The Impact of a Gratitude Intervention on Stress Reactivity

The Impact of a Gratitude Intervention on Stress Reactivity: A Randomised Control Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Stress, Psychological; Blood Pressure; Positive Emotions
• Intervention / Treatment: Behavioral: Gratitude letter; Behavioral: Control intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brian Leavy; Phone Number: 0861683798; Email: brian.leavy.2020@mumail.ie

Study Locations

• Ireland
  • Leinster
    • Maynooth, Leinster, Ireland
      • Recruiting
      • Maynooth Univeristy
      • Contact: Brian Leavy; Phone Number: 0861683798; Email: brian.leavy.2020@mumail.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gratitude intervention; 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; 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.
Active Comparator: Control intervention.; Participants spend eight minutes writing a note describing the lab in which the study is being run.	Behavioral: Control 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: National University of Ireland, Maynooth
• Collaborators: Bial Foundation; Dr. Brenda O'Connell; Dr. Deirdre O'Shea

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 24, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: 20501892

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No