Optimizing Cognitive-behavioral Therapy for Social Anxiety Disorder Using the Factorial Design
NCT ID: NCT04879641
Last Updated: 2024-05-16
Study Results
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Basic Information
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COMPLETED
NA
464 participants
INTERVENTIONAL
2021-08-15
2024-02-29
Brief Summary
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1. to investigate the active ingredients of ICBT for SAD by testing the main effects and interactions for the four main treatment components (i.e., psychoeducation, cognitive restructuring, attention training, and exposure);
2. to investigate the effects of each treatment component on hypothesized change mechanisms, and to explore whether and which change mechanisms mediate the effect of the treatment components on symptom reduction.
3. to investigate whether the specific mechanisms mediate the effect of the treatment components on primary and secondary outcomes.
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Detailed Description
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1. to investigate the active ingredients of ICBT for SAD by testing the main effects and interactions for the four main treatment components (i.e., psychoeducation, cognitive restructuring, attention training, and exposure);
2. to investigate the effects of each treatment component on hypothesized change mechanisms (change of the knowledge of SAD, change on negative social cognitions, changes on self-focused attention, changes on social avoidance and use of safety behaviors), and to explore whether and which change mechanisms mediate the effect of the treatment components on symptom reduction.
3. to investigate whether the specific mechanisms mediate the effect of the treatment components on primary and secondary outcomes.
The study is a single-center, factorial trial with four experimental factors (treatment components, i.e., psychoeducation, cognitive restructuring, attention training, and exposure) each evaluated at two levels (presence vs. absence) resulting in 16 conditions.
Recruitment: Participants will be recruited using reports in newspapers, through internet forums, social media (e.g., Facebook), and via our website (https://www.online-therapy.ch/) in German-speaking countries.
Sampling: After checking the inclusion criteria, participants will be randomized with equal probability to one of the 16 conditions. The random allocation will be unknown to the investigators. In order to keep the sample sizes of the 16 conditions similar, the allocation list will be made using randomly permuted blocks. A total of 464 participants with a Diagnostic and Statistical Manual of Mental Disorders diagnosis of SAD will be included, with 29 patients being assigned to each of the 16 conditions.
Assessment procedures: The primary outcome measure is change in symptoms of SAD at post-treatment, i.e., after 8 weeks. Secondary outcomes include sustaining change at follow up (6 months after baseline), changes in depressive symptoms, changes in general anxiety symptoms, changes in quality of life, adherence to treatment, treatment satisfaction, negative effects and changes of diagnosis of SAD. Furthermore, the hypothesized change mechanisms (change of the knowledge of SAD, change on negative social cognitions, changes in self-focused attention, changes in social avoidance and use of safety behaviors) will be assessed. Self-report measures are taken at pre-treatment (baseline), after 4 weeks (mid-treatment), after 8 weeks (post-treatment), and at 6 months after randomization (follow-up). Besides the self-report measures, a diagnostic interview will be conducted by phone at pre-treatment, eight weeks (posttreatment), and six months (follow-up). The structured M.I.N.I. Interview will be used. The interviews will be administered by advanced Master students in clinical psychology and psychotherapy supervised by the study team. Interrater reliability will be assessed on a subset of the cases.
Treatment: The internet-based self-help program ("Shyne", https://selfhelp1.psy.unibe.ch/shyne/) is based on the well-established cognitive-behavioral treatment of social anxiety by Clark and Wells and has been proven efficacious in previous studies. Shyne is accessed through a secure website, with each participant having a password-protected account. It consists of the following four treatment components: (1) psychoeducation (knowledge about SAD and its treatment); (2) cognitive restructuring (challenging dysfunctional social cognitions); (3) attention training (decrease of self-focused attention); and (4) exposure (decrease of avoidance of feared situations and safety behaviors). These treatment components will be offered in 16 different combinations.
