Study setting {9}
SPIRIT guidance: Description of study settings (eg, community clinic, academic hospital) and list of countries where data will be collected. Reference to where list of study sites can be obtained.
The study will be conducted in the laboratory of sports psychology of the Department of Sports Science at the University of Konstanz, Germany. The analyses of hormones, and alpha amylase will be performed in the biochemical laboratory of the Institute for Medical Psychology in Heidelberg, Germany.
Eligibility criteria {10}
SPIRIT guidance: Inclusion and exclusion criteria for participants. If applicable, eligibility criteria for study centres and individuals who will perform the interventions (eg, surgeons, psychotherapists).
Primary inclusion criteria
The following criteria must be fulfilled to participate in the study:
- The participants have given informed consent to all aspects of the study (agreement with video recording, hormone collection).
- The participants must be at least 18 years old and speak German as their native language.
Primary exclusion criteria
If the participant meets the following criteria, they will be excluded from study participation:
Previous participation in stress experiments as well as psychology and sports students from the 5th semester.
Physical or mental illness, nicotine consumption, drug use, a body mass index (BMI) of 30 or more, and any regular use of medication (including hormonal contraception) lead to exclusion from the experiment, as they are factors that could influence the physiological stress response (Foley & Kirschbaum, 2010).
Who will take informed consent? {26a}
SPIRIT guidance: Who will obtain informed consent or assent from potential trial participants or authorised surrogates, and how (see Item 32).
The participants will receive the study information sheet and give their informed consent in the screening online survey (for more details see Appendix B.1) before the lab session. If they fulfill the inclusion criteria, they will be invited to the lab session. Here the participants will again read the study information sheet and sign the informed consent (for more details see Appendix C.1 and C.2).
Additional consent provisions for collection and use of participant data and biological specimens {26b}
SPIRIT guidance: Additional consent provisions for collection and use of participant data and biological specimens in ancillary studies, if applicable.
Participants data and biological specimens will only be interpreted in ancillary studies, following the participants’ informed consent.
Interventions
Explanation for the choice of comparators {6b}
SPIRIT guidance: Explanation for choice of comparators.
Since stress research has already clearly shown that the TSST reliably induces stress (Kirschbaum et al., 1993), we refrain from comparing a stressed vs. non-stressed group. Instead, we focus on the role of social support by comparing a socially supported group of subjects with a non-socially supported group. At the same time, we analyse the moderating role of social motives, which we capture as continuous variables.
Intervention description {11a}
SPIRIT guidance: Interventions for each group with sufficient detail to allow replication, including how and when they will be administered.
Web-survey prior to the lab session
The participants complete an online questionnaire (Limesurvey) at home. Here, the eligibility criteria are checked, the implicit motives are assessed by using a Picture Story Exercise (Schultheiss & Pang, 2007) and gender role self-concepts (Zimmermann et al., 2011), as well as other control variables will be measured. The exercise and sports activity questionnaire (Fuchs et al., 2015) will be administered to test a related but different research question (for more details see appendix B.3). Participants, who are eligible for the study will be invited to the laboratory session via e-mail. Participants confirmed their agreement that they will be contacted by e-mail and learn that e-mail addresses will be deleted after having made the appointment.
Lab session
Figure 1 shows the schematic procedure of data collection. It starts with a general preparation phase, where the baseline measurement of the physiological parameters (hormones), the control variables, and psychological variables (self-reports about well-being, stress-experience and motive-specific affect) takes place. In the preparation phase for the TSST-G, the participants prepare for the task. The participants in the experimental group receive social support during this phase, while the participants in the control group do not receive any social support. Finally, there will be a 45-minute period of rest during which repeated physiological as well as the psychological questionnaires will be taken. A detailed procedure can be found in the study protocol (see Appendix A).
General preparation phase
In each lab session, three participants will arrive between 5:00 and 5:15 pm outside the laboratory and will be led individually to their own preparation room (so that they cannot contact each other). First, they will be asked to read the study information sheet again and then will provide their written consent (for details see Appendix C.1 and C.2). Afterwards, the participants will generate their participant code via paper and pencil format, which ensures that the saliva samples, as well as other collected data, can be stored anonymously. Then they complete a short day-screening questionnaire, (see Appendix D) on the computer which will assess control variables (a. o., sports, medication intake, smoking, caffeine- and alcohol consumption). Afterward they will be asked to wear the pulse belt which contains a Polar H10 sensor (Polar Electro UK Ltd., Warwick, UK). To put on the belt, the experimenter leaves the room. After that, the participants will provide an initial saliva sample at measurement time T0(-11min) and will complete the first test battery including different questionnaires on the computer (hereafter: psychological questionnaire).
Preparation phase TSST-G without social support.
For the preparation phase, each participant sits in a separate room. Here they receive the written instructions for the upcoming interview (see Appendix E). After they have had 10 minutes of preparation time for this task, they give a saliva sample (T1, 0min) and complete the psychological questionnaire again. Subsequently the participants are individually led to their places in front of the panel.
Preparation phase TSST-G with social support.
The preparation phase is identical with the described scenario for the participants without social support, with the exception that the experimenter introduces a female confederate as a student assistant that can assist the participant if he or she needed. The female confederate provides passive social support for the first five minutes, ostensibly working on the computer. In the second five minutes of the preparation phase, the confederate gives active social support and also notes the reactions of the participants (for a detailed procedure, see Appendix F). At the end of the 10-minute preparation period, the confederate asks the participant for a saliva sample (T1, 0min) and to complete the psychological questionnaire again. Then rooms are changed. All other instructions are the same as in the group without social support.
TSST -G
Our procedure is based on the TSST-G developed by Von Dawans et al. (2011). Each participant is required to present his or her interview individually in front of the panel for three minutes at a time. During this time, they are interrupted in a standardized manner by the panel (for more details see Appendix G). After that, they give a saliva sample (T2, +12min) and complete the psychological questionnaire. In the following, each participant has to perform the arithmetic task three times for 30 seconds. When this task is finished, they give another saliva sample (T3, +20min). During this whole procedure, the participants are recorded with a microphone and a camera. The experimenter then leads the participants individually from the TSST-G test room to the respective preparation rooms. There they again fill in the psychological questionnaire.
Rest-phase
During the rest period, three additional saliva samples are collected (T4,+30min; T5, +45min; T6, +65min). Participants who have received social support will complete a social support scale at T6(+65min) (see Appendix H).
Debriefing.
Finally, the experimenter leads all subjects to the TSST-G testing room and provides a debriefing about the aim of the study (see Appendix I). Questions are answered as needed. The participants receive their payment and are dismissed.
Criteria for discontinuing or modifying allocated interventions {11b}
SPIRIT guidance: Criteria for discontinuing or modifying allocated interventions for a given trial participant (eg, drug dose change in response to harms, participant request, or improving/worsening disease).
Participants can discontinue the study at any time without giving any reason. They will still receive their payment.
Strategies to improve adherence to interventions {11c}
SPIRIT guidance: Strategies to improve adherence to intervention protocols, and any procedures for monitoring adherence (eg, drug tablet return, laboratory tests).
The entire study takes place under controlled laboratory conditions and adherence with the study protocol is closely monitored.
Relevant concomitant care permitted or prohibited during the trial {11d}
SPIRIT guidance: Relevant concomitant care and interventions that are permitted or prohibited during the trial.
Study participants will be screened for medication, caffeine intake, smoking, sports and heavy meals prior to the experiment. Chronic illness and medication intake are defined as exclusion criteria for the study.
Provisions for post-trial care {30}
SPIRIT guidance: Provisions, if any, for ancillary and post-trial care, and for compensation to those who suffer harm from trial participation.
The TSST has not been linked to any adverse consequences, so no harm from trial participation is expected. At the end of the study, a detailed debriefing takes place, the experimenter inquires about the subjects' condition and is available for questions.
Outcomes {12}
SPIRIT guidance: Primary, secondary, and other outcomes, including the specific measurement variable (eg, systolic blood pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg, median, proportion), and time point for each outcome. Explanation of the clinical relevance of chosen efficacy and harm outcomes is strongly recommended.
