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Treatment of Social Phobia Over the Internet (SOFIE-8)

Primary Purpose

Social Phobia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-based cognitive behavioural therapy (iCBT)
Internet-based computerized attention training
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Phobia

Eligibility Criteria

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

Inclusion Criteria:

  • Participants must meet criteria for social phobia using the International classification system Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).

Exclusion Criteria:

  • Individuals with current depression and/or is suicide prone will be excluded from the study.
  • With fMRI the following criteria must not be filled: previous surgery in the heart or brain, metals implanted in the body, dental braces or bridge; piercings that can´t be taken out, tattoos (shoulders, arms and back is not so good, the legs are okay if it is not too large); trouble to lie still for about an hour, pregnancy or history of neurological diseases.

Sites / Locations

  • Department of Psychology, Umeå University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cognitive behavior therapy via the internet

Attentional retraining

Arm Description

Cognitive behavior therapy via the internet with therapist support.

Attentional retraining as described by Nader Amir.

Outcomes

Primary Outcome Measures

Differences in recruited brain regions measured using regional cerebral blood flow
Blood-oxygen-level dependence (BOLD) signal change as measured with 3.0 T fMRI Change from baseline in BOLD signal expected between time frames.
Social Phobia Screening Questionnaire (SPSQ)
Social Phobia Screening Questionnaire (SPSQ), diagnostic tool for social phobia. Change from baseline in social anxiety symptoms expected between time frames.
Liebowitz Social Anxiety Scale self rated version (LSAS-SR)
Measure social anxiety and social phobia. Change from baseline in social anxiety symptoms expected between time frames.
Social Interaction Anxiety Scale (SIAS)
Measure social anxiety and social phobia. Change from baseline in social anxiety symptoms expected between time frames.
Social Phobia Scale (SPS)
Measure social phobia. Change from baseline in social anxiety symptoms expected between time frames.

Secondary Outcome Measures

Variation in genes that have been associated with emotional processing
We will study allelic variation in genes that have been associated with emotional processing e.g. monoaminergic gene polymorphisms such as the serotonin-transporter-linked promoter region (5-HTTLPR), tryptophan hydroxylase-2 (TPH2) G-703T, and Catechol-O-methyltransferase (COMT) 158Val/Met polymorphism
Montgomery Åsberg Depression Rating Scale (MADRS-S)
Measure depression. Change from baseline in depressive symptoms expected between time frames.
Beck Anxiety Inventory (BAI)
Measure anxiety. Change from baseline in anxiety symptoms expected between time frames.
Quality of Life Inventory (QOLI)
Measure quality of life. Change from baseline in quality of life expected between time frames.

Full Information

First Posted
August 31, 2010
Last Updated
October 29, 2016
Sponsor
Umeå University
Collaborators
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT01312571
Brief Title
Treatment of Social Phobia Over the Internet
Acronym
SOFIE-8
Official Title
Functional Magnetic Resonance Imaging (fMRI) and Treatment of Social Phobia Over the Internet: Cognitive Behavioural Therapy (CBT) Versus Computerized Attention Training and the Possible Effect of Genetic Variation. (SOFIE-8)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University
Collaborators
Uppsala University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Forty-eight people diagnosed with social phobia in an experimental study that randomized into two treatment groups: 1) Internet-based Cognitive Behavioural Therapy (iCBT) (n = 24) or 2) computerized attention training (n = 24). After nine weeks we change the condition of the two groups of research participants, which should therefore be given both treatments. Pre-and post measurement of functional magnetic resonance imaging (fMRI) will take place in the first round of treatment. Genotyping based on saliva samples takes place before the start of treatment, at the first fMRI measurement, for those who voluntarily leave the sample. Study hypothesis How is the brain activity of emotional processing and anxiety affected after completing an Internet-based CBT compared with computerized attention training? Does the treatment response of an Internet based treatment affects by variations in serotonin-transporter-linked promoter region (5-HTTLPR) and tryptophan hydroxylase-3 (TPH3) genes? How is the genetic variations related to symptoms in social phobia (pre treatment)?