Data analysis: Primary analyses will be conducted on the Intention-To-Treat (ITT) sample (i.e., all randomized participants). The analyses are carried out on the basis of the intention-to-treat (ITT) approach using linear mixed models. In addition, but only secondary, completers analysis will be carried out. In order to test for main and interaction effects of treatment components on outcomes and change mechanisms across the time points of assessment, linear mixed models Analysis of Variance (ANOVA) or latent growth curve modelling will be used. Main effects and interactions will be based on aggregates across experimental conditions. Sensitivity analyses will explore the impact of the imputation of missing values. For binary outcome data (i.e., SAD diagnosis), a logistic regression model will be used. Furthermore, mediation analyses will be used to determine whether the hypothesized change mechanisms mediate the effect of the treatment components on primary and secondary outcomes. The mediation will be tested using an approach that allows multiple mediators in one model. In addition, potential moderation of the treatment components by various measured variables such as comorbid disorder, medication, the severity of SAD, age and sex will be investigated. Reporting will follow CONSORT E-Health standards.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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1_Waiting List control
Randomized participants will only get the full intervention after study completion period (6 months since the randomization)
No interventions assigned to this group
2_Exposure only
Randomized participants will only get the Exposure component
Exposure
Participants are instructed to plan and track in vivo exposures using an exposure diary. Participants are also instructed to reduce safety behaviors, which are overt or covert acts such as avoiding eye contact or rehearsing sentences to prevent a feared outcome.
3_Attention Training only
Randomized participants will only get the Attention Training component
Attention Training
Participants are trained to reduce self-focused and biased attention. Various audio exercises are introduced in which participants learn to intentionally direct the attention away from themselves (i.e., less private self-consciousness), and to be less alert to potentially dangerous external social stimuli (i.e., less public self-consciousness).
4_Exposure + Attention Training
Randomized participants will get Exposure + Attention Training components
Exposure
Participants are instructed to plan and track in vivo exposures using an exposure diary. Participants are also instructed to reduce safety behaviors, which are overt or covert acts such as avoiding eye contact or rehearsing sentences to prevent a feared outcome.
Attention Training
Participants are trained to reduce self-focused and biased attention. Various audio exercises are introduced in which participants learn to intentionally direct the attention away from themselves (i.e., less private self-consciousness), and to be less alert to potentially dangerous external social stimuli (i.e., less public self-consciousness).
5_Cognitive Restructuring only
Randomized participants will only get the Cognitive Restructuring component
Cognitive Restructuring
Participants are instructed to identify and modify dysfunctional and negatively biased assumptions. It includes a thought diary to track negative beliefs in daily routine, alongside with exercises to formulate helpful and adaptive thoughts.
6_Cognitive Restructuring + Exposure
Randomized participants will get Cognitive Restructuring + Exposure components
Exposure
Participants are instructed to plan and track in vivo exposures using an exposure diary. Participants are also instructed to reduce safety behaviors, which are overt or covert acts such as avoiding eye contact or rehearsing sentences to prevent a feared outcome.
Cognitive Restructuring
Participants are instructed to identify and modify dysfunctional and negatively biased assumptions. It includes a thought diary to track negative beliefs in daily routine, alongside with exercises to formulate helpful and adaptive thoughts.
7_Cognitive Restructuring + Attention Training
Randomized participants will get Cognitive Restructuring + Attention Training components
Attention Training
Participants are trained to reduce self-focused and biased attention. Various audio exercises are introduced in which participants learn to intentionally direct the attention away from themselves (i.e., less private self-consciousness), and to be less alert to potentially dangerous external social stimuli (i.e., less public self-consciousness).
Cognitive Restructuring
Participants are instructed to identify and modify dysfunctional and negatively biased assumptions. It includes a thought diary to track negative beliefs in daily routine, alongside with exercises to formulate helpful and adaptive thoughts.
8_Cognitive Restructuring + Attention Training + Exposure
Randomized participants will get Cognitive Restructuring + Attention Training + Exposure components
Exposure
Participants are instructed to plan and track in vivo exposures using an exposure diary. Participants are also instructed to reduce safety behaviors, which are overt or covert acts such as avoiding eye contact or rehearsing sentences to prevent a feared outcome.
Attention Training
Participants are trained to reduce self-focused and biased attention. Various audio exercises are introduced in which participants learn to intentionally direct the attention away from themselves (i.e., less private self-consciousness), and to be less alert to potentially dangerous external social stimuli (i.e., less public self-consciousness).