Manipulation check social support
To check whether social support was received as such by the participants, a modified version of the received support subscale of the Berlin Social Support Scale (BSSS; Schulz & Schwarzer, 2003) will be used (see Appendix H, T6(+65min)). Item wording was adapted to the study context. Two items from the original scale were deleted because they refer to instrumental support, and the social support in this study rather refers to emotional and informal social support. The item "This student assistant was there for me when I needed her" is also counted as instrumental support according to Schulz and Schwarzer (2003), but it can also be understood as emotional support and therefore remains included. Items are rated on a 4-point Likert scale ranging from 1 (not true) to 4 (exactly true). The original version of the received support scale has good internal consistency (α = .83). In addition, participants will be asked directly whether they received support from the student assistant and whether they found this support helpful.
Test battery of psychological questionnaires
Participants are asked to complete the psychological questionnaire a total of 7 times (see Figure 1).
Well-being will be captured via 6 items (short version A) from the Multidimensional Well-being questionnaire (MDBF; Steyer et al., 1997). The items start with “Right now I feel…” and will be continued with one of the following adjectives: good, bad, alertness, fatigue, relaxed, and restlessness. The participants will be able to rate them on a 5-level scale which will be labelled from not at all too very. A slightly modified version of the trait anxiety scale of the State - Trait Anxiety Inventory (Spielberger, 1970) will be used to assess the momentary anxiety of the participants. A total of 6 adapted items are included, which can be answered on a 5-point scale, “How big do you think your fear is at the moment?”, “How much do you feel physically uncomfortable right now?”, “How strong is your need to leave the situation?”, “How tense is your feeling right now?”, “How much are you in control of the situation?”, “How stressed do you feel? “. Per our knowledge, no standardized motive-specific affect questionnaire exists so far. We therefore created an adjective list which is theoretically derived from McClelland ́s (1985) early work and added adjectives that have been used in more recent research (Job et al., 2012) (see self- determination theory, Ryan & Deci, 2000). Participants indicated for 7 items how they feel right now by using a 7-point response scale (1: not at all to 7: very much). The items are “socially-related”, “calm” (affiliation motive specific affect) (the item “relaxed” from the MDBF questionnaire will also be used in the analysis for the affiliation motive), “strong”, “excited”, “enthusiastic” (power motive), and “competent” and “self-determined” as additional items representing achievement and autonomy motive-specific affect, respectively (see appendix J). Construct validity of this motive-specific affect scale will be checked.
Social Motives
Implicit social motives are measured using the Picture Story Exercise (Schultheiss & Pang, 2007) which is the most frequently used measure to assess implicit motives. Key validity criteria are met, interrater reliability is good, and retest reliability is satisfactory (Schultheiss & Köllner, in press; Schultheiss & Pang, 2007); for further discussion see (Schüler et al., 2015). The PSE will be part of the online questionnaire prior to the lab session (for validity of computer version of PSE, Bernecker & Job, 2011). Participants will be instructed that they will see six different pictures and for each of them, they should write a fictional story with a beginning, middle, and end. The pictures will be presented for 15 sec and then a text box will appear, where they can type their story. Questions that help participants to organize their stories will be presented above the pictures (e.g, "What is happening right now? Who are the characters?). For each story, the participants will have four minutes. After 3 min 30 sec, a small reminder will appear asking them to finish the story. After the four minutes have elapsed, the next picture will appear. The six pictures couple by the river, nightclub scene, sorrow, beachcombers, NewPic32, NewPic9 will be presented, for more details see appendix B.3. As recommended (Schultheiss & Pang, 2007), two experienced coders will score the stories for the power and affiliation motive according to Winter's scoring manual (Winter, 1994) (Interrater reliability is expected to be between ICC = .80-.90). Disagreements between coders will be resolved by discussion (Schultheiss & Pang, 2007). Motive scores will be corrected by word count. For further details about test administration and scoring procedure see Schultheiss & Pang (2007).
All participants will complete a short German version of the Bem Sex Role Inventory, to screen for GRSC (Zimmermann et al., 2011).
Physiological measures
Endocrine measurements
Saliva samples will be collected for the recording of cortisol, alpha amylase and reproductive hormones. Approximately 10ml of saliva will be dispensed through a straw into Salicaps (IBL International, Hamburg, Germany) (see Appendix K for instructions). After the study, all saliva samples will be frozen and stored at -20°C. Hormone and enzyme levels will be analysed at the stress biomarkers lab at the Institute of Medical Psychology, Heidelberg University Hospital.
