Dataset Information

Metacognitive therapy versus exposure and response prevention for obsessive-compulsive disorder: study protocol for a randomized controlled trial.

ABSTRACT:

Background

The recommended psychological treatment of choice for obsessive-compulsive disorder (OCD) is exposure with response prevention (ERP). However, recovery rates are relatively modest, so better treatments are needed. This superiority study aims to explore the relative efficacy of metacognitive therapy (MCT), a new form of cognitive therapy based on the metacognitive model of OCD.

Design and method

In a randomized controlled trial, we will compare MCT with ERP. One hundred patients diagnosed with OCD will be recruited in an outpatient mental health center in Rotterdam (the Netherlands). The primary outcome measure is OCD severity, measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). Data are assessed at baseline, after treatment, and at 6 and 30?months follow-up.

Discussion

By comparing MCT with ERP we hope to provide an indication whether MCT is efficacious in the treatment of OCD and, if so, whether it has the potential to be more efficacious than the current "gold standard" psychological treatment for OCD, ERP.

Trial registration

Dutch Trial Register, NTR4855 . Registered on 21 October 2014.

SUBMITTER: Melchior K

PROVIDER: S-EPMC6528220 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Metacognitive therapy versus exposure and response prevention for obsessive-compulsive disorder: study protocol for a randomized controlled trial.

Melchior Kim K Franken Ingmar I Deen Mathijs M van der Heiden Colin C

Trials 20190520 1

<h4>Background</h4>The recommended psychological treatment of choice for obsessive-compulsive disorder (OCD) is exposure with response prevention (ERP). However, recovery rates are relatively modest, so better treatments are needed. This superiority study aims to explore the relative efficacy of metacognitive therapy (MCT), a new form of cognitive therapy based on the metacognitive model of OCD.<h4>Design and method</h4>In a randomized controlled trial, we will compare MCT with ERP. One hundred ...[more]

PMID: 31109349

Similar Datasets

Project description:BackgroundPatients with obsessive-compulsive disorder (OCD) suffer from repetitive fearful intrusions which they try to neutralize by performing compulsions. OCD is considered to be the most resistant anxiety disorder with a remission rate of only 53% after a year of an evidence-based treatment. Therefore, it remains an obligation to develop and investigate more effective treatment interventions. This study aims to compare personalized exposure with response prevention (ERP) using experience sampling methodology-based feedback to ERP as usual in patients with OCD. Personalized exposure will be provided screen-to-screen in an ecologically valid (real time and real place) context by means of a smartphone application. This app will also be used to collect both objective and subjective data by means of experience sampling methodology (ESM). This ESM data will be used to identify triggers and protective factors for symptom severity, provide personalized feedback and optimize the effect of ERP. The primary goal of this RCT is to compare the effectiveness of personalized ERP to ERP as usual in the traditional context of a therapist's room in patients with OCD in OCD symptom severity, as well as differences in quality of life, depressive symptoms and anxiety states. Since both self-efficacy and experiential avoidance are known to influence symptom severity in OCS, a secondary goal is to examine if a possible treatment effect is mediated by self-efficacy or experiential avoidance.MethodsThis study involves a randomized controlled trial with 20 weekly sessions by 2 groups (ERP as usual versus personalized ERP), repeated measurements at baseline (T0), 5 weeks of treatment (T1), 10 weeks of treatment (T2), 15 weeks of treatment (T3), posttest at 20 weeks (T4), 6 weeks follow-up (T5), 3 months follow-up (T6), 6 months follow-up (T7) and a year follow-up (T8). A hundred and sixty patients with an OCD diagnosis according to DSM-5 criteria will participate. Half of the group will receive exposure with response prevention as usual, the other half will receive personalized exposure with response prevention with a smartphone application and personalized feedback sessions based on experience sampling data. Multilevel mixed modelling analysis will be used to investigate differences in treatment effect, as well as differences in quality of life, depressive symptoms and anxiety states. We will use the macro of Preacher and Hayes and apply bootstrapping methods to assess the possible mediating effect of changes in self-efficacy and experiential avoidance on subsequent treatment effects.DiscussionThis randomized controlled trial is the first to assess the influence of delivering ERP through video-calling and the use of an ESM intervention on the symptom severity of OCD. Since the global pandemic COVID-19, the use of video-calling to deliver psychological treatments has become more common, increasing the relevance of this study.Trial registrationICTRP Trial NL8254. Registered on 2019-12-24.

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).

Project description:BackgroundObsessive-compulsive disorder (OCD) in children can lead to a huge burden on the concerned patients and their family members. While successful state-of-the art cognitive behavioral interventions exist, there is still a lack of available experts for treatment at home, where most symptoms manifest. Internet-based cognitive behavioral therapy (iCBT) could overcome these restrictions; however, studies about iCBT in children with OCD are rare and mostly target computerized self-help resources and only email contact with the therapist. Therefore, we intended to build up and to evaluate an iCBT approach for children with OCD, replacing successful elements of traditional in-office face-to-face CBT, with face-to-face teleconferences, online materials, and apps.MethodsWith the help of a pilot feasibility study, we developed the iCBT consisting of 14 teleconference sessions with the child and parents. The sessions are supported by an app assessing daily and weekly symptoms and treatment course completed by children and parents. Additionally, we obtain heart rate and activity scores from the child via wristbands during several days and exposure sessions. Using a waiting list randomized control trial design, we aim to treat and analyze 20 children with OCD immediately after a diagnostic session whereas the control group of another set of 20 OCD patients will be treated after waiting period of 16 weeks. We will recruit 30 patients in each group to take account for potential dropouts. Outcomes for the treatment group are evaluated before randomization (baseline, t0), 16 weeks (end of treatment, t1), 32 weeks (follow-up 1, t2), and 48 weeks after randomization (follow-up 2, t3). For the waiting list group, outcomes are measured before the first randomization (baseline), at 16 weeks (waiting list period), 32 weeks (end of treatment), 48 weeks after the first randomization (follow-up I), and 64 weeks after the first randomization (follow-up II).DiscussionBased on our experience of feasibility during the pilot study, we were able to develop the iCBT approach and the current study will investigate treatment effectiveness. Building up an iCBT approach, resembling traditional in-office face-to-face therapy, may ensure the achievement of well-known therapy effect factors, the acceptance in both patients and clinicians, and the wide distribution within the health system.Trial registrationClinicalTrials.gov NCT05037344 . Registered May 2019, last release August 13th, 2021.

Dataset Information

Metacognitive therapy versus exposure and response prevention for obsessive-compulsive disorder: study protocol for a randomized controlled trial.

Background

Design and method

Discussion

Trial registration

Publications

Metacognitive therapy versus exposure and response prevention for obsessive-compulsive disorder: study protocol for a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets