Contact information
Type
Scientific
Primary contact
Prof Per Carlbring
ORCID ID
Contact details
Institute for Psychology
Umeå University
Umeå
90187
Sweden
+46 (0)90 786 7833
per.carlbring@psy.umu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2009-0222
Study information
Scientific title
Attention training in Social Phobia/Social anxiety disorder: a single-centre, randomised controlled interventional trial
Acronym
SOFIEsjunio
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
Ethics approval
Central Ethical Review Board (Centrala etikprövningsnämnden) Umeå, Sweden (Reference number: 2010-307-31Ö)
Study design
Single-centre randomised controlled interventional trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
www.kbt.info/sofie9 (Swedish)
Condition
Social phobia/social anxiety disorder
Intervention
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 measures
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.
Overall trial start date
01/01/2007
Overall trial end date
01/01/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. A Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSMIV) 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 DSMIV Axis I Disorders
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/01/2007
Recruitment end date
01/01/2012
Locations
Countries of recruitment
Sweden
Trial participating centre
Institute for Psychology
Umeå
90187
Sweden
Sponsor information
Organisation
Swedish Council for Working Life and Social Research (Sweden)
Sponsor details
FAS
Box 2220
Stockholm
10315
Sweden
+46 (0)87 754 070
fas@fas.se
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Swedish Council for Working Life and Social Research (Sweden) (grant number: 2009-0222)
Alternative name(s)
Swedish Council for Working Life and Social Research, FAS
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Sweden
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22731889
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24373984
Publication citations
-
Results
Carlbring P, Apelstrand M, Sehlin H, Amir N, Rousseau A, Hofmann SG, Andersson G, Internet-delivered attention bias modification training in individuals with social anxiety disorder--a double blind randomized controlled trial., BMC Psychiatry, 2012, 12, 66, doi: 10.1186/1471-244X-12-66.
-
Results
Kuckertz JM, Gildebrant E, Liliequist B, Karlström P, Väppling C, Bodlund O, Stenlund T, Hofmann SG, Andersson G, Amir N, Carlbring P, Moderation and mediation of the effect of attention training in social anxiety disorder, Behav Res Ther, 2014 , 53, 30-40, doi: 10.1016/j.brat.2013.12.003.