Salivary cortisol
The concentration of cortisol in saliva will be recorded in ng/ml. Seven saliva samples will be collected using Salicaps (IBL International, Hamburg, Germany) at measurement time points T0(-11min before TSST-G), T1(TSST-G onset), T2(after job interview), T3(after arithmetic task), at T4, T5, and T6 during resting phase (+30min, +45min, +65min after TSST-G onset). Cortisol will be determined with the Cortisol free in Saliva Elisa assay from Demeditec.
Alpha-amylase
Alpha-amylase is recorded in U/mL. The concentration is derived from the same seven salvia samples as used for the cortisol analysis and will be determined by a kinetic colorimetric test. The reagents for this will be obtained from DiaSys Diagnosic Systems (Holzheim, Germany).
Reproductive hormones
Reproductive hormones (testosterone, estradiol, and progesterone) will be recorded in pg/ml. Four saliva samples will be collected using Salicaps (IBL International, Hamburg, Germany) at the measurement time points T0(-11min before TSST-G), T1(TSST-G onset), T3(after the arithmetic task), and T6 during rest (+65min after TSST-G onset). Hormone concentrations will be determined by biochemical analysis in the laboratory. The following kits from IBL will be used for analysis: Testosterone Luminescence Immunoassay, 17 beta - Estradiol Saliva Luminescence Immunoassay, Progesterone Luminescence Immunoassay.
ANS measurements
Heart rate and heart rate variability will be measured with a Polar H10 sensor (Polar Electro UK Ltd., Warwick, UK). The sensor is placed in a pulse belt that the participants will wear around their chest. With the help of a Polar station and an iPad, the participants' data is transmitted wirelessly and in real time.
Speech performance
The participants will be videotaped while they complete the tasks (interview and arithmetic task) in front of the panel. The video sequences showing the recording of the interview will be coded for speech performance using a self-developed coding system. This system includes three quality criteria: the information content, the presentation style, and the perceived competence of the participants. The assessment of the information content is based on a checklist for the evaluation of a presentation according to Ascheron (2019). The content is scored on the following 5 items, "structure/ organization", "comprehensibility of content", "flow", "information content" and "message". These items will be rated on a scale that ranges from 1 (very good) to 6 (unsatisfactory). A modified questionnaire of Ascheron (2019) will be used to evaluate the presentation style. Two items (intonation, English quality) were left out because intonation overlaps with another item (emphasis), and English quality is irrelevant because the study will be conducted in German. The presentation style is rated on the basis of the following 5 items: "speed", "intelligibility", " emphasis ", "body language" and "eye contact", whereby we added the latter item to complement the construct in more detail. The items will be scored using a six-point scale (1: very good to 6: unsatisfactory). Since there is no suitable measurement tool for the assessment of perceived competence in the literature, we determined 5 items that should enable a differentiated evaluation of this construct. The following items will be also scored on a six-point scale: "technical language/vocabulary", "use of filler words", "use of everyday language", "interest" and "persuasiveness". Construct validity of this competence scale will be checked.
Participant timeline {13}
SPIRIT guidance: Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and visits for participants. A schematic diagram is highly recommended (see figure at http://www.spirit-statement.org/publications-downloads/).
The timeline for participants is displayed in Figure 1.
Sample size {14}
SPIRIT guidance: Estimated number of participants needed to achieve study objectives and how it was determined, including clinical and statistical assumptions supporting any sample size calculations.
It is intended to recruit 154 participants (77 women).This sample size was calculated using a power analysis G*Power 3.1 (Faul et al., 2009), with an additional 20% added to compensate for possible drop-outs.
Recruitment {15}
SPIRIT guidance: Strategies for achieving adequate participant enrolment to reach target sample size.
The recruitment will be done by flyer distribution in the University of Konstanz, as well as an entry in an online platform where experiments are offered by the departments of psychology and linguistics.
Assignment of interventions: allocation
Sequence generation {16a}
SPIRIT guidance: Method of generating the allocation sequence (eg, computer-generated random numbers), and list of any factors for stratification. To reduce predictability of a random sequence, details of any planned restriction (eg, blocking) should be provided in a separate document that is unavailable to those who enrol participants or assign interventions.
Participants will be randomly assigned into the social-support or no-social support group,
based on their arrival time in front of the laboratory.
