DepressionNCT06621745
A Gratitude Intervention App to Reduce Symptoms of Depression, Anxiety and Stress
A study testing Gratitude Intervention App in people with Depression and Anxiety, run by Dalhousie University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Stress
- What is being tested?
- Gratitude Intervention App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteCanada
- Study dates
- 3 Nov 2021to 14 Apr 2023
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- individuals aged 18-30, with access to an iPhone, and English speaking.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mobile Application-based Gratitude Intervention's Psychological Effects
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:
Read more
- 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.
Read the detailed description
Background: Gratitude interventions have been shown to decrease depression, stress and anxiety symptoms, support enhanced coping with health-related problems and might improve both psychological and physical functioning in areas. However, results have been mixed with effects varying by outcome, duration, follow-up length, format, and age. A recent meta-analysis including 27 studies focusing more specifically on symptoms of depression and anxiety suggest there is a limited effect of gratitude interventions on reducing symptoms of depression and anxiety at post-intervention and follow-up.
Objective: Thus, the present study aims to implement a three-week gratitude intervention including five different types of gratitude tasks embedded in a mobile sensing application and examine the intervention's psychological effects.
Method: Participants will be recruited and randomly allocated into the intervention and the control group. The study will measure depression, anxiety and stress symptoms, positive and negative affect, negative affectivity and social inhibition before and after the three-week intervention period as psychological variables. It will analyze the effect of the gratitude intervention on the measured variables as well as examine the impact of negative affectivity and social inhibition on depression, anxiety and stress symptoms.
Implications: If the intervention is shown to effectively reduce psychological problems, it will be tested and implemented to support the well-being of university students as a stand-alone tool.
The study will examine whether the gratitude intervention can effectively reduce depression, anxiety and stress symptoms. We intend to recruit 120 participants. Extending previous research, it will also examine whether negative affectivity and social inhibition have an impact on the measured outcomes and whether the intervention can influence these traits.
It is hypothesized that:
- Positive affect will increase, while negative affect, stress, anxiety and depression symptoms will decrease from before to after the three weeks in the group that practices the gratitude intervention tasks (intervention group) compared to the group which doesn't (control group).
- Negative affectivity and social inhibition will decrease from before to after the three weeks in the intervention group in comparison to the control group.
- Conditions
- Depression, Anxiety, Stress
- Being tested
- Gratitude Intervention App
- Keywords
- Gratitude intervention, Smartphone app, Gratitude exercises, Psychological well-being, Student mental health
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gratitude Intervention AppBehavioural
Also called GIA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start3 Nov 2021
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canada Foundation for Innovation
- Responsible party
- Sponsor
- Investigators
- Sandra M Meier, PhD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621745
- Sponsor's protocol ID
- 2021-5460_GIA
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be made available upon reasonable request to Dr. Sandra Meier (PI).
Publications
Fuller C, Marin-Dragu S, Iyer RS, Meier SM. A Mobile App-Based Gratitude Intervention's Effect on Mental Well-Being in University Students: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Jan 14;13:e53850. doi: 10.2196/53850.
PubMed 39810453
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Application-based Gratitude Intervention's Psychological Effects
- ClinicalTrials.gov ID
- NCT06621745
- Acronym / sponsor ID
- 2021-5460_GIA
- Conditions
- Depression, Anxiety, Stress
- Keywords
- Gratitude intervention, Smartphone app, Gratitude exercises, Psychological well-being, Student mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canada Foundation for Innovation
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Detailed description
Background: Gratitude interventions have been shown to decrease depression, stress and anxiety symptoms, support enhanced coping with health-related problems and might improve both psychological and physical functioning in areas. However, results have been mixed with effects varying by outcome, duration, follow-up length, format, and age. A recent meta-analysis including 27 studies focusing more specifically on symptoms of depression and anxiety suggest there is a limited effect of gratitude interventions on reducing symptoms of depression and anxiety at post-intervention and follow-up.
Objective: Thus, the present study aims to implement a three-week gratitude intervention including five different types of gratitude tasks embedded in a mobile sensing application and examine the intervention's psychological effects.
Method: Participants will be recruited and randomly allocated into the intervention and the control group. The study will measure depression, anxiety and stress symptoms, positive and negative affect, negative affectivity and social inhibition before and after the three-week intervention period as psychological variables. It will analyze the effect of the gratitude intervention on the measured variables as well as examine the impact of negative affectivity and social inhibition on depression, anxiety and stress symptoms.
Implications: If the intervention is shown to effectively reduce psychological problems, it will be tested and implemented to support the well-being of university students as a stand-alone tool.
The study will examine whether the gratitude intervention can effectively reduce depression, anxiety and stress symptoms. We intend to recruit 120 participants. Extending previous research, it will also examine whether negative affectivity and social inhibition have an impact on the measured outcomes and whether the intervention can influence these traits.
It is hypothesized that:
- Positive affect will increase, while negative affect, stress, anxiety and depression symptoms will decrease from before to after the three weeks in the group that practices the gratitude intervention tasks (intervention group) compared to the group which doesn't (control group).
- Negative affectivity and social inhibition will decrease from before to after the three weeks in the intervention group in comparison to the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Gratitude Intervention Group | Experimental | Behavioral: Gratitude Intervention AppThe 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. |
| 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). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- individuals aged 18-30, with access to an iPhone, and English speaking.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gratitude Intervention AppAlso: GIAThe 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. | Behavioural | Gratitude Intervention Group |
Primary outcome
Depression, anxiety, and stress
Time frame: three weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Derived from this study: PubMed 39810453Fuller C, Marin-Dragu S, Iyer RS, Meier SM. A Mobile App-Based Gratitude Intervention's Effect on Mental Well-Being in University Students: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Jan 14;13:e53850. doi: 10.2196/53850.
- Individual participant dataSharing planned: No. Participant data will be made available upon reasonable request to Dr. Sandra Meier (PI).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra M Meier, PhD principal investigator
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gratitude Intervention App in people with Depression and Anxiety, run by Dalhousie University at 1 site in Canada.
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 1 inclusion and 1 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 Oct 2024. 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 Canada. 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?
Depression, anxiety, and stress (time frame: three weeks). 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 NCT06621745, which also lists 1 linked publication.
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 Oct 2024.