Treatment of Social Phobia Over the Internet

NCT ID: NCT01312571

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2016-02-29

Brief Summary

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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)?

Detailed Description

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Conditions

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Social Phobia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive behavior therapy via the internet

Cognitive behavior therapy via the internet with therapist support.

Group Type ACTIVE_COMPARATOR

Internet-based cognitive behavioural therapy (iCBT)

Intervention Type BEHAVIORAL

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.

Attentional retraining

Attentional retraining as described by Nader Amir.

Group Type ACTIVE_COMPARATOR

Internet-based computerized attention training

Intervention Type BEHAVIORAL

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.

Interventions

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Internet-based cognitive behavioural therapy (iCBT)

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

Internet-based computerized attention training

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role collaborator

Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Per Carlbring, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Per Carlbring, Professor

Role: STUDY_DIRECTOR

Umeå University

Gerhard Andersson, Professor

Role: STUDY_CHAIR

Linkoeping University

Tomas Furmark, Ass. professor

Role: STUDY_CHAIR

Uppsala University

Carl-Johan Olsson, Post doc

Role: STUDY_CHAIR

Umeå center for Functional Brain Imaging

Owe Bodlund, Ass. professor

Role: STUDY_CHAIR

NUS

Kristoffer NT Månsson, Student

Role: STUDY_CHAIR

Umeå University

Locations

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Department of Psychology, Umeå University

Umeå, Västerbotten County, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 25781229 (View on PubMed)

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.

Reference Type RESULT
PMID: 26836415 (View on PubMed)

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.

Reference Type RESULT
PMID: 24064198 (View on PubMed)

Other Identifiers

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2010-185-31 M

Identifier Type: -

Identifier Source: org_study_id