Healthy ParticipantsBestBPSNCT04753801
What Are the Ingredients for the Best Form of the Best Possible Self (BPS) Intervention?
A study testing Thinking, writing and imagination in people with Healthy Participants, run by Philipps University Marburg at 1 site in Germany.
Trial summary
This study aims to determine the relevant 'ingredients' to make the best possible self (BPS) intervention most efficacious and test whether the BPS's efficacy can be enhanced by including mindfulness aspects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Thinking, writing and imagination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2021to 31 Mar 2021
- 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
- fluent in the German language
- access to a computer/tablet/smartphone with audio output/headphones
Who cannot join
- not willing to take part in an online-intervention (duration: 60 minutes)
- no access to a computer/tablet/smartphone with audio output/headphones
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg
Marburg, 35032
About this study
Official title: What Are the Ingredients for the Best Form of the Best Possible Self (BPS) Intervention? Combining the BPS Intervention With Mindfulness
This study aims to determine the relevant 'ingredients' to make the best possible self (BPS) intervention most efficacious and test whether the BPS's efficacy can be enhanced by including mindfulness aspects.
Read the detailed description
The best possible self (BPS) intervention is a brief positive psychology intervention to increase a person's positive affect and optimism. The BPS has been used in different forms (writing vs. imagining/visualizing vs. writing + imagining/visualizing the best possible self). However, it remains unclear which 'ingredients' are necessary to let the BPS unfold its effects. This online study aims to determine the relevant 'ingredients' to make the best possible self (BPS) intervention most efficacious. Since mindfulness interventions have recently indicated promising effects on positive and negative affect, another goal of this study is to test whether the BPS's efficacy can be enhanced by including aspects of mindfulness.
- Conditions
- Healthy Participants
- Being tested
- Thinking, writing and imagination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thinking, writing and imaginationBehavioural
All participants are asked to take some time to think and write about the respective intervention group's content. In some groups (after the writing exercise (approx. 15min)), participants are also asked to imagine that content or engage in a mindfulness activity or recall task for about 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Best Possible Self (writing only) | Experimental | Participants are asked to think and write about their best possible future self (15 min). Receives: Behavioral: Thinking, writing and imagination |
| Best Possible Self (writing+imagining) | Experimental | Participants are asked to think and write about their best possible future self (15 min) and, then to imagine their positive future (5 min). Receives: Behavioral: Thinking, writing and imagination |
| Best Possible Self (writing+mindfulness) | Experimental | Participants are asked to think and write about their best possible future self (15 min) and subsequently engage in a brief mindfulness sequence (5 min). Receives: Behavioral: Thinking, writing and imagination |
| Best Possible Self (writing+recall) | Experimental | Participants are asked to think and write about their best possible future self (15 min) and subsequently engage in a brief recall imagination task about the past two days (5 min). Receives: Behavioral: Thinking, writing and imagination |
| Writing about the past | Active comparator | Participants are asked to think and write about activities of the past two days (15 min). Receives: Behavioral: Thinking, writing and imagination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in emotions (PANAS)
Change scores are calculated for positive and negative sum scores (post- minus pre-scores; pre-scores will be used as a covariate).
Measured: Change from pre (baseline) to post scores (approx. 30 minutes later)
Secondary outcomes (2)
Change in state optimism ratings
State Optimism measure (SOM), 7 items (each item 1(strongly disagree)-5(strongly agree)). Change scores are calculated for positive and negative sum scores (post- minus pre-scores; pre-scores will be used as a covariate).
Measured: Change from pre (baseline) to post scores (approx. 30 minutes later)
Change in emotional responses to imagery of neutral, pleasant and aversive narrative scripts
Nine narrative imagery scripts are used. Scenes included three neutral, standard social threat and positive/reward events. All scripts were developed according to the recommendations of Lang (1979). Participants are asked to rate the vividness of imagery (1= not vivid at all, 9= very vivid), the wish to avoid imagery (1 = no wish to avoid , 9 = strong wish to avoid imagery), their experienced anxiety (1= no anxiety, 9=very strong anxiety), displeasure (1 = pleasant, 9 = unpleasant), and emotional arousal (1 = relaxed, 9 = aroused) during imagery on a 9-point rating scale. Emotional responses are averaged per category.
