Examination of Psychological and Physiological Pathways Linking Gratitude and Pain

March 30, 2026 updated by: Black Hills State University

Examination of Psychological and Physiological Pathways Linking Gratitude and Pain and the Moderating Effects of COMT Genotype on These Associations

The goal of this clinical trial is to compare the effects of a brief gratitude intervention on individuals' psychological and physiological responses to acute pain. Furthermore, these associations will be examined in the context of genetic variations associated with both pain and psychological processes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will be randomized to a behavioral writing intervention and a cold pressor task. Participants will be randomized to a gratitude or neutral writing condition.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
145

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • South Dakota
      • Spearfish, South Dakota, United States, 57799
        • Black Hills State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • must be pain-free
  • must be at least 18 years old

Exclusion Criteria:

  • cardiovascular disease
  • Raynaud's disease
  • epilepsy
  • being pregnant
  • having a current injury to or open cut or sore on one's non-dominant hand
  • history of fainting or seizures
  • history of frostbite in non-dominant hand
  • chronic pain conditions (e.g., fibromyalgia, neuropathy, arthritis)
  • diabetes
  • malignant tumor
  • chronic lung disease
  • liver disease
  • kidney disease
  • gastrointestinal diseases
  • currently taking opioids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Gratitude Writing
In the gratitude writing condition, participants will write continuously for 5 minutes about someone they are grateful for.
Behavioral: Behavioral Writing Intervention
This behavioral intervention will require participants to write about certain aspects of their lives.
Placebo Comparator: Neutral Writing
Participants in the neutral writing condition will write continuously for 5 minutes about how they got to the research laboratory.
Behavioral: Behavioral Writing Intervention
This behavioral intervention will require participants to write about certain aspects of their lives.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Differences in Pain Tolerance to Cold Pressor Test
Time Frame: Up to 1.5 minutes of Cold Pressor Test
Pain tolerance will be measured in terms of how many seconds individuals can keep their hand submerged in near-freezing water, for a maximum of up to 90 seconds (the task will be ended at that point).
Up to 1.5 minutes of Cold Pressor Test
Differences in Pain Onset to Cold Pressor Test
Time Frame: Up to 1.5 minutes of Cold Pressor Test
Pain onset will be measured in seconds between participants submerging their hands into near-freezing water and the self-reported beginning of pain.
Up to 1.5 minutes of Cold Pressor Test
Change in Subjective Pain Ratings From Baseline to 10-minutes Post Cold Pressor Test
Time Frame: Baseline to 10 minutes post cold pressor test
Self-reported measures of pain will be reported on a numeric scale of 0 (no pain) to 10 (strongest pain imaginable every 15 seconds throughout a cold pressor test and again 1 minute and 10 minutes post cold pressor test.
Baseline to 10 minutes post cold pressor test

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Differences in Autonomic Nervous System Responsivity
Time Frame: Baseline to 10 minutes post cold pressor test
Autonomic nervous system responsivity will be assessed using levels of salivary alpha-amylase. Unstimulated whole saliva samples will be collected using the passive drool technique at the following time points: 1) immediately following completion of baseline surveys, 2) immediately following the experimental writing task, 3) 1-minute post-cold pressor test, and 4) 10-minutes post-cold pressor test.
Baseline to 10 minutes post cold pressor test
Differences in Pain-Related Cognition
Time Frame: Immediately after the Cold Pressor Test
The Rumination and Reappraisal subscales from the Pain-Related Cognitive Processes Questionnaire were used to assess the extent to which individuals engaged in various thought processes during the cold pressor test. Each subscale is comprised of 6-items and answered on a 0 (Not at all) to 4 (All or most of the time) scale. Scores on each item are summed to calculate an overall score which can range from 0 to 24, with higher scores indicative of greater use of each cognitive process.
Immediately after the Cold Pressor Test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Black Hills State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of General Medical Sciences (NIGMS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nathan Deichert, PhD, Black Hills State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 19, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 19, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BlackHillsHealthPsych
  • P20GM103443 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All IPD that underlie results will be in a publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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