Mental HealthNCT05292560
The Effectiveness of a Positive Psychology App in the General Population
A study testing Training in positivity in people with Mental Health and Well-being, run by University of Twente at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Well-being, Depression
- What is being tested?
- Training in positivity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Apr 2022to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Mental Health, Well-being, Depression, Anxiety, Adults, App
- Being tested
- Training in positivity
- Medical subject headings
- Psychological Well-Being, Depression, Anxiety Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in positivityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Positive psychology app | Experimental | Not described Receives: Other: Training in positivity |
| Waiting list | Other | Not described Receives: Other: Training in positivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline mental well-being at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2).
Secondary outcomes (8)
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.
Measured: Change from baseline ability to adapt at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
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.
Measured: Change from baseline general self-efficacy at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
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.
Measured: Change from baseline savoring at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
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.
Measured: Change from baseline self-compassion at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
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.
Measured: Change from baseline positive reframing at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
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.
Measured: Change from baseline anxiety symptoms at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
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.
Measured: Change from baseline ability to adapt at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
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.
Measured: Change from baseline spiritual well-being at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start4 Apr 2022
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Twente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jannis Kraiss, University of Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292560
- Sponsor's protocol ID
- 220106
- Status last verified
- Nov 2022
- First submitted
- 1 Mar 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05292560
- Acronym / sponsor ID
- 220106
- Conditions
- Mental Health, Well-being, Depression, Anxiety, Adults, App
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of TwenteUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 23 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive psychology app | Experimental | Other: Training in positivity |
| Waiting list | Other | Other: Training in positivity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training in positivityThe 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 | Positive psychology app, Waiting list |
Primary outcome
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.
8 secondary outcomes
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)
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)
Savoring
Time frame: 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)
Positive reframing
Time frame: 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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in positivity in people with Mental Health and Well-being, run by University of Twente at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.