NCT05232422

Brief Summary

It has been indicated in recent research that Mindfulness-based interventions may offer possibilities of promoting human stress processing and reducing anxiety or depression. They also appear to positively influence cognitive performance. One mindfulness-based intervention next to a variety of others is yoga, a combination of physical, spiritual, and mental practices of Indian origin that arose to alleviate suffering and enhance psychological and physical well-being. The goal of the study is to find out how Hatha Yoga, the most common form of yoga, consisting of stretches, yoga postures and conscious breathing, affects emotional and cognitive processes. An essential part of yoga seems to be the increase of self-regulation and consequently the regulation of stress processing and of cognitive processes in general. Building on the Attentional Control Theory, it is hypothesized that anxiety and stress limit inhibitory function - the ability to block distracting, irrelevant information - and also impair the shifting of attention that normally accompanies smooth switching between different tasks and their processing requirements. In a randomized controlled trial with an experimental and a waiting group, the investigators aim to investigate whether active participation in a 60-minute hatha yoga class (intervention) at least three times a week for two months leads to less experienced stress and improves inhibition and attentional shifting. The intervention period with pre- and postmeasurements is expected to start in early January 2022 and end in December 2022. To measure the effect of the intervention, the investigators use three experimental test tasks, one each to examine inhibition function (here, measured by distractor interference in visual search), switching between different tasks or sensory modalities (here, collected by comparing performance after passagewise alternation vs. repetition of a sound vs. light discrimination), and alternation between different stimulus features (here, determined by comparing passagewise repetition vs. alternation of target stimulus color in visual search). In all of the experimental tasks, behavioral data (reaction times and error rates) and, in two, additional electrophysiological measures (event-related potentials) are collected using EEG. To investigate the role of stress the investigators use questionnaires as well as biological stress markers from saliva. In addition, participants will receive a link to questionnaires to complete by the start of the yoga intervention. On top, trait mindfulness will be examined as a potential mechanism underlying the effects of yoga practice on attention and stress. The subjects' trait mindfulness will be assessed by questionnaire as well.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2022

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

December 16, 2021

Last Update Submit

May 8, 2023

Conditions

Keywords

anxietystressmindfulnesshatha yogaattentional control settingsattentional control theoryinhibitionshiftingtask switchingcognitionattention

Outcome Measures

Primary Outcomes (7)

  • Change in switching between Attentional Control Sets

    Switching between Attentional Control Sets will be measured by switching costs, meaning longer response times (RTs) for trial-by-trial switches than repetitions of a task, and hit rate. Both variables will be combined to assess the change in ability to switch between processing different features which is expected in the intervention group in comparison to the waiting control group.

    Baseline plus 8 weeks

  • Change in task switching between modalities

    Task switching between modalities will be measured by speed regarding switches between modalities and error rate in the respective (auditive and visual) modalities. The ability to switch between different modalities is expected to have changed in the intervention group in comparison to the waiting control group. Switching speed will be analyzed by using steady-state visual evoked potentials and auditory steady-state potentials (both measured with EEG) with tagged frequencies. Switching speed and error rate will be combined to report task switching ability between modalities.

    Baseline plus 8 weeks

  • Change in inhibition function

    Inhibition function will be measured by response time, hit rate and number of false alarms. In addition, dependent electrophysiological variables will be the mean amplitudes of two event-related potential components, named N2-posterior contralateral (N2pc) and distractor positivity (Pd). Named variables will be combined to assess the change in inhibition function that is expected in the intervention group vs. the control group.

    Baseline plus 8 weeks

  • Change in attention shifting

    Attention shifting will be measured by an event-related potential named N2-posterior-contralateral (N2pc) with EEG. When target-similar items are processed, N2pc should be different in the intervention group than in the control group.

    Baseline plus 8 weeks

  • Change in self-reported stress

    Self-reported stress will be measured with the Perceived Stress Scale (PSS), ranging from 0 to 40 points, with higher scores indicating higher perceived stress.

    Baseline plus 8 weeks

  • Change in physiological stress

    Physiological stress levels will be measured by biological markers (cortisol and alpha-amylase). Both are expected to have changed in the intervention group in comparison to the waitlisted control group, indicated by changed cortisol levels as well as changed alpha-amylase concentration. Both cortisol and alpha-amylase levels will be combined to report physiological stress.

    Baseline plus 8 weeks

  • Change in self-reported anxiety

    Self-reported anxiety will be measured with the State-Trait-Anxiety Inventory (STAI) form Y, ranging from 20 to 80, with higher scores correlating with higher anxiety. Self-reported anxiety is expected to have changed in the intervention group in comparison to the waitlisted control group.

    Baseline plus 8 weeks

Study Arms (2)

Yoga-Intervention Group

EXPERIMENTAL

This arm will participate in a hatha yoga course for a time period of 8 weeks with a frequency of at least 3 up to 5 times per week. Further they will participate in the pre- as well as the post-tests before and after the intervention.

