What Are the Ingredients for the Best Form of the Best Possible Self (BPS) Intervention? (BestBPS)

August 6, 2024 updated by: Philipps University Marburg Medical Center

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.

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.

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 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.
181

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Marburg, Germany, 35032
        • Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg

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

Description

Inclusion Criteria:

  • fluent in the German language
  • access to a computer/tablet/smartphone with audio output/headphones

Exclusion Criteria:

  • not willing to take part in an online-intervention (duration: 60 minutes)
  • no access to a computer/tablet/smartphone with audio output/headphones

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: Best Possible Self (writing only)
Participants are asked to think and write about their best possible future self (15 min).
Behavioral: Thinking, writing and imagination
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.
Experimental: Best Possible Self (writing+imagining)
Participants are asked to think and write about their best possible future self (15 min) and, then to imagine their positive future (5 min).
Behavioral: Thinking, writing and imagination
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.
Experimental: Best Possible Self (writing+mindfulness)
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).
Behavioral: Thinking, writing and imagination
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.
Experimental: Best Possible Self (writing+recall)
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).
Behavioral: Thinking, writing and imagination
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.
Active Comparator: Writing about the past
Participants are asked to think and write about activities of the past two days (15 min).
Behavioral: Thinking, writing and imagination
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.

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
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).
Change from pre (baseline) to post scores (approx. 30 minutes later)

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
Change in state optimism ratings
Time Frame: Change from pre (baseline) to post scores (approx. 30 minutes later)
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).
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)]
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.
Change from pre (baseline) to post scores (approx. 30 minutes later)]

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.
Philipps University Marburg Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Winfried Rief, Prof., Philipps University Marburg Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
February 1, 2021

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.
March 27, 2021

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.
March 31, 2021

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).
February 9, 2021

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.
February 9, 2021

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.
February 15, 2021

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.
August 7, 2024

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.
August 6, 2024

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.
August 1, 2024

More Information

Terms related to this study

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.
  • BestBPS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual patient data will be shared with researchers providing a relevant and methodologically sound proposal

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.

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