Submission date
08/07/2016
Registration date
11/07/2016
Last edited
10/08/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Not Applicable
Prospectively registered
Protocol added
? SAP not yet added
Results added
? Raw data not yet added
Study completed

Plain English Summary

Background and study aims
Struggling to deliver performance in competitions is one of the main reasons why athletes seek the advice of sport psychologists. Psychologists apply a variety of techniques, many of which are not evidence-based. Evidence-based techniques could help athletes to increase and maintain functional athletic behaviour in competitions/games (i.e., being focused on task-relevant cues and executing movements and actions in high quality). However, well-designed studies investigating the effectiveness of sport psychological interventions for performance enhancement are scarce. The aim of this study is to examine the effectiveness of two interventions with elite and sub-elite athletes: psychological skills training (PST) and a mindfulness-based intervention (MI).

Who can participate?
Elite and sub-elite athletes aged 18 or over

What does the study involve?
Participants are randomly allocated to receive either the PST or MI intervention or to be put on a waiting list. Both interventions last 5 weeks, consist of four 2-hour sessions and are administered by a trained sport psychologist. All sessions take place in the same athletic performance centre. The participants’ functional athletic behavior is assessed during a competition/game. Competition anxiety, cognitive interference and negative outcome expectations are also assessed. Assessments are carried out before and after the intervention as well as at 2 months follow up.

What are the possible benefits and risks of participating?
Both PST and MI are expected to help improve functional behavior in athletes, and we will not only be able to answer the question of whether the interventions work, but also how, under what conditions, and for whom. There are no possible risks in participating in this study.

Where is the study run from?
Swiss Federal Institute of Sport Magglingen SFISM (Switzerland)

When is the study starting and how long is it expected to run for?
October 2016 to March 2018

Who is funding the study?
The Swiss National Science Foundation (Switzerland)

Who is the main contact?
Philipp Röthlin

Study website

Contact information

Type

Scientific

Contact name

Mr Philipp Röthlin

ORCID ID

http://orcid.org/0000-0003-2268-571X

Contact details

Alpenstrasse 18
Magglingen
2532
Switzerland

Additional identifiers

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

100019_156627

Study information

Scientific title

Psychological skills training and a mindfulness-based intervention to enhance functional athletic performance: design of a randomized controlled trial using ambulatory assessment

Acronym

Study hypothesis

The primary objective of this study is to assess the effects of a psychological skills training (PST) and mindfulness-based intervention (MI) in promoting functional athletic behavior (FAB) in elite athletes. We hypothesize that both active interventions are more effective than a waiting-list control condition in promoting FAB. We do not expect PST to be superior over MI or vice versa; rather, they are expected to increase FAB through different routes.

Ethics approval(s)

The ethics committee of the Swiss Federal Institute of Sport Magglingen SFISM, 15/03/2014

Study design

Interventional parallel-group randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Study setting(s)

Other

Study type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Functional behavior in athletes

Intervention

After a first contact and checking for inclusion and exclusion criteria (time 0), athletes will be stratified for gender, sport, and performance level, then randomly assigned to one of following three groups, and will be informed about their experimental condition:
1. Psychological skills training (PST): imagery, self-talk, goal-setting, arousal regulation
2. Mindfulness-based intervention (MI): mindful meditation, body scan, yoga
3. Waiting-list control group (WC)

The study is single-centre (all sessions will conducted at the center for elite sports of the Swiss Federal Institute of Sport). The interventions will be realized in groups of six athletes each, leading to six sub-groups in each condition (6 x 6 = 36 athletes, see power analysis). A manual will accompany the instructions for the interventions. All components of both interventions must be administered according to the manual’s specifications by a trained sport psychologist. Two independent raters will evaluate the adherence to each intervention on the basis of video recordings. In addition to psycho-education and practice at home guided by audio files that can be played on computers or portable devices such as smart phones. All participants will also be provided with a calendar of their exercises to tick off as they are completed, and daily text messages will remind them to practice their PST or mindfulness exercises. Each intervention consists of four 2-hour sessions over the course of 5 weeks. Participants will be advised to practice daily and record their amount of practice.

Intervention type

Behavioural

Primary outcome measure

Functional athletic behavior (FAB) assessed using ambulatory assessment (during games and competitions) before and after the intervention (pre-post) as well as at two months follow up (three timepoints in total).

Secondary outcome measures

1. Cognitive interference, competition anxiety, and negative outcome expectations measured by the according subscales of the Thought Occurrence Questionnaire (TOQS) and the Competition Anxiety Inventory State (CAI-S)
2. Objective measures of performance will be win/lose, points scored, unforced errors etc, subjective measures will be assessed using a single item (how well did you perform?)

Secondary outcome will be measured directly before and after the intervention (pre-post), as well as at two months follow up (three timepoints in total)

Overall study start date

01/07/2015

Overall study end date

30/03/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Elite, sub-elite, and recreational athletes from four sports (curling, volleyball, i.e., indoor and beach, tennis, and hockey, i.e., floorball and ice hockey), who are members of the respective Swiss national sport associations

Participant type(s)

Healthy volunteer

Age group

Adult

Sex

Both

Target number of participants

108

Total final enrolment

95

Participant exclusion criteria

1. Likely mental disorder
2. Significant previous experience with PST or MI
3. Less than 4 hours of athletic training per week
4. Being younger than 18

Recruitment start date

01/10/2016

Recruitment end date

30/09/2017

Locations

Countries of recruitment

Switzerland

Study participating centre

Swiss Federal Institute of Sport Magglingen SFISM
Alpenstrasse 18
Magglingen
2532
Switzerland

Sponsor information

Organisation

Swiss Federal Institute of Sport Magglingen SFISM (Switzerland)

Sponsor details

Hauptstrasse 247
Magglingen
2532
Switzerland
+41 (0)58 467 61 11
ehsm@baspo.admin.ch

Sponsor type

University/education

Website

http://www.ehsm.admin.ch

ROR

https://ror.org/00c9w1q32

Funders

Funder type

Research organisation

Funder name

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung

Alternative name(s)

Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

Switzerland

Results and Publications

Publication and dissemination plan

We intend to publish a study protocol first, the manuscript is finished and has already been submitted. Next, we intend to publish the results of our intervention study in approximately one years' time.

Intention to publish date

30/09/2018

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Data sharing statement to be made available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 26/07/2016 Yes No
Results article results 06/08/2020 07/08/2020 Yes No

Additional files

Editorial Notes

10/08/2020: Added PubMed address. 07/08/2020: The following changes have been made: 1. Publication reference added. 2. The total final enrolment number has been added from the reference. 05/02/2018: Recruitment end date was changed from 31/01/2017 to 30/09/2017 and intention to publish date was changed from 11/07/2017 to 30/09/2018. 31/01/2018: The overall trial end date was changed from 31/12/2017 to 30/03/2018. 28/07/2016: Publication reference added.