitive behaviour therapy for obsessive-compulsive disorder.

ABSTRACT: 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.

SUBMITTER: Ruck C

PROVIDER: S-EPMC6129083 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Study protocol for a single-blind, randomised controlled, non-inferiority trial of internet-based versus face-to-face cognitive behaviour therapy for obsessive-compulsive disorder.

Rück Christian C Lundström Lina L Flygare Oskar O Enander Jesper J Bottai Matteo M Mataix-Cols David D Andersson Erik E

BMJ open 20180905 9

<h4>Introduction</h4>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 whet ...[more]

PMID: 30185575

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Project description:OBJECTIVES:To evaluate the cost-effectiveness of a therapist-guided internet-delivered cognitive behaviour therapy (ICBT) intervention for adolescents with obsessive-compulsive disorder (OCD) compared with untreated patients on a waitlist. DESIGN:Single-blinded randomised controlled trial. SETTING:A research clinic within the regular child and adolescent mental health service in Stockholm, Sweden. PARTICIPANTS:Sixty-seven adolescents (12-17?years) with a Diagnostic and Statistical Manual of Mental Disorders Fifth Edition diagnosis of OCD. INTERVENTIONS:Either a 12-week, therapist-guided ICBT intervention or a wait list condition of equal duration. PRIMARY OUTCOME MEASURES:Cost data were collected at baseline and after treatment, including healthcare use, supportive resources, prescription drugs, prescription-free drugs, school absence and productivity loss, as well as the cost of ICBT. Health outcomes were defined as treatment responder rate and quality-adjusted life years gain. Bootstrapped mixed model analyses were conducted comparing incremental costs and health outcomes between the groups from the societal and healthcare perspectives. RESULTS:Compared with waitlist control, ICBT generated substantial societal cost savings averaging US$-144.98 (95%?CI -159.79 to -130.16) per patient. The cost reductions were mainly driven by reduced healthcare use in the ICBT group. From the societal perspective, the probability of ICBT being cost saving compared with waitlist control was approximately 60%. From the healthcare perspective, the cost per additional responder to ICBT compared with waitlist control was approximately US$78. CONCLUSIONS:The results suggest that therapist-guided ICBT is a cost-effective treatment and results in societal cost savings, compared with patients who do not receive evidence-based treatment. Since, at present, most patients with OCD do not have access to evidence-based treatments, the results have important implications for the increasingly strained national and healthcare budgets. Future studies should compare the cost-effectiveness of ICBT with regular face-to-face CBT. TRIAL REGISTRATION NUMBER:NCT02191631.

Project description:Importance:Internet-delivered cognitive behavior therapy is an effective treatment for children and adolescents with obsessive-compulsive disorder and has the potential to markedly increase access to treatment for patients while being cost-effective for health care organizations. Objective:To investigate whether internet-delivered cognitive behavior therapy implemented within a stepped care model is noninferior to, and cost-effective compared with, the gold standard of face-to-face cognitive behavior therapy for pediatric obsessive-compulsive disorder. Design, Setting, and Participants:Multicenter, single-blind, randomized clinical noninferiority trial implemented at 2 specialist pediatric obsessive-compulsive disorder clinics in Stockholm and Gothenburg, Sweden. Participants are 152 children and adolescents aged 7 to 17 years with obsessive compulsive disorder, recruited through the 2 clinics and online self-referral. Patients will be randomized 1:1 to the stepped care intervention or face-to-face therapy. Blind evaluations will be conducted after treatment and at 3-month and 6-month follow-ups. At the 6-month follow-up (primary end point), noninferiority will be tested and resource use will be compared between the 2 treatment groups. Data will be analyzed according to intention-to-treat principles. Intervention:Patients randomized to stepped care will first receive internet-delivered cognitive behavior therapy for 16 weeks; patients who are classified as nonresponders 3 months after treatment completion will receive additional face-to-face therapy. The control group will receive 16 weeks of face-to-face cognitive behavior therapy immediately following randomization and nonresponders at the 3-month follow-up will, as in the stepped care group, receive additional face-to-face therapy. Main Outcomes and Measures:Noninferiority is defined as a 4-point difference on the primary outcome measure (Children's Yale-Brown Obsessive Compulsive Scale). Discussion:Recruitment started October 6, 2017, and was completed May 24, 2019. Results from the primary end point will be available by May 2020. The naturalistic follow-ups (1, 2, and 5 years after the end of treatment) will continue to 2025. There are no interim analyses planned or stopping rules for the trial. Trial Registration:ClinicalTrials.gov identifier: NCT03263546.

