Not Flourishing PopulationNCT03072680
Efficacy of a Positive Psychology Intervention Through a Mobile App
A study testing BPS PAST, BPS FUT and DAILY ACTIVITIES in people with Not Flourishing Population, run by University of Valencia at 2 sites in 2 countries.
Trial summary
The aim of this study is to analyze the efficacy of several variations of an already validated Positive Psychology Intervention (PPI) called Best Possible Self in not flourishing population. This will be done through a mobile app specially designed for this aim. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Not Flourishing Population
- What is being tested?
- BPS PAST, BPS FUT and DAILY ACTIVITIES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Apr 2019to 27 Jul 2019
- 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
- Participants must be 18 years old or older.
- Participants must be willing to participate in the study.
- Participants must have a smartphone (Android or Ios).
Who cannot join
- To suffer from moderate depression or anxiety (scores of 11 or higher) measured by the Hospital Anxiety and Depression Scale (HADS; Zigmond \& Snaith, 1983).
- To have "Flourishing mental health" measured by the Mental Health Continuum Short Form (MHC-SF; Keyes, 2009)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Efficacy of a Positive Psychology Intervention Through a Mobile App: a Randomized Controlled Trial
The aim of this study is to analyze the efficacy of several variations of an already validated Positive Psychology Intervention (PPI) called Best Possible Self in not flourishing population. This will be done through a mobile app specially designed for this aim.
Concretely, the design will permit to compare the classic intervention (BPS Future), a new variation (BPS Past), and a combination of both components (BPS Past+Future).
Read more
Participants will be randomly assigned to one of 3 conditions, in which they will practice the intervention for two weeks:
- BPS-PAST + BPS FUT condition: Participants will practice BPS Past for one week, and then they will switch to BPS future for another week.
- BPS-FUT condition: Participants will practice BPS Future for two weeks.
- CONTROL condition: Participants will practice DAILY ACTIVITIES for two weeks.
Read the detailed description
The design will permit two comparisons:
After the first week of the intervention, participants will answer the assessment. It will permit to compare BPS PAST, BPS FUTURE and CONTROL conditions (pre-post).
After the second week, participants will answer the assessment and then it will be possible to compare BPS PAST + BPS FUTURE combination, BPS FUTURE, and CONTROL conditions.
- Conditions
- Not Flourishing Population
- Being tested
- BPS PAST, BPS FUT, DAILY ACTIVITIES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPS PASTBehavioural
Participants think about themselves in a past when they displayed their best self. Then, they visualize this with the help of audio instructions.
They will practice within a mobile app.
BPS FUTBehavioural
Participants think about themselves in the future after everything has gone as well as it possibly could. Then, they visualize this with the help of audio instructions.
They will practice within a mobile app.
DAILY ACTIVITIESBehavioural
Participants think about the activities they did during the last 24 hours. Then, they visualize this with the help of audio instructions.
They will practice within a mobile app.
| Study group | Role | What they receive |
|---|---|---|
| BPS PAST + BPS FUT | Experimental | Participants practice BPS PAST the first week, then they switch fot BPS FUT. Receives: Behavioral: BPS PAST; Behavioral: BPS FUT |
| BPS FUT | Experimental | Participants practice BPS FUT during the two weeks. Receives: Behavioral: BPS FUT |
| CONTROL | Active comparator | Participants practice DAILY ACTIVITIES for the two weeks. Receives: Behavioral: DAILY ACTIVITIES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Positive and Negative Affect from baseline to post-intervention
Positive and Negative Affect Scale (PANAS; Watson, Clark \& Tellegen, 1988)
Measured: Change from pre-intervention to post-intervention (2 weeks)
Secondary outcomes (4)
Wellbeing
The Mental Health Continuum Short Form (MHC-SF; Keyes, 2009)
Measured: Change from pre-intervention to post-intervention (2 weeks)
Optimism
Life Orientation Test (LOT-R; Scheier, Carver \& Bridges, 1994).
Measured: Change from pre-intervention to post-intervention (2 weeks)
Satisfaction with life
Temporal Satisfaction with Life Scale (TSWLS; Pavot, Diener \& Suh, 1998).
Measured: Change from pre-intervention to post-intervention (2 weeks)
Self-efficacy
New General Self-efficacy Scale (NGSES; Chen, Gully \& Eden, 2001).
Measured: Change from pre-intervention to post-intervention (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start23 Apr 2019
- Primary completion27 Jul 2019
- Study completion27 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Not Flourishing PopulationStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Twente
- Responsible party
- Principal investigator, Rosa María Baños Rivera, University of Valencia
- Investigators
- Rosa Baños, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072680
- Sponsor's protocol ID
- 16337
- Status last verified
- Sep 2019
- First submitted
- 2 Mar 2017
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meevissen YM, Peters ML, Alberts HJ. Become more optimistic by imagining a best possible self: effects of a two week intervention. J Behav Ther Exp Psychiatry. 2011 Sep;42(3):371-8. doi: 10.1016/j.jbtep.2011.02.012. Epub 2011 Mar 2.
PubMed 21450262King L. The Health Benefits of Writing About Life Goals. Personality and Social Psychology Bulletin 27(7): 798-807, 2001.
