Treatment of Social Phobia Over the Internet

NCT01312571 | Completed DMC

• 1 other identifier: 2010-185-31 M
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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)?

Conditions

Social Phobia

Outcome Measures

Primary Outcomes (5)

• 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.

  pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)

• 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.

  pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)

• 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.

  pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)

• Social Interaction Anxiety Scale (SIAS)

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

  pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)

• Social Phobia Scale (SPS)

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

  pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)

Secondary Outcomes (4)

• Variation in genes that have been associated with emotional processing

  pretreatment (week 0).

• Montgomery Åsberg Depression Rating Scale (MADRS-S)

  pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)

• Beck Anxiety Inventory (BAI)

  pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)

• Quality of Life Inventory (QOLI)

  pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)

Study Arms (2)

Cognitive behavior therapy via the internet

ACTIVE COMPARATOR

Cognitive behavior therapy via the internet with therapist support.

Behavioral: Internet-based cognitive behavioural therapy (iCBT)

Attentional retraining

ACTIVE COMPARATOR

Attentional retraining as described by Nader Amir.

Behavioral: Internet-based computerized attention training

Interventions

Internet-based cognitive behavioural therapy (iCBT) 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.

Cognitive behavior therapy via the internet

Internet-based computerized attention training 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.

Attentional retraining

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umeå University: lead
• Uppsala University: collaborator

Study Sites (1)

Department of Psychology, Umeå University

Umeå, Västerbotten County, 901 87, Sweden

Location

Related Publications (3)

• 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.

  PMID: 25781229 BACKGROUND

• 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.

  PMID: 26836415 RESULT

• 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.

  PMID: 24064198 RESULT

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Per Carlbring, Professor

  Umeå University

  STUDY DIRECTOR

• Gerhard Andersson, Professor

  Linkoeping 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: March 10, 2011
• Study Start: August 1, 2010
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

SE (1)