The Effectiveness of a Positive Psychology App in the General Population

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05292560
• Other study ID #: 220106
• Status: Completed
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: November 2022
• Source: University of Twente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Adults
• Anxiety
• Depression
• Mental Health
• Well-being

Intervention

Other:
• Training in positivity
The University of Twente developed an evidence-based positive psychology app that is aimed at increasing mental well-being and resilience (Training in positivity; TiP). TiP consists of a 3-week structured intervention, in which participants do two exercises every week for 6 days, aimed at increasing resilience and mental well-being. An exercise takes an average of 15 minutes per day.

Locations

Country	Name	City	State
Netherlands	University of Twente	Enschede	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
University of Twente

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mental well-being	Mental well-being measured with the 14-item Mental Health Continuum-Short Form. Scores are calculated as mean scores and can range from 0 to 5. Higher scores indicate more mental well-being.	Change from baseline mental well-being at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2).
Secondary	Ability to adapt	Measured with the 10-item Generic sense of ability to adapt scale. Scores are calculated as sum scores and can range from 10 to 50. Higher scores indicate more ability to adapt.	Change from baseline ability to adapt at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
Secondary	General self-efficacy	Measured with the 10-item General Self-Efficacy Scale. Scores are calculated as sum scores and can range from 10 to 40. Higher scores indicate more general self-efficacy.	Change from baseline general self-efficacy at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
Secondary	Savoring	Measured with the 24-item Savoring Beliefs inventory. Scores are calculated as mean scores and can range from 1 to 7. Higher scores indicate more savoring.	Change from baseline savoring at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
Secondary	Self-compassion	Measured with the 8-item self-reassurance subscale of the Forms of self-criticising/attacking & self-reassuring scale. Scores are calculated as mean scores and can range from 0 to 4. Higher scores indicate more self-compassion.	Change from baseline self-compassion at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
Secondary	Positive reframing	Measured with 2 items of the positive reframing subscale of the Coping Orientations and Problems Experienced inventory. Scores are calculated as mean scores and can range from 1 to 4. Higher scores indicate more positive reframing.	Change from baseline positive reframing at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
Secondary	Anxiety symptoms	Measured with the 7-item Generalized Anxiety Disorder-7 questionnaire. Scores are calculated as sum scores and can range from 0 to 21. Higher scores indicate more anxiety symptoms.	Change from baseline anxiety symptoms at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
Secondary	Depression symptoms	Measured with the 9-item Patient Health Questionnaire-9. Scores are calculated as sum scores and can range from 0 to 27. Higher scores indicate more depression symptoms.	Change from baseline ability to adapt at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
Secondary	Spiritual well-being	Measured with the 7-item Spiritual Attitude and Involvement List-Short Form. Scores are calculated as mean scores and can range from 1 to 6. Higher scores indicate more spiritual well-being.	Change from baseline spiritual well-being at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)