NCT05133063

Brief Summary

This study will employ a randomized mixed between-within experimental stress-testing protocol design. Physiological responses (blood pressure and pulse) will be recorded throughout a baseline, gratitude induction, standard stress-task and recovery period. Participants will be randomly allocated to the experimental (grateful induction) or control condition (neutral induction). Gratitude will be induced by completing a gratitude letter. Demographics will be measured. Psychosocial and health variables will be measured psychometrically at baseline to assess pre-existing levels and after both manipulations (allocated induction and stress task) to monitor expected change over time between conditions. Stress task is an adapted version of the Trier Stress Testing protocol.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

October 5, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

October 20, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

12 months

First QC Date

October 5, 2021

Last Update Submit

April 24, 2022

Conditions

Outcome Measures

Primary Outcomes (6)

  • Systolic Blood pressure reactivity

    This will be done by taking the mean of the baseline measures and subtracting it from the mean of the stress task measures.

    Measured over the course of the study (1 hour)

  • Diastolic Blood pressure reactivity

    This will be done by taking the mean of the baseline measures and subtracting it from the mean of the stress task measures.

    Measured over the course of the study (1 hour)

  • Heart rate reactivity

    This will be done by taking the mean of the baseline measures and subtracting it from the mean of the stress task measures.

    Measured over the course of the study (1 hour)

  • Systolic Recovery

    This will be done by taking the mean of the baseline measures and subtracting it from the mean of the recovery measures taken after the stress task.

    Measured over the course of the study (1 hour)

  • Diastolic Recovery

    This will be done by taking the mean of the baseline measures and subtracting it from the mean of the recovery measures taken after the stress task.

    Measured over the course of the study (1 hour)

  • Heart Rate Recovery

    This will be done by taking the mean of the baseline measures and subtracting it from the mean of the recovery measures taken after the stress task.

    Measured over the course of the study (1 hour)

Study Arms (2)

Gratitude intervention

EXPERIMENTAL

Participants will complete a gratitude letter where they spend eight minutes writing a letter of gratitude. The individual writes about his feelings of gratitude through a letter, based on a written instruction.

Behavioral: Gratitude letter

Control intervention.

ACTIVE COMPARATOR

Participants spend eight minutes writing a note describing the lab in which the study is being run.

Behavioral: Control intervention

Interventions

Participants are given the following instructions: Think of someone in your life who you feel like you have never fully or properly thanked for something meaningful or important that they did for you. . . . In the space provided below, please write a note to this person that describes why you feel like you never properly thanked them and letting them know why you feel thankful for something important that they did for you. Though this letter will not actually be sent to this person and is simply an exercise for you, please use this as an opportunity to really explore those feelings surrounding how you feel about what they have done for you and write honestly and openly from your heart. You have ten minutes.

Gratitude intervention

Participants receive the following instructions: Think of the room you are in…. In the space below, please provide a description of the room you are in. Try to focus on the specific elements in the room, the colours of the wall or objects in the room. Use this writing session as an opportunity to paint a detailed picture of this room and include as much specific information as you can. You have ten minutes.

Control intervention.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • Able to consent

You may not qualify if:

  • Participants with a diagnosis of cardiovascular disease, hypertension, oran immune disorder
  • Participants who are pregnant.
  • Participants taking medication influencing cardiovascular measures.
  • Participants who consumed alcohol 12 hours before study.
  • Participants who exercised 12 hours before study.
  • Participants who consumed nicotine 2 hours before study.
  • Participants who consumed caffeine 2 hours before study.
  • Participants who ate 1 hour before study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maynooth Univeristy

Maynooth, Leinster, Ireland

RECRUITING

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 5, 2021

First Posted

November 24, 2021

Study Start

October 20, 2021

Primary Completion

September 30, 2022

Study Completion

November 30, 2022

Last Updated

April 29, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations