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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01463137
Other study ID # SOFIE-11
Secondary ID
Status Completed
Phase N/A
First received October 27, 2011
Last updated October 29, 2016
Start date October 2011
Est. completion date January 2013

Study information

Verified date October 2016
Source Umeå University
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

A study investigating six different versions of a computerized attention bias modification internet program in the treatment of social phobia / social anxiety disorder.


Description:

Previous studies have shown that individuals with social phobia have attention biases, often focusing on aversive stimuli or avoiding aversive stimuli. Computerized training programs have been developed to implicitly direct the users attention towards a neutral, non-threatening stimuli. In this study, such a program will be compared with a program that implicitly directs the users' attention towards threatening cues. Pre/post-measurements will be compared in a sample of individuals that meet diagnostic criteria of Social Anxiety Disorder. Participants will be randomized to one of three groups, receiving one of the two variants of the attention bias modification program or a control training program.


Recruitment information / eligibility

Status Completed
Enrollment 129
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 100 Years
Eligibility 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).

- Comorbidity is allowed, but social phobia must be the primary diagnosis.

Exclusion Criteria:

- Below 18 years old.

- Individuals who are suicide prone will be excluded from the study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Attention bias modification
All arms will consist of 10 minutes of training in front of a computer screen (192 trials) once a day for 14 days.

Locations

Country Name City State
Sweden Department of Psychology, Umeå University Umeå Västerbotten

Sponsors (1)

Lead Sponsor Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Boettcher J, Leek L, Matson L, Holmes EA, Browning M, MacLeod C, Andersson G, Carlbring P. Internet-based attention bias modification for social anxiety: a randomised controlled comparison of training towards negative and training towards positive cues. P — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in Liebowitz Social Anxiety Scale self rated version Change from baseline in social anxiety symptoms expected between time frames. pretreatment (week 0), post treatment (week 2), 4 month follow-up No
Secondary Change from baseline in Social Phobia Screening Questionnaire 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 2), 4 month follow-up No
Secondary Change from baseline in Social Interaction Anxiety Scale (SIAS) Change from baseline in social anxiety symptoms expected between time frames. Pretreatment (week 0), post treatment (week 2), 4 month follow-up No
Secondary Change from baseline in Social Phobia Scale (SPS) Change from baseline in social anxiety symptoms expected between time frames. Pretreatment (week 0), post treatment (week 2), 4 month follow-up No
Secondary Change from baseline in Montgomery Åsberg Depression Rating Scale (MADRS-S) Measure depression.
Change from baseline in depressive symptoms expected between time frames.
Pretreatment (week 0), post treatment (week 2), 4 month follow-up No
Secondary Change from baseline in Quality of Life Inventory (QOLI) Measure quality of life.
Change from baseline in quality of life expected between time frames.
Pretreatment (week 0), post treatment (week 2), 4 month follow-up No
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