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Attention training in Social Phobia/Social anxiety disorder
ISRCTN ISRCTN01715124
DOI 10.1186/ISRCTN01715124
ClinicalTrials.gov identifier
EudraCT number
Public title Attention training in Social Phobia/Social anxiety disorder
Scientific title Attention training in Social Phobia/Social anxiety disorder: a single-centre, randomised controlled interventional trial
Acronym SOFIEsjunio
Serial number at source 2009-0222
Study hypothesis The aim of this research is to evaluate the effectiveness of an Internet-based attention modification program in the treatment of social phobia/social anxiety disorder. This project will use a randomised controlled trial to assess:
1. Whether a self-administered Internet-based attention modification training program is effective in reducing symptoms of social phobia, anxiety, and depression and increasing quality of life
2. Whether instructions to induce arousal immediately before the training optimizes the effectiveness
Lay summary Not provided at time of registration
Ethics approval Central Ethical Review Board (Centrala etikprövningsnämnden) Umeå, Sweden (Reference number: 2010-307-31Ö)
Study design Single-centre randomised controlled interventional trial
Countries of recruitment Sweden
Disease/condition/study domain Social phobia/social anxiety disorder
Participants - inclusion criteria 1. A Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM–IV) diagnosis of social anxiety disorder according to the Social Phobia Screening Questionnaire
2. Scoring below 31 on the self-rated version of the Montgomery and Åsberg Depression Rating Scale depression scale and below 4 on the suicide item of this scale (to prevent the inclusion of individuals in strong need of specialist consultation)
3. Not undergoing any other psychological treatment during the study period
4. If prescribed drugs for anxiety or depression, the dosage had to be constant for 2 months before the treatment onset and kept constant throughout the study
5. Being at least 18 years old
6. Living in Sweden
7. Having access to a computer with internet connection
8. Not having a having a significant vision impairment
9. Not admitting another serious or dominant disorder (e.g. psychosis, substance misuse) that could be expected to influence the outcome of the study
10. Having a primary diagnosis of social anxiety disorder according to the Structured Clinical Interview for DSM–IV Axis I Disorders
Participants - exclusion criteria Does not meet inclusion criteria
Anticipated start date 01/01/2007
Anticipated end date 01/01/2012
Status of trial Completed
Patient information material www.kbt.info/sofie9 (Swedish)
Target number of participants 160
Interventions 1. Study 1:
1.1. Participants were either assigned to the real attention modification program or to a placebo version
1.2. Everything was identical in both conditions except for the location of the probe
1.3. Hence, in both conditions a trial began with a fixation cross (“+”) presented in the centre of the screen for 500ms
1.4. Immediately following termination of the fixation cue, the web based flash program in full screen mode presented two faces of the same person, one face on the top and one on the bottom, with each pair displaying one of two combinations of emotions
1.5. Either neutral-disgust, or neutral-neutral
1.6. After presentation of the faces for 500 ms, a probe appeared in the location of one of the two faces
1.7. Participants were instructed to indicate whether the probe was the letter E or F by pressing the corresponding arrow on the keyboard using their dominant hand
1.8. The probe remained on the screen until a response was given, after which the next trial began
1.9. During each session 160 trials with various combinations of probe type (E/F), probe position (top/bottom), face type (neutral/disgust) and person (four male/four female were presented)
1.10. In the real condition the probe was always presented (100% of the trials) at the ocation of the neutral face if there also was a disgust face present (n=128 trials)
1.11. In contrast, in the placebo condition the location of the probe could not be predicted since the probe appeared with equal frequency in the position of the disgust face and the neutral face
1.12. Participants were encouraged to do the training on Tuesdays and Thursdays
1.13. They received an email and a SMS reminding them to do the training on the training days
1.14. If a session was missed a reminder was sent the following day
1.15. The participants could only do the training between 5 AM and 11 PM, and there should always be least one day between the sessions.
2. Study 2:
2.1. Half the participants were randomised to either an internet-based tailored 9-week treatment for social phobia/social anxiety disorder with therapist support or to an attention modification as described above but with the addition of a specific instruction
2.2. The instruction was that immediately before starting the attention modification training he/she should invoke arousal by doing something anxiety provoking
Primary outcome measure(s) 1. Study part 1:
Liebowitz Social Anxiety Scale self-report evaluated at three time points: pre, after week 1, after week 2, after week 3, post and 4 month follow-up
2. Study part 2:
Liebowitz Social Anxiety Scale self-report evaluated at three time points: pre, post and 4 month follow-up
Secondary outcome measure(s) 1. Social Phobia Scale
2. Social Interaction Anxiety Scale
3. Social Phobia Screening Questionnaire
4. Beck Anxiety Inventory
5. Montgomery Asberg Depression Rating Scale
6. Quality of Life Inventory
7. Evaluated at three time points: pre, post and 4 month follow-up.
Sources of funding Swedish Council for Working Life and Social Research (Sweden) (grant number: 2009-0222)
Trial website http://www.sofie9.nu/
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22731889
Contact name Prof  Per  Carlbring
  Address Institute for Psychology
Umeå University
  City/town Umeå
  Zip/Postcode 90187
  Country Sweden
  Tel +46 (0)90 786 7833
  Fax +46 (0)90 786 7833
  Email per.carlbring@psy.umu.se
Sponsor Swedish Council for Working Life and Social Research (Sweden)
  Address FAS
Box 2220
  City/town Stockholm
  Zip/Postcode 10315
  Country Sweden
  Tel +46 (0)87 754 070
  Fax +46 (0)87 754 075
  Email fas@fas.se
  Sponsor website: http://www.fas.se
Date applied 08/05/2011
Last edited 08/10/2012
Date ISRCTN assigned 20/05/2011
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