|- candidate number||28245|
|- NTR Number||NTR6845|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-nov-2017|
|- Secondary IDs||CEP16-0923/289 |
|- Public Title||Conditioning of a stress management training to a distinctive scent|
|- Scientific Title||Conditioning of a stress management training to a distinctive scent|
|- ACRONYM||Scent conditioning|
|- hypothesis||The goal of the current study is to examine whether a neutral scent can be conditioned to a stress management training, by examining whether administration of the scent alone can evoke conditioned effects on psychological and physiological stress responses after exposure to acute stress. Primary research question is whether the experimental group will show a lowered stress response after acute stress compared to two combined control groups, consisting of the no-treatment control group and the treatment control group.
|- Healt Condition(s) or Problem(s) studied||Odors, Healthy subjects, Conditioning, Stress Management Training|
|- Inclusion criteria||1. Healthy subjects |
2. Between 18 and 35 years of age
3. Able to understand both Dutch and English
|- Exclusion criteria||1. Regular use of (illegal) drugs including cannabis, habits of heavy drinking (more than 3 glasses of alcohol a day).|
2. The presence of current or recent (< 3 months) serious life events.
3. Serious psychiatric and (acute) somatic disorders, and acute infections that might interfere with the study protocol.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2016|
|- planned closingdate||1-jun-2018|
|- Target number of participants||96|
|- Interventions||A randomized controlled between-subjects design will be applied, consisting of two phases (acquisition phase and test phase), which will take place on two consecutive days at a similar time of the day. Participants are randomly allocated to one of three groups:|
Group 1 (no-treatment control group) will perform a neutral filler task. Group 2 (treatment control group) and 3 (treatment conditioned group) will undergo a stress management training. Before and after the filler task or stress management training, all participants will be exposed to the same distinctive scent for one minute.
Participants in group 1 and 3 will be exposed to the same distinctive
scent as in the acquisition phase. Participants in group 2 will not receive the scent and testing will be done in a different lab in order to avoid conditioning effects. After baseline measures and the scent exposure (in group 1 and 3), a psychosocial stress task will be applied (the Trier Social Stress Test).
|- Primary outcome||The primary outcome is state anxiety (as measured by the Shortened State-Trait Anxiety Inventory-State version (STAI-S-s: Spielberger et al., 1983)) after acute stress compared to the no-treatment control group and the treatment control group combined.|
|- Secondary outcome||Secondary parameters are physiological measures (e.g., heart rate and skin conductance) and self-report measures (e.g., positive and negative affect). |
|- Timepoints||The study consists of two test sessions on two consecutive days at a similar time of day.|
|- Trial web site||n/a|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. A.W.M. Evers|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. A.W.M. Evers|
|- Sponsor/Initiator ||Leiden University|
(Source(s) of Monetary or Material Support)
|- Brief summary||Various studies have shown that scents can be conditioned to pleasant and unpleasant environmental cues, as scents and the association with specific memories are easily formed. Research has also shown that a brief stress management training can have significant positive effects on both psychological and physiological stress responses after exposure to acute stress. In the current study, we aim to investigate whether the administration of a distinctive scent after conditioning of the scent to a stress management training can result in positive psychological and physiological stress response effects after acute stress in a population of healthy adults.
|- Main changes (audit trail)|
|- RECORD||21-nov-2017 - 12-dec-2017|