NCT05015166

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

August 18, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2023

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

1.4 years

First QC Date

August 9, 2021

Last Update Submit

January 12, 2023

Conditions

Social Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Generalised Anxiety Disorder 7- item scale (GAD-7)

    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)

    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)

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

Other Outcomes (6)

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

    Baseline

  • The Difficulties in Emotion Regulation Scale (DERS)

    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)

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

  • +3 more other outcomes

Study Arms (3)

Internet delivered self-help program with therapist support

EXPERIMENTAL

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

Internet delivered self-help program without therapist support

ACTIVE COMPARATOR

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

Waitlist

NO INTERVENTION

Participants will receive no intervention for 8 weeks.

Interventions

Experimental: Internet delivered self-help program with therapist supportBEHAVIORAL

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 with therapist support
Internet delivered self-help program without therapist supportBEHAVIORAL

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.

Internet delivered self-help program without therapist support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stockholm University

Stockholm, 10691, Sweden

Location

Related Publications (1)

  • Mechler J, Lindqvist K, Magnusson K, Ringstrom A, Krafman JD, Alvinzi P, Kassius L, Sowa J, Andersson G, Carlbring P. Guided and unguided internet-delivered psychodynamic therapy for social anxiety disorder: A randomized controlled trial. Npj Ment Health Res. 2024 May 10;3(1):21. doi: 10.1038/s44184-024-00063-0.

    PMID: 38730030DERIVED

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Per Carlbring, PhD

    Department of Psychology at Stockholm University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 9, 2021

First Posted

August 20, 2021

Study Start

August 18, 2021

Primary Completion

January 12, 2023

Study Completion

January 12, 2023

Last Updated

January 13, 2023

Record last verified: 2023-01

Locations

SE(1)