跳至主要内容
临床试验/NCT03846375
NCT03846375招募中不适用

Emotional Dysregulation in Para-suicidal Behavior: Effects of Dialectical Behavioral Therapy on Emotional Processing, a Triangulation Approach

Haukeland University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Change in the intensity of impulse to non-suicidal self-injury.

研究概览

简要总结

This is a naturalistic cohort pre-post study investigating aspects of emotional processing and how possible changes in emotional processing is related to the successful treatment of non-suicidal self-injury and suicidal ideation in a program of Dialectical Behavior Therapy. In addition we wish to identify to what extent the intensity and frequency of non-suicidal self-injury and suicidal ideation is related to difficulty in emotion regulation, as indicated by self-report measures and psychophysiological measures.

详细描述

This naturalistic pre-port study tests if Dialectical Behavior Therapy (DBT) - an established therapy addressing emotion regulation and reduction of non-suicidal self-injury and suicidal ideation - result in increased emotion regulation capacity, indicated by lowered heart rate variability (HRV) and self-report measures. The study will also test the impact of DBT on lowered non-suicidal self-injury and suicidal ideation. Standard Clinical symptom scales will be included in order to control for anxiety, depression, as well as a measure of impulsivity, which is common co-morbidities.

Since DBT was developed in the 80ies, DBT has gathered increased empirical support as a treatment that reduce suicidality, para-suicidal behavior, experienced and expressed anger, and increased social skills. In DBT, emotional dysregulation is assumed to arise from a combination of biological vulnerability and living in an invalidating environment.

Self-harm and chronic suicidality is considered to be an emotion regulation strategy. In DBT, the ability to regulate emotions adaptively requires a set of skills; the ability to experience emotions, the ability to label emotions, and the ability to modulate stimuli that serve to reactivate negative or positive emotions. In the absence of these skills, or instances where the individual is hindered from applying them, more maladaptive behavior is learned and applied. Individuals that engage in non-suicidal self-injury often report greater emotion dysregulation than those without an non-suicidal self-injury history. Such behavior can e.g. be self-inflicted harm, cutting, burning, or hitting , and/or suicidal ideation. Non-suicidal self-injury is viewed as a learned emotion regulation strategy; because such behavior instantly can decrease the experience of negative affect. Therapies that focus on increasing adaptive emotion regulations skills have demonstrated reduced non-suicidal self-injury and suicidal ideation.

The physiological manifestations of emotions rely on an activation of the Autonomic Nervous System. The individual experience of emotions is reciprocally related to the continuously changing levels of physiological arousal. The functioning of this system is in turn related to adapting to environmental demands. A well established measure of Autonomic Nervous activity is variation in inter-beat-intervals due to respiratory influence on heart rate, i.e. respiratory sinus arrhythmia, which is predominately a parasympathetic related innervation of the heart. Hence, HRV is considered a psychophysiological index of emotion regulation abilities. HRV is considered an index of the nervous system's ability to flexibly adapt to changing environmental demands and is considered a biological index of emotion regulation.

We include a matched control sample of healthy controls to complete the battery of measurements at baseline assessment of emotion regulation functions (pre-intervention assessments). This will give the opportunity to characterize the group of patients with non-suicidal self-injury and suicidal ideation included in the current planned study in relation to previous research findings of the same functions in samples of patients with non-suicidal self-injury and suicidal ideation. The combination of clinical, cognitive and psychophysiological measures is a unique feature of this study, and will provide new information regarding the mechanisms underpinning clinical change following DBT, and possibly validate heart rate variability as a possible psychophysiological outcome measure for studies on treatment for non-suicidal self-injury and suicidal ideation.

研究设计

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

盲法说明

Control group only at pre-intervention.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with non-suicidal self-injury and/or suicidal ideation that undergo standard clinical outpatient DBT treatment will be recruited.

排除标准

  • Lack of informed consent
  • Exclusion Criteria Healthy Controls:
  • Lack of informed consent
  • former or current neurological conditions
  • severe psychiatric illness
  • cardiac conditions.

研究组 & 干预措施

Participants in DBT

Experimental

Psychotherapy: The participants will be given standard DBT treatment.

干预措施: Psychotherapy (Behavioral)

Participants in DBT

Experimental

Psychotherapy: The participants will be given standard DBT treatment.

干预措施: Pre-intervention testing (Other)

Control Group

Other

Control Group at preintervention.

干预措施: Pre-intervention testing (Other)

结局指标

主要结局

Change in the intensity of impulse to non-suicidal self-injury.

时间窗: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.

The intensity in the impulse to non-suicidal self-injury on a likert scale from 0 - 5, the last week.

Change in intensity of Suicidal thoughts.

时间窗: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.

Intensity of suicidal thoughts on a likert scale from 0 - 5 the last week.

Change in Heart rate variability .

时间窗: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.

Heart rate variability is considered an index of the nervous system's ability to flexibly adapt to changing environmental demands and is considered a biological index of emotion regulation.

Change in self reported emotion regulation ability through Difficulties in Emotion Regulation Scale.

时间窗: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.

It is a 36 item questionnaire designed for measuring six facets of difficulties in emotion regulation. The response is give in the from of a rating of 5 point likert scale from 1 ("almost never" to 5 ("almost always). Total score range: 36- 180. It includes the following sub-scales: 1. Nonacceptance of emotional responses, 2. Difficulties engaging in goal directed behavior, 3. Impulse control difficulties, 4. Lack of emotional awareness, 5. Limited access to emotion regulation strategies, 6. Lack of emotional clarity.

Change in frequency of suicidal thoughts.

时间窗: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.

Frequency of suicidal thoughts, that is the number of suicidal thoughts the last week.

Change in frequency of non-suicidal self-injury.

时间窗: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.

The frequency of non-suicidal self-injury the last week.

次要结局

  • Change in impulsivity through The Barratt Impulsiveness Scale.(Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.)
  • Change in self reported ability to be mindful through the Five Facet Mindfulness Questionnaire.(Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.)
  • Change in self reported self-compassion through the Self-compassion Scale.(Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.)
  • Change in anxiety symptoms through the Beck Anxiety Inventory.(Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.)
  • Change in depressive symptoms through the Beck Depression Inventory.(Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.)
  • Change in ability to experience and verbalise emotions through Toronto Alexithymia Scale 20.(Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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