Dataset Information

Efficacy of Behavioral Experiments in Cognitive Therapy for Social Anxiety Disorder: Study protocol for a randomized controlled trial.

ABSTRACT:

Background

While the efficacy of cognitive therapy (CT) has been well established for social anxiety disorder (SAD) in several randomized controlled trials, there are still large differences between trials with respect to effect sizes. The present study investigates the question of whether enhanced training and the use of behavioral experiments (BEs) increases the efficacy of traditional CT, based on verbal methods of cognitive restructuring.

Methods/design

A mixed within/between conditions design will be applied, with therapists and patients being randomly allocated to one of two conditions: (1) training of CT plus BEs, (2) training of CT "as usual". Sixty patients with the primary diagnosis of SAD will be recruited and treated in the outpatient clinic of the Department of Psychology, University of Frankfurt. To ensure adherence to therapist protocols, all therapists will be trained and supervised by the project coordinators. In addition, videotaped treatment sessions will be independently evaluated to guarantee both adherence to protocols and the quality of the intervention. Treatment effects will be assessed by independent SAD symptom ratings using the Liebowitz Social Anxiety Scale as the primary outcome measure and self-report measures as secondary outcome measures.

Discussion

The present cognitive behavioral therapy (CBT) trial will be the first to clarify the contribution of BEs to the efficacy of CT in a randomized controlled design. Study results are relevant to clinical training and implementation of evidence-based treatments.

Trial registration

German Clinical Trials Register International Clinical Trials Registry Platform (ICTRP) identifier: DRKS00014349. Trial status: recruiting.

SUBMITTER: Clement C

PROVIDER: S-EPMC6921437 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Publications

Efficacy of Behavioral Experiments in Cognitive Therapy for Social Anxiety Disorder: Study protocol for a randomized controlled trial.

Clément Celina C Lin Jihong J Stangier Ulrich U

Trials 20191219 1

<h4>Background</h4>While the efficacy of cognitive therapy (CT) has been well established for social anxiety disorder (SAD) in several randomized controlled trials, there are still large differences between trials with respect to effect sizes. The present study investigates the question of whether enhanced training and the use of behavioral experiments (BEs) increases the efficacy of traditional CT, based on verbal methods of cognitive restructuring.<h4>Methods/design</h4>A mixed within/between ...[more]

PMID: 31856903

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Project description:Background and aimsInternet-based cognitive-behavioral therapy (iCBT) for social anxiety disorder has been found effective, as attested by independently conducted randomized controlled trials in four languages. The study aim is to test the efficacy of an iCBT program in a culture where it was not tested before (i.e. Romania).MethodsParticipants (n = 76) were recruited, screened and randomized to either a nine-week guided iCBT or a wait-list control group in April and May 2012. Self-report measures were collected before (April 2012) and after the intervention (July 2012), as well as six months later (January 2013). Although social anxiety was assessed with multiple measures, the Liebowitz Social Anxiety Scale - Self Report version (LSAS-SR) and Social Phobia Inventory (SPIN) were used as the primary outcome measures.ResultsA significant difference with a large between-group effect size in favor of iCBT was found (Cohen's d = 1.19 for LSAS-SR and d = 1.27 for SPIN). Recovery rates show that 36.8% (n = 14) in the treatment group score below the SPIN clinical cut-off compared to only 2.6% (n = 1) in the wait-list control group. Post-intervention clinical interviews also revealed that 34.2% (n = 13) of the treatment group was completely recovered (full remission) while additionally 36.8% (n = 14) retained some social anxiety symptoms (partial remission). However, an important study limitation is that post-intervention interviewers were not blinded to the study conditions. The program also effectively reduced depression and dysfunctional thinking (between-group Cohen's d = 0.84 for depression and d = 0.63 for dysfunctional thinking). Moreover, the iCBT intervention appears to have a long-term impact for participants' functioning, as the treatment gains were maintained six months later.ConclusionsInternet-delivered interventions display a high potential to quickly and widely disseminate effective evidence-based programs around the world. This study provides support for guided iCBT as a promising treatment approach in Romania.Trial registrationClinicalTrials.gov NCT01557894.