Concealment mechanism {16b}
SPIRIT guidance: Mechanism of implementing the allocation sequence (eg, central telephone; sequentially numbered, opaque, sealed envelopes), describing any steps to conceal the sequence until interventions are assigned.
The participants do not have any information in which group they will be assigned to, nor do they know that the other participants may be undergoing a different form of the experiment.
Implementation {16c}
SPIRIT guidance: Who will generate the allocation sequence, who will enrol participants, and who will assign participants to interventions.
Depending on the order in which the participants arrive before the laboratory, they may or may not receive social support.
Assignment of interventions: Blinding
Who will be blinded {17a}
SPIRIT guidance: Who will be blinded after assignment to interventions (eg, trial participants, care providers, outcome assessors, data analysts), and how.
The participants will be blind to the condition, until the end of the experiment. The advertisement for the study states that we are investigating the relationship between verbal creativity and physiological reactions (for the exact wording of the cover story see appendix B.1). The experimenter, as well as the confederate, know who will be in which condition. The TSST- panel will not know who is in which condition. The coders of the motive measure are also condition blind.
Procedure for unblinding if needed {17b}
SPIRIT guidance: If blinded, circumstances under which unblinding is permissible, and procedure for revealing a participant’s allocated intervention during the trial.
The participants will be debriefed about the aims, as well as the group assignments in the study (for more details, see appendix I).
Data collection and management
Plans for assessment and collection of outcomes {18a}
SPIRIT guidance: Plans for assessment and collection of outcome, baseline, and other trial data, including any related processes to promote data quality (eg, duplicate measurements, training of assessors) and a description of study instruments (eg, questionnaires, laboratory tests) along with their reliability and validity, if known. Reference to where data collection forms can be found, if not in the protocol.
In the section “Outcomes 12b” the measures for psychological and physiological parameters are explained in detail.
Plans to promote participant retention and complete follow-up {18b}
SPIRIT guidance: Plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols.
Participants will receive 30 Euro payment at the end of the lab session independently of whether or when participants decide to discontinue the study. To promote participant adherence with the appointment and study protocol, they will receive a reminder e-mail after having filled in the web-survey and one day before their lab appointment.
Data management {19}
SPIRIT guidance: Plans for data entry, coding, security, and storage, including any related processes to promote data quality (eg, double data entry; range checks for data values). Reference to where details of data management procedures can be found, if not in the protocol.
The questionnaire data will be downloaded from Limesurvey and stored on the university server. The psychological questionnaire from T2, which were collected by paper and pencil format, as well as heart rate, and heart rate variability will be stored in an excel table by the study experimenter directly after the study. The video file will also be saved directly after the experiment, on a laptop of the sport psychology lab and a back-up server. The saliva samples will be sent to the biochemical laboratory of the Institute for Medical Psychology in Heidelberg, Germany. To guarantee the accuracy of the analyses, 10% of the cortisol samples, as well as 20% of the samples for the reproductive hormones will be double-determined. The signed consent forms of the participants will be collected in a folder laboratory of the sports psychology department in Konstanz. Only the experimenter will have access to the data, which will be stored for 10 years on a server of the University.
Confidentiality {27}
SPIRIT guidance: How personal information about potential and enrolled participants will be collected, shared, and maintained in order to protect confidentiality before, during, and after the trial.
The participants will generate their own code that allows to merge the data of the web surveys with the data gained in the laboratory.
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
SPIRIT guidance: Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in the current trial and for future use in ancillary studies, if applicable.
Saliva samples will be stored at the biochemical lab at Heidelberg University Hospital for at least two years after completion of the study and will then be discarded.
Statistical methods
Statistical methods for primary and secondary outcomes {20a}
SPIRIT guidance: Statistical methods for analysing primary and secondary outcomes. Reference to where other details of the statistical analysis plan can be found, if not in the protocol.
Statistical analysis will be performed using the freely available software R-Studio (current version: R version 4.0.2; (Team, 2017)) for statistical analysis and graphs. We will use a nested random effect regression as a multi-level regression approach that allows the intercept to vary with participants to account for the fact that the dependent variables are assessed multiple times. The regression model will be built by sequentially adding predictors after an intercept-only model and its random intercept (random = 1 | ID) has been specified. Every newly added predictor (social support condition, social motive, sex), or interaction-term (condition x social motive, condition x sex, social motive x sex and condition x social motive x sex) is stored as a separate regression model in R-studio to allow for a final comparison of all stages of model-specification. All predictors are kept in a regression model when a further predictor or interaction-term was added to that model. Main and interaction effect models were compared using ANOVAS.
