The Impact of a Gratitude Intervention on Stress Reactivity
Primary Purpose
Positive Emotions, Blood Pressure, Stress, Psychological
Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Gratitude letter
Control intervention
Sponsored by
About this trial
This is an interventional basic science trial for Positive Emotions
Eligibility Criteria
Inclusion Criteria:
- 18 years and older
- Able to consent
Exclusion Criteria:
- 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.
Sites / Locations
- Maynooth UniveristyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Gratitude intervention
Control intervention.
Arm Description
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.
Participants spend eight minutes writing a note describing the lab in which the study is being run.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05133063
First Posted
October 5, 2021
Last Updated
April 24, 2022
Sponsor
National University of Ireland, Maynooth
Collaborators
Bial Foundation, Dr. Brenda O'Connell, Dr. Deirdre O'Shea
1. Study Identification
Unique Protocol Identification Number
NCT05133063
Brief Title
The Impact of a Gratitude Intervention on Stress Reactivity
Official Title
The Impact of a Gratitude Intervention on Stress Reactivity: A Randomised Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Ireland, Maynooth
Collaborators
Bial Foundation, Dr. Brenda O'Connell, Dr. Deirdre O'Shea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This study will employ an experimental within-subjects design, in which all participants are exposed to the same task and measures. The study will take place in Cubicle 1 of the Psychology Department, 2nd floor John Hume Building. On entry into the lab, participants will first be required to read the study information sheet and provide informed consent before the formal testing session begins. This standard protocol will comprise of the collection of demographic information, the administration of questionnaires (See supporting documentation) and the monitoring of physiological responses. The monitoring phase involves the following periods, a 20 minute acclimatisation, 10 minute baseline, 8 minute intervention, a 12-stress task and a 10 minute recovery period. During baseline general socio-demographic and lifestyle information will be collected through standard questionnaires (e.g. age, gender, height smoking status, health status and family history pertaining to the cardiovascular system; see supporting documentation). If predictive of blood pressure in the current study all potential confounds will be controlled for statistically in relevant analyses to isolate the contribution of the predictor variables, in this case state and trait gratitude, to the cardiovascular changes. Physiological responses -systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR)- will be measured noninvasively using a GE Dinamap Pro 400 and will be recorded throughout with a standard blood pressure cuff placed over the brachial artery on the participant's non-dominant arm. During the baseline phase psychological variables will be measured psychometrically.
Following this baseline phase, participants will randomly be allocated to either the control or experimental condition. The experimental condition will involve writing a letter thanking someone the participant had not thanked before. The control group will complete a writing exercise wherein they describe the laboratory room. They will have 8 minutes to complete this.
Following this intervention phase, participants will then complete an adapted form of the widely used Trier Social Stress Test, which involves participants subtracting numbers out loud and giving a short speech wherein they describe three of their best and worst characteristics . After the stress task, in the recovery phase participants will answer a series of questions pertaining to how they found the stress task. They will then sit for 8 minutes while recovery measures are taken.
Following this, all participants will be fully debriefed (supporting documentation) and thanked for their participation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Positive Emotions, Blood Pressure, Stress, Psychological
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gratitude intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control intervention.
Arm Type
Active Comparator
Arm Description
Participants spend eight minutes writing a note describing the lab in which the study is being run.
Intervention Type
Behavioral
Intervention Name(s)
Gratitude letter
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Systolic Blood pressure reactivity
Description
This will be done by taking the mean of the baseline measures and subtracting it from the mean of the stress task measures.
Time Frame
Measured over the course of the study (1 hour)
Title
Diastolic Blood pressure reactivity
Description
This will be done by taking the mean of the baseline measures and subtracting it from the mean of the stress task measures.
Time Frame
Measured over the course of the study (1 hour)
Title
Heart rate reactivity
Description
This will be done by taking the mean of the baseline measures and subtracting it from the mean of the stress task measures.
Time Frame
Measured over the course of the study (1 hour)
Title
Systolic Recovery
Description
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.
Time Frame
Measured over the course of the study (1 hour)
Title
Diastolic Recovery
Description
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.
Time Frame
Measured over the course of the study (1 hour)
Title
Heart Rate Recovery
Description
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.
Time Frame
Measured over the course of the study (1 hour)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years and older
Able to consent
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Leavy
Phone
0861683798
Email
brian.leavy.2020@mumail.ie
Facility Information:
Facility Name
Maynooth Univeristy
City
Maynooth
State/Province
Leinster
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Leavy
Phone
0861683798
Email
brian.leavy.2020@mumail.ie
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Impact of a Gratitude Intervention on Stress Reactivity
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