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

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.

Study Overview

• Status: Completed
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: Behavioral: Experimental: Internet delivered self-help program with therapist support; Behavioral: Internet delivered self-help program without therapist support

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 10691
    • Stockholm University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet delivered self-help program with therapist support; The intervention consists of 8 therapist-supported self-help modules delivered over 8 weeks on a secure online platform. Modules consist of texts and video followed by exercises which they send to their therapist and receive feedback within a few days. The treatment is based on principles from affect-focused psychodynamic psychotherapy.	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.
Active Comparator: Internet delivered self-help program without therapist support; The intervention consists of 8 self-help modules delivered over 8 weeks on a secure online platform. Modules consist of texts and video followed by exercises which the participants are encouraged to try. The treatment is based on principles from affect-focused psychodynamic psychotherapy.	Behavioral: 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.
No Intervention: Waitlist; Participants will receive no intervention for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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)
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)
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).
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).

Collaborators and Investigators

• Sponsor: Stockholm University
• Investigators: Principal Investigator: Per Carlbring, PhD, Department of Psychology at Stockholm University

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Actual): January 12, 2023
• Study Completion (Actual): January 12, 2023

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 14, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: STEPS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Parts will be shared in an open data repository.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No