Cognitive Restructuring
Participants are instructed to identify and modify dysfunctional and negatively biased assumptions. It includes a thought diary to track negative beliefs in daily routine, alongside with exercises to formulate helpful and adaptive thoughts.
9_Psychoeducation only
Randomized participants will only get the Psychoeducation component
Psychoeducation
Participants are delivered detailed evidence-based information on SAD with a focus on maintaining processes (e.g., the vicious circle of negative thoughts and emotions, cognitions, and behaviors associated with the maintenance of SAD). Based on the information provided, participants are encouraged to develop an individual model of their social anxiety symptoms.
10_Psychoeducation + Exposure
Randomized participants will get the Psychoeducation + Exposure components
Exposure
Participants are instructed to plan and track in vivo exposures using an exposure diary. Participants are also instructed to reduce safety behaviors, which are overt or covert acts such as avoiding eye contact or rehearsing sentences to prevent a feared outcome.
Psychoeducation
Participants are delivered detailed evidence-based information on SAD with a focus on maintaining processes (e.g., the vicious circle of negative thoughts and emotions, cognitions, and behaviors associated with the maintenance of SAD). Based on the information provided, participants are encouraged to develop an individual model of their social anxiety symptoms.
11_Psychoeducation + Attention Training
Randomized participants will get the Psychoeducation + Attention Training components
Attention Training
Participants are trained to reduce self-focused and biased attention. Various audio exercises are introduced in which participants learn to intentionally direct the attention away from themselves (i.e., less private self-consciousness), and to be less alert to potentially dangerous external social stimuli (i.e., less public self-consciousness).
Psychoeducation
Participants are delivered detailed evidence-based information on SAD with a focus on maintaining processes (e.g., the vicious circle of negative thoughts and emotions, cognitions, and behaviors associated with the maintenance of SAD). Based on the information provided, participants are encouraged to develop an individual model of their social anxiety symptoms.
12_Psychoeducation + Attention Training + Exposure
Randomized participants will get the Psychoeducation + Attention Training + Exposure components
Exposure
Participants are instructed to plan and track in vivo exposures using an exposure diary. Participants are also instructed to reduce safety behaviors, which are overt or covert acts such as avoiding eye contact or rehearsing sentences to prevent a feared outcome.
Attention Training
Participants are trained to reduce self-focused and biased attention. Various audio exercises are introduced in which participants learn to intentionally direct the attention away from themselves (i.e., less private self-consciousness), and to be less alert to potentially dangerous external social stimuli (i.e., less public self-consciousness).
Psychoeducation
Participants are delivered detailed evidence-based information on SAD with a focus on maintaining processes (e.g., the vicious circle of negative thoughts and emotions, cognitions, and behaviors associated with the maintenance of SAD). Based on the information provided, participants are encouraged to develop an individual model of their social anxiety symptoms.
13_Psychoeducation + Cognitive Restructuring
Randomized participants will get the Psychoeducation + Cognitive Restructuring components
Cognitive Restructuring
Participants are instructed to identify and modify dysfunctional and negatively biased assumptions. It includes a thought diary to track negative beliefs in daily routine, alongside with exercises to formulate helpful and adaptive thoughts.
Psychoeducation
Participants are delivered detailed evidence-based information on SAD with a focus on maintaining processes (e.g., the vicious circle of negative thoughts and emotions, cognitions, and behaviors associated with the maintenance of SAD). Based on the information provided, participants are encouraged to develop an individual model of their social anxiety symptoms.
14_Psychoeducation + Cognitive Restructuring + Exposure
Randomized participants will get the Psychoeducation + Cognitive Restructuring + Exposure components
Exposure
Participants are instructed to plan and track in vivo exposures using an exposure diary. Participants are also instructed to reduce safety behaviors, which are overt or covert acts such as avoiding eye contact or rehearsing sentences to prevent a feared outcome.
Cognitive Restructuring
Participants are instructed to identify and modify dysfunctional and negatively biased assumptions. It includes a thought diary to track negative beliefs in daily routine, alongside with exercises to formulate helpful and adaptive thoughts.
Psychoeducation
Participants are delivered detailed evidence-based information on SAD with a focus on maintaining processes (e.g., the vicious circle of negative thoughts and emotions, cognitions, and behaviors associated with the maintenance of SAD). Based on the information provided, participants are encouraged to develop an individual model of their social anxiety symptoms.
15_Psychoeducation + Cognitive Restructuring + Attention Training
Randomized participants will get the Psychoeducation + Cognitive Restructuring + Attention Training components
Attention Training
Participants are trained to reduce self-focused and biased attention. Various audio exercises are introduced in which participants learn to intentionally direct the attention away from themselves (i.e., less private self-consciousness), and to be less alert to potentially dangerous external social stimuli (i.e., less public self-consciousness).
Cognitive Restructuring
Participants are instructed to identify and modify dysfunctional and negatively biased assumptions. It includes a thought diary to track negative beliefs in daily routine, alongside with exercises to formulate helpful and adaptive thoughts.
Psychoeducation
Participants are delivered detailed evidence-based information on SAD with a focus on maintaining processes (e.g., the vicious circle of negative thoughts and emotions, cognitions, and behaviors associated with the maintenance of SAD). Based on the information provided, participants are encouraged to develop an individual model of their social anxiety symptoms.
16_full version (Psychoeducation + Cognitive Restructuring + Attention Training + Exposure)
Randomized participants will get the Psychoeducation + Cognitive Restructuring + Attention Training + Exposure components
Exposure
Participants are instructed to plan and track in vivo exposures using an exposure diary. Participants are also instructed to reduce safety behaviors, which are overt or covert acts such as avoiding eye contact or rehearsing sentences to prevent a feared outcome.
Attention Training
Participants are trained to reduce self-focused and biased attention. Various audio exercises are introduced in which participants learn to intentionally direct the attention away from themselves (i.e., less private self-consciousness), and to be less alert to potentially dangerous external social stimuli (i.e., less public self-consciousness).
Cognitive Restructuring
Participants are instructed to identify and modify dysfunctional and negatively biased assumptions. It includes a thought diary to track negative beliefs in daily routine, alongside with exercises to formulate helpful and adaptive thoughts.
Psychoeducation
Participants are delivered detailed evidence-based information on SAD with a focus on maintaining processes (e.g., the vicious circle of negative thoughts and emotions, cognitions, and behaviors associated with the maintenance of SAD). Based on the information provided, participants are encouraged to develop an individual model of their social anxiety symptoms.
Interventions
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Exposure
Participants are instructed to plan and track in vivo exposures using an exposure diary. Participants are also instructed to reduce safety behaviors, which are overt or covert acts such as avoiding eye contact or rehearsing sentences to prevent a feared outcome.
Attention Training
Participants are trained to reduce self-focused and biased attention. Various audio exercises are introduced in which participants learn to intentionally direct the attention away from themselves (i.e., less private self-consciousness), and to be less alert to potentially dangerous external social stimuli (i.e., less public self-consciousness).
Cognitive Restructuring
Participants are instructed to identify and modify dysfunctional and negatively biased assumptions. It includes a thought diary to track negative beliefs in daily routine, alongside with exercises to formulate helpful and adaptive thoughts.
Psychoeducation
Participants are delivered detailed evidence-based information on SAD with a focus on maintaining processes (e.g., the vicious circle of negative thoughts and emotions, cognitions, and behaviors associated with the maintenance of SAD). Based on the information provided, participants are encouraged to develop an individual model of their social anxiety symptoms.
Eligibility Criteria
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Inclusion Criteria
* 2\. are 18 years or older;
* 3\. have access to the Internet, to a smartphone, PC or tablet;
* 4\. have sufficient knowledge of German;
* 5\. exceed predefined cut-off scores on one of the social anxiety measures (22 points on the Social Phobia Scale or 33 points on the Social Interaction Anxiety Scale; SPS \& SIAS);
* 6\. fulfil the diagnostic criteria of SAD according to the diagnostic telephone interview (the presence of other disorders does not result in exclusion if SAD is the primary diagnosis)
* 7\. in the case of taking psychiatric medication, the treatment is stabilized (over one month)
Exclusion Criteria
* 2\. they have other comorbid psychiatric conditions that might be the main focus of clinical attention (e.g., psychotic symptoms, bipolar disorder, or other severe disorder)
* 3\. they undergo another psychological treatment at the beginning of the study.
