- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05292560
The Effectiveness of a Positive Psychology App in the General Population
November 2, 2022 updated by: Jannis Kraiss, University of Twente
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Overijssel
-
Enschede, Overijssel, Netherlands, 7522NB
- University of Twente
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The participant is at least 18 years old
- The participant has an e-mail address and is in possession of a smartphone or tablet with access to the internet.
- The participant is willing to do a positive psychology exercise 6 days a week for 3 weeks
- The participant has sufficient command of the Dutch language to be able to complete questionnaires and exercises.
- The participant gives consent to participate in the study using the online informed consent procedure.
Exclusion Criteria:
- The presence of severe anxiety symptoms: a score of 15 or higher on the Generalized Anxiety Disorder 7 items (GAD-7)
- The presence of severe depressive symptoms: a score of 20 or higher on the Patient Health Questionnaire (PHQ-9).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Positive psychology app
|
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.
|
|
OTHER: Waiting list
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental well-being
Time Frame: Change from baseline mental well-being at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ability to adapt
Time Frame: Change from baseline ability to adapt at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
|
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)
|
|
General self-efficacy
Time Frame: Change from baseline general self-efficacy at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
|
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)
|
|
Savoring
Time Frame: Change from baseline savoring at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
|
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)
|
|
Self-compassion
Time Frame: Change from baseline self-compassion at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
|
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)
|
|
Positive reframing
Time Frame: Change from baseline positive reframing at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
|
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)
|
|
Anxiety symptoms
Time Frame: Change from baseline anxiety symptoms at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
|
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)
|
|
Depression symptoms
Time Frame: Change from baseline ability to adapt at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
|
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)
|
|
Spiritual well-being
Time Frame: Change from baseline spiritual well-being at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 4, 2022
Primary Completion (ACTUAL)
October 1, 2022
Study Completion (ACTUAL)
October 1, 2022
Study Registration Dates
First Submitted
March 1, 2022
First Submitted That Met QC Criteria
March 22, 2022
First Posted (ACTUAL)
March 23, 2022
Study Record Updates
Last Update Posted (ACTUAL)
November 3, 2022
Last Update Submitted That Met QC Criteria
November 2, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 220106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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