DepressionNCT05896436
Emotion Focused Therapy for Competitive Athletes
A study testing Emotion Focused Therapy in people with Depression and Anxiety, run by University of Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Emotion Focused Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 7 Oct 2023to 25 Jun 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Faculty of Kinesiology and Physical Education
Toronto, Ontario, M5S2W6
About this study
Official title: Emotion Focused Therapy for Depression and Anxiety Among Competitive Athletes - A Feasibility Study
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.
Read the detailed description
This project will be a pilot study to test the feasibility of using Emotion Focused Therapy (EFT) among 24 competitive athletes over the age of 18 in Ontario. Athletes will be screened and allocated to receive 12 weekly one-hour sessions of Emotion Focused Therapy, or they will be allocated to a wait-list control group.
Screening: Participants interested in the study can contact the study coordinator, who will provide them with information about the study and conduct an initial screening process to ask them their age, competitive level, and province of residence. Athletes who are under the age of 18, not participating in competitive sport, or not living in Ontario will not be eligible to participate in the study; these athletes will be provided with community mental health support information if they would like to seek other options for mental health support. Athletes who are over the age of 18, participating in competitive sport, and living in Ontario will be provided with information about the study and the study coordinator will review the information letter verbally with them and answer any questions they have about the study. If they are interested in participating, they will be sent the baseline survey measures (to be completed online) and responses will be screened to determine whether the intervention will be appropriate for them.
Measures: The measures include a demographics form and the primary and secondary outcome measures. After completing these measures online, the study coordinator will score and screen the measures to determine the participant's eligibility to be allocated to the study. Athletes whose scores indicate severe levels of anxiety or depression, or who indicate a high likelihood of an eating disorder, will be referred for immediate treatment and will be not be eligible for the study from the study. Athletes who indicate low levels of depression or anxiety will not be eligible for the study and provided with information about mental health support services. Participants will be randomly allocated to the intervention condition or a wait-list control group; once assigned to the intervention group, participants will also be assigned on a rotating basis to the three student therapists delivering the intervention. The study coordinator will electronically randomize participants to the intervention or wait-list control group. Participants will not be blinded to their group allocation.
Intervention: The Emotion Focused Therapy (EFT) intervention is a process-experiential approach to psychotherapy that is grounded in humanistic approaches to therapy. EFT focuses on promoting client experiencing and being nondirective; that is, the therapist emphasizes facilitating clients' 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. The role of the therapist in EFT is considered as an 'emotion coach' and guides the processing of emotions. While there is no set schedule for the sessions, common tasks that may arise in the course of therapy include developing a therapeutic alliance with the athlete; increasing awareness and attention to emotions; increasing capacity tolerance of emotional arousal; validation of emotional experience; evocation and exploration of emotions; and transformation of emotions (helping athlete develop new emotional responses and making sense of experiences, validating new feelings and an emerging sense of self).
Survey Timing: Athletes will complete baseline questionnaires before randomization, at postintervention, and at follow-up one month later.
Post-Intervention Interview: Participants will be invited to take part in an online interview following the completion of the intervention and after completing the final survey in the study. Participants will be asked about their experiences during the intervention and their experiences of receiving Emotion Focused Therapy.
- Conditions
- Depression, Anxiety
- Being tested
- Emotion Focused Therapy
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion Focused TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Emotion Focused Therapy | Experimental | Participants will receive 12 weekly 1-hour sessions of Emotion Focused Therapy with a trained student therapist. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Emotion Dysregulation measured using the Difficulties in Emotion Regulation Scale. Items are rated on a scale of 1 (almost never [0-10%]) to 5 (almost always [91-100%]). Scores are summed (scores ranging from 36-180) with higher scores indicate more difficulty in emotion regulation.
Measured: At 12 weeks or immediately after termination of intervention, if terminated earlier than 12 sessions.
Change from baseline score in alexithymia
Alexithymia measured using the Toronto Alexithymia Scale-20. Items are rated on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The total score can be used from the three subscales, or the sum of each subscale score can be used; for the present study only the subscales related to difficulty in identifying feelings and difficulty in describing feelings will be used; higher scores indicate greater degree of difficulty in identifying feelings and describing feelings.
Measured: 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
Sport-Related Distress will be measured using the Athlete Psychological Strain Questionnaire (APSQ). The APSQ utilizes a 5-point scale (1 = "None of the time"; 5 = "All of the time"). Scores are totaled and presented from 10 to 50 with a higher score indicating more psychological strain.
Measured: 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
Sport-Related Distress will be measured using the Sport Psychology Outcomes and Research Tool (SPORT). The SPORT utilizes a 5-point scale (1= Strongly Agree, 5= Strongly Disagree) where statements 16 and 17 are reverse coded, and lower scores reflect better functioning.