18 Years
ALL
No
Sponsors
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University of Luebeck
OTHER
University of Bern
OTHER
Responsible Party
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Principal Investigators
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Thomas T Berger, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Bern, Clinical Psychology and Psychotherapy Department
Locations
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Clinical Psychology and Psychotherapy Department, University of Bern
Bern, , Switzerland
Countries
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References
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Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
Berger T, Hohl E, Caspar F. Internet-based treatment for social phobia: a randomized controlled trial. J Clin Psychol. 2009 Oct;65(10):1021-35. doi: 10.1002/jclp.20603.
Schulz A, Stolz T, Vincent A, Krieger T, Andersson G, Berger T. A sorrow shared is a sorrow halved? A three-arm randomized controlled trial comparing internet-based clinician-guided individual versus group treatment for social anxiety disorder. Behav Res Ther. 2016 Sep;84:14-26. doi: 10.1016/j.brat.2016.07.001. Epub 2016 Jul 7.
Eysenbach G; CONSORT-EHEALTH Group. CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions. J Med Internet Res. 2011 Dec 31;13(4):e126. doi: 10.2196/jmir.1923.
Mattick RP, Clarke JC. Development and validation of measures of social phobia scrutiny fear and social interaction anxiety. Behav Res Ther. 1998 Apr;36(4):455-70. doi: 10.1016/s0005-7967(97)10031-6.
Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
Andersson G, Carlbring P, Furmark T; S. O. F. I. E. Research Group. Therapist experience and knowledge acquisition in internet-delivered CBT for social anxiety disorder: a randomized controlled trial. PLoS One. 2012;7(5):e37411. doi: 10.1371/journal.pone.0037411. Epub 2012 May 23.
Watson D, Friend R. Measurement of social-evaluative anxiety. J Consult Clin Psychol. 1969 Aug;33(4):448-57. doi: 10.1037/h0027806. No abstract available.
American Psychiatric Association. (2000). DSM-IV: Diagnostic and Statistical Manual of Mental Disorders (4th). Author.
Clark, D. M., & Wells, A. (1995). A cognitive model of social phobia. In R. G. Heimberg, M. R. Liebowitz, D. Hope, & F. Schneider (Eds.), Social Phobia: Diagnosis, Assessment, and Treatment (pp. 69-93). Guilford Press.
Ladwig, I., Rief, W., & Nestoriuc, Y. (2014). What Are the Risks and Side Effects of Psychotherapy? - Development of an Inventory for the Assessment of Negative Effects of Psychotherapy (INEP). Verhaltenstherapie, 24(4), 252-263. https://doi.org/0.1159/000367928
Wells, A., Stopa, L., & Clark, D. M. (1993). The social cognitions questionnaire. Unpublished, Department of Psychiatry, University of Oxford, Warnerford Hospital, Oxford, UK.
Fenigstein, A., Scheier, M. F., & Buss, A. H. (1975). Public and private self-consciousness: Assessment and theory. Journal of Consulting and Clinical Psychology, 43(4), 522-527. https://doi.org/10.1037/h0076760
Clark, D. M., Wells, A., Salkoviskis, P., & Hackmann, A. (1995). Social behaviour questionnaire [Unpublished Manuscript].
Lopes RCT, Sipka D, Krieger T, Klein JP, Berger T. Optimizing cognitive-behavioral therapy for social anxiety disorder and understanding the mechanisms of change: Study protocol for a randomized factorial trial. Internet Interv. 2021 Nov 10;26:100480. doi: 10.1016/j.invent.2021.100480. eCollection 2021 Dec.
Related Links
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The guided internet-based program Shyne, which will be the studied treatment (requires password)
Other Identifiers
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OPTIMIZE_TRIAL
Identifier Type: -
Identifier Source: org_study_id
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