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

Primary Purpose

Social Anxiety Disorder

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Experimental: Internet delivered self-help program with therapist support

Internet delivered self-help program without therapist support

About this trial

This is an interventional treatment trial for Social Anxiety Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Stockholm University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Internet delivered self-help program with therapist support

Internet delivered self-help program without therapist support

Waitlist

Arm Description

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.

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.

Participants will receive no intervention for 8 weeks.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

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

Brunnsviken Brief Quality of Life Scale (BBQ)

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

Full Information

NCT ID

NCT05015166

First Posted

August 9, 2021

Last Updated

January 12, 2023

Sponsor

Stockholm University

1. Study Identification

Unique Protocol Identification Number

NCT05015166

Brief Title

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

Acronym

STePS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

August 18, 2021 (Actual)

Primary Completion Date

January 12, 2023 (Actual)

Study Completion Date

January 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stockholm University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Social Anxiety Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

181 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Internet delivered self-help program with therapist support

Arm Type

Experimental

Arm Description

Arm Title

Internet delivered self-help program without therapist support

Arm Type

Active Comparator

Arm Description

Arm Title

Waitlist

Arm Type

No Intervention

Arm Description

Participants will receive no intervention for 8 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Experimental: Internet delivered self-help program with therapist support

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Internet delivered self-help program without therapist support

Intervention Description

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

Brunnsviken Brief Quality of Life Scale (BBQ)

Description

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

Time Frame

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

Other Pre-specified Outcome Measures:

Title

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

Description

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

Time Frame

Baseline

Title

The Difficulties in Emotion Regulation Scale (DERS)

Description

Features 30 items assessing psychological strategies for handling emotional distress.

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

Change from baseline to post-treatment (8 week)

Title

Reflective Functioning Questionnaire 8 (RFQ-8)

Description

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

Time Frame

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

Title

Internet Intervention Patient Adherence Scale

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Per Carlbring, PhD

Organizational Affiliation

Department of Psychology at Stockholm University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stockholm University

City

Stockholm

ZIP/Postal Code

10691

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Parts will be shared in an open data repository.

Learn more about this trial

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

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