Positive EmotionsNCT05133063
The Impact of a Gratitude Intervention on Stress Reactivity
A study testing Gratitude letter in people with Positive Emotions and Blood Pressure, run by National University of Ireland, Maynooth at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Positive Emotions, Blood Pressure, Stress, Psychological
- What is being tested?
- Gratitude letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteIreland
- Study dates
- 20 Oct 2021to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
- Able to consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Maynooth Univeristy
Maynooth, Leinster
Brian Leavy, 0861683798, brian.leavy.2020@mumail.ie
About this study
Official title: 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.
Read the 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.
- Conditions
- Positive Emotions, Blood Pressure, Stress, Psychological
- Being tested
- Gratitude letter, Control intervention
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gratitude letterBehavioural
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.
Control interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Gratitude letter |
| Control intervention. | Active comparator | Participants spend eight minutes writing a note describing the lab in which the study is being run. Receives: Behavioral: Control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: 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: 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: Measured over the course of the study (1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start20 Oct 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive EmotionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Maynooth
- Sponsor type
- University, hospital or other
- Collaborators
- Bial Foundation, Dr. Brenda O'Connell, Dr. Deirdre O'Shea
- Responsible party
- Principal investigator, Brian Leavy, National University of Ireland, Maynooth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133063
- Sponsor's protocol ID
- 20501892
- Status last verified
- Apr 2022
- First submitted
- 5 Oct 2021
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Gratitude Intervention on Stress Reactivity: A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT05133063
- Acronym / sponsor ID
- 20501892
- Conditions
- Positive Emotions, Blood Pressure, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- National University of Ireland, MaynoothUniversity, hospital or other
- Collaborators
- Bial Foundation, Dr. Brenda O'Connell, Dr. Deirdre O'Shea
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gratitude intervention | Experimental | Behavioral: Gratitude letterParticipants 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. |
| Control intervention. | Active comparator | Behavioral: Control interventionParticipants spend eight minutes writing a note describing the lab in which the study is being run. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years and older
- Able to consent
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gratitude letterParticipants 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. | Behavioural | Gratitude intervention |
| Control interventionParticipants 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. | Behavioural | Control intervention. |
Primary outcome
Systolic Blood pressure reactivity
Time frame: Measured over the course of the study (1 hour)
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
Time frame: Measured over the course of the study (1 hour)
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
Time frame: Measured over the course of the study (1 hour)
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
Time frame: Measured over the course of the study (1 hour)
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
Time frame: Measured over the course of the study (1 hour)
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
Time frame: Measured over the course of the study (1 hour)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Positive Emotions
Recruiting
Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia
BPSD (Behavioral and Psycological Symptoms of Dementia), Expressed Emotion
Recruiting
Promoting Positive Emotions in Adolescents Using Positive Events Training: An Indicated Approach
Emotional Distress, Anhedonia
Active, not recruiting
Fostering Optimal Regulation of Emotion for Prevention of Secondary Trauma (FOREST)
Burnout, Burnout, Professional
Enrolling by invitation
Positive Events Training to Enhance Positive Emotions in Adolescents With Elevated Depressive Symptoms: An N=1 Trial
Emotional Distress, Anhedonia
Not yet recruiting
Do Different Arousal Levels Affect Pressure Pain Thresholds?
High Arousing Positive Emotion, Low Arousing Positive Condition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gratitude letter in people with Positive Emotions and Blood Pressure, run by National University of Ireland, Maynooth at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian Leavy (0861683798, brian.leavy.2020@mumail.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood pressure reactivity (time frame: Measured over the course of the study (1 hour)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.