Attention training in Social Phobia/Social anxiety disorder
| ISRCTN | ISRCTN01715124 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01715124 |
| Secondary identifying numbers | 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
Scientific
Institute for Psychology
Umeå University
Umeå
90187
Sweden
| Phone | +46 (0)90 786 7833 |
|---|---|
| per.carlbring@psy.umu.se |
Study information
| Study design | Single-centre randomised controlled interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | http://www.kbt.info/sofie9 (Swedish) |
| 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 | 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 study start date | 01/01/2007 |
| Completion date | 01/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
90187
Sweden
Sponsor information
Swedish Council for Working Life and Social Research (Sweden)
Research council
Research council
FAS
Box 2220
Stockholm
10315
Sweden
| Phone | +46 (0)87 754 070 |
|---|---|
| fas@fas.se | |
| Website | http://www.fas.se |
"ROR" |
https://ror.org/02d290r06 |
Funders
Funder type
Research council
Swedish Council for Working Life and Social Research (Sweden) (grant number: 2009-0222)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Swedish Council for Working Life and Social Research, FAS
- Location
- Sweden
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
20/03/2020: Internal review.
