Clinical trial NCT05015166: Study of an Internet-delivered Treatment Based on Experiential Dynamic Psychotherapy for Social Anxiety Disorder
Official title: Study of an Internet-delivered Treatment Based on Experiential Dynamic Psychotherapy for Social Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Lead sponsor: Stockholm University
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Liebowitz Social Anxiety Scale, Self-Report, (LSAS-SR)
timeFrame: Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)
Secondary outcomes:
measure: Generalised Anxiety Disorder 7- item scale (GAD-7)
timeFrame: Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)
measure: Patient Health Questionnaire 9-item scale (PHQ-9)
timeFrame: Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)
measure: Brunnsviken Brief Quality of Life Scale (BBQ)
timeFrame: Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)
Other outcomes:
measure: The Personality Inventory for DSM Short Form (PID-5)
timeFrame: Baseline
measure: The Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)
measure: Self-Compassion Scale short-form (SCS-SF)
timeFrame: Change from baseline, week 3 and 6, to post-treatment (8 weeks) and follow up (6, 12 and 24 months after treatment)
measure: Defense Mechanism Rating Scale, Self-Report-30 (DMRS-SR-30)
timeFrame: Change from baseline to post-treatment (8 week)
measure: Reflective Functioning Questionnaire 8 (RFQ-8)
timeFrame: Change from baseline, treatment week 1-8, to post-treatment (8 weeks).
measure: Internet Intervention Patient Adherence Scale
timeFrame: Change from baseline, and week 4, to post-treatment (8 weeks).
Locations:
city: Stockholm
country: Sweden
facility: Stockholm University
Study officials:
affiliation: Department of Psychology at Stockholm University
name: Per Carlbring, PhD
role: PRINCIPAL_INVESTIGATOR
References: