NCT04884438

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

May 5, 2021

Last Update Submit

May 26, 2022

Conditions

Keywords

GratitudeWellbeingPositive affectEcological momentary assessment

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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 Outcomes (7)

  • 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.

    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.

    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.

    Up to 2 months

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

    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.

    Up to 2 months

  • +2 more secondary outcomes

Interventions

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: 1. Gratitude walk 2. Three positive things 3. Sharing gratitude 3. Social gratitude: 1. Daily thanks to others 2. Gratitude letter 3. Proof of gratitude 4. Self-gratitude: this part includes an exercise aimed at fostering self-gratitude in three different areas: 1. Gratitude for the things I do to take care of my physical health. 2. Gratitude for what I do to take care of my mental health, my self-esteem and my personal development. 3. Gratitude for what I do to take care of others.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edificio de Investigación

Castellon, 12071, Spain

Location

MeSH Terms

Interventions

Psychosocial Intervention

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 13, 2021

Study Start

October 1, 2021

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations