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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Netherlands
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Positive psychology app
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.
OTHER: Waiting list
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Twente

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2022

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings