Virginia Commonwealth University Stress Reduction Study
2 augusti 2022 uppdaterad av: Virginia Commonwealth University
This research study seeks to understand how stress reduction training influences neural responses (brain activation) and behavior related to stress, including emotions and reactions to social conflict.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The full research project will be conducted over approximately 2-3 weeks, and will consist of two data collection sessions, one before and one after a 14-day stress reduction training course conducted via a smartphone that participants provide.
This course entails instructor-facilitated stress reduction exercises previously shown to reduce stress and improve well-being.
Participants will be randomly assigned to a mindfulness course or a cognitive reappraisal course.
Both of these courses -mindfulness training (MT) and cognitive reappraisal training (RT) - involve expert-facilitated mental wellness techniques.
MT emphasizes mindfulness-based techniques to reduce stress and promote wellbeing, whereas CT emphasizes reframing and reappraisal techniques to reduce stress and promote well-being.
Studietyp
Interventionell
Inskrivning (Faktisk)
72
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Virginia
-
Richmond, Virginia, Förenta staterna, 23298
- Virginia Commonwealth University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 88 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Stable medication regiment for 8 weeks prior to enrollment if taking antidepressant or anxiolytic medications. (will not be advertised but screened)
- Free of major, uncorrected sensory impairments and cognitive deficits
- Free of a certain psychiatric disorders or history thereof; specifically, a new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months, report a hospitalization over the last 3 months, report current drug abuse (e.g., recreational drug use, alcohol intake in excess of 2 drinks per day).
- Adults aged 18 - 55 years of age
- Right hand dominant (will not be advertised but screened)
- Personal SmartPhone (Android or iOS operating systems).
- Naive to meditation practice (will not be advertised but screened)
- At least a moderate level of perceived stress (scale score > 5 on the 4-item Perceived Stress Scale (PSS; reflects above-average perceived stress)
Exclusion Criteria:
- left-handed
- are unwilling or unable to complete study assessments or treatments
- report a new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months
- report a hospitalization over the last 3 months
- report current drug abuse (e.g., recreational drug use, smoke more than � pack per day, alcohol intake in excess of 2 drinks per day)
- are prisoners
- no personal SmartPhone (Android or iOS operating systems)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Mindfulness
|
Participants will listen to 20-minute lessons each day for 14 days plus complete brief (3 to 10 minute) exercises daily via their personal smartphone.
Each course will involve mental exercises to reduce stress in daily life, along with direct instruction from the course leader to help in learning and applying the stress reduction techniques.
|
|
Aktiv komparator: Cognitive reappraisal
|
Participants will listen to 20-minute lessons each day for 14 days plus complete brief (3 to 10 minute) exercises daily via their personal smartphone.
Each course will involve mental exercises to reduce stress in daily life, along with direct instruction from the course leader to help in learning and applying the stress reduction techniques.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Functional near-infrared spectroscopy (fNIRS) hemodynamic signal change
Tidsram: Baseline and 16 weeks
|
Proportion of participants who show a statistically significant change in regional specificity, as measured by fNIRS-recorded blood oxygenation representing markers of emotion reactivity and regulation during observation of video stimuli.
|
Baseline and 16 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in anger response
Tidsram: Baseline and 16 weeks
|
The Anger subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess s the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli.
Lower scores indicate less anger and more emotion downregulation.
Higher scores would indicate more anger and less emotion downregulation.
|
Baseline and 16 weeks
|
|
Change in disgust response
Tidsram: Baseline and 16 weeks
|
The Disgust subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli.
Lower scores indicate less disgust and more emotion downregulation.
Higher scores would indicate more disgust and less emotion downregulation.
|
Baseline and 16 weeks
|
|
Change in fear response
Tidsram: Baseline and 16 weeks
|
The Fear subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli.
Lower scores indicate less fear and more emotion downregulation.
Higher scores would indicate more fear and less emotion downregulation.
|
Baseline and 16 weeks
|
|
Change in anxiety response
Tidsram: Baseline and 16 weeks
|
The Anxiety subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli.
Lower scores indicate less anxiety and more emotion downregulation.
Higher scores would indicate more anxiety and less emotion downregulation.
|
Baseline and 16 weeks
|
|
Change in sadness response
Tidsram: Baseline and 16 weeks
|
The Sadness subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli.
Lower scores indicate less sadness and more emotion downregulation.
Higher scores would indicate more sadness and less emotion downregulation.
|
Baseline and 16 weeks
|
|
Change in intergroup attitudes
Tidsram: Baseline and 16 weeks
|
The Beliefs about Groups survey will be used to assess explicit intergroup attitudes.
Participants answer 4 questions using a scale from 1 to 6. Higher scores indicate poorer attitude outcomes.
|
Baseline and 16 weeks
|
|
Behavioral willingness to participate in a dyad-based future experiment
Tidsram: 16 weeks
|
Number of participants who express willingness to participate in a dyad-based future experiment using a scale from 1 to 5. Higher scores indicate greater willingness or preference to participate.
|
16 weeks
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Hadley Rahrig, M.S., Virginia Commonwealth University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
19 juli 2021
Primärt slutförande (Faktisk)
31 juli 2022
Avslutad studie (Faktisk)
31 juli 2022
Studieregistreringsdatum
Först inskickad
4 december 2019
Först inskickad som uppfyllde QC-kriterierna
4 december 2019
Första postat (Faktisk)
9 december 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 augusti 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 augusti 2022
Senast verifierad
1 augusti 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- HM20015897
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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