Project description:BackgroundSocial anxiety disorders are among the most prevalent anxiety disorders in the general population. The efficacy of cognitive behavioral therapy (CBT) for social anxiety disorders is well demonstrated. However, only three studies point to the efficacy of systemic therapy (ST) in anxiety disorders, and only two of them especially focus on social anxiety disorders. These ST studies either do not use a good comparator but minimal supportive therapy, they do not use a multi-person ST but a combined therapy, or they do not especially focus on social anxiety disorders but mood and anxiety disorders in general. Though ST was approved as evidence based in Germany for a variety of disorders in 2008, evidence did not include anxiety disorders. This is the first pilot study that will investigate multi-person ST, integrating a broad range of systemic methods, specifically for social anxiety disorders and that will compare ST to the "gold standard" CBT.DesignThis article describes the rationale and protocol of a prospective, open, interventive, balanced, bi-centric, pilot randomized controlled trial (RCT). A total of 32 patients with a primary SCID diagnosis of social anxiety disorder will be randomized to either CBT or ST. Both treatments will be manualized. The primary outcome will include social anxiety symptoms at the end of therapy. Therapy will be restricted to no more than 26 hours (primary endpoint). Secondary outcomes will include psychological, social systems and interpersonal functioning, symptom adjustment, and caregiver burden, in addition to change measures, therapist variables and treatment adherence. At the secondary endpoints, 9 and 12 months after the beginning of therapy, we will again assess all outcomes.DiscussionThe study is expected to pilot test a RCT which will be the first to directly compare CBT and multi-person ST, integrating a broad range of systemic methods, for social anxiety disorders, and it will provide empirical evidence for the calculation of the number of patients needed for a confirmatory RCT.Trial registrationClinicalTrials.gov: NCT02360033 ; date of registration: 21 January 2015.

Project description:Background Social anxiety disorder (SAD) is characterized by a marked fear of negative evaluation in social situations and significant impairments. Even with the most effective treatments, remission rates are around 50%. An important reason for the limited effectiveness of treatments is the lack of evidence-based explanation of how treatments work and what their active ingredients might be. An approach to unpack the active ingredients and mechanisms of treatment is the factorial design. Objectives The study is a factorial trial aiming (1) to examine the main effects and interactions for the four main treatment components of internet-based cognitive-behavioral therapy (ICBT) for SAD (i.e., psychoeducation, cognitive restructuring, attentional training, and exposure) and (2) to examine whether and which change mechanisms mediate the relationship between treatment components and symptom reduction. Methods A total of 464 adults diagnosed with SAD will be randomized to one of 16 conditions containing combinations of the treatment components. The primary endpoint is SAD symptomatology at eight weeks. Secondary endpoints include symptoms of depression and anxiety, quality of life, and negative effects. Hypothesized change mechanisms are the increase of knowledge about SAD, the decrease of dysfunctional cognitions, the decrease of self-focused attention, and the decrease of avoidance and safety behaviors. Discussion A better understanding of the differential efficacy of treatment components and mechanisms of treatment underlying ICBT for SAD might inform clinicians and researchers to plan more potent and scalable treatments. Trial registration clinicaltrials.gov (NCT04879641) on June, 11th 2021. https://clinicaltrials.gov/ct2/show/NCT04879641. Highlights • Internet-based cognitive-behavioral therapy (ICBT) allows us to disentangle treatment components of complex treatment packages.• Factorial trials are a suitable design to understand main and interaction effects of treatment components and the mechanisms of change.• Our program for social anxiety disorder consists of four components: psychoeducation, cognitive restructuring, attention training, and exposure.• We will test the effects for the four treatment components and the mediation of hypothesized mechanisms of change on outcomes.• Hypothesized mechanisms of change are knowledge gain of SAD, decrease of dysfunctional social cognitions, decrease of self-focused attention, decrease of avoidance and safety behaviors

Dataset Information

Efficacy of Behavioral Experiments in Cognitive Therapy for Social Anxiety Disorder: Study protocol for a randomized controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

Efficacy of Behavioral Experiments in Cognitive Therapy for Social Anxiety Disorder: Study protocol for a randomized controlled trial.

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