Behavioral: Hatha yoga course

Waiting Control Group

NO INTERVENTION

For the first 8 weeks of the study this group will not receive any intervention. After the second measurement is completed they will get the possibility to participate in a hatha yoga course as well. Further they will participate in the pre- as well as the post-tests around the same time as the Yoga-Intervention group.

Interventions

Participants will join a free hatha yoga course, conducted by a professional yoga teacher, over a time period of eight weeks with a frequency of at least three up to five times a week. The quality of the implementation of the intervention will be checked through post-monitoring by short questionnaires to be filled out by participants.

Yoga-Intervention Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy individual without mental or neurological disorder or disease
  • years

You may not qualify if:

  • Insufficient comprehension of the German language
  • Current mental or neurological disorders (except eating disorders)
  • Current or regular yoga practice in the past
  • Uncorrected visual or auditive impairment
  • Scull fractures or head concussions within the last 6 weeks
  • Non-existence of a vaccination or convalescence certificate of COVID-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vienna

Vienna, 1070, Austria

Location

Related Publications (9)

  • Busel C, Pomper U, Ansorge U. Capture of attention by target-similar cues during dual-color search reflects reactive control among top-down selected attentional control settings. Psychon Bull Rev. 2019 Apr;26(2):531-537. doi: 10.3758/s13423-018-1543-5.

    PMID: 30402797BACKGROUND
  • Eysenck MW, Derakshan N, Santos R, Calvo MG. Anxiety and cognitive performance: attentional control theory. Emotion. 2007 May;7(2):336-53. doi: 10.1037/1528-3542.7.2.336.

    PMID: 17516812BACKGROUND
  • Norcia AM, Appelbaum LG, Ales JM, Cottereau BR, Rossion B. The steady-state visual evoked potential in vision research: A review. J Vis. 2015;15(6):4. doi: 10.1167/15.6.4.

    PMID: 26024451BACKGROUND
  • Sawaki R, Luck SJ. Capture versus suppression of attention by salient singletons: electrophysiological evidence for an automatic attend-to-me signal. Atten Percept Psychophys. 2010 Aug;72(6):1455-70. doi: 10.3758/APP.72.6.1455.

    PMID: 20675793BACKGROUND
  • Monsell S. Task switching. Trends Cogn Sci. 2003 Mar;7(3):134-140. doi: 10.1016/s1364-6613(03)00028-7.

    PMID: 12639695BACKGROUND
  • de Jong R, Toffanin P, Harbers M. Dynamic crossmodal links revealed by steady-state responses in auditory-visual divided attention. Int J Psychophysiol. 2010 Jan;75(1):3-15. doi: 10.1016/j.ijpsycho.2009.09.013. Epub 2009 Oct 9.

    PMID: 19819271BACKGROUND
  • Saupe K, Schroger E, Andersen SK, Muller MM. Neural mechanisms of intermodal sustained selective attention with concurrently presented auditory and visual stimuli. Front Hum Neurosci. 2009 Nov 30;3:58. doi: 10.3389/neuro.09.058.2009. eCollection 2009.

  • Szaszko B, Schmid RR, Pomper U, Maiworm M, Laiber S, Lange MJ, Tschenett H, Nater UM, Ansorge U. Testing the impact of hatha yoga on task switching: a randomized controlled trial. Front Hum Neurosci. 2024 Nov 5;18:1438017. doi: 10.3389/fnhum.2024.1438017. eCollection 2024.

  • Szaszko B, Schmid RR, Pomper U, Maiworm M, Laiber S, Tschenett H, Nater UM, Ansorge U. The influence of hatha yoga on stress, anxiety, and suppression: A randomized controlled trial. Acta Psychol (Amst). 2023 Nov;241:104075. doi: 10.1016/j.actpsy.2023.104075. Epub 2023 Nov 4.

MeSH Terms

Conditions

Inhibition, PsychologicalAnxiety Disorders

Condition Hierarchy (Ancestors)

BehaviorMental Disorders

Study Officials

  • Ulrich Ansorge, Univ.-Prof. Dr.

    University of Vienna

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A pretest-posttest design is planned, with the pre- as well as the posttests each split into two sessions. Pretests are scheduled in the weeks before the intervention, posttests relatively soon after the intervention. At both data collection times, stress as well as cognitive performance (namely of attention) will be recorded in both groups (experimental group, waiting control group). While the experimental group participates in a 60-minute hatha yoga intervention at least three times a week for 8 weeks, the wait-list control group does not receive the yoga intervention until after the end of data collection.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 16, 2021

First Posted

February 9, 2022

Study Start

January 15, 2022

Primary Completion

August 10, 2022

Study Completion

August 10, 2022

Last Updated

May 9, 2023

Record last verified: 2023-05

Locations