Measured: At 12 weeks or immediately after termination of intervention, if terminated earlier than 12 sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start7 Oct 2023
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Tamminen, University of Toronto
- Investigators
- Katherine Tamminen, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896436
- Sponsor's protocol ID
- 00044207
- Other IDs
- 430-2022-00033
- Status last verified
- May 2025
- First submitted
- 6 Apr 2023
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Focused Therapy for Depression and Anxiety Among Competitive Athletes - A Feasibility Study
- ClinicalTrials.gov ID
- NCT05896436
- Acronym / sponsor ID
- 00044207
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 7 Oct 2023 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 9 Jun 2023 (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 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.
Detailed description
This project will be a pilot study to test the feasibility of using Emotion Focused Therapy (EFT) among 24 competitive athletes over the age of 18 in Ontario. Athletes will be screened and allocated to receive 12 weekly one-hour sessions of Emotion Focused Therapy, or they will be allocated to a wait-list control group.
Screening: Participants interested in the study can contact the study coordinator, who will provide them with information about the study and conduct an initial screening process to ask them their age, competitive level, and province of residence. Athletes who are under the age of 18, not participating in competitive sport, or not living in Ontario will not be eligible to participate in the study; these athletes will be provided with community mental health support information if they would like to seek other options for mental health support. Athletes who are over the age of 18, participating in competitive sport, and living in Ontario will be provided with information about the study and the study coordinator will review the information letter verbally with them and answer any questions they have about the study. If they are interested in participating, they will be sent the baseline survey measures (to be completed online) and responses will be screened to determine whether the intervention will be appropriate for them.
Measures: The measures include a demographics form and the primary and secondary outcome measures. After completing these measures online, the study coordinator will score and screen the measures to determine the participant's eligibility to be allocated to the study. Athletes whose scores indicate severe levels of anxiety or depression, or who indicate a high likelihood of an eating disorder, will be referred for immediate treatment and will be not be eligible for the study from the study. Athletes who indicate low levels of depression or anxiety will not be eligible for the study and provided with information about mental health support services. Participants will be randomly allocated to the intervention condition or a wait-list control group; once assigned to the intervention group, participants will also be assigned on a rotating basis to the three student therapists delivering the intervention. The study coordinator will electronically randomize participants to the intervention or wait-list control group. Participants will not be blinded to their group allocation.
Intervention: The Emotion Focused Therapy (EFT) intervention is a process-experiential approach to psychotherapy that is grounded in humanistic approaches to therapy. EFT focuses on promoting client experiencing and being nondirective; that is, the therapist emphasizes facilitating clients' 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. The role of the therapist in EFT is considered as an 'emotion coach' and guides the processing of emotions. While there is no set schedule for the sessions, common tasks that may arise in the course of therapy include developing a therapeutic alliance with the athlete; increasing awareness and attention to emotions; increasing capacity tolerance of emotional arousal; validation of emotional experience; evocation and exploration of emotions; and transformation of emotions (helping athlete develop new emotional responses and making sense of experiences, validating new feelings and an emerging sense of self).
Survey Timing: Athletes will complete baseline questionnaires before randomization, at postintervention, and at follow-up one month later.
Post-Intervention Interview: Participants will be invited to take part in an online interview following the completion of the intervention and after completing the final survey in the study. Participants will be asked about their experiences during the intervention and their experiences of receiving Emotion Focused Therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotion Focused Therapy | Experimental | Behavioral: Emotion Focused TherapyParticipants will receive 12 weekly 1-hour sessions of Emotion Focused Therapy with a trained student therapist. |
| Wait list control | No intervention | –No intervention; waitlist control group will receive intervention once the data collection during the intervention period has concluded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Emotion Focused Therapy12 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. | Behavioural | Emotion Focused Therapy |
Primary outcome
Change from baseline score in depressive symptoms
Time frame: At 12 weeks or immediately after termination of intervention, if terminated earlier than 12 sessions.
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.
Change from baseline score in anxiety symptoms
Time frame: At 12 weeks or immediately after termination of intervention, if terminated earlier than 12 sessions.
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.
4 secondary outcomes
Change from baseline score in Emotion Dysregulation
Time frame: At 12 weeks or immediately after termination of intervention, if terminated earlier than 12 sessions.
Change from baseline score in alexithymia
Time frame: 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
Time frame: 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
Time frame: At 12 weeks or immediately after termination of intervention, if terminated earlier than 12 sessions.
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 6 May 2025.
- Individual participant dataSharing planned: Yes. 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.
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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.
Katherine Tamminen, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion Focused Therapy in people with Depression and Anxiety, run by University of Toronto at 1 site in Canada.
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 6 inclusion and 7 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 6 May 2025. 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 Canada. 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 from baseline score in depressive symptoms (time frame: At 12 weeks or immediately after termination of intervention, if terminated earlier than 12 sessions.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2025; AzTrials last refreshed its copy on 29 Oct 2026.