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AzTrials

AffectNCT04884438

Intervention for the Promotion of Gratitude

A study testing Psychological intervention for the promotion of gratitude in people with Affect, run by Universitat Jaume I at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Affect
What is being tested?
Psychological intervention for the promotion of gratitude
How many people
15 participants
Where
1 siteSpain
Study dates
1 Oct 2021to 30 Mar 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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Edificio de Investigación

    Castellon, 12071

Other trials in Spain

About this study

Official title: 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.

Conditions
Affect
Being tested
Psychological intervention for the promotion of gratitude
Keywords
Gratitude, Wellbeing, Positive affect, Ecological momentary assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychological intervention for the promotion of gratitudeBehavioural

    A brief intervention protocol has been developed for the promotion of gratitude. The protocol is manualized and the content will be explained to each participant in the videoconference sessions, and a copy of the manual will be given (or sent) to the patients at the end of the therapy sessions.

    The structure and contents of the intervention are summarized below:

    1. Psychoeducation about gratitude and its effects on health (both physical and psychological).
    2. Gratitude towards life:
    3. Gratitude walk
    4. Three positive things
    5. Sharing gratitude
    6. Social gratitude:
    7. Daily thanks to others
    8. Gratitude letter
    9. Proof of gratitude
    10. Self-gratitude: this part includes an exercise aimed at fostering self-gratitude in three different areas:
    11. Gratitude for the things I do to take care of my physical health.
    12. Gratitude for what I do to take care of my mental health, my self-esteem and my personal development.
    13. Gratitude for what I do to take care of others.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    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.

    Measured: Up to 2 months

  2. 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.

    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)

    Measured: Up to 2 months

Secondary outcomes (7)

  1. 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.

    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).

    Measured: Up to 2 months

  2. 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.

    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.

    Measured: Up to 2 months

  3. 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.

    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.

    Measured: Up to 2 months

  4. Change in Pemberton Happiness Index (PHI) (Hervás & Vázquez, 2013) at pre-intervention, post-intervention, and 1-month follow-up.

    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).

    Measured: Up to 2 months

  5. 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.

    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.

    Measured: Up to 2 months

  6. 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.

    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.

    Measured: Up to 2 months

  7. Change in Credibility/Expectancy Questionnaire (CEQ) (Devilly & Borkovec, 2000) at pre-intervention.

    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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2021
  2. Study start1 Oct 2021
  3. Primary completion30 Mar 2022
  4. Study completion30 Mar 2022

Resources

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
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04884438
Sponsor's protocol ID
Gratitude
Status last verified
May 2022
First submitted
5 May 2021
Last updated
1 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Psychological intervention for the promotion of gratitude in people with Affect, run by Universitat Jaume I at 1 site in Spain.

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 4 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: finished, as of the sponsor's last update on 1 Jun 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 Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04884438.

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 1 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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