Measured: Change from pre (baseline) to post scores (approx. 30 minutes later)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Feb 2021
- Primary completion27 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Winfried Rief, Prof., Principal investigator, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753801
- Sponsor's protocol ID
- BestBPS
- Acronym
- BestBPS
- Status last verified
- Aug 2024
- First submitted
- 9 Feb 2021
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual patient data will be shared with researchers providing a relevant and methodologically sound proposal
Publications
Millstein RA, Chung WJ, Hoeppner BB, Boehm JK, Legler SR, Mastromauro CA, Huffman JC. Development of the State Optimism Measure. Gen Hosp Psychiatry. 2019 May-Jun;58:83-93. doi: 10.1016/j.genhosppsych.2019.04.002. Epub 2019 Apr 4.
PubMed 31026732
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are the Ingredients for the Best Form of the Best Possible Self (BPS) Intervention? Combining the BPS Intervention With Mindfulness
- ClinicalTrials.gov ID
- NCT04753801
- Acronym / sponsor ID
- BestBPS / BestBPS
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 27 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 15 Feb 2021 (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.
This study aims to determine the relevant 'ingredients' to make the best possible self (BPS) intervention most efficacious and test whether the BPS's efficacy can be enhanced by including mindfulness aspects.
Detailed description
The best possible self (BPS) intervention is a brief positive psychology intervention to increase a person's positive affect and optimism. The BPS has been used in different forms (writing vs. imagining/visualizing vs. writing + imagining/visualizing the best possible self). However, it remains unclear which 'ingredients' are necessary to let the BPS unfold its effects. This online study aims to determine the relevant 'ingredients' to make the best possible self (BPS) intervention most efficacious. Since mindfulness interventions have recently indicated promising effects on positive and negative affect, another goal of this study is to test whether the BPS's efficacy can be enhanced by including aspects of mindfulness.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Best Possible Self (writing only) | Experimental | Behavioral: Thinking, writing and imaginationParticipants are asked to think and write about their best possible future self (15 min). |
| Best Possible Self (writing+imagining) | Experimental | Behavioral: Thinking, writing and imaginationParticipants are asked to think and write about their best possible future self (15 min) and, then to imagine their positive future (5 min). |
| Best Possible Self (writing+mindfulness) | Experimental | Behavioral: Thinking, writing and imaginationParticipants are asked to think and write about their best possible future self (15 min) and subsequently engage in a brief mindfulness sequence (5 min). |
| Best Possible Self (writing+recall) | Experimental | Behavioral: Thinking, writing and imaginationParticipants are asked to think and write about their best possible future self (15 min) and subsequently engage in a brief recall imagination task about the past two days (5 min). |
| Writing about the past | Active comparator | Behavioral: Thinking, writing and imaginationParticipants are asked to think and write about activities of the past two days (15 min). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- fluent in the German language
- access to a computer/tablet/smartphone with audio output/headphones
Key exclusion criteria (2 listed)
- not willing to take part in an online-intervention (duration: 60 minutes)
- no access to a computer/tablet/smartphone with audio output/headphones
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 |
|---|---|---|
| Thinking, writing and imaginationAll participants are asked to take some time to think and write about the respective intervention group's content. In some groups (after the writing exercise (approx. 15min)), participants are also asked to imagine that content or engage in a mindfulness activity or recall task for about 5 minutes. | Behavioural | Best Possible Self (writing only), Best Possible Self (writing+imagining), Best Possible Self (writing+mindfulness), Best Possible Self (writing+recall), Writing about the past |
Primary outcome
Change in emotions (PANAS)
Time frame: Change from pre (baseline) to post scores (approx. 30 minutes later)
Change scores are calculated for positive and negative sum scores (post- minus pre-scores; pre-scores will be used as a covariate).
2 secondary outcomes
Change in state optimism ratings
Time frame: Change from pre (baseline) to post scores (approx. 30 minutes later)
Change in emotional responses to imagery of neutral, pleasant and aversive narrative scripts
Time frame: Change from pre (baseline) to post scores (approx. 30 minutes later)]
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 7 Aug 2024.
- Background: PubMed 31026732Millstein RA, Chung WJ, Hoeppner BB, Boehm JK, Legler SR, Mastromauro CA, Huffman JC. Development of the State Optimism Measure. Gen Hosp Psychiatry. 2019 May-Jun;58:83-93. doi: 10.1016/j.genhosppsych.2019.04.002. Epub 2019 Apr 4.
- Individual participant dataSharing planned: Undecided. Individual patient data will be shared with researchers providing a relevant and methodologically sound proposal
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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.
Winfried Rief, Prof. principal investigator
Philipps University Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thinking, writing and imagination in people with Healthy Participants, run by Philipps University Marburg at 1 site in Germany.
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 2 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 7 Aug 2024. 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 Germany. 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 in emotions (PANAS) (time frame: Change from pre (baseline) to post scores (approx. 30 minutes later)). 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 NCT04753801, which also lists 1 linked publication.
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 7 Aug 2024.