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavior therapy via the internet
Arm Type
Active Comparator
Arm Description
Cognitive behavior therapy via the internet with therapist support.
Arm Title
Attentional retraining
Arm Type
Active Comparator
Arm Description
Attentional retraining as described by Nader Amir.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based cognitive behavioural therapy (iCBT)
Intervention Description
The Internet-based cognitive behavioural therapy (iCBT) consists of our structured self-help program lasting a total of nine active treatment weeks. This treatment program has been well evaluated and involved in several research projects.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based computerized attention training
Intervention Description
The Internet-based computerized attention training program lasting a total of four active treatment weeks. The treatment is consist of two training sessions per week, about 10 minutes long.
Primary Outcome Measure Information:
Title
Differences in recruited brain regions measured using regional cerebral blood flow
Description
Blood-oxygen-level dependence (BOLD) signal change as measured with 3.0 T fMRI Change from baseline in BOLD signal expected between time frames.
Time Frame
pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Title
Social Phobia Screening Questionnaire (SPSQ)
Description
Social Phobia Screening Questionnaire (SPSQ), diagnostic tool for social phobia. Change from baseline in social anxiety symptoms expected between time frames.
Time Frame
pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Title
Liebowitz Social Anxiety Scale self rated version (LSAS-SR)
Description
Measure social anxiety and social phobia. Change from baseline in social anxiety symptoms expected between time frames.
Time Frame
pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Title
Social Interaction Anxiety Scale (SIAS)
Description
Measure social anxiety and social phobia. Change from baseline in social anxiety symptoms expected between time frames.
Time Frame
pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Title
Social Phobia Scale (SPS)
Description
Measure social phobia. Change from baseline in social anxiety symptoms expected between time frames.
Time Frame
pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Secondary Outcome Measure Information:
Title
Variation in genes that have been associated with emotional processing
Description
We will study allelic variation in genes that have been associated with emotional processing e.g. monoaminergic gene polymorphisms such as the serotonin-transporter-linked promoter region (5-HTTLPR), tryptophan hydroxylase-2 (TPH2) G-703T, and Catechol-O-methyltransferase (COMT) 158Val/Met polymorphism
Time Frame
pretreatment (week 0).
Title
Montgomery Åsberg Depression Rating Scale (MADRS-S)
Description
Measure depression. Change from baseline in depressive symptoms expected between time frames.
Time Frame
pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Title
Beck Anxiety Inventory (BAI)
Description
Measure anxiety. Change from baseline in anxiety symptoms expected between time frames.
Time Frame
pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Title
Quality of Life Inventory (QOLI)
Description
Measure quality of life. Change from baseline in quality of life expected between time frames.
Time Frame
pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must meet criteria for social phobia using the International classification system Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV). Exclusion Criteria: Individuals with current depression and/or is suicide prone will be excluded from the study. With fMRI the following criteria must not be filled: previous surgery in the heart or brain, metals implanted in the body, dental braces or bridge; piercings that can´t be taken out, tattoos (shoulders, arms and back is not so good, the legs are okay if it is not too large); trouble to lie still for about an hour, pregnancy or history of neurological diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Carlbring, Professor
Organizational Affiliation
Umeå University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gerhard Andersson, Professor
Organizational Affiliation
Linkoeping University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tomas Furmark, Ass. professor
Organizational Affiliation
Uppsala University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carl-Johan Olsson, Post doc
Organizational Affiliation
Umeå center for Functional Brain Imaging
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Owe Bodlund, Ass. professor
Organizational Affiliation
NUS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kristoffer NT Månsson, Student
Organizational Affiliation
Umeå University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Psychology, Umeå University
City
Umeå
State/Province
Västerbotten
ZIP/Postal Code
901 87
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25781229
Citation
Mansson KN, Frick A, Boraxbekk CJ, Marquand AF, Williams SC, Carlbring P, Andersson G, Furmark T. Predicting long-term outcome of Internet-delivered cognitive behavior therapy for social anxiety disorder using fMRI and support vector machine learning. Transl Psychiatry. 2015 Mar 17;5(3):e530. doi: 10.1038/tp.2015.22.
Results Reference
background
PubMed Identifier
26836415
Citation
Mansson KN, Salami A, Frick A, Carlbring P, Andersson G, Furmark T, Boraxbekk CJ. Neuroplasticity in response to cognitive behavior therapy for social anxiety disorder. Transl Psychiatry. 2016 Feb 2;6(2):e727. doi: 10.1038/tp.2015.218.
Results Reference
result
PubMed Identifier
24064198
Citation
Mansson KN, Carlbring P, Frick A, Engman J, Olsson CJ, Bodlund O, Furmark T, Andersson G. Altered neural correlates of affective processing after internet-delivered cognitive behavior therapy for social anxiety disorder. Psychiatry Res. 2013 Dec 30;214(3):229-37. doi: 10.1016/j.pscychresns.2013.08.012. Epub 2013 Sep 21.
Results Reference
result

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Treatment of Social Phobia Over the Internet

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