Social Anxiety Disorder (Social Phobia)OPTIMIZENCT04879641

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

A study testing Exposure, Attention Training and Cognitive Restructuring in people with Social Anxiety Disorder (Social Phobia), run by University of Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Social Anxiety Disorder (Social Phobia)
What is being tested?: Exposure, Attention Training and Cognitive Restructuring
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 464 participants
Where: 1 siteSwitzerland
Study dates: 15 Aug 2021to 29 Feb 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. read the study information and sign informed consent;
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)

Who cannot join

1. 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.
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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Clinical Psychology and Psychotherapy Department, University of Bern
Bern, 3012

Other trials in Switzerland

About this study

Official title: Optimizing Cognitive-behavioral Therapy for Social Anxiety Disorder Using the Factorial Design: What Works Best and How Does it Work (OPTIMIZE)

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:

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

Read the detailed description

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. 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 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:

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);
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.
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: Social Anxiety Disorder (Social Phobia)
Being tested: Exposure, Attention Training, Cognitive Restructuring, Psychoeducation
Medical subject headings: Phobia, Social

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ExposureBehavioural
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 TrainingBehavioural
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 RestructuringBehavioural
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.
PsychoeducationBehavioural
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.

Study groups in NCT04879641
Study group	Role	What they receive
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 Receives: Behavioral: Exposure
3_Attention Training only	Experimental	Randomized participants will only get the Attention Training component Receives: Behavioral: Attention Training
4_Exposure + Attention Training	Experimental	Randomized participants will get Exposure + Attention Training components Receives: Behavioral: Exposure; Behavioral: Attention Training
5_Cognitive Restructuring only	Experimental	Randomized participants will only get the Cognitive Restructuring component Receives: Behavioral: Cognitive Restructuring
6_Cognitive Restructuring + Exposure	Experimental	Randomized participants will get Cognitive Restructuring + Exposure components Receives: Behavioral: Exposure; Behavioral: Cognitive Restructuring
7_Cognitive Restructuring + Attention Training	Experimental	Randomized participants will get Cognitive Restructuring + Attention Training components Receives: Behavioral: Attention Training; Behavioral: Cognitive Restructuring
8_Cognitive Restructuring + Attention Training + Exposure	Experimental	Randomized participants will get Cognitive Restructuring + Attention Training + Exposure components Receives: Behavioral: Exposure; Behavioral: Attention Training; Behavioral: Cognitive Restructuring
9_Psychoeducation only	Experimental	Randomized participants will only get the Psychoeducation component Receives: Behavioral: Psychoeducation
10_Psychoeducation + Exposure	Experimental	Randomized participants will get the Psychoeducation + Exposure components Receives: Behavioral: Exposure; Behavioral: Psychoeducation
11_Psychoeducation + Attention Training	Experimental	Randomized participants will get the Psychoeducation + Attention Training components Receives: Behavioral: Attention Training; Behavioral: Psychoeducation
12_Psychoeducation + Attention Training + Exposure	Experimental	Randomized participants will get the Psychoeducation + Attention Training + Exposure components Receives: Behavioral: Exposure; Behavioral: Attention Training; Behavioral: Psychoeducation
13_Psychoeducation + Cognitive Restructuring	Experimental	Randomized participants will get the Psychoeducation + Cognitive Restructuring components Receives: Behavioral: Cognitive Restructuring; Behavioral: Psychoeducation
14_Psychoeducation + Cognitive Restructuring + Exposure	Experimental	Randomized participants will get the Psychoeducation + Cognitive Restructuring + Exposure components Receives: 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 Receives: 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 Receives: Behavioral: Exposure; Behavioral: Attention Training; Behavioral: Cognitive Restructuring; Behavioral: Psychoeducation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

