NCT06621745

Brief Summary

The goal of this clinical trial is to examine whether a newly developed gratitude intervention app can effectively improve psychological functioning, as measured by depression, anxiety, and stress symptoms, positive and negative affect The main questions it aims to answer are: 1\. Will people who are in the intervention group feel more positive emotions and experience fewer negative emotions such as stress, anxiety, and depression after three weeks? Researchers will compare the intervention to a control group (a group not given the gratitude intervention) to see if the intervention works to improve psychological functioning. Participants will:

  • Complete an online survey on emotional well-being and personality traits at the beginning and end of the three-week study, with daily mood ratings and stress assessments every three days.
  • Participants in the intervention group will use a mobile app to practice gratitude exercises.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Nov 2021

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

Study Start

First participant enrolled

November 3, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

1.4 years

First QC Date

September 27, 2024

Last Update Submit

September 27, 2024

Conditions

Keywords

Gratitude interventionSmartphone appGratitude exercisesPsychological well-beingStudent mental health

Outcome Measures

Primary Outcomes (1)

  • Depression, anxiety, and stress

    Participant's depression, anxiety, and stress levels were measured with the Depression, Anxiety, and Stress Scale (DASS-21), which is a set of three self-report scales each consisting of seven items to measure the individual's emotional states of depression ("I couldn't seem to experience any positive feeling at all"), anxiety ("I felt I was close to panic"), and stress ("I found it difficult to relax"). Participants rated how much each statement applied to them in the past week, from 0 ("Did not apply to me at all") to 3 ("Applied to me very much or most of the time"). High scores indicate higher levels of symptoms of anxiety, depression, and stress. There are subscale score cut-offs for normal, mild, moderate, severe, and extremely severe emotional states. Participants were considered to show at least moderate symptomatology if they scored higher than 7 on the depression subscale, 6 on the anxiety subscale, and 10 on the stress subscale.

    three weeks

Study Arms (2)

Gratitude Intervention Group

EXPERIMENTAL

The intervention group used the Gratitude Intervention App (GIA), and the Predicting Risk and Outcomes of Social InTerActions (PROSIT) app, which is a mobile sensing app.

Behavioral: Gratitude Intervention App

Control Non-gratitude Intervention Group

NO INTERVENTION

Participants in the control group downloaded and used only the PROSIT app, they did not use the Gratitude Intervention App (GIA).

Interventions

The GIA app, an iOS application designed for this study, is based on effective gratitude interventions and tailored for youth. Access required a unique login. It features five exercises: a journal, photo book, imagine exercise, speech exercise, and meditation. The journal encourages daily entries. The photo book involves uploading photos of things users are grateful for, promoting mindfulness. The imagine exercise reflects on gratitude, while the speech exercise records users' gratitude. The meditation exercise enhances well-being. During the three-week study, daily notifications prompted exercise completion. The app, green and white with a flower-heart icon, offers email support for technical issues.

Also known as: GIA
Gratitude Intervention Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • individuals aged 18-30, with access to an iPhone, and English speaking.

You may not qualify if:

  • any self-reported cardiovascular disease; endocrine disease, kidney disease, tumor, hypertension, coarctation of the aorta, fibromuscular dysplasia, sleep apnea, which can impact the function of the cardiovascular system, as well as any current mental health treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalhousie University

Halifax, Nova Scotia, B3H 4R2, Canada

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPersonal Satisfaction

Study Officials

  • Sandra M Meier, PhD

    Dalhousie University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study used a randomized experimental design to test the effectiveness of a gratitude intervention smartphone app. Participants were asked to answer 90 questions in an online survey on emotional well-being and personality traits at the beginning and end of the three-week research period. The intervention group used the Gratitude Intervention App (GIA), and the Predicting Risk and Outcomes of Social InTerActions (PROSIT) app, which is a mobile sensing app. All participants used the PROSIT app in the background of their mobile devices throughout the three-week study period. In addition, those allocated to the intervention group practiced gratitude intervention tasks during the same three-week period using the GIA app. This study was approved by the Dalhousie University Research Ethics Board (REB 2021-5460).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2024

First Posted

October 1, 2024

Study Start

November 3, 2021

Primary Completion

April 14, 2023

Study Completion

April 14, 2023

Last Updated

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Participant data will be made available upon reasonable request to Dr. Sandra Meier (PI).

Locations