NCT05292560

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

April 4, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

March 1, 2022

Last Update Submit

November 2, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

    Change from baseline general self-efficacy at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)

  • Savoring

    Change from baseline savoring at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)

  • Self-compassion

    Change from baseline self-compassion at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)

  • Positive reframing

    Change from baseline positive reframing at 3 weeks (T1) and change from baseline mental well-being at 3 months (T2)

  • +3 more secondary outcomes

Study Arms (2)

Positive psychology app

EXPERIMENTAL
Other: Training in positivity

Waiting list

OTHER
Other: Training in positivity

Interventions

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.

Positive psychology appWaiting list

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Twente

Enschede, Overijssel, 7522NB, Netherlands

Location

MeSH Terms

Conditions

Psychological Well-BeingDepressionAnxiety DisordersAlzheimer Disease

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorBehavioral SymptomsMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 1, 2022

First Posted

March 23, 2022

Study Start

April 4, 2022

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

November 3, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

Locations