CFT@TeenSAD - Understanding the Impact of Online Delivered Compassion Focused Therapy on Social Anxiety Symptoms, Emotion Regulation and Heart Rate Variability.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Psychophyiological markers (MeanHR)
研究概览
简要总结
Emotion regulation (ER) is a key competence developed mainly throughout adolescence. According to an evolutionary perspective, threat, drive, and soothing systems interact to achieve ER. Difficulties in ER are transdiagnostic features in different psychopathologies and have been hypothesized as resulting from an unbalance of these ER systems. Research findings support Heart Rate Variability (HRV) as a biomarker of ER in adolescents. Higher HRV associates with adaptive ER; lower HRV associates with difficulties in ER and with both Social Anxiety Disorder (SAD) and Conduct Disorder (CD). This project aims to test for differences in HRV patterns linked to the triggering of different ER systems, contrasting healthy controls with clinical adolescent samples (SAD vs. CD). Compassion-focused interventions have been effective in reducing SAD symptom severity in adults; however, this approach was not tested in pediatric samples.
Here we test the efficacy of an online-delivered compassion focused intervention for teens with Social Anxiety Disorder and assess its effect on (self)compassion, fears of compassion, social safeness, emotion regulation and social anxiety symptoms, as well as Heart Rate Variability.
详细描述
Emotion Regulation (ER) is defined as the process through which the experience and expression of emotions are shaped to serve adaptive behavior. It is a key socio-emotional skill, substantially developed during adolescence, as reliance on parental support decreases in favor of internal ER. Emotion dysregulation has been linked to the development of psychopathology in adolescents, including Social Anxiety Disorder (SAD), and Conduct Disorder (CD). Both disorders are highly prevalent, presenting high rates of comorbidity and putting adolescents at risk for psychopathology in adulthood.
According to Gilbert's evolutionary theory, there are three ER systems. The threat system works towards protection/safety when facing danger; the drive system motivates individuals to seek resources/achieve goals; the soothing system allows for social affiliation/safeness and is stimulated through compassion. ER reflects the balance between these systems; their unbalanced/disproportional use is stimulated throughout childhood care experiences, creating a diathesis to emotion dysregulation.
Socially anxious and disruptive adolescents often come from critical/abusive environments, lacking social acceptance/safeness experiences and presenting overactivated threat and drive systems and an underdeveloped soothing system. In these cases, soothing situations may trigger the perception of interpersonal unsafeness and be considered threatening. Adolescents with CD are traditionally less responsive to reward and adolescents with SAD have fear of negative evaluation; both present withdrawal from reward-seeking, as motivational drive is processed as threat.
Emotional experiences associate with variations in physiological correlates. Stress responses and motivations to approach reward, related to threat/drive activity, are associated with decreased Heart Rate Variability (HRV), while soothing activity/social safeness are associated with increased HRV.
HRV is a suitable biomarker to be used within the framework of compassion and Gilbert's evolutionary theory on ER. Lower HRV relates to difficulties in ER; higher HRV relates to ER and compassion. Subjects with SAD and CD present lower HRV than healthy controls. Healthy adolescent females have lower HRV than healthy adolescent males; literature on sex-differences in adolescents with CD and SAD is sparse and reports inconsistent findings.
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
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Diagnosis of Social Anxiety Disorder
排除标准
- •Presence of an externalizing disorder according to the MINI-KID
- •Cognitive impairment
- •Presence of psychotic symptoms according to the MINI-KID
- •Presence of diseases and/or use of substances/medications that alter cardiac functioning
- •Body mass index over 30 kg/m2, due to its impact on cardiac functioning
- •Illiteracy
研究组 & 干预措施
Compassion Focused Therapy Treatment Group
These participants get a 10-session online delivered compassion focused therapy intervention.
干预措施: Compassion Focused Therapy (Behavioral)
Control Group
Waitlist Control Group
结局指标
主要结局
Psychophyiological markers (MeanHR)
时间窗: From pre-treatment to 3-month follow-up.
MeanHR (average of heartbeats per minute).
Psychophyiological markers (RMSSD)
时间窗: From pre-treatment to 3-month follow-up.
Root Mean Square of Successive Differences between normal heartbeats.
Psychophysiological markers (HFn.u.)
时间窗: From pre-treatment to 3-month follow-up
Heart Rate Variability - High Frequency band, in normalized units (n.u.).
Psychophysiological markers (LFHF)
时间窗: From pre-treatment to 3-month follow-up.
Heart Rate Variability, Low Frequency/High Frequency ratio.
Psychophysiological markers (HFms2)
时间窗: From pre-treatment to 3-month follow-up.
Heart Rate Variability - High Frequency band in absolute units (ms2).
Emotion Regulation
时间窗: From pre-treatment to 3-month follow-up.
Difficulties in Emotion Regulation Scale The DERS-AV is 36-item self-report measure that assesses multiple aspects of difficulties in emotion regulation and is composed of six dimensions: Nonacceptance of Emotional Responses (nonacceptance); Difficulties Engaging in Goal-Directed Behavior (goals); Impulse Control Difficulties (impulse); Lack of Emotional Awareness (awareness); Limited Access to Emotion Regulation Strategies (strategies); and Lack of Emotional Clarity (clarity). Participants are asked to rate in a five-point scale how often the items apply to them from 1 (almost never) to 5 (almost always). Scores range from 36 to 180. Higher scores indicate greater difficulties in emotion regulation.
Social Anxiety (Social Anxiety Scale - Adolescents)
时间窗: From pre-treatment to 3-month follow-up.
SAS-A is a self-report instrument, which assesses adolescents' social anxiety experiences in the context of peer relations. It consists of 22 items, 4 of which are neutral/filler items, to be rated on a 5-point Likert scale according to how often the items apply to the participants, from 1 (not at all) to 5 (all the time). It's composed by three factors: fear of negative evaluation (FNE), social avoidance and distress in new situations (SAD-New), and social avoidance and distress in general (SAD-General). Scores range from 18 to 90. Higher scores indicate a more severe subjective experience of social anxiety.
Social Anxiety and Avoidance (Social Anxiety and Avoidance Scale for Adolescents)
时间窗: From pre-treatment to 3-month follow-up.
Social Anxiety and Avoidance Scale for Adolescents (Cunha, Pinto-Gouveia \& Salvador, 2002) SAASA is a 34-item self-report 5-point Likert-type instrument assessing the degree of anxiety (1=none to 5=very much) and frequency of avoidance (1=never to 5=almost always) in a wide range of social situations, representing the most frequent social fears in adolescence. Both subscales load in 6 factors: interactions in new situations, interaction with the opposite sex, performance in social situations, assertive interaction, observation by others, eating and drinking in public. Scores range from 34 to 170 for anxiety and avoidance, with higher scores meaning more severe anxiety and avoidance experienced by the participant.
次要结局
未报告次要终点
研究者
Mariana Linharelhos Fernandes
PhD researcher
University of Coimbra