Attention training in Social Phobia/Social anxiety disorder

ISRCTN	ISRCTN01715124
DOI	https://doi.org/10.1186/ISRCTN01715124
Protocol serial number	2009-0222
Sponsor	Swedish Council for Working Life and Social Research (Sweden)
Funder	Swedish Council for Working Life and Social Research (Sweden) (grant number: 2009-0222)

Submission date: 08/05/2011
Registration date: 20/05/2011
Last edited: 20/03/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Per Carlbring
Scientific

Institute for Psychology
Umeå University
Umeå
90187
Sweden

Phone	+46 (0)90 786 7833
Email	per.carlbring@psy.umu.se

Study information

Primary study design	Interventional
Study design	Single-centre randomised controlled interventional trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Attention training in Social Phobia/Social anxiety disorder: a single-centre, randomised controlled interventional trial
Study acronym	SOFIEsjunio
Study objectives	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(s)	Central Ethical Review Board (Centrala etikprövningsnämnden) Umeå, Sweden (Reference number: 2010-307-31Ö)
Health condition(s) or problem(s) studied	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
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
Key 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.
Completion date	01/01/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	160
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/01/2007
Date of final enrolment	01/01/2012

Locations

Countries of recruitment

Sweden

Study participating centre

Institute for Psychology

Umeå
90187
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	25/06/2012		Yes	No
Results article	results	01/02/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

20/03/2020: Internal review.