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临床试验/NCT05448014
NCT05448014已完成不适用

The Effects of a Self-compassion Therapist-led Online Group Treatment for Adolescents With Distress, Anxiety and Depression

Umeå University2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年6月1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
42
试验地点
2
主要终点
Perceived Stress Scale

研究概览

简要总结

Background: Distress, anxiety and depression are highly prevalent in school health care or primary care. Many of these conditions remain undiscovered and/or untreated. Compassion-focused therapy (CFT) is effective in the treatment of adults' distress and depression, and we will now evaluate the preliminary effect of a brief therapist-led online group CFT, feasibility, and acceptability in low-threshold distressed, anxious, and depressed adolescents. We use online group CFT to increase availability.

Purpose: The purpose of this study is to determine whether therapist-led online group CFT is feasible and acceptable for the treatment of depression in adolescents between 15 and 20 years of age, in Sweden. The preliminary effect will be calculated to examine if a larger experimental randomized controlled trial is justified.

Study design: A two-arm (treatment group vs. control group) pilot randomized controlled trial will be carried out with 40 adolescents. The effect, feasibility, and acceptability of the therapist-led online CFT in groups will be evaluated.

详细描述

Adolescence is a vulnerable period of growth and challenges, characterized by rapid physiological and emotional changes. All these changes happen at the same time as relationships expand. A developing self together with a pressure to "fit in" can lead to self-critic and distress. Without appropriate coping skills to manage these challenges, adolescents are more vulnerable to psychological problems. Distress, anxiety, and depression have also increased in the western world during the last years, and especially girls or young women are affected [1]. In addition, depressive disorders are the single largest contributor to global disability [2]. Adolescents-appropriate training in compassion may help adolescents successfully overcome the challenges in the future and help adolescents to take care of themselves.

Schools are not just about acquiring knowledge, they are playing a central role in cultivating necessary social, emotional, and ethical skills required to lead successful lives [3]. Recently, there has been a great interest in bringing mindfulness and compassion to educators and students.

The construct of compassion is defined by Paul Gilbert as a "sensitivity to suffering in self and others with a commitment to try to alleviate and prevent it" [4] and include compassion for oneself, compassion for others, and receiving compassion from others. Compassion strategies are core competencies in life, already taught by large religions as Christianity and Buddhism, but now in a modern version along with new neurobiological research and cognitive behavior therapy interventions. These skills or strategies can be taught, but have not yet been widely used in the contexts of adolescents [3].

Research supporting compassion focused therapy for depression Compassion focused therapy (CFT) was developed two decades ago and is a well-established talking therapy for depression and stress [5]. Compassion has a protective effect against depression and suicidality [6], in youth. Training in compassion is linked to well-being and perceived life satisfaction [7]. Meta-analytic findings of CFT on adults has recently showed moderate effects on stress, depression and anxiety [7]. Studies with adolescents are few. For example one small study [8] with 34 14-17 year old students found that a mindful self-compassion school program in six weeks was feasible and acceptable. The intervention group had significantly greater self-compassion and less depression than the waitlist control.

The CFT intervention Compassion Focused Training (CFT). The investigators have developed a new manual for CFT training with seven modules [9] including 1) what is compassion, 2) understanding myself, 3) life-compass, 4) self-compassion and my body, 5) feelings and compassion, 6) create balanced thoughts, and 7) imagination. CFT is an internet-delivered (zoom or teams) real time group training (for 15-20 years old adolescents), 1,5h, in seven weeks. The youth will receive a manual for practice. The investigators were inspired by Professor Paul Gilbert, Mary Welford, and Elaine Beaumont's approach [10], but the investigators have shortened and adapted Welford and Beaumont manual to Swedish context. In addition, the investigators are influenced by cognitive behavior principles. Functional analyses and thoughts records are for example, used. The intervention focuses on the present and not on processing memories. The intervention is made for primary care and school health. A psychotherapist/psychologist or social worker will lead the training.

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
15 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Symptoms of distress (≥ 22 in PSS) and/or
  • Symptoms of anxiety (≥ 9 in subscale Anxiety in TSCC) and/or
  • Symptoms of depression (≥ 10 in subscale Depression in TSCC)
  • Adolescent giving informed consent
  • Caregiver giving informed consent if needed
  • Speaking Swedish
  • Able to read and fill forms in Swedish without troubles
  • At least one close and stable relationship with an adult
  • Able to be in a group on the internet

排除标准

  • Severe psychological problems that can be hindering for participation in a group treatment
  • No close stable relationship with an adult
  • Suicidal risk (4 or higher in item 12 in MADRS-Y, together with a clinical decision of active suicidal plans during the diagnostic screening interview)
  • Bipolar Disorder
  • Anorexia Nervosa
  • Current substance and alcohol dependence
  • Current psychosis
  • Current active psychotherapy
  • Current deposit or withdrawal of antidepressant
  • Prescribed medications for anxiety or depressive disorders do not exclude participants from the study, if the dosage had remained constant for at least one month.

结局指标

主要结局

Perceived Stress Scale

时间窗: 8 weeks

The 10-item Perceived Stress Scale (PSS-10) measures perceived stress related to unpredictability, uncontrollability, and overload in daily life. Each item is rated on a 5-point scale from 0 (never) to 4 (very often), yielding a total score ranging from 0 to 40. Higher scores indicate higher levels of perceived stress. In this study, the total score was used for analysis.

The Subscale Anxiety in Trauma Symptom Checklist for Children

时间窗: 8- weeks

The Trauma Symptom Checklist for Children (TSCC), Anxiety Subscale, measures trauma-related anxiety symptoms in children and adolescents. The subscale includes 9 items rated on a 4-point scale from 0 (never) to 3 (almost all the time). Total scores range from 0 to 27, with higher scores indicating more severe anxiety symptoms.

The Subscale Depression in Trauma Symptom Checklist for Children

时间窗: 8 weeks

The Trauma Symptom Checklist for Children (TSCC), Depression Subscale, measures trauma-related depressive symptoms in children and adolescents. The subscale includes 9 items rated on a 4-point scale from 0 (never) to 3 (almost all the time). Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.

次要结局

未报告次要终点

研究者

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

Inga Dennhag

PhD, lecturer

Umeå University

研究点 (2)

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