Study of an Internet-delivered Treatment Based on Experiential Dynamic Psychotherapy for Social Anxiety Disorder

Social Anxiety Disorder Clinical Trial

— STePS  

Official title:

Study of an Internet-delivered Treatment Based on Experiential Dynamic Psychotherapy for Social Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05015166
• Other study ID #: STePS
• Status: Completed
• Phase: N/A
• Start date: August 18, 2021
• Est. completion date: January 12, 2023

Study information

• Verified date: January 2023
• Source: Stockholm University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this randomized, controlled study is to examine an internet delivered, self-help program for social anxiety based on psychodynamic therapy. The study will compare three conditions: the psychodynamic program with therapist support, without therapist support and a waitlist control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: January 12, 2023
• Est. primary completion date: January 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old or older
• Fulfill the DSM-5 criteria for social anxiety disorder (Score > 60 on the self-assessment instrument LSAS-SR)
• Have access to a computer/smartphone/tablet with internet connection
• Be able to read and write Swedish.

Exclusion Criteria:

• Suicidal (within the previous month, assessed with the self-assessment instrument C-SSRS)
• Partaking in psychological treatment
• Ongoing treatment with psychopharmacological drugs with dose adjustments within the nearest month or planned dose adjustments.

The following self-reported diagnoses are excluded:

• Autism spectrum disorder
• Serious depression (Score = 20 on the PHQ9)
• Indications of psychosis or bipolar disorder (type 1 or 2).

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety Disorder

Intervention

Behavioral:
• Experimental: Internet delivered self-help program with therapist support
During 8 weeks of treatment participants are taught how emotional conflicts may underlie and perpetuate symptoms of social anxiety. They are also taught how to observe their own anxiety and emotional avoidance (i.e. defenses) and how to gradually approach previously warded off feelings. The final part of the program contains material on how one may express previously warded off emotions to improve important relationships. The treatment program consists of text, videos and a series of experiential exercises which a therapist gives feedback on.
• Internet delivered self-help program without therapist support
During 8 weeks of treatment participants are taught how emotional conflicts may underlie and perpetuate symptoms of social anxiety. They are also taught how to observe their own anxiety and emotional avoidance (i.e. defenses) and how to gradually approach previously warded off feelings. The final part of the program contains material on how one may express previously warded off emotions to improve important relationships. The treatment program consists of text, videos and a series of experiential exercises.

Locations

Country	Name	City	State
Sweden	Stockholm University	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Stockholm University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Personality Inventory for DSM Short Form (PID-5)	The PID-5 is a self-rated measure of personality-related problems featuring 25 items.	Baseline
Other	The Difficulties in Emotion Regulation Scale (DERS)	Features 30 items assessing psychological strategies for handling emotional distress.	Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)
Other	Self-Compassion Scale short-form (SCS-SF)	The SCS-SF features 12 items to record self-compassion towards yourself in difficult life situations.	Change from baseline, week 3 and 6, to post-treatment (8 weeks) and follow up (6, 12 and 24 months after treatment)
Other	Defense Mechanism Rating Scale, Self-Report-30 (DMRS-SR-30)	DMRS-SR-30 features 30 items assessing psychological factors that influence emotional distress and quality of life.	Change from baseline to post-treatment (8 week)
Other	Reflective Functioning Questionnaire 8 (RFQ-8)	RFQ features 8 items assessing the ability to understand mental states of the self and others.	Change from baseline, treatment week 1-8, to post-treatment (8 weeks).
Other	Internet Intervention Patient Adherence Scale	iiPAS is rated by a clinician and features 5 items assessing a particular patient's adherence to internet-delivered psychological interventions.	Change from baseline, and week 4, to post-treatment (8 weeks).
Primary	Liebowitz Social Anxiety Scale, Self-Report, (LSAS-SR)	The LSAS-SR features 48 items assessing social anxiety symptoms.	Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)
Secondary	Generalised Anxiety Disorder 7- item scale (GAD-7)	The GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.	Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)
Secondary	Patient Health Questionnaire 9-item scale (PHQ-9)	The PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population	Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)
Secondary	Brunnsviken Brief Quality of Life Scale (BBQ)	The BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.	Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)