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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Umeå University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Uppsala University
Information provided by (Responsible Party):
Per Carlbring, PhD, Umeå University
ClinicalTrials.gov Identifier:
NCT01312571
First received: August 31, 2010
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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)?


Condition Intervention
Social Phobia
Behavioral: Internet-based cognitive behavioural therapy (iCBT)
Behavioral: Internet-based computerized attention training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Differences in recruited brain regions measured using regional cerebral blood flow [ Time Frame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63) ] [ Designated as safety issue: Yes ]

    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) [ Time Frame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63) ] [ Designated as safety issue: No ]

    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) [ Time Frame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63) ] [ Designated as safety issue: No ]

    Measure social anxiety and social phobia.

    Change from baseline in social anxiety symptoms expected between time frames.


  • Social Interaction Anxiety Scale (SIAS) [ Time Frame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63) ] [ Designated as safety issue: No ]

    Measure social anxiety and social phobia.

    Change from baseline in social anxiety symptoms expected between time frames.


  • Social Phobia Scale (SPS) [ Time Frame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63) ] [ Designated as safety issue: No ]

    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 [ Time Frame: pretreatment (week 0). ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63) ] [ Designated as safety issue: No ]

    Measure depression.

    Change from baseline in depressive symptoms expected between time frames.


  • Beck Anxiety Inventory (BAI) [ Time Frame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63) ] [ Designated as safety issue: No ]

    Measure anxiety.

    Change from baseline in anxiety symptoms expected between time frames.


  • Quality of Life Inventory (QOLI) [ Time Frame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63) ] [ Designated as safety issue: No ]

    Measure quality of life.

    Change from baseline in quality of life expected between time frames.



Estimated Enrollment: 48
Study Start Date: August 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cognitive behavior therapy via the internet
Cognitive behavior therapy via the internet with therapist support.
Behavioral: 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.
Active Comparator: Attentional retraining
Attentional retraining as described by Nader Amir.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312571

Locations
Sweden
Department of Psychology, Umeå University
Umeå, Västerbotten, Sweden, 901 87
Sponsors and Collaborators
Umeå University
Uppsala University
Investigators
Study Director: Per Carlbring, Professor Umeå University
Study Chair: Gerhard Andersson, Professor Linköping University
Study Chair: Tomas Furmark, Ass. professor Uppsala University
Study Chair: Carl-Johan Olsson, Post doc Umeå center for Functional Brain Imaging
Study Chair: Owe Bodlund, Ass. professor NUS
Study Chair: Kristoffer NT Månsson, Student Umeå University
  More Information

Additional Information:
No publications provided

Responsible Party: Per Carlbring, PhD, Professor, Umeå University
ClinicalTrials.gov Identifier: NCT01312571     History of Changes
Other Study ID Numbers: 2010-185-31 M
Study First Received: August 31, 2010
Last Updated: June 12, 2012
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014