Optimizing Cognitive-behavioral Therapy for Social Anxiety Disorder Using the Factorial Design

NCT04879641 | Completed DMC

• 1 other identifier: OPTIMIZE_TRIAL
• Study Type: interventional
• Target: 464
• Locations: 1 country
• Sites: 1

Brief Summary

Social Anxiety Disorder (SAD) is characterized by a marked fear of negative evaluation in social situations. It is the third most common psychiatric disorder and highly disabling (American Psychiatric Association, 2000). Although effective treatments such as cognitive-behavioral therapy (CBT) are available, most individuals suffering from SAD do not seek and eventually find help, and even in the best available treatments, remission rates are below 50%. The overall aim of the project is to better understand and improve the efficacy of Internet-based CBT (ICBT) that has shown to be efficacious in many trials and that provide broad and low-threshold access to empirically supported treatments. Specifically the objectives of the study are:

1. 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. 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. 3.to investigate whether the specific mechanisms mediate the effect of the treatment components on primary and secondary outcomes.

Conditions

Social Anxiety Disorder (Social Phobia)

Outcome Measures

Primary Outcomes (1)

• Change on social anxiety symptoms at post-treatment

  Composite endpoint. Social anxiety symptoms are measured as the combined score of the Social Phobia Scale and the Social Interaction Anxiety Scale (SPS \& SIAS; Mattick \& Clarke, 1998). These instruments are complementary and used as one single measurement. They assess the fear of being judged by others during daily activities (SPS) and more general fears in social interaction (SIAS). The combined scale consists of 40 items and scores range from 0 (no social anxiety symptoms) to 160 (severe social anxiety symptoms).

  Baseline, Mid-treatment (4 weeks after baseline), Post-treatment (8 weeks after baseline)

Secondary Outcomes (7)

• Change on social anxiety symptoms at follow-up

  Baseline, Mid-treatment (4 weeks after baseline), Post-treatment (8 weeks after baseline), Follow-up (6 months after baseline)

• Change on the severity of depressive symptoms

  Baseline, Mid-treatment (4 weeks after baseline), Post-treatment (8 weeks after baseline), Follow-up (6 months after baseline)

• Change on the severity of general anxiety symptoms

  Baseline, Mid-treatment (4 weeks after baseline), Post-treatment (8 weeks after baseline), Follow-up (6 months after baseline)

• Change on quality of life

  Baseline, Mid-treatment (4 weeks after baseline), Post-treatment (8 weeks after baseline), Follow-up (6 months after baseline)

• Level of satisfaction with the treatment

  Post-treatment (8 weeks after baseline)

Other Outcomes (5)

• Change on the knowledge of social anxiety disorder

  Baseline, Mid-treatment (4 weeks after baseline), Post-treatment (8 weeks after baseline), Follow-up (6 months after baseline)

• Change on negative social cognitions

  Baseline, Mid-treatment (4 weeks after baseline), Post-treatment (8 weeks after baseline), Follow-up (6 months after baseline)

• Change on self-focused attention (or self-consciousness)

  Baseline, Mid-treatment (4 weeks after baseline), Post-treatment (8 weeks after baseline), Follow-up (6 months after baseline)

Study Arms (16)

1_Waiting List control

NO INTERVENTION

Randomized participants will only get the full intervention after study completion period (6 months since the randomization)

2_Exposure only

EXPERIMENTAL

Randomized participants will only get the Exposure component

Behavioral: Exposure

3_Attention Training only

EXPERIMENTAL

Randomized participants will only get the Attention Training component

Behavioral: Attention Training

4_Exposure + Attention Training

EXPERIMENTAL

Randomized participants will get Exposure + Attention Training components

Behavioral: Exposure; Behavioral: Attention Training

5_Cognitive Restructuring only

EXPERIMENTAL

Randomized participants will only get the Cognitive Restructuring component

Behavioral: Cognitive Restructuring

6_Cognitive Restructuring + Exposure

EXPERIMENTAL

Randomized participants will get Cognitive Restructuring + Exposure components

Behavioral: Exposure; Behavioral: Cognitive Restructuring

7_Cognitive Restructuring + Attention Training

EXPERIMENTAL

Randomized participants will get Cognitive Restructuring + Attention Training components

Behavioral: Attention Training; Behavioral: Cognitive Restructuring

8_Cognitive Restructuring + Attention Training + Exposure

EXPERIMENTAL

Randomized participants will get Cognitive Restructuring + Attention Training + Exposure components

Behavioral: Exposure; Behavioral: Attention Training; Behavioral: Cognitive Restructuring

9_Psychoeducation only

EXPERIMENTAL

Randomized participants will only get the Psychoeducation component

Behavioral: Psychoeducation

10_Psychoeducation + Exposure

EXPERIMENTAL

Randomized participants will get the Psychoeducation + Exposure components

Behavioral: Exposure; Behavioral: Psychoeducation

11_Psychoeducation + Attention Training

EXPERIMENTAL

Randomized participants will get the Psychoeducation + Attention Training components

Behavioral: Attention Training; Behavioral: Psychoeducation

12_Psychoeducation + Attention Training + Exposure

EXPERIMENTAL

Randomized participants will get the Psychoeducation + Attention Training + Exposure components

Behavioral: Exposure; Behavioral: Attention Training; Behavioral: Psychoeducation

13_Psychoeducation + Cognitive Restructuring

EXPERIMENTAL

Randomized participants will get the Psychoeducation + Cognitive Restructuring components

Behavioral: Cognitive Restructuring; Behavioral: Psychoeducation

14_Psychoeducation + Cognitive Restructuring + Exposure

EXPERIMENTAL

Randomized participants will get the Psychoeducation + Cognitive Restructuring + Exposure components

Behavioral: Exposure; Behavioral: Cognitive Restructuring; Behavioral: Psychoeducation

15_Psychoeducation + Cognitive Restructuring + Attention Training

EXPERIMENTAL

Randomized participants will get the Psychoeducation + Cognitive Restructuring + Attention Training components

Behavioral: Attention Training; Behavioral: Cognitive Restructuring; Behavioral: Psychoeducation

16_full version (Psychoeducation + Cognitive Restructuring + Attention Training + Exposure)

EXPERIMENTAL

Randomized participants will get the Psychoeducation + Cognitive Restructuring + Attention Training + Exposure components

Behavioral: Exposure; Behavioral: Attention Training; Behavioral: Cognitive Restructuring; Behavioral: Psychoeducation

Interventions

Exposure BEHAVIORAL

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.

10_Psychoeducation + Exposure; 12_Psychoeducation + Attention Training + Exposure; 14_Psychoeducation + Cognitive Restructuring + Exposure; 16_full version (Psychoeducation + Cognitive Restructuring + Attention Training + Exposure); 2_Exposure only; 4_Exposure + Attention Training; 6_Cognitive Restructuring + Exposure; 8_Cognitive Restructuring + Attention Training + Exposure

Attention Training BEHAVIORAL

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).

11_Psychoeducation + Attention Training; 12_Psychoeducation + Attention Training + Exposure; 15_Psychoeducation + Cognitive Restructuring + Attention Training; 16_full version (Psychoeducation + Cognitive Restructuring + Attention Training + Exposure); 3_Attention Training only; 4_Exposure + Attention Training; 7_Cognitive Restructuring + Attention Training; 8_Cognitive Restructuring + Attention Training + Exposure

Cognitive Restructuring BEHAVIORAL

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.

13_Psychoeducation + Cognitive Restructuring; 14_Psychoeducation + Cognitive Restructuring + Exposure; 15_Psychoeducation + Cognitive Restructuring + Attention Training; 16_full version (Psychoeducation + Cognitive Restructuring + Attention Training + Exposure); 5_Cognitive Restructuring only; 6_Cognitive Restructuring + Exposure; 7_Cognitive Restructuring + Attention Training; 8_Cognitive Restructuring + Attention Training + Exposure

Psychoeducation BEHAVIORAL

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; 11_Psychoeducation + Attention Training; 12_Psychoeducation + Attention Training + Exposure; 13_Psychoeducation + Cognitive Restructuring; 14_Psychoeducation + Cognitive Restructuring + Exposure; 15_Psychoeducation + Cognitive Restructuring + Attention Training; 16_full version (Psychoeducation + Cognitive Restructuring + Attention Training + Exposure); 9_Psychoeducation only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. read the study information and sign informed consent;
• \. are 18 years or older;
• \. have access to the Internet, to a smartphone, PC or tablet;
• \. have sufficient knowledge of German;
• \. 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);
• \. in the case of taking psychiatric medication, the treatment is stabilized (over one month)

You may not qualify if:

• \. they score 2 or higher on the suicide item of the PHQ-9 (Spitzer, 1999) or with active suicidal plans in the diagnostic telephone interview.
• \. 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)
• \. they undergo another psychological treatment at the beginning of the study.

Sponsors & Collaborators

• University of Bern: lead
• University of Luebeck: collaborator

Study Sites (1)

Clinical Psychology and Psychotherapy Department, University of Bern

Bern, 3012, Switzerland

Location

Related Publications (19)

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• 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.

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• 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.

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• 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.

  PMID: 9670605 BACKGROUND

• 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.

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• 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.

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• American Psychiatric Association. (2000). DSM-IV: Diagnostic and Statistical Manual of Mental Disorders (4th). Author.

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• Wells, A., Stopa, L., & Clark, D. M. (1993). The social cognitions questionnaire. Unpublished, Department of Psychiatry, University of Oxford, Warnerford Hospital, Oxford, UK.

  BACKGROUND

• 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

  BACKGROUND

• Clark, D. M., Wells, A., Salkoviskis, P., & Hackmann, A. (1995). Social behaviour questionnaire [Unpublished Manuscript].

  BACKGROUND

• Sipka D, Lopes R, Krieger T, Klein JP, Berger T. Active Components in Internet-Based Cognitive-Behavioral Therapy for Social Anxiety Disorder: A Randomized Full Factorial Trial. Psychother Psychosom. 2025;94(1):40-59. doi: 10.1159/000542425. Epub 2025 Jan 10.

  PMID: 39799943 DERIVED

• 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.

  PMID: 34824982 DERIVED

Related Links

• The guided internet-based program Shyne, which will be the studied treatment (requires password)

MeSH Terms

Conditions

Phobia, Social

Interventions

Cognitive Restructuring

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Thomas T Berger, Prof.

  University Bern, Clinical Psychology and Psychotherapy Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 treatment conditions.

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: May 10, 2021
• Study Start: August 15, 2021
• Primary Completion: October 18, 2023
• Study Completion: February 29, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CH (1)