Clinical trial NCT05292560: The Effectiveness of a Positive Psychology App in the General Population
Official title: A Randomized Controlled Trial on the Effectiveness of a Positive Psychology App for Adults in the General Population Dealing With Negatives Consequences of the Corona Crisis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Well-being
Depression
Anxiety
Adults
App
Positive Psychology
Lead sponsor: University of Twente
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The corona crisis has a negative impact on the mental wellbeing of the Dutch population. Positive psychology exercises (PPOs) can potentially improve mental well-being and reduce mild and moderate psychological complaints. Previous research has shown moderate to large effects of PPOs on well-being in people with reduced wellbeing and psychological symptoms at baseline. The University of Twente developed an app (Training in Positivity; TiP) based on an effective intervention. The goal of this study is to investigate the effectiveness of TiP in the general population in people experiencing reduced mental wellbeing as a result of the corona crisis. People using the app will be compared to a waiting list control group.


Eligibility criteria: Inclusion Criteria:

1. The participant is at least 18 years old
2. The participant has an e-mail address and is in possession of a smartphone or tablet with access to the internet.
3. The participant is willing to do a positive psychology exercise 6 days a week for 3 weeks
4. The participant has sufficient command of the Dutch language to be able to complete questionnaires and exercises.
5. The participant gives consent to participate in the study using the online informed consent procedure.

Exclusion Criteria:

1. The presence of severe anxiety symptoms: a score of 15 or higher on the Generalized Anxiety Disorder 7 items (GAD-7)
2. The presence of severe depressive symptoms: a score of 20 or higher on the Patient Health Questionnaire (PHQ-9).

Primary outcomes:
measure: Mental well-being
timeFrame: Change from baseline mental well-being at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2).
Secondary outcomes:
measure: Ability to adapt
timeFrame: Change from baseline ability to adapt at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
measure: General self-efficacy
timeFrame: Change from baseline general self-efficacy at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
measure: Savoring
timeFrame: Change from baseline savoring at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
measure: Self-compassion
timeFrame: Change from baseline self-compassion at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
measure: Positive reframing
timeFrame: Change from baseline positive reframing at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
measure: Anxiety symptoms
timeFrame: Change from baseline anxiety symptoms at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
measure: Depression symptoms
timeFrame: Change from baseline ability to adapt at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
measure: Spiritual well-being
timeFrame: Change from baseline spiritual well-being at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: University of Twente
state: Overijssel
Study officials:
References: