- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04884438
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- 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
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Castelló de la Plana, Spain, 12071
- Edificio de Investigación
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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
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
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
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.
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Up to 2 months
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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.
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Up to 2 months
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Change in Credibility/Expectancy Questionnaire (CEQ) (Devilly & Borkovec, 2000) at pre-intervention.
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
October 1, 2021
Primary Completion (Actual)
March 30, 2022
Study Completion (Actual)
March 30, 2022
Study Registration Dates
First Submitted
May 5, 2021
First Submitted That Met QC Criteria
May 11, 2021
First Posted (Actual)
May 13, 2021
Study Record Updates
Last Update Posted (Actual)
June 1, 2022
Last Update Submitted That Met QC Criteria
May 26, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID 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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