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临床试验/NCT05896436
NCT05896436已完成不适用

Emotion Focused Therapy for Depression and Anxiety Among Competitive Athletes - A Feasibility Study

University of Toronto2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年10月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Change from baseline score in anxiety symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change from baseline score in anxiety symptoms

时间窗: 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.

Change from baseline score in depressive symptoms

时间窗: 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.

次要结局

  • 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.)
  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katherine Tamminen

Associate Professor

University of Toronto

研究点 (2)

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