Interim analyses {21b}
SPIRIT guidance: Description of any interim analyses and stopping guidelines, including who will have access to these interim results and make the final decision to terminate the trial.
No interim analyses or stopping guidelines are planned.
Methods for additional analyses (e.g. subgroup analyses) {20b}
SPIRIT guidance: Methods for any additional analyses (eg, subgroup and adjusted analyses).
There are exploratory analyses planned on the association of self-reported gender role self-concepts with social motives and their moderating role on psychobiological responses to social support.
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
SPIRIT guidance: Definition of analysis population relating to protocol non-adherence (eg, as randomised analysis), and any statistical methods to handle missing data (eg, multiple imputation).
Only data from individuals who have fully completed the TSST protocol will be included in the final analyses. Missing data are completed by multiple imputation.
Plans to give access to the full protocol, participant level-data and statistical code {31c}
SPIRIT guidance: Plans, if any, for granting public access to the full protocol, participant-level dataset, and statistical code.
Study protocol, data and statistical codes will be published on Open Science Framework (OSF).
We will guarantee that the data are still accessible after they will be published by choosing publishing houses that support an open data policy. Furthermore, we will inform researchers about the openness of our data (e.g., state repositories in publications, aim to publish in journals that use badges for open data), and explicitly invite members of our specific scientific disciplines to reuse the data (i.e., in collaborations, at conferences, in talks, and poster presentations).
Oversight and monitoring
Composition of the coordinating centre and trial steering committee {5d}
Trials guidance: Provide information on the composition, roles and responsibilities of the coordinating centre and trial steering committee and all groups providing day to day support for the trial. There will always be a group running the trial day-to-day and providing organisational support and knowing how often they will meet, plus information on other committees providing oversight such as a Trial Steering Committee, and how often they will meet over the course of the trial, is what we need for item 5d. We do not need names of staff.
SPIRIT guidance: Composition, roles, and responsibilities of the coordinating centre, steering committee, endpoint adjudication committee, data management team, and other individuals or groups overseeing the trial, if applicable (see Item 21a for data monitoring committee).
This study is a collaboration project between principal investigator of the University of Konstanz, Constance, and the co-PI at the Institute for Medical Psychology in Heidelberg, Germany. Day to day support for the study will be provided by two principle investigators, who hold responsibility for the study execution, a study coordinator and 4 assistants who participate in data collection (e.g., social supporter, experimenter, plenary members in TSST). The whole team will meet once a week. There is no stakeholder or public involvement group.
Composition of the data monitoring committee, its role and reporting structure {21a}
SPIRIT guidance: Composition of data monitoring committee (DMC); summary of its role and reporting structure; statement of whether it is independent from the sponsor and competing interests; and reference to where further details about its charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not needed.
There will be no data monitoring committee (DMC), as our participants will not undergo any unproven intervention. Therefore, there will be no safety concerns for our participants and thus no committee is needed for this study.
Adverse event reporting and harms {22}
SPIRIT guidance: Plans for collecting, assessing, reporting, and managing solicited and spontaneously reported adverse events and other unintended effects of trial interventions or trial conduct.
No adverse side effects have been reported with the TSST protocol.
Frequency and plans for auditing trial conduct {23}
SPIRIT guidance: Frequency and procedures for auditing trial conduct, if any, and whether the process will be independent from investigators and the sponsor.
Not applicable.
Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}
SPIRIT guidance: Plans for communicating important protocol modifications (eg, changes to eligibility criteria, outcomes, analyses) to relevant parties (eg, investigators, REC/IRBs, trial participants, trial registries, journals, regulators).
Protocol amendments will be routinely reported to the ethics committee.
Dissemination plans {31a}
SPIRIT guidance: Plans for investigators and sponsor to communicate trial results to participants, healthcare professionals, the public, and other relevant groups (eg, via publication, reporting in results databases, or other data sharing arrangements), including any publication restrictions.
The results of the study will be submitted for publication in peer-reviewed scientific journals.