Sheldon KM, Lyubomirsky S. How to increase and sustain positive emotion: The effects of expressing gratitude and visualizing best possible selves. The Journal of Positive Psychology 1(2): 73-82, 2006.
Peters ML, Flink IK, Boersma K, Linton SJ. Manipulating optimism: Can imagining a best possible self be used to increase positive future expectancies? The Journal of Positive Psychology 5(3): 204-211, 2010.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Positive Psychology Intervention Through a Mobile App: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03072680
- Acronym / sponsor ID
- 16337
- Conditions
- Not Flourishing Population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- University of Twente
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 27 Jul 2019 (actual)
- Study completion
- 27 Jul 2019 (actual)
- First posted
- 7 Mar 2017 (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 aim of this study is to analyze the efficacy of several variations of an already validated Positive Psychology Intervention (PPI) called Best Possible Self in not flourishing population. This will be done through a mobile app specially designed for this aim.
Concretely, the design will permit to compare the classic intervention (BPS Future), a new variation (BPS Past), and a combination of both components (BPS Past+Future).
Participants will be randomly assigned to one of 3 conditions, in which they will practice the intervention for two weeks:
- BPS-PAST + BPS FUT condition: Participants will practice BPS Past for one week, and then they will switch to BPS future for another week.
- BPS-FUT condition: Participants will practice BPS Future for two weeks.
- CONTROL condition: Participants will practice DAILY ACTIVITIES for two weeks.
Detailed description
The design will permit two comparisons:
After the first week of the intervention, participants will answer the assessment. It will permit to compare BPS PAST, BPS FUTURE and CONTROL conditions (pre-post).
After the second week, participants will answer the assessment and then it will be possible to compare BPS PAST + BPS FUTURE combination, BPS FUTURE, and CONTROL conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BPS PAST + BPS FUT | Experimental | Behavioral: BPS PAST, Behavioral: BPS FUTParticipants practice BPS PAST the first week, then they switch fot BPS FUT. |
| BPS FUT | Experimental | Behavioral: BPS FUTParticipants practice BPS FUT during the two weeks. |
| CONTROL | Active comparator | Behavioral: DAILY ACTIVITIESParticipants practice DAILY ACTIVITIES for the two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be 18 years old or older.
- Participants must be willing to participate in the study.
- Participants must have a smartphone (Android or Ios).
Key exclusion criteria (2 listed)
- To suffer from moderate depression or anxiety (scores of 11 or higher) measured by the Hospital Anxiety and Depression Scale (HADS; Zigmond \& Snaith, 1983).
- To have "Flourishing mental health" measured by the Mental Health Continuum Short Form (MHC-SF; Keyes, 2009)
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 |
|---|---|---|
| BPS PASTParticipants think about themselves in a past when they displayed their best self. Then, they visualize this with the help of audio instructions. They will practice within a mobile app. | Behavioural | BPS PAST + BPS FUT |
| BPS FUTParticipants think about themselves in the future after everything has gone as well as it possibly could. Then, they visualize this with the help of audio instructions. They will practice within a mobile app. | Behavioural | BPS FUT, BPS PAST + BPS FUT |
| DAILY ACTIVITIESParticipants think about the activities they did during the last 24 hours. Then, they visualize this with the help of audio instructions. They will practice within a mobile app. | Behavioural | CONTROL |
Primary outcome
Change of Positive and Negative Affect from baseline to post-intervention
Time frame: Change from pre-intervention to post-intervention (2 weeks)
Positive and Negative Affect Scale (PANAS; Watson, Clark \& Tellegen, 1988)
4 secondary outcomes
Wellbeing
Time frame: Change from pre-intervention to post-intervention (2 weeks)
Optimism
Time frame: Change from pre-intervention to post-intervention (2 weeks)
Satisfaction with life
Time frame: Change from pre-intervention to post-intervention (2 weeks)
Self-efficacy
Time frame: Change from pre-intervention to post-intervention (2 weeks)
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 23 Sep 2019.
- Background: PubMed 21450262Meevissen YM, Peters ML, Alberts HJ. Become more optimistic by imagining a best possible self: effects of a two week intervention. J Behav Ther Exp Psychiatry. 2011 Sep;42(3):371-8. doi: 10.1016/j.jbtep.2011.02.012. Epub 2011 Mar 2.
- BackgroundKing L. The Health Benefits of Writing About Life Goals. Personality and Social Psychology Bulletin 27(7): 798-807, 2001.
- BackgroundSheldon KM, Lyubomirsky S. How to increase and sustain positive emotion: The effects of expressing gratitude and visualizing best possible selves. The Journal of Positive Psychology 1(2): 73-82, 2006.
- BackgroundPeters ML, Flink IK, Boersma K, Linton SJ. Manipulating optimism: Can imagining a best possible self be used to increase positive future expectancies? The Journal of Positive Psychology 5(3): 204-211, 2010.
- Individual participant dataSharing planned: No
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.
Rosa Baños, PhD principal investigator
University of Valencia
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BPS PAST, BPS FUT and DAILY ACTIVITIES in people with Not Flourishing Population, run by University of Valencia at 2 sites in 2 countries.
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 3 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 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Spain. 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?
Change of Positive and Negative Affect from baseline to post-intervention (time frame: Change from pre-intervention to post-intervention (2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03072680, which also lists 4 linked publications.
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 23 Sep 2019.