Optimizing cognitive-behavioral therapy for social anxiety disorder and understanding the mechanisms of change: Study protocol for a randomized factorial trial

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...

Full description

Bibliographic Details
Main Authors: Rodrigo C.T. Lopes, Dajana Šipka, Tobias Krieger, Jan Philipp Klein, Thomas Berger
Format: Article
Language:English
Published: Elsevier 2021-12-01
Series:Internet Interventions
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2214782921001202
_version_ 1818461710037549056
author Rodrigo C.T. Lopes
Dajana Šipka
Tobias Krieger
Jan Philipp Klein
Thomas Berger
author_facet Rodrigo C.T. Lopes
Dajana Šipka
Tobias Krieger
Jan Philipp Klein
Thomas Berger
author_sort Rodrigo C.T. Lopes
collection DOAJ
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.
first_indexed 2024-12-14T23:50:28Z
format Article
id doaj.art-5c1ee12f377f440ab64d0a3f927d2fcf
institution Directory Open Access Journal
issn 2214-7829
language English
last_indexed 2024-12-14T23:50:28Z
publishDate 2021-12-01
publisher Elsevier
record_format Article
series Internet Interventions
spelling doaj.art-5c1ee12f377f440ab64d0a3f927d2fcf2022-12-21T22:43:16ZengElsevierInternet Interventions2214-78292021-12-0126100480Optimizing cognitive-behavioral therapy for social anxiety disorder and understanding the mechanisms of change: Study protocol for a randomized factorial trialRodrigo C.T. Lopes0Dajana Šipka1Tobias Krieger2Jan Philipp Klein3Thomas Berger4Department of Clinical Psychology and Psychotherapy, University of Bern, Fabrikstrasse, 8, 3012 Bern, Switzerland; Corresponding author at: Universität Bern, Institut für Psychologie, Klinische Psychologie und Psychotherapie, Fabrikstrasse 8, 3012 Bern, Switzerland.Department of Clinical Psychology and Psychotherapy, University of Bern, Fabrikstrasse, 8, 3012 Bern, SwitzerlandDepartment of Clinical Psychology and Psychotherapy, University of Bern, Fabrikstrasse, 8, 3012 Bern, SwitzerlandDepartment of Psychiatry, Psychosomatics and Psychotherapy, Luebeck University, Luebeck, GermanyDepartment of Clinical Psychology and Psychotherapy, University of Bern, Fabrikstrasse, 8, 3012 Bern, SwitzerlandBackground: 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.http://www.sciencedirect.com/science/article/pii/S2214782921001202Internet-based cognitive-behavioral therapySocial anxietyFactorial designMechanisms of change
spellingShingle Rodrigo C.T. Lopes
Dajana Šipka
Tobias Krieger
Jan Philipp Klein
Thomas Berger
Optimizing cognitive-behavioral therapy for social anxiety disorder and understanding the mechanisms of change: Study protocol for a randomized factorial trial
Internet Interventions
Internet-based cognitive-behavioral therapy
Social anxiety
Factorial design
Mechanisms of change
title Optimizing cognitive-behavioral therapy for social anxiety disorder and understanding the mechanisms of change: Study protocol for a randomized factorial trial
title_full Optimizing cognitive-behavioral therapy for social anxiety disorder and understanding the mechanisms of change: Study protocol for a randomized factorial trial
title_fullStr Optimizing cognitive-behavioral therapy for social anxiety disorder and understanding the mechanisms of change: Study protocol for a randomized factorial trial
title_full_unstemmed Optimizing cognitive-behavioral therapy for social anxiety disorder and understanding the mechanisms of change: Study protocol for a randomized factorial trial
title_short Optimizing cognitive-behavioral therapy for social anxiety disorder and understanding the mechanisms of change: Study protocol for a randomized factorial trial
title_sort optimizing cognitive behavioral therapy for social anxiety disorder and understanding the mechanisms of change study protocol for a randomized factorial trial
topic Internet-based cognitive-behavioral therapy
Social anxiety
Factorial design
Mechanisms of change
url http://www.sciencedirect.com/science/article/pii/S2214782921001202
work_keys_str_mv AT rodrigoctlopes optimizingcognitivebehavioraltherapyforsocialanxietydisorderandunderstandingthemechanismsofchangestudyprotocolforarandomizedfactorialtrial
AT dajanasipka optimizingcognitivebehavioraltherapyforsocialanxietydisorderandunderstandingthemechanismsofchangestudyprotocolforarandomizedfactorialtrial
AT tobiaskrieger optimizingcognitivebehavioraltherapyforsocialanxietydisorderandunderstandingthemechanismsofchangestudyprotocolforarandomizedfactorialtrial
AT janphilippklein optimizingcognitivebehavioraltherapyforsocialanxietydisorderandunderstandingthemechanismsofchangestudyprotocolforarandomizedfactorialtrial
AT thomasberger optimizingcognitivebehavioraltherapyforsocialanxietydisorderandunderstandingthemechanismsofchangestudyprotocolforarandomizedfactorialtrial