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Internet-delivered Psychodynamic Therapy for Social Anxiety Disorder (SOFIA) (SOFIA)

Primary Purpose

Social Anxiety Disorder

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Psychodynamic Internet Treatment

Waiting list

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Test, psychodynamic, Internet-delivered psychodynamic treatment, patients with social anxiety disorder

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Social anxiety disorder as diagnosed by the MINI diagnostic interview

Exclusion Criteria:

Severe depression

Sites / Locations

Department of Behavioural Sciences and Learning, Linköping University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Psychodynamic Internet Treatment

Waiting list with support

Arm Description

Psychodynamic Internet Treatment for social anxiety disorder during 10 weeks and guided by a psychologist

Behavioral: supportive check-ups via the Internet during 10 weeks

Outcomes

Primary Outcome Measures

Liebowitz Social Anxiety Scale

Secondary Outcome Measures

Patient Health Questionnaire Depression 9 item

Patient Health Questionnaire Anxiety 7 item

Full Information

NCT ID

NCT02105259

First Posted

April 2, 2014

Last Updated

October 4, 2023

Sponsor

Linkoeping University

Collaborators

Karolinska Institutet, Stockholm University

1. Study Identification

Unique Protocol Identification Number

NCT02105259

Brief Title

Internet-delivered Psychodynamic Therapy for Social Anxiety Disorder (SOFIA)

Acronym

SOFIA

Official Title

Internet-delivered Psychodynamic Therapy for Social Anxiety Disorder: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Linkoeping University

Collaborators

Karolinska Institutet, Stockholm University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The overall aim of this study is to develop and test a psychodynamic Internet--delivered psychological treatment for patients with social anxiety disorder and compare its efficacy to a waiting list.

Detailed Description

Participants with social anxiety disorder (MINI telephone interview) will be recruited via mass media and randomly allocated to psychodynamic Internet--delivered psychological treatment or to a waiting list control condition.

6. Conditions and Keywords

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

Social Anxiety Disorder

Keywords

Test, psychodynamic, Internet-delivered psychodynamic treatment, patients with 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

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Psychodynamic Internet Treatment

Arm Type

Experimental

Arm Description

Psychodynamic Internet Treatment for social anxiety disorder during 10 weeks and guided by a psychologist

Arm Title

Waiting list with support

Arm Type

Active Comparator

Arm Description

Behavioral: supportive check-ups via the Internet during 10 weeks

Intervention Type

Behavioral

Intervention Name(s)

Psychodynamic Internet Treatment

Intervention Description

Psychodynamic Internet Treatment for patients social anxiety disorder

Intervention Type

Other

Intervention Name(s)

Waiting list

Intervention Description

Waiting list, where participants wait for delayed treatment

Primary Outcome Measure Information:

Title

Liebowitz Social Anxiety Scale

Time Frame

Baseline and End of treatment (10 weeks)

Secondary Outcome Measure Information:

Title

Patient Health Questionnaire Depression 9 item

Time Frame

Baseline

Title

Patient Health Questionnaire Depression 9 item

Time Frame

End of treatment (10 weeks)

Title

Patient Health Questionnaire Anxiety 7 item

Time Frame

Baseline

Title

Patient Health Questionnaire Anxiety 7 item

Time Frame

End of treatment (10 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Social anxiety disorder as diagnosed by the MINI diagnostic interview Exclusion Criteria: Severe depression

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerhard Andersson

Organizational Affiliation

Linkoeping University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Behavioural Sciences and Learning, Linköping University

City

Linköping

ZIP/Postal Code

58183

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

29251954

Citation

Johansson R, Hesslow T, Ljotsson B, Jansson A, Jonsson L, Fardig S, Karlsson J, Hesser H, Frederick RJ, Lilliengren P, Carlbring P, Andersson G. Internet-based affect-focused psychodynamic therapy for social anxiety disorder: A randomized controlled trial with 2-year follow-up. Psychotherapy (Chic). 2017 Dec;54(4):351-360. doi: 10.1037/pst0000147.

Results Reference

derived

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Internet-delivered Psychodynamic Therapy for Social Anxiety Disorder (SOFIA)

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