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Completed

NCT Number: NCT05015166

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

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.

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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stockholm University

Stockholm, 10691, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Experimental: Internet delivered self-help program with therapist support

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Liebowitz Social Anxiety Scale, Self-Report, (LSAS-SR)

    Time frame: Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)

    The LSAS-SR features 48 items assessing social anxiety symptoms.

Secondary outcomes

  1. Generalised Anxiety Disorder 7- item scale (GAD-7)

    Time frame: Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)

    The GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.

  2. Patient Health Questionnaire 9-item scale (PHQ-9)

    Time frame: Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)

    The PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population

  3. Brunnsviken Brief Quality of Life Scale (BBQ)

    Time frame: Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)

    The BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.

Other outcomes

  1. The Personality Inventory for DSM Short Form (PID-5)

    Time frame: Baseline

    The PID-5 is a self-rated measure of personality-related problems featuring 25 items.

  2. The Difficulties in Emotion Regulation Scale (DERS)

    Time frame: Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)

    Features 30 items assessing psychological strategies for handling emotional distress.

  3. Self-Compassion Scale short-form (SCS-SF)

    Time frame: Change from baseline, week 3 and 6, to post-treatment (8 weeks) and follow up (6, 12 and 24 months after treatment)

    The SCS-SF features 12 items to record self-compassion towards yourself in difficult life situations.

  4. Defense Mechanism Rating Scale, Self-Report-30 (DMRS-SR-30)

    Time frame: Change from baseline to post-treatment (8 week)

    DMRS-SR-30 features 30 items assessing psychological factors that influence emotional distress and quality of life.

  5. Reflective Functioning Questionnaire 8 (RFQ-8)

    Time frame: Change from baseline, treatment week 1-8, to post-treatment (8 weeks).

    RFQ features 8 items assessing the ability to understand mental states of the self and others.

  6. Internet Intervention Patient Adherence Scale

    Time frame: Change from baseline, and week 4, to post-treatment (8 weeks).

    iiPAS is rated by a clinician and features 5 items assessing a particular patient's adherence to internet-delivered psychological interventions.

Sponsors and collaborators

Lead sponsor

Stockholm University

Other

Registry information

Acronym: STePS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 20, 2021
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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