NCT05896436

Brief Summary

This project will be a pilot study to test the feasibility of using Emotion Focused Therapy (EFT) among competitive athletes experiencing mild-to-moderate depression or anxiety. To test whether the intervention works, the researchers will assess athletes' emotion dysregulation, symptoms of mood disorders (anxiety and depression), sport-related distress, subjective performance satisfaction, and well-being. In addition to assessing athlete outcomes, key aspects to be examined in the pilot study include the recruitment and randomization procedures, informed consent procedures, data collection tools, implementation of the intervention, and retention of participants. Feasibility will be assessed by recruitment (willingness to be randomized, number of eligible participants in the recruitment process). Retention will be assessed by the number of athletes who continue or discontinue attendance. Participants' experiences in the intervention will be assessed via qualitative interviews to gain in-depth information about their perceptions of the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 7, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2024

Completed
Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

April 6, 2023

Last Update Submit

May 3, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change from baseline score in depressive symptoms

    Depression will be assessed using the Patient Health Questionnaire (PHQ-9), which is a 9-item, self-report questionnaire designed to assess the participant's depression levels during the past 2 weeks. The PHQ-9 utilizes a 4-point scale (0= not at all, 3= nearly every day). Scores are totaled and presented from 0 to 27. Scores of 5, 10, 15, and 20 represent cut-off points for mild, moderate, moderately severe, and severe depression, respectively.

    At 12 weeks or immediately after termination of intervention, if terminated earlier than 12 sessions.

  • Change from baseline score in anxiety symptoms

    Anxiety will be assessed with the Generalized Anxiety Disorder Scale (GAD-7), which is a 7-item, self-report anxiety questionnaire designed to assess the participant's anxiety levels during the past 2 weeks. The GAD-7 utilizes a 4-point scale (0= not at all, 3= nearly every day). Scores are totaled and presented from 0 to 21. Scores of 5, 10, and 15 represent cut-off points for mild, moderate, and severe anxiety, respectively.

    At 12 weeks or immediately after termination of intervention, if terminated earlier than 12 sessions.

Secondary Outcomes (4)

  • Change from baseline score in Emotion Dysregulation

    At 12 weeks or immediately after termination of intervention, if terminated earlier than 12 sessions.

  • Change from baseline score in alexithymia

    At 12 weeks or immediately after termination of intervention, if terminated earlier than 12 sessions.

  • Change in baseline score for Sport Related Distress - Athlete Psychological Strain

    At 12 weeks or immediately after termination of intervention, if terminated earlier than 12 sessions.

  • Changes in baseline score for Sport Related Distress - Sport Psychology Outcomes

    At 12 weeks or immediately after termination of intervention, if terminated earlier than 12 sessions.

Other Outcomes (2)

  • Client-Therapist Working Alliance

    Working alliance will be assessed at 4 weeks, 8 weeks, and 12 weeks during the intervention.

  • Athletes' experiences of participating in psychotherapy

    After conclusion of intervention (one-month follow up).

Study Arms (2)

Emotion Focused Therapy

EXPERIMENTAL

Participants will receive 12 weekly 1-hour sessions of Emotion Focused Therapy with a trained student therapist.

Behavioral: Emotion Focused Therapy

Wait list control

NO INTERVENTION

No intervention; waitlist control group will receive intervention once the data collection during the intervention period has concluded.

Interventions

12 sessions of Emotion Focused Therapy (EFT). The focus in EFT is to promote the individual's experiencing and facilitate participants' self-disclosure and openness to their own experience, rather than the therapist's agenda or techniques. Key processes within EFT include helping people overcome their avoidance of emotion, maintaining a collaborative focus on emotions, and exploring emotions in therapy.

Emotion Focused Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over the age of 18 and capable of consenting to participate in the study
  • Participating in competitive sport (highly trained/national level or above); athletes may be participating in any able-bodied or para-sport.
  • Speak and comprehend English
  • Meet criteria for mild-to-moderate depression or anxiety
  • Reside in Ontario
  • Not currently receiving psychotherapy

You may not qualify if:

  • Athletes under the age of 18 who are not able to provide informed consent to participate in the study
  • Athletes participating in recreational sport
  • Athletes who meet criteria for high risk of eating disorder
  • Athletes who meet criteria for severe depression or anxiety
  • Athletes who do not live in Ontario
  • Athletes indicating low levels of depression or anxiety
  • Athletes who are currently receiving psychotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Kinesiology and Physical Education

Toronto, Ontario, M5S2W6, Canada

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Emotion-Focused Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Katherine Tamminen, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 6, 2023

First Posted

June 9, 2023

Study Start

October 7, 2023

Primary Completion

June 25, 2024

Study Completion

June 25, 2024

Last Updated

May 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

The datasets generated during and/or analyzed during the current study will be stored in a non-publicly available repository (Dataverse: https://borealisdata.ca/dataverse/toronto). De-identified survey data and interview transcripts will be stored indefinitely in an online repository (Dataverse). Researchers wishing to access the data for research purposes/secondary analyses will require ethical approval from a recognized research ethics board and submit a request for access to the data from the lead investigator. No personally-identifying data will be stored, only variable data and results. Participants will be asked to provide consent to store their data for future research purposes.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Intention to publish date: 30/06/2025
Access Criteria
Researchers wishing to access the data for research purposes/secondary analyses will require ethical approval from a recognized research ethics board and submit a request for access to the data from the lead investigator.

Locations