Social anxiety symptoms Mental and Behavioural Disorders
Conditions
Interventions
This procedure has already been described in the pre-registration of a preliminary study (registration number: https://www.isrctn.com/ISRCTN64408867) and a pilot study (registration number: https://ww
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 35 years old 2. Female gender 3. A score over 30 on the Liebowitz Social Anxiety Scale in its self-report formulation (LSAS-SR) 4. A confirmation of the disorder during a face-to-face interview (SCID 5-CV) 5. Normosmic as screened with Sniffin’ Stick test 6. No pregnancy 7. Non-smokers
Exclusion criteria
Exclusion criteria: 1. Chronic rhinitis or other conditions that may affect the ability to perceive odors 2. Breastfeeding 3. Presence of other mental disorders (including substance abuse disorders) apart from major depression, chronic depression, minor depression, or dysphoria and social anxiety disorder 4. Presence of any severe somatic or neurological conditions 5. Use of psychotropic drugs at the moment of the recruitment (including antidepressants, antipsychotics, anxiolytics and mood stabilizers) 6. Presently undergoing psychological therapy, 7. Presence of severe psychotic symptoms (i.e., hallucinations and/or delusions) 8. Presence of suicidal thoughts 9. Incapability to understand and to give an informed consent for the experiment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anxiety symptoms measured using the State-Trait Anxiety Inventory (STAI) at baseline, pre-treatment (after the beginning of the stress induction) and post-treatment of day 1, at pre-treatment, post-treatment and after the end of the stress induction of day 2, and during day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Heart rate variability measured using ECG at baseline (3 min), during treatment and post-treatment (3 min) of day 1; at baseline (3 min), during treatment and post-treatment (3 min) of day 2 2. Skin conductance measured using electrodermal activity (EDA) at baseline (3 min), during treatment and post-treatment (3 min) of day 1; at baseline (3 min), during treatment and post-treatment (3 min) of day 2 3. Awareness of social odors measured using the Social Odor Scale (SOS) at baseline during day 1 4. Presence and level of social anxiety symptoms are measured using recruitment and baseline of day 1 5. Presence of depressive symptoms measured using the Patient Health Questionnaire (PHQ-9) at baseline during day 1 6. Previous experience with mindfulness meditation (answering the question “Do you practice, or have you ever practiced mindfulness meditation?”, if yes there is a follow-up question “how often do you practice?” with possible answers “not currently”, “practice less than one time a week”, “less than three times a week”, “practice three times a week or more”, “practice every day”) measured using baseline during day 1 7. State mindfulness measured using the State Mindfulness Scale (SMS) post-treatment on day 1 and post-treatment on day 2 8. Overall changes in mood during the trial measured using the short form of the Positive and Negative Affect Schedule (PANAS) at baseline and pre-treatment of day 1 and post-treatment and after the end of the stress induction of day 2 9. Intensity, pleasantness and familiarity of the odor (each one on a scale from 1 to 10 from “not at all” to “very much”) on post-treatment on day 2 10. Perceived helpfulness of the intervention (0 to 10 rating scale from “not useful at all” to “very useful”) on day 3 or in case of drop-out 11. Acceptability questionnaire consisting of 10 questions asking to rate the levels of stress during different parts of the trial, the likelihood of repeating the intervention during the second day, the lik | — |
Countries
Italy
Contacts
Public ContactVladimir Carli
Outcome results
None listed