Changing catastrophic scenarios in imagery in people with severe social anxiety
| ISRCTN | ISRCTN14600708 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14600708 |
| Secondary identifying numbers | ECP-134; 04_11_2013 |
- Submission date
- 14/02/2020
- Registration date
- 17/02/2020
- Last edited
- 16/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Social anxiety disorder, also called social phobia, is a long-lasting and overwhelming fear of social situations. It's a common problem that usually starts during the teenage years. Social anxiety is more than shyness. It's an intense fear that does not go away and affects everyday activities, self-confidence, relationships and work or school life.
Patients with social anxiety disorder (SAD) do not only experience dysfunctional negative thoughts in anxiety-provoking social interactions but recent studies show that they also suffer from recurrent, intrusive, negative images. A study showed in most patients with social anxiety disorder these images were linked to past social traumatic memories. Recently a treatment technique ‘imagery rescripting’ is applied to update these traumatic memories. This resulted in a strong decrease in social anxiety complaints. However, rescripting of the intrusive, negative images itself, the future-oriented catastrophic scenarios or ‘flashforwards’ has not been studied yet. It is possible this is an even more direct way to treat anxiety in social situations.
The research question is whether imagery rescripting focused on flashforwards can reduce social anxiety symptoms in patients with social anxiety disorder.
Who can participate?
Patients with a diagnosis of social anxiety disorder, IQ above 80, and able to read and write in Dutch or English.
What does the study involve?
Patients with social anxiety disorder follow treatment with imagery rescripting focused on flashforwards: images of future
catastrophic scenarios of social interaction. The treatment consists of two sessions of 60 minutes per week with a total of 12 sessions. At waitlist, pre-treatment, post-treatment, 1-month follow-up and 6-month follow-up patients fill out various questionnaires to assess their symptom level. Prior to each session and twice a week during waiting-list patients fill out 2 short questionnaires on social anxiety complaints and 1 that comprised idiosyncratic social situations.
Sessions were audio-recorded.
What are the possible benefits and risks of participating?
The possible benefits of participating of this study are that the treatment will reduce social anxiety disorder complaints. There are no risks involved in participating in this study. The disadvantage of participating in this study is the time it requires to participate in the interviews and fill out the questionnaires.
Where is the study run from?
1. Virenze-Riagg Maastricht (Netherlands)
2. Vincent van Gogh Instituut (Netherlands)
When is the study starting and how long is it expected to run for?
December 2013 to September 2018
Who is funding the study?
Maastricht University (Netherlands)
Who is the main contact?
Prof Marleen Rijkeboer
marleen.rijkeboer@maastrichtuniversity.nl
Contact information
Scientific
Postbox 616
Maastricht
6200 MD
Netherlands
 ORCID ID |
0000-0002-3083-6891 |
|---|---|
| Phone | +31 433882222 |
| marleen.rijkeboer@maastrichtuniversity.nl |
Study information
| Study design | Interventional case series |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Case series |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Flashforward Rescripting in Social Anxiety Disorder |
| Study acronym | FFinSAD |
| Study objectives | A treatment regimen focused on flashforward rescripting can substantially change social anxiety symptoms in patients with Social Anxiety Disorder (SAD) |
| Ethics approval(s) | Approved 15/09/2014, Maastricht University Ethics Committee Psychology (ECP) (Ethics Review Committee Psychology and Neuroscience (ERCPN), Maastricht University, Department of the Faculty of Psychology and Neuroscience, Postbox 616, 6200 MD Maastricht, Netherlands; +31 43 3884008; no email provided), ref: ECP-134; 04_11_2013 |
| Health condition(s) or problem(s) studied | Social anxiety disorder |
| Intervention | This study has a case-study design, with a randomized waitlist between 2 and 7 weeks. Patients were randomised over the number of weeks of their waitlist period. The randomization list was provided by a computerized randomization program. Patients with social anxiety disorder (n=6) followed treatment with imagery rescripting focused on flashforwards: images of future catastrophic scenarios of social interaction. The treatment consists of two sessions of 60 minutes per week with a total of 12 sessions. At waitlist, pre-treatment, post-treatment, 1-month follow-up and 6-month follow-up patients fill out various questionnaires to assess their symptom level. Prior to each session and twice a week during waiting-list patients fill out 2 short questionnaires on social anxiety complaints and 1 that comprised idiosyncratic social situations. Sessions were audio-recorded. Flashforward Rescripting: 60 minutes sessions twice a week, with a total of 12 sessions depending on the progress of treatment. Three types of imagery exercises are provided, all focus on future catastrophic scenarios. |
| Intervention type | Behavioural |
| Primary outcome measure | At waitlist, pre-treatment, post-treatment, 1-month follow-up and 6-month follow-up: 1. The Social Interaction Anxiety Scale (SIAS) 2. The Social Performance Scale (SPS) 3. Situational anxiety severity and avoidance measured using the idiosyncratic rating scale |
| Secondary outcome measures | At waitlist, pre-treatment, post-treatment, 1-month follow-up and 6-month follow-up: 1. The shortened Social Phobia and Anxiety Inventory (SPAI-18) 2. Center for Epidemiologic Studies Depression scale (CES-D) 3. Self-focused Attention scale (SFA) 4. Social Phobic Beliefs (SPB) 5. Subtle Avoidance Frequency Examination (SAFE) 6. Remoralisation measured using the Remoralisation Questionnaire 7. Subjective Happiness Scale (SHS) 8. The avoidant personality items of the Personality Disorders Questionnaire (ADP-IV) |
| Overall study start date | 01/06/2013 |
| Completion date | 01/09/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 6 |
| Total final enrolment | 6 |
| Key inclusion criteria | 1. Diagnosis of Social Anxiety Disorder 2. IQ above 80 3. Able to read and write in Dutch or English |
| Key exclusion criteria | 1. Diagnosis of substance abuse disorder 2. Diagnosis of Psychotic Disorder 3. Diagnosis of Bipolar Disorder 4. Acute Suicidality |
| Date of first enrolment | 16/12/2013 |
| Date of final enrolment | 01/09/2018 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Maastricht
6221 BD
Netherlands
Venray
5803 AC
Netherlands
Sponsor information
University/education
Postbox 616
Maastricht
6200 MD
Netherlands
| Phone | +31 433882222 |
|---|---|
| d.vanderschuren@maastrichtuniversity.nl | |
| Website | https://www.maastrichtuniversity.nl/ |
"ROR" |
https://ror.org/02jz4aj89 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Maastricht University, UM
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Editorial Notes
16/03/2021: The intention to publish date was changed from 01/09/2020 to 01/01/2022.
17/02/2020: Trial’s existence confirmed by Maastricht University Ethics Committee Psychology (ECP)
