Intervention for the Promotion of Gratitude

May 26, 2022 updated by: Universitat Jaume I

A Brief Intervention for the Promotion of Wellbeing: the Power of Gratitude

This study aims to analyze the effects of a psychological intervention to promote wellbeing. To do so, a brief intervention is developed to enhance a sense of gratitude through a multiple baseline across components design. Traditional measures will be used together with the incorporation of a novel evaluation methodology such as the EMA, which allows the collection of data in the context of people's daily lives and at different specific times, that is, in real time.

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.

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.
15

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 Locations

  • Spain
      • Castelló de la Plana, Spain, 12071
        • Edificio de Investigación

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years old or older
  • A score of, at least, 1 standard deviation below the mean for the PANAS positive subscale, based on the norms of the general population

Exclusion Criteria:

  • Suicide risk
  • Bipolar disorder
  • Psychosis
  • Any medical or psychiatric condition that hinders participation in the study

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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
Change in Positive and Negative Affect Schedule (PANAS) (Watson, Clark, & Tellegen, 1988; Spanish version: Sandín et al., 1999) at pre-intervention, during the intervention, post-intervention, and 1-month follow-up.
Time Frame: Up to 2 months
The PANAS consists of 20 items with a range from 1 (very slightly or not at all) to 5 (extremely). Respondents have to indicate the extent to which they experienced the feeling or emotion during the past few weeks. This scale evaluates two independent dimensions: positive affect and negative affect. The maximum score for each subscale is 50. The scale showed excellent internal consistency (α between .84 and .90) and convergent and discriminant validity. The Spanish version has demonstrated high internal consistency (α = 0.89 and 0.91 for positive affect and negative affect in women, respectively, and α = 0.87 and 0.89 for PA and NA in men, respectively) in college students.
Up to 2 months
Change in Gratitude Questionnaire 6-item (GQ-6) (McCullough, Emmons, & Tsang, 2001; Spanish version: Magallares, Recio, & Sanjuán, 2018) at pre-intervention, during the intervention, post-intervention, and 1-month follow-up.
Time Frame: Up to 2 months
The GQ-5 consists of six items that measure span, frequency, intensity and density of gratitude and primarily focuses on the unidimensional emotional component of gratitude. Participants have to rate six items (e.g., "I have so much in life to be thankful for") on a seven-point Likert scale (GQ-6: α = 0.82)
Up to 2 months

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
Change in Satisfaction with life (SWLS) (Diener, Emmos, Larse, & Griffin, 1985; Spanish version: Vázquez, Duque, & Hervás, 2013) at pre-intervention, post-intervention, and 1-month follow-up.
Time Frame: Up to 2 months
This is a life satisfaction scale consisting of five items. Participants are asked to indicate their degree of agreement with each statement using a 7-point Likert scale (from 1 = strongly disagree to 7 = strongly agree). Scores can range from 5 to 35 points, indicating a greater life satisfaction with higher scores (alpha = .88).
Up to 2 months
Change in Overall Anxiety Severity and Impairment Scale (OASIS) (Campbell-Sills et al., 2009; Spanish version: González-Robles et al., 2018) at at pre-intervention, during the intervention, post-intervention, and 1-month follow-up.
Time Frame: Up to 2 months
The OASIS is a 5-item self-report scale that evaluates the frequency and severity of anxiety symptoms, the functional impairment related to these symptoms (i.e. school, work, home, or social impairment), and behavioral avoidance. Each item instructs respondents to endorse one of five responses that best describes their experiences over the past week. Response items are coded from 0 to 4, added together to obtain a total score ranging from 0 to 20. Previous studies have shown good internal consistency (α = 0.80), test-retest reliability, and convergent and discriminant validity. The Spanish version has shown good internal consistency (α = 0.86), and convergent and discriminant validity.
Up to 2 months
Change in Overall Depression Severity and Impairment Scale (ODSIS) (Bentley et al., 2014; Spanish version: Mira et al., 2019) at pre-intervention, during the intervention, post-intervention, and 1-month follow-up.
Time Frame: Up to 2 months
The ODSIS is a brief self-reported scale with 5 items that assess the severity and functional impairment associated with depressive symptoms. Items are coded on a 5-point scale (0-4). The sum of the scores is used to obtain the total score, which can be a maximum of 20. The measure has shown excellent internal consistency (α = 0.94 in an outpatient sample, 0.92 in a community sample, and 0.91 in a student sample) and good convergent/discriminant validity. The Spanish validation has excellent internal consistency (α = 0.93), as well as convergent and discriminant validity.
Up to 2 months
Change in Pemberton Happiness Index (PHI) (Hervás & Vázquez, 2013) at pre-intervention, post-intervention, and 1-month follow-up.
Time Frame: Up to 2 months
The Pemberton Happiness Index (PHI) is a self-reported scale of overall well-being that includes both remembered and experienced well-being. PHI index incorporates two components: (a) an 11-item measure that includes general, eudaimonic, hedonic, and social well-being rated on a scale from 0 to 10 (in this scale, participants are asked to rate each statement using a scale from 0 -fully disagree- to 10 -fully agree-) and (b) a single score that results from the combination of positive and negative experiences from the day before, also on a scale from 0 to 10. The scale has shown excellent internal consistency in Spanish samples (alpha between .91 and .92).
Up to 2 months
Change in Dispositional Hope Scale (DHS) (Snyder et al., 1991; Spanish version: Galiana et al., 2015) at pre-intervention, post-intervention, and 1-month follow-up.
Time Frame: Up to 2 months
The Dispositional Hope Scale (DHS) is a 12-item instrument, with 4 pathways items, measuring abilities to identify feasible ways to goal, and four agency items, which evaluate motivations for pursuing goals, and four filler items. Items are scored in a scale from 1(definitely false) to 4 (definitely true). In the Spanish version, Cronbach's alphas ranged between .67 and .83.
Up to 2 months
Change in Subjective Happiness Scale (SHS) (Lyubomirsky & Lepper, 1999; Spanish version: Extremera & Fernández-Berrocal, 2014) at pre-intervention, post-intervention, and 1-month follow-up.
Time Frame: Up to 2 months
The SHS is a 4-item Likert-type (from 1 to 7) scale measure that evaluates global subjective happiness using statements with which participants either self-rate themselves or compare themselves to others. The scale has an adequate unitary structure and temporal stability confirmed in 14 samples, showing moderate correlations with constructs such as self-esteem, depression, satisfaction, or neuroticism.
Up to 2 months
Change in Credibility/Expectancy Questionnaire (CEQ) (Devilly & Borkovec, 2000) at pre-intervention.
Time Frame: Baseline
The scale comprises 6 items, rated on a scale from 0 (nothing at all) to 9 (completely), that cover how logical the treatment seems to be, how successfully the patients think the treatment will be in reducing their symptoms, how confident they are in recommending the treatment to a friend, how much improvement in their symptoms they think will occur, how much they really feel that therapy will help them to reduce their symptoms, and how much improvement in their symptoms they really feel will occur.
Baseline

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.
Universitat Jaume I

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.
October 1, 2021

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.
March 30, 2022

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.
March 30, 2022

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).
May 5, 2021

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.
May 11, 2021

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.
May 13, 2021

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.
June 1, 2022

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.
May 26, 2022

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.
May 1, 2022

More Information

Terms related to this study

Keywords

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.
  • Gratitude

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

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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