Social anxiety symptoms Mental and Behavioural Disorders
Conditions
Interventions
This procedure was already described in the pre-registration of a preliminary study (registration number: ISRCTN64408867) conducted within the same project (POTION project, serial number 824153). Give
Sponsors
Karolinska Institute
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 19/12/2022: 1. Aged between 18 and 35 years 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 5. Normosmic as screened with Sniffin’ Stick test 6. No pregnancy 7. Non-smokers _____ Previous inclusion criteria: 1. Aged between 18 and 35 years 2. Female gender 3. A score over 50 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 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, presence of severe psychotic symptoms (i.e. hallucinations and/or delusions) 7. Presence of suicidal thoughts 8. Incapability to understand and to give an informed consent for the experiment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anxiety symptoms measured by the State-Trait Anxiety Inventory (STAI) at baseline, at the end of day 1, at the beginning of day 2, after mindfulness intervention at day 2, after stress induction and during day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Awareness of social odors measured using the Social Odor Scale (SOS) at baseline during day 1 2. Heart rate variability measured using ECG at baseline, during treatment and post-treatment of day 1; at baseline, during treatment, post-treatment and post-stress induction of day 2. 3. Skin conductance measured using electrodermal activity (EDA) at baseline, during treatment and post-treatment of day 1; at baseline, during treatment, post-treatment and post-stress induction of day 2 4. 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 at baseline during day 1 5. State mindfulness assessed with the State Mindfulness Scale (SMS) at post-treatment during day 2 6. Manipulation check of anxiety induction (after stress induction): Social anxiety; Task-related anxiety; Task importance. Done after the stress induction during day 2 7. Perceived helpfulness of the intervention (0 to 10 rating scale from “not useful at all” to “very useful”) measured after the stress induction on day 2 8. Intensity, pleasantness and familiarity of the odor (each one on a scale from 1 to 10 from “not at all” to “very much”) measured after the stress induction on day 2 9. Number of drop-outs in each odor group measured at the follow-up online session during day 3 | — |
Countries
Italy
Outcome results
None listed