Project description:BackgroundTelephone cognitive-behaviour therapy (TCBT) may be a cost-effective method for improving access to evidence-based treatment for obsessive-compulsive disorder (OCD) in young people.AimsEconomic evaluation of TCBT compared with face-to-face CBT for OCD in young people.MethodRandomised non-inferiority trial comparing TCBT with face-to-face CBT for 72 young people (aged 11 to 18) with a diagnosis of OCD. Cost-effectiveness at 12-month follow-up was explored in terms of the primary clinical outcome (Children's Yale-Brown Obsessive-Compulsive Scale, CY-BOCS) and quality-adjusted life-years (QALYs) (trial registration: ISRCTN27070832).ResultsTotal health and social care costs were higher for face-to-face CBT (mean total cost £2965, s.d. = £1548) than TCBT (mean total cost £2475, s.d. = £1024) but this difference was non-significant (P = 0.118). There were no significant between-group differences in QALYs or the CY-BOCS and there was strong evidence to support the clinical non-inferiority of TCBT. Cost-effectiveness analysis suggests a 74% probability that face-to-face CBT is cost-effective compared with TCBT in terms of QALYs, but the result was less clear in terms of CY-BOCS, with TCBT being the preferred option at low levels of willingness to pay and the probability of either intervention being cost-effective at higher levels of willingness to pay being around 50%.ConclusionsAlthough cost-effectiveness of TCBT was sensitive to the outcome measure used, TCBT should be considered a clinically non-inferior alternative when access to standard clinic-based CBT is limited, or when patient preference is expressed.Declaration of interestD.M.-C. reports research grants from the Swedish Research Council (Vetenskapsrådet), the Swedish Research Council for Health, working life and welfare (Forte), the US National Institute of Mental Health (NIMH), the UK National Institute of Health Research (NIHR), as well as royalties from Wolters Kluwer Health and Elsevier, all unrelated to the submitted work.

Project description:BACKGROUND:Obsessive-compulsive disorder (OCD) is a highly disabling psychological disorder with a chronic course if left untreated. Cognitive behavioral therapy (CBT) has been shown to be an effective treatment, but access to face-to-face CBT is not always possible. Internet-based CBT (iCBT) has become an increasingly viable option. However, no study has compared iCBT to an analogous control condition using a randomized controlled trial (RCT). OBJECTIVE:A 2-armed RCT was used to compare a therapist-assisted 12-module iCBT to an analogous active attention control condition (therapist-assisted internet-based standard progressive relaxation training, iPRT) in adult OCD. This paper reports pre-post findings for OCD symptom severity. METHOD:In total, 179 participants (117 females, 65.7%) were randomized (stratified by gender) into iCBT or iPRT. The iCBT intervention included psychoeducation, mood and behavioral management, exposure and response prevention (ERP), cognitive therapy, and relapse prevention; the iPRT intervention included psychoeducation and relaxation techniques as a way of managing OCD-related anxiety but did not incorporate ERP or other CBT elements. Both treatments included audiovisual content, case stories, demonstrations of techniques, downloadable audio content and worksheets, and expert commentary. All participants received 1 weekly email, with a maximum 15-minute preparation time per client from a remote therapist trained in e-therapy. Emails aimed to monitor progress, provide support and encouragement, and assist in individualizing the treatment. Participants were assessed for baseline and posttreatment OCD severity with the telephone-administered clinician-rated Yale-Brown Obsessive-Compulsive Scale and other measures by assessors who were blinded to treatment allocation. RESULTS:No pretreatment differences were found between the 2 conditions. Intention-to-treat analysis revealed significant pre-post improvements in OCD symptom severity for both conditions (P<.001). However, relative to iPRT, iCBT showed significantly greater symptom severity improvement (P=.001); Cohen d for iCBT was 1.05 (95% CI 0.72-1.37), whereas for iPRT it was 0.48 (95% CI 0.22-0.73). The iCBT condition was superior in regard to reliable improvement (25/51, 49% vs 16/55, 29%; P=.04) and clinically significant pre-post-treatment changes (17/51, 33% vs 6/55, 11%; P=.005). Those undertaking iCBT post completion of iPRT showed further significant symptom amelioration (P<.001), although the sequential treatment was no more efficacious than iCBT alone (P=.63). CONCLUSION:This study is the first to compare a therapist-assisted iCBT program for OCD to an analogous active attention control condition using iPRT. Our findings demonstrate the large magnitude effect of iCBT for OCD; interestingly, iPRT was also moderately efficacious, albeit significantly less so than the iCBT intervention. The findings are compared to previous internet-based and face-to-face CBT treatment programs for OCD. Future directions for technology-enhanced programs for the treatment of OCD are outlined. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12611000321943; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=336704 (Archived by WebCite at http://www.webcitation.org/70ovUiOmd).

Dataset Information

Study protocol for a single-blind, randomised controlled, non-inferiority trial of internet-based versus face-to-face cognitive behaviour therapy for obsessive-compulsive disorder.

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Study protocol for a single-blind, randomised controlled, non-inferiority trial of internet-based versus face-to-face cognitive behaviour therapy for obsessive-compulsive disorder.

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