- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06621745
A Gratitude Intervention App to Reduce Symptoms of Depression, Anxiety and Stress
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:
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 4R2
- Dalhousie University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- individuals aged 18-30, with access to an iPhone, and English speaking.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Gratitude Intervention Group
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.
|
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.
Other Names:
|
|
No Intervention: Control Non-gratitude Intervention Group
Participants in the control group downloaded and used only the PROSIT app, they did not use the Gratitude Intervention App (GIA).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
three weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sandra M Meier, PhD, Dalhousie University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-5460_GIA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Depression
-
Massachusetts General HospitalRecruitingDepression | Depression - Major Depressive Disorder | Depression Chronic | Depression in Adults | Depression Disorders | Depression DisorderUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
ProgenaBiomeWithdrawnDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RecruitingMild DepressionUnited States
-
Fondation FondaMentalGYNOVNot yet recruitingDepression | Depression in Adults | Depression DisorderFrance
Clinical Trials on Gratitude Intervention App
-
Centre Hospitalier Universitaire VaudoisCompletedPalliative CareSwitzerland
-
University of California, Los AngelesCompletedGratitude + No Expectations | Gratitude + Expectations | Events ControlUnited States
-
University of SheffieldThe Leeds Teaching Hospitals NHS Trust; Sheffield Teaching Hospitals NHS Foundation... and other collaboratorsCompletedDepression | Wellbeing | Psychological Distress | Happiness | Emotional Distress | AffectUnited Kingdom
-
University of FloridaNational Institute on Aging (NIA)CompletedExercise | Breast Neoplasm Female | Feasibility Studies | Cardiometabolic Syndrome | Cancer Survivors | African Americans | Women | Psychology, PositiveUnited States
-
National University of Ireland, MaynoothBial Foundation; Dr. Brenda O'Connell; Dr. Deirdre O'SheaRecruitingStress, Psychological | Blood Pressure | Positive EmotionsIreland
-
Kinnaird College for WomenNot yet recruitingPsychological DistressPakistan
-
University of FloridaRecruitingTemporomandibular Disorders (TMD)United States