Change on social anxiety symptoms at follow-up
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 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).
Measured: 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
Depressive symptoms will be measured by the Patient Health Questionnaire (PHQ-9; Spitzer et al., 1999). Scores range from 0 (no depressive symptoms) to 27 (severe depressive symptoms).
Measured: 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
Severity of anxiety symptoms will be measured by the Generalized Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006). Scores range from 0 (no general anxiety symptoms) to 21 (severe general anxiety symptoms)
Measured: Baseline, Mid-treatment (4 weeks after baseline), Post-treatment (8 weeks after baseline), Follow-up (6 months after baseline)
Change on quality of life
Quality of life will be measured by the Short-Form Health Survey-12 (SF-12; Ware et al., 1996). Scores range from 12 (high quality of life) to 53 (poor quality of life).
Measured: 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
Treatment satisfaction will be measured by the Client Satisfaction Questionnaire (CSQ-8; Attkisson \& Zwick, 1982), adapted to internet-based interventions. Scores range from 0 (not satisfied at all) to 24 (extremely satisfied).
Measured: Post-treatment (8 weeks after baseline)
Negative effects of the treatment
Adverse effects on social, intrapersonal or work-related situations and whether they are attributed to the intervention will be measured on the 15 items Negative Effects of the Treatment scale (INEP; Ladwig et al., 2014). The scores range from - 39 (worse) to +18 (best), in which negative values indicate negative effects of the intervention
Measured: Mid-treatment (4 weeks after baseline), Post-treatment (8 weeks after baseline), Follow-up (6 months after baseline)
Change on the diagnosis of social anxiety disorder
Diagnosis of social anxiety disorder will be assessed with M.I.N.I International Neuropsychiatric Interview for DSM-IV 6.0.0 (M.I.N.I; Sheehan et al., 1998). Possible diagnoses are absence or presence of SAD, current or past, generalized or specific, primary diagnosis (yes or no)
Measured: Baseline, Post-treatment (8 weeks after baseline), Follow-up (6 months after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 202129 Feb 2024

First posted10 May 2021
Study start15 Aug 2021
Primary completion18 Oct 2023
Study completion29 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Social Anxiety Disorder (Social Phobia)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Model description: 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.
Masking: Single blind
Who is masked: Participant
Enrolment: 464 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04879641
Sponsor's protocol ID: OPTIMIZE_TRIAL
Acronym: OPTIMIZE
Status last verified: May 2024
First submitted: 9 Apr 2021
Last updated: 16 May 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

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.
PubMed 9881538
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.
PubMed 19437505
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.
PubMed 27423374
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.
PubMed 22209829
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.
PubMed 9670605
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.
PubMed 10568646
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.
PubMed 16717171
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.
PubMed 8628042
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.
PubMed 10259963
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.
PubMed 22649526
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.
PubMed 5810590
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing Cognitive-behavioral Therapy for Social Anxiety Disorder Using the Factorial Design: What Works Best and How Does it Work (OPTIMIZE)
ClinicalTrials.gov ID: NCT04879641
Acronym / sponsor ID: OPTIMIZE / OPTIMIZE_TRIAL
Conditions: Social Anxiety Disorder (Social Phobia)
Study type: Interventional
Recruitment status: Completed
Enrolment: 464 participants (actual)
Lead sponsor: University of BernUniversity, hospital or other
Collaborators: University of Luebeck
Study start: 15 Aug 2021 (actual)
Primary completion: 18 Oct 2023 (actual)
Study completion: 29 Feb 2024 (actual)
First posted: 10 May 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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. 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 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:

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (participant)
Number of arms: 16
Model description: 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.

Arm	Type	Receives
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	Behavioral: ExposureRandomized participants will only get the Exposure component
3_Attention Training only	Experimental	Behavioral: Attention TrainingRandomized participants will only get the Attention Training component
4_Exposure + Attention Training	Experimental	Behavioral: Exposure, Behavioral: Attention TrainingRandomized participants will get Exposure + Attention Training components
5_Cognitive Restructuring only	Experimental	Behavioral: Cognitive RestructuringRandomized participants will only get the Cognitive Restructuring component
6_Cognitive Restructuring + Exposure	Experimental	Behavioral: Exposure, Behavioral: Cognitive RestructuringRandomized participants will get Cognitive Restructuring + Exposure components
7_Cognitive Restructuring + Attention Training	Experimental	Behavioral: Attention Training, Behavioral: Cognitive RestructuringRandomized participants will get Cognitive Restructuring + Attention Training components
8_Cognitive Restructuring + Attention Training + Exposure	Experimental	Behavioral: Exposure, Behavioral: Attention Training, Behavioral: Cognitive RestructuringRandomized participants will get Cognitive Restructuring + Attention Training + Exposure components
9_Psychoeducation only	Experimental	Behavioral: PsychoeducationRandomized participants will only get the Psychoeducation component
10_Psychoeducation + Exposure	Experimental	Behavioral: Exposure, Behavioral: PsychoeducationRandomized participants will get the Psychoeducation + Exposure components
11_Psychoeducation + Attention Training	Experimental	Behavioral: Attention Training, Behavioral: PsychoeducationRandomized participants will get the Psychoeducation + Attention Training components
12_Psychoeducation + Attention Training + Exposure	Experimental	Behavioral: Exposure, Behavioral: Attention Training, Behavioral: PsychoeducationRandomized participants will get the Psychoeducation + Attention Training + Exposure components
13_Psychoeducation + Cognitive Restructuring	Experimental	Behavioral: Cognitive Restructuring, Behavioral: PsychoeducationRandomized participants will get the Psychoeducation + Cognitive Restructuring components
14_Psychoeducation + Cognitive Restructuring + Exposure	Experimental	Behavioral: Exposure, Behavioral: Cognitive Restructuring, Behavioral: PsychoeducationRandomized participants will get the Psychoeducation + Cognitive Restructuring + Exposure components
15_Psychoeducation + Cognitive Restructuring + Attention Training	Experimental	Behavioral: Attention Training, Behavioral: Cognitive Restructuring, Behavioral: PsychoeducationRandomized participants will get the Psychoeducation + Cognitive Restructuring + Attention Training components
16_full version (Psychoeducation + Cognitive Restructuring + Attention Training + Exposure)	Experimental	Behavioral: Exposure, Behavioral: Attention Training, Behavioral: Cognitive Restructuring, Behavioral: PsychoeducationRandomized participants will get the Psychoeducation + Cognitive Restructuring + Attention Training + Exposure components

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

1. read the study information and sign informed consent;
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);

Key exclusion criteria (3 listed)

1. 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.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ExposureParticipants 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.	Behavioural	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 TrainingParticipants 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).	Behavioural	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 RestructuringParticipants 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.	Behavioural	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
PsychoeducationParticipants 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.	Behavioural	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

Primary outcome

Change on social anxiety symptoms at post-treatment
Time frame: Baseline, Mid-treatment (4 weeks after baseline), Post-treatment (8 weeks after baseline)
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).

7 secondary outcomes

Change on social anxiety symptoms at follow-up
Time frame: 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
Time frame: 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
Time frame: Baseline, Mid-treatment (4 weeks after baseline), Post-treatment (8 weeks after baseline), Follow-up (6 months after baseline)
Change on quality of life
Time frame: 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
Time frame: Post-treatment (8 weeks after baseline)
Negative effects of the treatment
Time frame: Mid-treatment (4 weeks after baseline), Post-treatment (8 weeks after baseline), Follow-up (6 months after baseline)
Change on the diagnosis of social anxiety disorder
Time frame: Baseline, Post-treatment (8 weeks after baseline), Follow-up (6 months after baseline)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Background: PubMed 9881538Sheehan 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.
Background: PubMed 19437505Berger 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.
Background: PubMed 27423374Schulz 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.
Background: PubMed 22209829Eysenbach 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.
Background: PubMed 9670605Mattick 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.
Background: PubMed 10568646Spitzer 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.
Background: PubMed 16717171Spitzer 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.
Background: PubMed 8628042Ware 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.
Background: PubMed 10259963Attkisson 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.
Background: PubMed 22649526Andersson 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.
Background: PubMed 5810590Watson 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.
BackgroundAmerican Psychiatric Association. (2000). DSM-IV: Diagnostic and Statistical Manual of Mental Disorders (4th). Author.
The guided internet-based program Shyne, which will be the studied treatment (requires password)Link provided by the sponsor.
Individual participant dataSharing planned: Yes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas T Berger, Prof. principal investigator

University Bern, Clinical Psychology and Psychotherapy Department

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Exposure, Attention Training and Cognitive Restructuring in people with Social Anxiety Disorder (Social Phobia), run by University of Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change on social anxiety symptoms at post-treatment (time frame: Baseline, Mid-treatment (4 weeks after baseline), Post-treatment (8 weeks after baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04879641, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.