Clinical trial NCT06621745: A Gratitude Intervention App to Reduce Symptoms of Depression, Anxiety and Stress
Official title: A Mobile Application-based Gratitude Intervention's Psychological Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Stress
Keywords: Gratitude intervention
Smartphone app
Gratitude exercises
Psychological well-being
Student mental health
Lead sponsor: Dalhousie University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Canada Foundation for Innovation
First posted: 2024-10-01
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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:

1. 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).
2. Negative affectivity and social inhibition will decrease from before to after the three weeks in the intervention group in comparison to the control group.

Eligibility criteria: 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.

Primary outcomes:
measure: Depression, anxiety, and stress
timeFrame: three weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Sandra M Meier, PhD
role: PRINCIPAL_INVESTIGATOR
References: